HIV
Conditions
Keywords
Pre-exposure prophylaxis, HIV Prevention, Truvada, Many Men, Many Voices, Emtricitabine, Tenofovir disoproxil fumarate, Young men who have sex with men, HIV Seronegativity
Brief summary
This is an exploratory mixed-methods research study that compares an efficacious behavioral HIV-prevention intervention (3MV) alone to the behavioral HIV-prevention intervention combined with a biomedical intervention (PrEP). After completing the 3MV behavioral intervention, participants will be randomly assigned to one of three study arms: 1) daily FTC/TDF as PrEP, 2) placebo pill control, or 3) no pill control. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks. Youth who decline to participate will be asked to complete a brief survey about their opinions on PrEP. Qualitative interviews will be completed with six study participants and the study coordinators at the end of the trial to explore further the issues of trial acceptability and feasibility. Finally, focus groups will be conducted to explore feasibility and acceptability issues with YMSM who meet all eligibility requirements of the study except for not being age 18 or older, but are at least 16 years of age.
Interventions
DRUGcoformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP
Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
DRUGPlacebo
Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
BEHAVIORALMany Men, Many Voices (3MV)
Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
Sponsors
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 22 Years
Healthy volunteers
Yes
Inclusion criteria
* Willing and able to independently provide written informed consent; * Of male gender at birth; * Between the ages of 18 years and 0 days through 22 years and 364 days at the time of signed informed consent; * Self-reporting at least one episode of unprotected anal intercourse with a male within the last 12 months at the time of Personal Digital Assistant (PDA) Screening Interview; * Tests HIV negative at time of screening (using any FDA-approved HIV diagnostic test); * Willing to provide locator information to study staff; * Willing to be assigned to any of the three biomedical intervention conditions; * Does not report intention to relocate out of the study area during the course of the study; and * Does not have job/other obligations that would require long absences from the area (\> 4 weeks at a time).
Exclusion criteria
* Transgender (behavioral intervention not targeted toward this population); * Presence of serious psychiatric symptoms (e.g., active hallucinations); * Visibly distraught at the time of consent (e.g., suicidal, homicidal, exhibiting violent behavior); * Intoxicated or under the influence of alcohol or other drugs at the time of consent; * Acute or chronic hepatitis B infection (exclude if hepatitis B surface antigen positive); * Renal dysfunction (Creatinine Clearance \< 75 ml/min); Use Cockcroft-Gault equation: Glomerular Filtration Rate (GFR) = (140-Age in years) x (Weight in kg) / (72 x serum creatinine) for males * Any history of bone fractures not explained by trauma; * Confirmed proteinuria (repeated positive \[\> 2+\] urine dipstick), unless explained by orthostatic proteinuria; * Confirmed glucosuria (repeated positive \[\> 1+\] urine dipstick) in the presence of normal blood glucose (\<120 mg/dL); * Any Grade 3 toxicity on screening tests/assessments; * Concurrent participation in an HIV vaccine study or other investigational drug study; or * Known allergy/sensitivity to the study drug or its components. * Use of disallowed medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perceived HIV Risk Reduction at Week 24: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Week 24 | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I have already risked getting infected with HIV through unsafe sex while I've been in this study. |
| Perceived HIV Risk Reduction at Week 20: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Week 20 | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am less concerned about having unprotected anal sex now that I am in this PrEP study. |
| Perceived HIV Risk Reduction at Week 24: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Week 24 | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am less concerned about having unprotected anal sex now that I am in this PrEP study. |
| Perceived HIV Risk Reduction at Week 4: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Week 4 | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I have already risked getting infected with HIV through unsafe sex while I've been in this study. |
| Perceived HIV Risk Reduction at Week 8: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Week 8 | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I have already risked getting infected with HIV through unsafe sex while I've been in this study. |
| Perceived HIV Risk Reduction at Week 12: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Week 12 | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I have already risked getting infected with HIV through unsafe sex while I've been on this study. |
| Perceived HIV Risk Reduction at Week 16: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Week 16 | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I have already risked getting infected with HIV through unsafe sex while I've been in this study. |
| Perceived HIV Risk Reduction at Week 20: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Week 20 | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I have already risked getting infected with HIV through unsafe sex while I've been in this study. |
| Actual Number of Study Visits Completed by 24 Weeks | 24 weeks | This outcome measure looked at whether the actual number of study visits conducted by 24 weeks differed by treatment group over time. |
| Acceptability of Size of Pill | Week 24 | — |
| Acceptability of the Taste of the Pill | Week 24 | — |
| Acceptability of the Color of the Pill | Week 24 | — |
| Acceptability of Taking the Pill Everyday | Week 24 | — |
| Acceptability of Taking Part in the Study | Week 24 | — |
| Acceptability of Participating in Group Sessions | Week 24 | — |
| Acceptability of Being Randomly Assigned to a Group | Week 24 | — |
| Acceptability of Having an HIV Test at Every Visit | Week 24 | — |
| Acceptability of Risk Reduction Counseling at Every Visit | Week 24 | — |
| Acceptability of Questions About Sexual Behavior at Every Visit | Week 24 | — |
| Acceptability of Being Contacted by the Research Team in Between Visits | Week 24 | — |
| Acceptability of Physical Examination by a Doctor | Week 24 | — |
| Acceptability of Health Clinic for Study Visits | Week 24 | — |
| Number of Missed Doses Based on Self-Report Calendar Data-Week 4 | 4 weeks | Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. |
| Number of Missed Doses Based on Self-Report Calendar Data-Week 8 | Week 8 | Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. |
| Number of Missed Doses Based on Self-Report Calendar Data-Week 12 | Week 12 | Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. |
| Number of Missed Doses Based on Self-Report Calendar Data-Week 16 | Week 16 | Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. |
| Number of Missed Doses Based on Self-Report Calendar Data-Week 20 | Week 20 | Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. |
| Number of Missed Doses Based on Self-Report Calendar Data-Week 24 | Week 24 | Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. |
| Number of Missed Doses Over Time Based on Self-Report Calendar Data | 24 weeks | The outcome measure presents the least square means from the generalized linear model. The outcome here is a binary variable that determines whether the subject missed a dose or not. In a binomial model with logit link, the least squares means are predicted population margins of the logits. |
| Number of Missed Doses Based on Medication Refill Dates-Week 4 | Week 4 | Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. |
| Number of Missed Doses Based on Medication Refill Dates-Week 8 | Week 8 | Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. |
| Number of Missed Doses Based on Medication Refill Dates-Week 12 | Week 12 | Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. |
| Number of Missed Doses Based on Medication Refill Dates-Week 16 | Week 16 | Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. |
| Number of Missed Doses Based on Medication Refill Dates-Week 20 | Week 20 | Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. |
| Number of Missed Doses Based on Medication Refill Dates-Overall | 20 Weeks | Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. |
| Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Baseline | Baseline | Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (\<10 ng/mL) were included in this count. |
| Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 4 | Week 4 | Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (\<10 ng/mL) were included in this count. |
| Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 8 | Week 8 | Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (\<10 ng/mL) were included in this count. |
| Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 12 | Week 12 | Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (\<10 ng/mL) were included in this count. |
| Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 16 | Week 16 | Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (\<10 ng/mL) were included in this count. |
| Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 20 | Week 20 | Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (\<10 ng/mL) were included in this count. |
| Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 24 | Week 24 | Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (\<10 ng/mL) were included in this count. |
| Frequency of Missing Study Pills Because Participant Was Away From Home | 24 Weeks | — |
| Frequency of Missing Study Pills Because Participant Was Too Busy With Other Things | 24 Weeks | — |
| Frequency of Missing Study Pills Because Participant Simply Forgot | 24 Weeks | — |
| Frequency of Missing Study Pills Because Participant Ran Out of Study Pills | 24 weeks | — |
| Frequency of Missing Study Pills Because Participant Had Too Many Study Pills to Take | 24 weeks | — |
| Frequency of Missing Study Pills Because Participant Wanted to Avoid Side Effects | 24 weeks | — |
| Frequency of Missing Study Pills Because Participant Did Not Want Others to Notice Participant Was Taking Medications | 24 weeks | — |
| Frequency of Missing Study Pills Because Participant Had a Change in Daily Routine | 24 weeks | — |
| Frequency of Missing Pills Because Participant Felt Like the Study Pill Was Toxic/Harmful | 24 weeks | — |
| Frequency of Missing Study Pills Because Participant Fell Asleep/Slept Through Dose Time | 24 weeks | — |
| Frequency of Missing Study Pills Because Participant Felt Sick or Ill | 24 weeks | — |
| Frequency of Missing Study Pills Because Participant Felt Depressed/Overwhelmed | 24 weeks | — |
| Frequency of Missing Study Pills Because Participant Didn't Think it Was Needed Because he/She Was Not Engaged in Risky Sex | 24 weeks | — |
| Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 4 | Week 4 | — |
| Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 8 | Week 8 | — |
| Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 12 | Week 12 | — |
| Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 16 | Week 16 | — |
| Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 20 | Week 20 | — |
| Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 24 | Week 24 | — |
| Perceived Risk of Becoming HIV Positive at Week 4 | Week 4 | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: Because I am in this PrEP study, I am less concerned about becoming HIV positive. |
| Perceived Risk of Becoming HIV Positive at Week 8 | Week 8 | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: Because I am in this PrEP study, I am less concerned about becoming HIV positive. |
| Perceived Risk of Becoming HIV Positive at Week 12 | Week 12 | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: Because I am in this PrEP study, I am less concerned about becoming HIV positive. |
| Perceived Risk of Becoming HIV Positive at Week 16 | Week 16 | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: Because I am in this PrEP study, I am less concerned about becoming HIV positive. |
| Perceived Risk of Becoming HIV Positive at Week 20 | Week 20 | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: Because I am in this PrEP study, I am less concerned about becoming HIV positive. |
| Perceived Risk of Becoming HIV Positive at Week 24 | Week 24 | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: Because I am in this PrEP study, I am less concerned about becoming HIV positive. |
| Perceived HIV Risk Reduction at Week 4: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Week 4 | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am more willing to take a chance of getting infected now that I am in this PrEP study. |
| Perceived HIV Risk Reduction at Week 8: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Week 8 | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am more willing to take a chance of getting infected now that I am in this PrEP study. |
| Perceived HIV Risk Reduction at Week 12: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Week 12 | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am more willing to take a chance of getting infected now that I am in this PrEP study. |
| Perceived HIV Risk Reduction at Week 16: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Week 16 | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am more willing to take a chance of getting infected now that I am in this PrEP study. |
| Perceived HIV Risk Reduction at Week 20: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Week 20 | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am more willing to take a chance of getting infected now that I am in this PrEP study. |
| Perceived HIV Risk Reduction at Week 24: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Week 24 | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am more willing to take a chance of getting infected now that I am in this PrEP study. |
| Perceived HIV Risk Reduction at Week 4: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Week 4 | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex. |
| Perceived HIV Risk Reduction at Week 8: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Week 8 | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex. |
| Perceived HIV Risk Reduction at Week 12: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Week 12 | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex. |
| Perceived HIV Risk Reduction at Week 16: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Week 16 | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex. |
| Perceived HIV Risk Reduction at Week 20: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Week 20 | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex. |
| Perceived HIV Risk Reduction at Week 24: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Week 24 | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex. |
| Perceived HIV Risk Reduction at Week 4: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Week 4 | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: The availability of PrEP makes me less worried about having unprotected sex. |
| Perceived HIV Risk Reduction at Week 8: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Week 8 | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: The availability of PrEP makes me less worried about having unprotected sex. |
| Perceived HIV Risk Reduction at Week 12: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Week 12 | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: The availability of PrEP makes me less worried about having unprotected sex. |
| Perceived HIV Risk Reduction at Week 16: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Week 16 | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: The availability of PrEP makes me less worried about having unprotected sex. |
| Perceived HIV Risk Reduction at Week 20: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Week 20 | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: The availability of PrEP makes me less worried about having unprotected sex. |
| Perceived HIV Risk Reduction at Week 24: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Week 24 | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: The availability of PrEP makes me less worried about having unprotected sex. |
| Perceived HIV Risk Reduction at Week 4: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Week 4 | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am less concerned about having unprotected anal sex now that I am in this PrEP study. |
| Perceived HIV Risk Reduction at Week 8: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Week 8 | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am less concerned about having unprotected anal sex now that I am in this PrEP study. |
| Perceived HIV Risk Reduction at Week 12: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Week 12 | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am less concerned about having unprotected anal sex now that I am in this PrEP study. |
| Perceived HIV Risk Reduction at Week 16: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Week 16 | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am less concerned about having unprotected anal sex now that I am in this PrEP study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting No High-Risk Man With Man Sex Acts at Baseline | Baseline | A high-risk sex act was defined as an answer of greater than 0 to any of the following questions: With your male HIV positive male partners during the past month: How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? |
| Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 4 | Week 4 | A high-risk sex act was defined as an answer of greater than 0 to any of the following questions: With your male HIV positive male partners during the past month: How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? |
| Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 8 | Week 8 | A high-risk sex act was defined as an answer of greater than 0 to any of the following questions: With your male HIV positive male partners during the past month: How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? |
| Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 12 | Week 12 | A high-risk sex act was defined as an answer of greater than 0 to any of the following questions: With your male HIV positive male partners during the past month: How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? |
| Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 20 | Week 20 | A high-risk sex act was defined as an answer of greater than 0 to any of the following questions: With your male HIV positive male partners during the past month: How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? |
| Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 24 | Week 24 | A high-risk sex act was defined as an answer of greater than 0 to any of the following questions: With your male HIV positive male partners during the past month: How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? |
| Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 16 | Week 16 | A high-risk sex act was defined as an answer of greater than 0 to any of the following questions: With your male HIV positive male partners during the past month: How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? |
Countries
United States
Participant flow
Recruitment details
This research was conducted at two clinical sites in Chicago. Accrual was open between August 2009 and May 2011.
Pre-assignment details
Young males were approached for screening in the community. If eligible, a clinic-based screening was done to confirm eligibility. If confirmed, participants attended a behavioral intervention. Then a week 0 was scheduled for randomization. 68 participants were enrolled; 10 discontinued prior to randomization, for a total of 58 participants.
Participants by arm
| Arm | Count |
|---|---|
| FTC/TDF as PrEP Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks. | 20 |
| Placebo Pill Control Blinded administration of placebo pill; HIV behavioral intervention
Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks. | 19 |
| No Pill Control Subjects receive HIV behavioral intervention but no pill.
Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks. | 19 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Enrolled in Extension Study | 0 | 3 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 1 |
Baseline characteristics
| Characteristic | Placebo Pill Control | Total | FTC/TDF as PrEP | No Pill Control |
|---|---|---|---|---|
| Age, Continuous | 20.26 years STANDARD_DEVIATION 1.45 | 19.97 years STANDARD_DEVIATION 1.3 | 19.8 years STANDARD_DEVIATION 1.44 | 19.84 years STANDARD_DEVIATION 0.96 |
| Current Employment Full Time | 2 participants | 6 participants | 2 participants | 2 participants |
| Current Employment Part Time | 6 participants | 20 participants | 6 participants | 8 participants |
| Current Employment Unemployed | 11 participants | 32 participants | 12 participants | 9 participants |
| Education Eighth Grade of Less | 0 participants | 1 participants | 0 participants | 1 participants |
| Education GED | 1 participants | 2 participants | 0 participants | 1 participants |
| Education Highschool Diploma | 3 participants | 18 participants | 10 participants | 5 participants |
| Education Some College | 14 participants | 30 participants | 8 participants | 8 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 23 Participants | 7 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 35 Participants | 13 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Housing Experience (Responded YES) Have Exchanged Sex for Money or Place to Stay | 3 participants | 10 participants | 2 participants | 5 participants |
| Housing Experience (Responded YES) Kicked out of House Due to Sexual Orientation | 2 participants | 9 participants | 4 participants | 3 participants |
| Housing Experience (Responded YES) Spent at least 1 Night in Shelter S | 6 participants | 19 participants | 5 participants | 8 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 31 Participants | 10 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 22 Participants | 8 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 4 Participants | 1 Participants | 2 Participants |
| Region of Enrollment United States | 19 participants | 58 participants | 20 participants | 19 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 19 Participants | 58 Participants | 20 Participants | 19 Participants |
| Unprotected Anal or Vaginal Sex with Woman No | 17 participants | 55 participants | 20 participants | 18 participants |
| Unprotected Anal or Vaginal Sex with Woman Yes | 2 participants | 3 participants | 0 participants | 1 participants |
| Unprotected Anal Sex with Man in Past 30 Days No | 12 participants | 34 participants | 11 participants | 11 participants |
| Unprotected Anal Sex with Man in Past 30 Days Yes | 7 participants | 24 participants | 9 participants | 8 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 4 / 20 | 1 / 19 | 0 / 19 |
| serious Total, serious adverse events | 0 / 20 | 0 / 19 | 0 / 19 |
Outcome results
Primary
Acceptability of Being Contacted by the Research Team in Between Visits
Time frame: Week 24
Population: Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Acceptability of Being Contacted by the Research Team in Between Visits | Did not like | 0 participants |
| FTC/TDF as PrEP | Acceptability of Being Contacted by the Research Team in Between Visits | Liked | 4 participants |
| FTC/TDF as PrEP | Acceptability of Being Contacted by the Research Team in Between Visits | Liked a lot | 6 participants |
| FTC/TDF as PrEP | Acceptability of Being Contacted by the Research Team in Between Visits | Missing response | 10 participants |
| Placebo Pill Control | Acceptability of Being Contacted by the Research Team in Between Visits | Missing response | 8 participants |
| Placebo Pill Control | Acceptability of Being Contacted by the Research Team in Between Visits | Did not like | 2 participants |
| Placebo Pill Control | Acceptability of Being Contacted by the Research Team in Between Visits | Liked a lot | 4 participants |
| Placebo Pill Control | Acceptability of Being Contacted by the Research Team in Between Visits | Liked | 5 participants |
| No Pill Control | Acceptability of Being Contacted by the Research Team in Between Visits | Missing response | 6 participants |
| No Pill Control | Acceptability of Being Contacted by the Research Team in Between Visits | Liked | 3 participants |
| No Pill Control | Acceptability of Being Contacted by the Research Team in Between Visits | Liked a lot | 10 participants |
| No Pill Control | Acceptability of Being Contacted by the Research Team in Between Visits | Did not like | 0 participants |
p-value: 0.185Fisher Exact
Primary
Acceptability of Being Randomly Assigned to a Group
Time frame: Week 24
Population: Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Acceptability of Being Randomly Assigned to a Group | Liked a lot | 1 participants |
| FTC/TDF as PrEP | Acceptability of Being Randomly Assigned to a Group | Liked | 4 participants |
| FTC/TDF as PrEP | Acceptability of Being Randomly Assigned to a Group | Did not like it at all | 1 participants |
| FTC/TDF as PrEP | Acceptability of Being Randomly Assigned to a Group | Did not like | 3 participants |
| FTC/TDF as PrEP | Acceptability of Being Randomly Assigned to a Group | Missing response | 11 participants |
| Placebo Pill Control | Acceptability of Being Randomly Assigned to a Group | Liked | 4 participants |
| Placebo Pill Control | Acceptability of Being Randomly Assigned to a Group | Did not like it at all | 4 participants |
| Placebo Pill Control | Acceptability of Being Randomly Assigned to a Group | Did not like | 2 participants |
| Placebo Pill Control | Acceptability of Being Randomly Assigned to a Group | Liked a lot | 2 participants |
| Placebo Pill Control | Acceptability of Being Randomly Assigned to a Group | Missing response | 7 participants |
| No Pill Control | Acceptability of Being Randomly Assigned to a Group | Missing response | 6 participants |
| No Pill Control | Acceptability of Being Randomly Assigned to a Group | Liked a lot | 6 participants |
| No Pill Control | Acceptability of Being Randomly Assigned to a Group | Did not like it at all | 0 participants |
| No Pill Control | Acceptability of Being Randomly Assigned to a Group | Liked | 5 participants |
| No Pill Control | Acceptability of Being Randomly Assigned to a Group | Did not like | 2 participants |
p-value: 0.224Fisher Exact
Primary
Acceptability of Having an HIV Test at Every Visit
Time frame: Week 24
Population: Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Acceptability of Having an HIV Test at Every Visit | Did not like | 0 participants |
| FTC/TDF as PrEP | Acceptability of Having an HIV Test at Every Visit | Liked | 0 participants |
| FTC/TDF as PrEP | Acceptability of Having an HIV Test at Every Visit | Liked a lot | 10 participants |
| FTC/TDF as PrEP | Acceptability of Having an HIV Test at Every Visit | Missing response | 10 participants |
| Placebo Pill Control | Acceptability of Having an HIV Test at Every Visit | Missing response | 7 participants |
| Placebo Pill Control | Acceptability of Having an HIV Test at Every Visit | Did not like | 1 participants |
| Placebo Pill Control | Acceptability of Having an HIV Test at Every Visit | Liked a lot | 8 participants |
| Placebo Pill Control | Acceptability of Having an HIV Test at Every Visit | Liked | 3 participants |
| No Pill Control | Acceptability of Having an HIV Test at Every Visit | Missing response | 6 participants |
| No Pill Control | Acceptability of Having an HIV Test at Every Visit | Liked | 1 participants |
| No Pill Control | Acceptability of Having an HIV Test at Every Visit | Liked a lot | 12 participants |
| No Pill Control | Acceptability of Having an HIV Test at Every Visit | Did not like | 0 participants |
p-value: 0.1538Fisher Exact
Primary
Acceptability of Health Clinic for Study Visits
Time frame: Week 24
Population: Not all participants answered every question.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Acceptability of Health Clinic for Study Visits | Liked a lot | 6 participants |
| FTC/TDF as PrEP | Acceptability of Health Clinic for Study Visits | Liked | 4 participants |
| FTC/TDF as PrEP | Acceptability of Health Clinic for Study Visits | Did not like | 0 participants |
| FTC/TDF as PrEP | Acceptability of Health Clinic for Study Visits | Missing response | 10 participants |
| Placebo Pill Control | Acceptability of Health Clinic for Study Visits | Liked a lot | 6 participants |
| Placebo Pill Control | Acceptability of Health Clinic for Study Visits | Did not like | 2 participants |
| Placebo Pill Control | Acceptability of Health Clinic for Study Visits | Liked | 4 participants |
| Placebo Pill Control | Acceptability of Health Clinic for Study Visits | Missing response | 7 participants |
| No Pill Control | Acceptability of Health Clinic for Study Visits | Did not like | 0 participants |
| No Pill Control | Acceptability of Health Clinic for Study Visits | Liked a lot | 10 participants |
| No Pill Control | Acceptability of Health Clinic for Study Visits | Missing response | 6 participants |
| No Pill Control | Acceptability of Health Clinic for Study Visits | Liked | 3 participants |
p-value: 0.4089Fisher Exact
Primary
Acceptability of Participating in Group Sessions
Time frame: Week 24
Population: Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Acceptability of Participating in Group Sessions | Liked a lot | 9 participants |
| FTC/TDF as PrEP | Acceptability of Participating in Group Sessions | Liked | 0 participants |
| FTC/TDF as PrEP | Acceptability of Participating in Group Sessions | Did not like it at all | 0 participants |
| FTC/TDF as PrEP | Acceptability of Participating in Group Sessions | Did not like | 1 participants |
| FTC/TDF as PrEP | Acceptability of Participating in Group Sessions | Missing response | 10 participants |
| Placebo Pill Control | Acceptability of Participating in Group Sessions | Liked | 2 participants |
| Placebo Pill Control | Acceptability of Participating in Group Sessions | Did not like it at all | 1 participants |
| Placebo Pill Control | Acceptability of Participating in Group Sessions | Did not like | 2 participants |
| Placebo Pill Control | Acceptability of Participating in Group Sessions | Liked a lot | 7 participants |
| Placebo Pill Control | Acceptability of Participating in Group Sessions | Missing response | 7 participants |
| No Pill Control | Acceptability of Participating in Group Sessions | Missing response | 6 participants |
| No Pill Control | Acceptability of Participating in Group Sessions | Liked a lot | 9 participants |
| No Pill Control | Acceptability of Participating in Group Sessions | Did not like it at all | 0 participants |
| No Pill Control | Acceptability of Participating in Group Sessions | Liked | 4 participants |
| No Pill Control | Acceptability of Participating in Group Sessions | Did not like | 0 participants |
p-value: 0.1908Fisher Exact
Primary
Acceptability of Physical Examination by a Doctor
Time frame: Week 24
Population: Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Acceptability of Physical Examination by a Doctor | Liked a lot | 7 participants |
| FTC/TDF as PrEP | Acceptability of Physical Examination by a Doctor | Liked | 2 participants |
| FTC/TDF as PrEP | Acceptability of Physical Examination by a Doctor | Did not like it at all | 0 participants |
| FTC/TDF as PrEP | Acceptability of Physical Examination by a Doctor | Did not like | 1 participants |
| FTC/TDF as PrEP | Acceptability of Physical Examination by a Doctor | Missing response | 10 participants |
| Placebo Pill Control | Acceptability of Physical Examination by a Doctor | Liked | 3 participants |
| Placebo Pill Control | Acceptability of Physical Examination by a Doctor | Did not like it at all | 3 participants |
| Placebo Pill Control | Acceptability of Physical Examination by a Doctor | Did not like | 0 participants |
| Placebo Pill Control | Acceptability of Physical Examination by a Doctor | Liked a lot | 6 participants |
| Placebo Pill Control | Acceptability of Physical Examination by a Doctor | Missing response | 7 participants |
| No Pill Control | Acceptability of Physical Examination by a Doctor | Missing response | 6 participants |
| No Pill Control | Acceptability of Physical Examination by a Doctor | Liked a lot | 10 participants |
| No Pill Control | Acceptability of Physical Examination by a Doctor | Did not like it at all | 0 participants |
| No Pill Control | Acceptability of Physical Examination by a Doctor | Liked | 3 participants |
| No Pill Control | Acceptability of Physical Examination by a Doctor | Did not like | 0 participants |
p-value: 0.2366Fisher Exact
Primary
Acceptability of Questions About Sexual Behavior at Every Visit
Time frame: Week 24
Population: Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Acceptability of Questions About Sexual Behavior at Every Visit | Liked a lot | 9 participants |
| FTC/TDF as PrEP | Acceptability of Questions About Sexual Behavior at Every Visit | Liked | 1 participants |
| FTC/TDF as PrEP | Acceptability of Questions About Sexual Behavior at Every Visit | Did not like it at all | 0 participants |
| FTC/TDF as PrEP | Acceptability of Questions About Sexual Behavior at Every Visit | Did not like | 0 participants |
| FTC/TDF as PrEP | Acceptability of Questions About Sexual Behavior at Every Visit | Missing response | 10 participants |
| Placebo Pill Control | Acceptability of Questions About Sexual Behavior at Every Visit | Liked | 4 participants |
| Placebo Pill Control | Acceptability of Questions About Sexual Behavior at Every Visit | Did not like it at all | 1 participants |
| Placebo Pill Control | Acceptability of Questions About Sexual Behavior at Every Visit | Did not like | 1 participants |
| Placebo Pill Control | Acceptability of Questions About Sexual Behavior at Every Visit | Liked a lot | 6 participants |
| Placebo Pill Control | Acceptability of Questions About Sexual Behavior at Every Visit | Missing response | 7 participants |
| No Pill Control | Acceptability of Questions About Sexual Behavior at Every Visit | Missing response | 6 participants |
| No Pill Control | Acceptability of Questions About Sexual Behavior at Every Visit | Liked a lot | 9 participants |
| No Pill Control | Acceptability of Questions About Sexual Behavior at Every Visit | Did not like it at all | 0 participants |
| No Pill Control | Acceptability of Questions About Sexual Behavior at Every Visit | Liked | 4 participants |
| No Pill Control | Acceptability of Questions About Sexual Behavior at Every Visit | Did not like | 0 participants |
p-value: 0.2809Fisher Exact
Primary
Acceptability of Risk Reduction Counseling at Every Visit
Time frame: Week 24
Population: Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Acceptability of Risk Reduction Counseling at Every Visit | Did not like it at all | 0 participants |
| FTC/TDF as PrEP | Acceptability of Risk Reduction Counseling at Every Visit | Liked | 1 participants |
| FTC/TDF as PrEP | Acceptability of Risk Reduction Counseling at Every Visit | Liked a lot | 9 participants |
| FTC/TDF as PrEP | Acceptability of Risk Reduction Counseling at Every Visit | Missing response | 10 participants |
| Placebo Pill Control | Acceptability of Risk Reduction Counseling at Every Visit | Missing response | 7 participants |
| Placebo Pill Control | Acceptability of Risk Reduction Counseling at Every Visit | Did not like it at all | 1 participants |
| Placebo Pill Control | Acceptability of Risk Reduction Counseling at Every Visit | Liked a lot | 6 participants |
| Placebo Pill Control | Acceptability of Risk Reduction Counseling at Every Visit | Liked | 5 participants |
| No Pill Control | Acceptability of Risk Reduction Counseling at Every Visit | Missing response | 6 participants |
| No Pill Control | Acceptability of Risk Reduction Counseling at Every Visit | Liked | 4 participants |
| No Pill Control | Acceptability of Risk Reduction Counseling at Every Visit | Liked a lot | 9 participants |
| No Pill Control | Acceptability of Risk Reduction Counseling at Every Visit | Did not like it at all | 0 participants |
p-value: 0.2151Fisher Exact
Primary
Acceptability of Size of Pill
Time frame: Week 24
Population: Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Acceptability of Size of Pill | Did not like | 3 Participants |
| FTC/TDF as PrEP | Acceptability of Size of Pill | Liked a lot | 1 Participants |
| FTC/TDF as PrEP | Acceptability of Size of Pill | Liked | 3 Participants |
| FTC/TDF as PrEP | Acceptability of Size of Pill | Missing response | 10 Participants |
| FTC/TDF as PrEP | Acceptability of Size of Pill | Did not like it at all | 3 Participants |
| Placebo Pill Control | Acceptability of Size of Pill | Missing response | 7 Participants |
| Placebo Pill Control | Acceptability of Size of Pill | Did not like it at all | 3 Participants |
| Placebo Pill Control | Acceptability of Size of Pill | Did not like | 3 Participants |
| Placebo Pill Control | Acceptability of Size of Pill | Liked | 6 Participants |
| Placebo Pill Control | Acceptability of Size of Pill | Liked a lot | 0 Participants |
p-value: 0.6921Fisher Exact
Primary
Acceptability of Taking Part in the Study
Time frame: Week 24
Population: Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Acceptability of Taking Part in the Study | Liked a lot | 8 participants |
| FTC/TDF as PrEP | Acceptability of Taking Part in the Study | Liked | 0 participants |
| FTC/TDF as PrEP | Acceptability of Taking Part in the Study | Did not like it at all | 2 participants |
| FTC/TDF as PrEP | Acceptability of Taking Part in the Study | Did not like | 0 participants |
| FTC/TDF as PrEP | Acceptability of Taking Part in the Study | Missing response | 10 participants |
| Placebo Pill Control | Acceptability of Taking Part in the Study | Liked | 2 participants |
| Placebo Pill Control | Acceptability of Taking Part in the Study | Did not like it at all | 0 participants |
| Placebo Pill Control | Acceptability of Taking Part in the Study | Did not like | 1 participants |
| Placebo Pill Control | Acceptability of Taking Part in the Study | Liked a lot | 9 participants |
| Placebo Pill Control | Acceptability of Taking Part in the Study | Missing response | 7 participants |
| No Pill Control | Acceptability of Taking Part in the Study | Missing response | 6 participants |
| No Pill Control | Acceptability of Taking Part in the Study | Liked a lot | 12 participants |
| No Pill Control | Acceptability of Taking Part in the Study | Did not like it at all | 0 participants |
| No Pill Control | Acceptability of Taking Part in the Study | Liked | 1 participants |
| No Pill Control | Acceptability of Taking Part in the Study | Did not like | 0 participants |
p-value: 0.1886Fisher Exact
Primary
Acceptability of Taking the Pill Everyday
Time frame: Week 24
Population: Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Acceptability of Taking the Pill Everyday | Missing response | 10 participants |
| FTC/TDF as PrEP | Acceptability of Taking the Pill Everyday | Did not like | 3 participants |
| FTC/TDF as PrEP | Acceptability of Taking the Pill Everyday | Did not like it at all | 3 participants |
| FTC/TDF as PrEP | Acceptability of Taking the Pill Everyday | Liked | 2 participants |
| FTC/TDF as PrEP | Acceptability of Taking the Pill Everyday | Liked a lot | 2 participants |
| Placebo Pill Control | Acceptability of Taking the Pill Everyday | Liked | 4 participants |
| Placebo Pill Control | Acceptability of Taking the Pill Everyday | Liked a lot | 0 participants |
| Placebo Pill Control | Acceptability of Taking the Pill Everyday | Missing response | 7 participants |
| Placebo Pill Control | Acceptability of Taking the Pill Everyday | Did not like it at all | 1 participants |
| Placebo Pill Control | Acceptability of Taking the Pill Everyday | Did not like | 7 participants |
p-value: 0.2297Fisher Exact
Primary
Acceptability of the Color of the Pill
Time frame: Week 24
Population: Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Acceptability of the Color of the Pill | Did not like | 2 participants |
| FTC/TDF as PrEP | Acceptability of the Color of the Pill | Liked a lot | 3 participants |
| FTC/TDF as PrEP | Acceptability of the Color of the Pill | Liked | 4 participants |
| FTC/TDF as PrEP | Acceptability of the Color of the Pill | Missing response | 10 participants |
| FTC/TDF as PrEP | Acceptability of the Color of the Pill | Did not like it at all | 1 participants |
| Placebo Pill Control | Acceptability of the Color of the Pill | Missing response | 7 participants |
| Placebo Pill Control | Acceptability of the Color of the Pill | Did not like it at all | 1 participants |
| Placebo Pill Control | Acceptability of the Color of the Pill | Did not like | 3 participants |
| Placebo Pill Control | Acceptability of the Color of the Pill | Liked | 5 participants |
| Placebo Pill Control | Acceptability of the Color of the Pill | Liked a lot | 3 participants |
p-value: 0.9999Fisher Exact
Primary
Acceptability of the Taste of the Pill
Time frame: Week 24
Population: Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Acceptability of the Taste of the Pill | Did not like | 1 participants |
| FTC/TDF as PrEP | Acceptability of the Taste of the Pill | Liked a lot | 1 participants |
| FTC/TDF as PrEP | Acceptability of the Taste of the Pill | Liked | 4 participants |
| FTC/TDF as PrEP | Acceptability of the Taste of the Pill | Missing response | 10 participants |
| FTC/TDF as PrEP | Acceptability of the Taste of the Pill | Did not like it at all | 4 participants |
| Placebo Pill Control | Acceptability of the Taste of the Pill | Missing response | 7 participants |
| Placebo Pill Control | Acceptability of the Taste of the Pill | Did not like it at all | 3 participants |
| Placebo Pill Control | Acceptability of the Taste of the Pill | Did not like | 4 participants |
| Placebo Pill Control | Acceptability of the Taste of the Pill | Liked | 5 participants |
| Placebo Pill Control | Acceptability of the Taste of the Pill | Liked a lot | 0 participants |
p-value: 0.4655Fisher Exact
Primary
Actual Number of Study Visits Completed by 24 Weeks
This outcome measure looked at whether the actual number of study visits conducted by 24 weeks differed by treatment group over time.
Time frame: 24 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| FTC/TDF as PrEP | Actual Number of Study Visits Completed by 24 Weeks | 3.5927 Visits | Standard Error 0.7387 |
| Placebo Pill Control | Actual Number of Study Visits Completed by 24 Weeks | 4.6263 Visits | Standard Error 0.9783 |
| No Pill Control | Actual Number of Study Visits Completed by 24 Weeks | 4.6374 Visits | Standard Error 0.9784 |
p-value: 0.6983Chi-squared
Primary
Frequency of Missing Pills Because Participant Felt Like the Study Pill Was Toxic/Harmful
Time frame: 24 weeks
Population: Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Frequency of Missing Pills Because Participant Felt Like the Study Pill Was Toxic/Harmful | Never | 87.06 % of participants in each category |
| FTC/TDF as PrEP | Frequency of Missing Pills Because Participant Felt Like the Study Pill Was Toxic/Harmful | Rarely | 5.88 % of participants in each category |
| FTC/TDF as PrEP | Frequency of Missing Pills Because Participant Felt Like the Study Pill Was Toxic/Harmful | Sometimes | 3.53 % of participants in each category |
| FTC/TDF as PrEP | Frequency of Missing Pills Because Participant Felt Like the Study Pill Was Toxic/Harmful | Often | 3.53 % of participants in each category |
| Placebo Pill Control | Frequency of Missing Pills Because Participant Felt Like the Study Pill Was Toxic/Harmful | Often | 2.15 % of participants in each category |
| Placebo Pill Control | Frequency of Missing Pills Because Participant Felt Like the Study Pill Was Toxic/Harmful | Never | 95.70 % of participants in each category |
| Placebo Pill Control | Frequency of Missing Pills Because Participant Felt Like the Study Pill Was Toxic/Harmful | Sometimes | 0.00 % of participants in each category |
| Placebo Pill Control | Frequency of Missing Pills Because Participant Felt Like the Study Pill Was Toxic/Harmful | Rarely | 2.15 % of participants in each category |
p-value: 0.1661Chi-squared
Primary
Frequency of Missing Study Pills Because Participant Did Not Want Others to Notice Participant Was Taking Medications
Time frame: 24 weeks
Population: Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Frequency of Missing Study Pills Because Participant Did Not Want Others to Notice Participant Was Taking Medications | Never | 88.24 % of participants in each category |
| FTC/TDF as PrEP | Frequency of Missing Study Pills Because Participant Did Not Want Others to Notice Participant Was Taking Medications | Rarely | 5.88 % of participants in each category |
| FTC/TDF as PrEP | Frequency of Missing Study Pills Because Participant Did Not Want Others to Notice Participant Was Taking Medications | Sometimes | 2.35 % of participants in each category |
| FTC/TDF as PrEP | Frequency of Missing Study Pills Because Participant Did Not Want Others to Notice Participant Was Taking Medications | Often | 3.53 % of participants in each category |
| Placebo Pill Control | Frequency of Missing Study Pills Because Participant Did Not Want Others to Notice Participant Was Taking Medications | Often | 3.23 % of participants in each category |
| Placebo Pill Control | Frequency of Missing Study Pills Because Participant Did Not Want Others to Notice Participant Was Taking Medications | Never | 92.47 % of participants in each category |
| Placebo Pill Control | Frequency of Missing Study Pills Because Participant Did Not Want Others to Notice Participant Was Taking Medications | Sometimes | 0.00 % of participants in each category |
| Placebo Pill Control | Frequency of Missing Study Pills Because Participant Did Not Want Others to Notice Participant Was Taking Medications | Rarely | 4.30 % of participants in each category |
p-value: 0.3846Chi-squared
Primary
Frequency of Missing Study Pills Because Participant Didn't Think it Was Needed Because he/She Was Not Engaged in Risky Sex
Time frame: 24 weeks
Population: Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Frequency of Missing Study Pills Because Participant Didn't Think it Was Needed Because he/She Was Not Engaged in Risky Sex | Rarely | 4.71 % of participants in each category |
| FTC/TDF as PrEP | Frequency of Missing Study Pills Because Participant Didn't Think it Was Needed Because he/She Was Not Engaged in Risky Sex | Often | 3.53 % of participants in each category |
| FTC/TDF as PrEP | Frequency of Missing Study Pills Because Participant Didn't Think it Was Needed Because he/She Was Not Engaged in Risky Sex | Sometimes | 1.18 % of participants in each category |
| FTC/TDF as PrEP | Frequency of Missing Study Pills Because Participant Didn't Think it Was Needed Because he/She Was Not Engaged in Risky Sex | Never | 90.59 % of participants in each category |
| Placebo Pill Control | Frequency of Missing Study Pills Because Participant Didn't Think it Was Needed Because he/She Was Not Engaged in Risky Sex | Sometimes | 2.15 % of participants in each category |
| Placebo Pill Control | Frequency of Missing Study Pills Because Participant Didn't Think it Was Needed Because he/She Was Not Engaged in Risky Sex | Rarely | 0.00 % of participants in each category |
| Placebo Pill Control | Frequency of Missing Study Pills Because Participant Didn't Think it Was Needed Because he/She Was Not Engaged in Risky Sex | Never | 96.77 % of participants in each category |
| Placebo Pill Control | Frequency of Missing Study Pills Because Participant Didn't Think it Was Needed Because he/She Was Not Engaged in Risky Sex | Often | 1.08 % of participants in each category |
p-value: 0.2342Chi-squared
Primary
Frequency of Missing Study Pills Because Participant Fell Asleep/Slept Through Dose Time
Time frame: 24 weeks
Population: Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Frequency of Missing Study Pills Because Participant Fell Asleep/Slept Through Dose Time | Never | 68.24 % of participants in each category |
| FTC/TDF as PrEP | Frequency of Missing Study Pills Because Participant Fell Asleep/Slept Through Dose Time | Rarely | 24.71 % of participants in each category |
| FTC/TDF as PrEP | Frequency of Missing Study Pills Because Participant Fell Asleep/Slept Through Dose Time | Sometimes | 4.71 % of participants in each category |
| FTC/TDF as PrEP | Frequency of Missing Study Pills Because Participant Fell Asleep/Slept Through Dose Time | Often | 2.35 % of participants in each category |
| Placebo Pill Control | Frequency of Missing Study Pills Because Participant Fell Asleep/Slept Through Dose Time | Often | 3.23 % of participants in each category |
| Placebo Pill Control | Frequency of Missing Study Pills Because Participant Fell Asleep/Slept Through Dose Time | Never | 86.02 % of participants in each category |
| Placebo Pill Control | Frequency of Missing Study Pills Because Participant Fell Asleep/Slept Through Dose Time | Sometimes | 4.30 % of participants in each category |
| Placebo Pill Control | Frequency of Missing Study Pills Because Participant Fell Asleep/Slept Through Dose Time | Rarely | 6.45 % of participants in each category |
p-value: 0.0729Chi-squared
Primary
Frequency of Missing Study Pills Because Participant Felt Depressed/Overwhelmed
Time frame: 24 weeks
Population: Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Frequency of Missing Study Pills Because Participant Felt Depressed/Overwhelmed | Never | 83.53 % of participants in each category |
| FTC/TDF as PrEP | Frequency of Missing Study Pills Because Participant Felt Depressed/Overwhelmed | Rarely | 12.94 % of participants in each category |
| FTC/TDF as PrEP | Frequency of Missing Study Pills Because Participant Felt Depressed/Overwhelmed | Sometimes | 0.00 % of participants in each category |
| FTC/TDF as PrEP | Frequency of Missing Study Pills Because Participant Felt Depressed/Overwhelmed | Often | 3.53 % of participants in each category |
| Placebo Pill Control | Frequency of Missing Study Pills Because Participant Felt Depressed/Overwhelmed | Often | 2.15 % of participants in each category |
| Placebo Pill Control | Frequency of Missing Study Pills Because Participant Felt Depressed/Overwhelmed | Never | 92.47 % of participants in each category |
| Placebo Pill Control | Frequency of Missing Study Pills Because Participant Felt Depressed/Overwhelmed | Sometimes | 3.23 % of participants in each category |
| Placebo Pill Control | Frequency of Missing Study Pills Because Participant Felt Depressed/Overwhelmed | Rarely | 2.15 % of participants in each category |
p-value: 0.2829Chi-squared
Primary
Frequency of Missing Study Pills Because Participant Felt Sick or Ill
Time frame: 24 weeks
Population: Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Frequency of Missing Study Pills Because Participant Felt Sick or Ill | Never | 81.18 % of participants in each category |
| FTC/TDF as PrEP | Frequency of Missing Study Pills Because Participant Felt Sick or Ill | Rarely | 11.76 % of participants in each category |
| FTC/TDF as PrEP | Frequency of Missing Study Pills Because Participant Felt Sick or Ill | Sometimes | 4.71 % of participants in each category |
| FTC/TDF as PrEP | Frequency of Missing Study Pills Because Participant Felt Sick or Ill | Often | 2.35 % of participants in each category |
| Placebo Pill Control | Frequency of Missing Study Pills Because Participant Felt Sick or Ill | Often | 2.15 % of participants in each category |
| Placebo Pill Control | Frequency of Missing Study Pills Because Participant Felt Sick or Ill | Never | 89.25 % of participants in each category |
| Placebo Pill Control | Frequency of Missing Study Pills Because Participant Felt Sick or Ill | Sometimes | 3.23 % of participants in each category |
| Placebo Pill Control | Frequency of Missing Study Pills Because Participant Felt Sick or Ill | Rarely | 5.38 % of participants in each category |
p-value: 0.1912Chi-squared
Primary
Frequency of Missing Study Pills Because Participant Had a Change in Daily Routine
Time frame: 24 weeks
Population: Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Frequency of Missing Study Pills Because Participant Had a Change in Daily Routine | Never | 62.35 % of participants in each category |
| FTC/TDF as PrEP | Frequency of Missing Study Pills Because Participant Had a Change in Daily Routine | Rarely | 25.53 % of participants in each category |
| FTC/TDF as PrEP | Frequency of Missing Study Pills Because Participant Had a Change in Daily Routine | Sometimes | 7.06 % of participants in each category |
| FTC/TDF as PrEP | Frequency of Missing Study Pills Because Participant Had a Change in Daily Routine | Often | 7.06 % of participants in each category |
| Placebo Pill Control | Frequency of Missing Study Pills Because Participant Had a Change in Daily Routine | Often | 3.23 % of participants in each category |
| Placebo Pill Control | Frequency of Missing Study Pills Because Participant Had a Change in Daily Routine | Never | 70.97 % of participants in each category |
| Placebo Pill Control | Frequency of Missing Study Pills Because Participant Had a Change in Daily Routine | Sometimes | 10.75 % of participants in each category |
| Placebo Pill Control | Frequency of Missing Study Pills Because Participant Had a Change in Daily Routine | Rarely | 15.05 % of participants in each category |
p-value: 0.5133Chi-squared
Primary
Frequency of Missing Study Pills Because Participant Had Too Many Study Pills to Take
Time frame: 24 weeks
Population: Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Frequency of Missing Study Pills Because Participant Had Too Many Study Pills to Take | Never | 92.94 % of participants in each category |
| FTC/TDF as PrEP | Frequency of Missing Study Pills Because Participant Had Too Many Study Pills to Take | Rarely | 7.06 % of participants in each category |
| FTC/TDF as PrEP | Frequency of Missing Study Pills Because Participant Had Too Many Study Pills to Take | Sometimes | 0.00 % of participants in each category |
| FTC/TDF as PrEP | Frequency of Missing Study Pills Because Participant Had Too Many Study Pills to Take | Often | 0.00 % of participants in each category |
| Placebo Pill Control | Frequency of Missing Study Pills Because Participant Had Too Many Study Pills to Take | Often | 1.08 % of participants in each category |
| Placebo Pill Control | Frequency of Missing Study Pills Because Participant Had Too Many Study Pills to Take | Never | 95.70 % of participants in each category |
| Placebo Pill Control | Frequency of Missing Study Pills Because Participant Had Too Many Study Pills to Take | Sometimes | 1.08 % of participants in each category |
| Placebo Pill Control | Frequency of Missing Study Pills Because Participant Had Too Many Study Pills to Take | Rarely | 2.15 % of participants in each category |
p-value: 0.5265Chi-squared
Primary
Frequency of Missing Study Pills Because Participant Ran Out of Study Pills
Time frame: 24 weeks
Population: Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Frequency of Missing Study Pills Because Participant Ran Out of Study Pills | Never | 94.12 % of participants in each category |
| FTC/TDF as PrEP | Frequency of Missing Study Pills Because Participant Ran Out of Study Pills | Rarely | 4.71 % of participants in each category |
| FTC/TDF as PrEP | Frequency of Missing Study Pills Because Participant Ran Out of Study Pills | Sometimes | 0.00 % of participants in each category |
| FTC/TDF as PrEP | Frequency of Missing Study Pills Because Participant Ran Out of Study Pills | Often | 1.18 % of participants in each category |
| Placebo Pill Control | Frequency of Missing Study Pills Because Participant Ran Out of Study Pills | Often | 0.00 % of participants in each category |
| Placebo Pill Control | Frequency of Missing Study Pills Because Participant Ran Out of Study Pills | Never | 97.85 % of participants in each category |
| Placebo Pill Control | Frequency of Missing Study Pills Because Participant Ran Out of Study Pills | Sometimes | 1.08 % of participants in each category |
| Placebo Pill Control | Frequency of Missing Study Pills Because Participant Ran Out of Study Pills | Rarely | 1.08 % of participants in each category |
p-value: 0.2685Chi-squared
Primary
Frequency of Missing Study Pills Because Participant Simply Forgot
Time frame: 24 Weeks
Population: Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Frequency of Missing Study Pills Because Participant Simply Forgot | Never | 38.82 % of participants in each category |
| FTC/TDF as PrEP | Frequency of Missing Study Pills Because Participant Simply Forgot | Rarely | 40.00 % of participants in each category |
| FTC/TDF as PrEP | Frequency of Missing Study Pills Because Participant Simply Forgot | Sometimes | 9.41 % of participants in each category |
| FTC/TDF as PrEP | Frequency of Missing Study Pills Because Participant Simply Forgot | Often | 11.76 % of participants in each category |
| Placebo Pill Control | Frequency of Missing Study Pills Because Participant Simply Forgot | Often | 8.60 % of participants in each category |
| Placebo Pill Control | Frequency of Missing Study Pills Because Participant Simply Forgot | Never | 60.22 % of participants in each category |
| Placebo Pill Control | Frequency of Missing Study Pills Because Participant Simply Forgot | Sometimes | 15.05 % of participants in each category |
| Placebo Pill Control | Frequency of Missing Study Pills Because Participant Simply Forgot | Rarely | 16.13 % of participants in each category |
p-value: 0.2Chi-squared
Primary
Frequency of Missing Study Pills Because Participant Wanted to Avoid Side Effects
Time frame: 24 weeks
Population: Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Frequency of Missing Study Pills Because Participant Wanted to Avoid Side Effects | Never | 82.35 % of participants in each category |
| FTC/TDF as PrEP | Frequency of Missing Study Pills Because Participant Wanted to Avoid Side Effects | Rarely | 9.41 % of participants in each category |
| FTC/TDF as PrEP | Frequency of Missing Study Pills Because Participant Wanted to Avoid Side Effects | Sometimes | 0.00 % of participants in each category |
| FTC/TDF as PrEP | Frequency of Missing Study Pills Because Participant Wanted to Avoid Side Effects | Often | 8.24 % of participants in each category |
| Placebo Pill Control | Frequency of Missing Study Pills Because Participant Wanted to Avoid Side Effects | Often | 3.23 % of participants in each category |
| Placebo Pill Control | Frequency of Missing Study Pills Because Participant Wanted to Avoid Side Effects | Never | 91.40 % of participants in each category |
| Placebo Pill Control | Frequency of Missing Study Pills Because Participant Wanted to Avoid Side Effects | Sometimes | 2.15 % of participants in each category |
| Placebo Pill Control | Frequency of Missing Study Pills Because Participant Wanted to Avoid Side Effects | Rarely | 3.23 % of participants in each category |
p-value: 0.2559Chi-squared
Primary
Frequency of Missing Study Pills Because Participant Was Away From Home
Time frame: 24 Weeks
Population: Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Frequency of Missing Study Pills Because Participant Was Away From Home | Never | 31.76 % of participants in each category |
| FTC/TDF as PrEP | Frequency of Missing Study Pills Because Participant Was Away From Home | Rarely | 34.12 % of participants in each category |
| FTC/TDF as PrEP | Frequency of Missing Study Pills Because Participant Was Away From Home | Sometimes | 16.47 % of participants in each category |
| FTC/TDF as PrEP | Frequency of Missing Study Pills Because Participant Was Away From Home | Often | 17.65 % of participants in each category |
| Placebo Pill Control | Frequency of Missing Study Pills Because Participant Was Away From Home | Often | 4.30 % of participants in each category |
| Placebo Pill Control | Frequency of Missing Study Pills Because Participant Was Away From Home | Never | 48.39 % of participants in each category |
| Placebo Pill Control | Frequency of Missing Study Pills Because Participant Was Away From Home | Sometimes | 26.88 % of participants in each category |
| Placebo Pill Control | Frequency of Missing Study Pills Because Participant Was Away From Home | Rarely | 20.43 % of participants in each category |
p-value: 0.7434Chi-squared
Primary
Frequency of Missing Study Pills Because Participant Was Too Busy With Other Things
Time frame: 24 Weeks
Population: Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Frequency of Missing Study Pills Because Participant Was Too Busy With Other Things | Never | 47.06 % of participants in each category |
| FTC/TDF as PrEP | Frequency of Missing Study Pills Because Participant Was Too Busy With Other Things | Rarely | 30.59 % of participants in each category |
| FTC/TDF as PrEP | Frequency of Missing Study Pills Because Participant Was Too Busy With Other Things | Sometimes | 15.29 % of participants in each category |
| FTC/TDF as PrEP | Frequency of Missing Study Pills Because Participant Was Too Busy With Other Things | Often | 7.06 % of participants in each category |
| Placebo Pill Control | Frequency of Missing Study Pills Because Participant Was Too Busy With Other Things | Often | 4.30 % of participants in each category |
| Placebo Pill Control | Frequency of Missing Study Pills Because Participant Was Too Busy With Other Things | Never | 58.06 % of participants in each category |
| Placebo Pill Control | Frequency of Missing Study Pills Because Participant Was Too Busy With Other Things | Sometimes | 21.51 % of participants in each category |
| Placebo Pill Control | Frequency of Missing Study Pills Because Participant Was Too Busy With Other Things | Rarely | 16.13 % of participants in each category |
p-value: 0.6153Chi-squared
Primary
Number of Missed Doses Based on Medication Refill Dates-Overall
Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.
Time frame: 20 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FTC/TDF as PrEP | Number of Missed Doses Based on Medication Refill Dates-Overall | 0 Missed doses |
| Placebo Pill Control | Number of Missed Doses Based on Medication Refill Dates-Overall | 0 Missed doses |
p-value: 0.8505Chi-squared
Primary
Number of Missed Doses Based on Medication Refill Dates-Week 12
Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.
Time frame: Week 12
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FTC/TDF as PrEP | Number of Missed Doses Based on Medication Refill Dates-Week 12 | 0 Missed doses |
| Placebo Pill Control | Number of Missed Doses Based on Medication Refill Dates-Week 12 | 0 Missed doses |
p-value: 0.9999Fisher Exact
Primary
Number of Missed Doses Based on Medication Refill Dates-Week 16
Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.
Time frame: Week 16
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FTC/TDF as PrEP | Number of Missed Doses Based on Medication Refill Dates-Week 16 | 0 Missed doses |
| Placebo Pill Control | Number of Missed Doses Based on Medication Refill Dates-Week 16 | 0 Missed doses |
p-value: 0.4003Fisher Exact
Primary
Number of Missed Doses Based on Medication Refill Dates-Week 20
Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.
Time frame: Week 20
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FTC/TDF as PrEP | Number of Missed Doses Based on Medication Refill Dates-Week 20 | 0 Missed doses |
| Placebo Pill Control | Number of Missed Doses Based on Medication Refill Dates-Week 20 | 0 Missed doses |
p-value: 0.6462Fisher Exact
Primary
Number of Missed Doses Based on Medication Refill Dates-Week 4
Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.
Time frame: Week 4
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FTC/TDF as PrEP | Number of Missed Doses Based on Medication Refill Dates-Week 4 | 0 Missed doses |
| Placebo Pill Control | Number of Missed Doses Based on Medication Refill Dates-Week 4 | 0 Missed doses |
p-value: 0.9999Fisher Exact
Primary
Number of Missed Doses Based on Medication Refill Dates-Week 8
Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.
Time frame: Week 8
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FTC/TDF as PrEP | Number of Missed Doses Based on Medication Refill Dates-Week 8 | 0 Missed doses |
| Placebo Pill Control | Number of Missed Doses Based on Medication Refill Dates-Week 8 | 0 Missed doses |
p-value: 0.9999Fisher Exact
Primary
Number of Missed Doses Based on Self-Report Calendar Data-Week 12
Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.
Time frame: Week 12
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FTC/TDF as PrEP | Number of Missed Doses Based on Self-Report Calendar Data-Week 12 | 10 Missed Doses |
| Placebo Pill Control | Number of Missed Doses Based on Self-Report Calendar Data-Week 12 | 6.5 Missed Doses |
p-value: 0.9999Fisher Exact
Primary
Number of Missed Doses Based on Self-Report Calendar Data-Week 16
Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.
Time frame: Week 16
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FTC/TDF as PrEP | Number of Missed Doses Based on Self-Report Calendar Data-Week 16 | 5 Missed Doses |
| Placebo Pill Control | Number of Missed Doses Based on Self-Report Calendar Data-Week 16 | 19 Missed Doses |
p-value: 0.7007Fisher Exact
Primary
Number of Missed Doses Based on Self-Report Calendar Data-Week 20
Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.
Time frame: Week 20
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FTC/TDF as PrEP | Number of Missed Doses Based on Self-Report Calendar Data-Week 20 | 5 Missed Doses |
| Placebo Pill Control | Number of Missed Doses Based on Self-Report Calendar Data-Week 20 | 10 Missed Doses |
p-value: 0.9999Fisher Exact
Primary
Number of Missed Doses Based on Self-Report Calendar Data-Week 24
Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.
Time frame: Week 24
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FTC/TDF as PrEP | Number of Missed Doses Based on Self-Report Calendar Data-Week 24 | 17 Missed Doses |
| Placebo Pill Control | Number of Missed Doses Based on Self-Report Calendar Data-Week 24 | 5.5 Missed Doses |
p-value: 0.9999Fisher Exact
Primary
Number of Missed Doses Based on Self-Report Calendar Data-Week 4
Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.
Time frame: 4 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FTC/TDF as PrEP | Number of Missed Doses Based on Self-Report Calendar Data-Week 4 | 10 Missed Doses |
| Placebo Pill Control | Number of Missed Doses Based on Self-Report Calendar Data-Week 4 | 10 Missed Doses |
p-value: 0.9999Fisher Exact
Primary
Number of Missed Doses Based on Self-Report Calendar Data-Week 8
Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.
Time frame: Week 8
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FTC/TDF as PrEP | Number of Missed Doses Based on Self-Report Calendar Data-Week 8 | 14 Missed Doses |
| Placebo Pill Control | Number of Missed Doses Based on Self-Report Calendar Data-Week 8 | 8 Missed Doses |
p-value: 0.9999Fisher Exact
Primary
Number of Missed Doses Over Time Based on Self-Report Calendar Data
The outcome measure presents the least square means from the generalized linear model. The outcome here is a binary variable that determines whether the subject missed a dose or not. In a binomial model with logit link, the least squares means are predicted population margins of the logits.
Time frame: 24 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| FTC/TDF as PrEP | Number of Missed Doses Over Time Based on Self-Report Calendar Data | 0.4752 Doses | Standard Error 0.3965 |
| Placebo Pill Control | Number of Missed Doses Over Time Based on Self-Report Calendar Data | 0.4021 Doses | Standard Error 0.3596 |
p-value: 0.8934Chi-squared
Primary
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 12
Time frame: Week 12
Population: Not all participants answered every question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 12 | Placebo | 6 participants |
| FTC/TDF as PrEP | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 12 | PrEP | 3 participants |
| FTC/TDF as PrEP | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 12 | Don't Know | 5 participants |
| FTC/TDF as PrEP | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 12 | Don't Understand Question | 0 participants |
| Placebo Pill Control | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 12 | Don't Understand Question | 0 participants |
| Placebo Pill Control | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 12 | Placebo | 6 participants |
| Placebo Pill Control | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 12 | Don't Know | 8 participants |
| Placebo Pill Control | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 12 | PrEP | 2 participants |
p-value: 0.7004Fisher Exact
Primary
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 16
Time frame: Week 16
Population: Not all participants answered every question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 16 | Placebo | 6 participants |
| FTC/TDF as PrEP | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 16 | PrEP | 2 participants |
| FTC/TDF as PrEP | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 16 | Don't Know | 4 participants |
| FTC/TDF as PrEP | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 16 | Don't Understand Question | 0 participants |
| Placebo Pill Control | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 16 | Don't Understand Question | 0 participants |
| Placebo Pill Control | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 16 | Placebo | 5 participants |
| Placebo Pill Control | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 16 | Don't Know | 9 participants |
| Placebo Pill Control | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 16 | PrEP | 1 participants |
p-value: 0.4668Fisher Exact
Primary
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 20
Time frame: Week 20
Population: Not all participants answered every question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 20 | Placebo | 4 participants |
| FTC/TDF as PrEP | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 20 | PrEP | 3 participants |
| FTC/TDF as PrEP | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 20 | Don't Know | 4 participants |
| FTC/TDF as PrEP | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 20 | Don't Understand Question | 0 participants |
| Placebo Pill Control | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 20 | Don't Understand Question | 0 participants |
| Placebo Pill Control | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 20 | Placebo | 6 participants |
| Placebo Pill Control | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 20 | Don't Know | 6 participants |
| Placebo Pill Control | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 20 | PrEP | 2 participants |
p-value: 0.7573Fisher Exact
Primary
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 24
Time frame: Week 24
Population: Not all participants answered every question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 24 | PrEP | 3 participants |
| FTC/TDF as PrEP | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 24 | Don't Understand Question | 0 participants |
| FTC/TDF as PrEP | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 24 | Don't Know | 4 participants |
| FTC/TDF as PrEP | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 24 | Placebo | 2 participants |
| Placebo Pill Control | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 24 | Placebo | 8 participants |
| Placebo Pill Control | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 24 | PrEP | 0 participants |
| Placebo Pill Control | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 24 | Don't Know | 4 participants |
| Placebo Pill Control | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 24 | Don't Understand Question | 0 participants |
p-value: 0.0356Fisher Exact
Primary
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 4
Time frame: Week 4
Population: Not all participants answered every question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 4 | Placebo | 9 participants |
| FTC/TDF as PrEP | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 4 | PrEP | 4 participants |
| FTC/TDF as PrEP | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 4 | Don't Know | 5 participants |
| FTC/TDF as PrEP | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 4 | Don't Understand Question | 1 participants |
| Placebo Pill Control | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 4 | Don't Understand Question | 1 participants |
| Placebo Pill Control | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 4 | Placebo | 10 participants |
| Placebo Pill Control | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 4 | Don't Know | 6 participants |
| Placebo Pill Control | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 4 | PrEP | 1 participants |
p-value: 0.7314Fisher Exact
Primary
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 8
Time frame: Week 8
Population: Not all participants answered every question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 8 | Placebo | 8 participants |
| FTC/TDF as PrEP | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 8 | PrEP | 5 participants |
| FTC/TDF as PrEP | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 8 | Don't Know | 4 participants |
| FTC/TDF as PrEP | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 8 | Don't Understand Question | 0 participants |
| Placebo Pill Control | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 8 | Don't Understand Question | 0 participants |
| Placebo Pill Control | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 8 | Placebo | 9 participants |
| Placebo Pill Control | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 8 | Don't Know | 7 participants |
| Placebo Pill Control | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 8 | PrEP | 2 participants |
p-value: 0.377Fisher Exact
Primary
Perceived HIV Risk Reduction at Week 12: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am less concerned about having unprotected anal sex now that I am in this PrEP study.
Time frame: Week 12
Population: Not all participants answered every question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 12: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Strongly Disagree | 57.14 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 12: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Disagree | 28.57 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 12: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Neutral | 7.14 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 12: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Agree | 7.14 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 12: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Strongly Agree | 0.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 12: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Disagree | 12.50 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 12: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Neutral | 6.25 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 12: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Agree | 0.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 12: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Strongly Disagree | 81.25 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 12: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Strongly Agree | 0.00 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 12: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Strongly Disagree | 50.00 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 12: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Strongly Agree | 0.00 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 12: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Disagree | 18.75 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 12: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Neutral | 25.00 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 12: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Agree | 6.25 percentage of participants |
p-value: 0.4207Fisher Exact
Primary
Perceived HIV Risk Reduction at Week 12: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: The availability of PrEP makes me less worried about having unprotected sex.
Time frame: Week 12
Population: Not all participants answered every question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 12: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Strongly Disagree | 73.33 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 12: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Disagree | 20.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 12: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Neutral | 6.67 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 12: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Strongly Agree | 0.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 12: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Agree | 0.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 12: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Disagree | 6.25 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 12: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Neutral | 6.25 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 12: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Agree | 0.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 12: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Strongly Agree | 6.25 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 12: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Strongly Disagree | 81.25 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 12: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Strongly Agree | 0.00 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 12: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Disagree | 18.75 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 12: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Strongly Disagree | 43.75 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 12: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Agree | 12.50 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 12: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Neutral | 25.00 percentage of participants |
p-value: 0.1747Fisher Exact
Primary
Perceived HIV Risk Reduction at Week 12: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex.
Time frame: Week 12
Population: Not all participants answered every question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 12: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Agree | 14.29 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 12: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Neutral | 21.43 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 12: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Disagree | 0.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 12: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Strongly Agree | 0.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 12: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Strongly Disagree | 64.29 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 12: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Agree | 6.25 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 12: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Strongly Disagree | 68.75 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 12: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Disagree | 12.50 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 12: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Neutral | 12.50 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 12: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Strongly Agree | 0.00 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 12: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Neutral | 18.75 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 12: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Strongly Disagree | 43.75 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 12: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Strongly Agree | 0.00 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 12: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Disagree | 18.75 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 12: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Agree | 18.75 percentage of participants |
p-value: 0.5826Fisher Exact
Primary
Perceived HIV Risk Reduction at Week 12: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I have already risked getting infected with HIV through unsafe sex while I've been on this study.
Time frame: Week 12
Population: Not all participants answered every question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 12: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Strongly Agree | 13.33 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 12: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Neutral | 13.33 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 12: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Strongly Disagree | 46.67 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 12: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Disagree | 13.33 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 12: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Agree | 13.33 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 12: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Neutral | 18.75 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 12: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Strongly Disagree | 68.75 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 12: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Disagree | 6.25 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 12: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Agree | 6.25 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 12: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Strongly Agree | 0.00 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 12: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Agree | 18.75 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 12: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Disagree | 25.00 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 12: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Strongly Agree | 12.50 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 12: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Neutral | 18.75 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 12: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Strongly Disagree | 25.00 percentage of participants |
p-value: 0.3791Fisher Exact
Primary
Perceived HIV Risk Reduction at Week 12: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am more willing to take a chance of getting infected now that I am in this PrEP study.
Time frame: Week 12
Population: Not all participants answered every question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 12: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Agree | 0.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 12: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Neutral | 6.67 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 12: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Strongly Disagree | 60.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 12: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Disagree | 33.33 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 12: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Strongly Agree | 0.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 12: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Neutral | 6.25 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 12: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Strongly Disagree | 93.75 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 12: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Disagree | 0.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 12: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Agree | 0.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 12: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Strongly Agree | 0.00 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 12: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Strongly Agree | 0.00 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 12: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Agree | 0.00 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 12: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Strongly Disagree | 68.75 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 12: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Neutral | 12.50 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 12: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Disagree | 18.75 percentage of participants |
p-value: 0.0945Fisher Exact
Primary
Perceived HIV Risk Reduction at Week 16: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am less concerned about having unprotected anal sex now that I am in this PrEP study.
Time frame: Week 16
Population: Not all participants answered every question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 16: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Agree | 0.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 16: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Neutral | 0.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 16: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Strongly Disagree | 75.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 16: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Disagree | 25.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 16: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Strongly Agree | 0.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 16: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Neutral | 13.33 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 16: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Strongly Disagree | 80.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 16: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Disagree | 6.67 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 16: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Agree | 0.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 16: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Strongly Agree | 0.00 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 16: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Strongly Agree | 7.14 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 16: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Agree | 7.14 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 16: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Strongly Disagree | 42.86 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 16: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Neutral | 14.29 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 16: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Disagree | 28.57 percentage of participants |
p-value: 0.2187Fisher Exact
Primary
Perceived HIV Risk Reduction at Week 16: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: The availability of PrEP makes me less worried about having unprotected sex.
Time frame: Week 16
Population: Not all participants answered every question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 16: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Agree | 0.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 16: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Neutral | 8.33 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 16: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Strongly Disagree | 58.33 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 16: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Disagree | 33.33 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 16: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Strongly Agree | 0.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 16: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Neutral | 13.33 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 16: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Strongly Disagree | 80.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 16: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Disagree | 6.67 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 16: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Agree | 0.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 16: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Strongly Agree | 0.00 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 16: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Strongly Agree | 14.29 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 16: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Agree | 0.00 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 16: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Strongly Disagree | 35.71 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 16: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Neutral | 28.57 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 16: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Disagree | 21.43 percentage of participants |
p-value: 0.1203Fisher Exact
Primary
Perceived HIV Risk Reduction at Week 16: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex.
Time frame: Week 16
Population: Not all participants answered every question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 16: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Strongly Disagree | 53.85 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 16: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Disagree | 15.38 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 16: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Neutral | 23.08 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 16: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Strongly Agree | 0.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 16: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Agree | 7.69 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 16: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Disagree | 0.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 16: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Neutral | 6.67 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 16: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Agree | 0.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 16: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Strongly Agree | 0.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 16: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Strongly Disagree | 93.33 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 16: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Strongly Agree | 7.14 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 16: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Disagree | 42.86 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 16: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Strongly Disagree | 42.86 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 16: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Agree | 0.00 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 16: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Neutral | 7.14 percentage of participants |
p-value: 0.0087Fisher Exact
Primary
Perceived HIV Risk Reduction at Week 16: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I have already risked getting infected with HIV through unsafe sex while I've been in this study.
Time frame: Week 16
Population: Not all participants answered every question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 16: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Agree | 7.69 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 16: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Neutral | 15.38 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 16: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Strongly Disagree | 46.15 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 16: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Disagree | 15.38 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 16: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Strongly Agree | 15.38 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 16: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Strongly Disagree | 66.67 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 16: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Disagree | 6.67 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 16: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Neutral | 6.67 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 16: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Agree | 20.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 16: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Strongly Agree | 0.00 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 16: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Strongly Agree | 14.29 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 16: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Agree | 21.43 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 16: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Strongly Disagree | 42.86 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 16: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Neutral | 7.14 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 16: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Disagree | 14.29 percentage of participants |
p-value: 0.7374Fisher Exact
Primary
Perceived HIV Risk Reduction at Week 16: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am more willing to take a chance of getting infected now that I am in this PrEP study.
Time frame: Week 16
Population: Not all participants answered every question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 16: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Agree | 8.33 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 16: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Neutral | 0.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 16: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Strongly Disagree | 66.67 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 16: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Disagree | 25.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 16: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Strongly Agree | 0.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 16: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Neutral | 0.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 16: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Strongly Disagree | 93.33 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 16: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Disagree | 6.67 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 16: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Agree | 0.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 16: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Strongly Agree | 0.00 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 16: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Strongly Agree | 7.14 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 16: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Agree | 7.14 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 16: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Strongly Disagree | 71.43 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 16: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Neutral | 7.14 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 16: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Disagree | 7.14 percentage of participants |
p-value: 0.3884Fisher Exact
Primary
Perceived HIV Risk Reduction at Week 20: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am less concerned about having unprotected anal sex now that I am in this PrEP study.
Time frame: Week 20
Population: Not all participants answered every question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 20: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Agree | 8.33 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 20: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Neutral | 0.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 20: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Strongly Disagree | 75.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 20: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Disagree | 16.67 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 20: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Strongly Agree | 0.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 20: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Neutral | 0.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 20: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Strongly Disagree | 92.86 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 20: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Disagree | 7.14 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 20: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Agree | 0.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 20: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Strongly Agree | 0.00 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 20: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Strongly Agree | 0.00 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 20: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Agree | 7.69 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 20: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Strongly Disagree | 61.54 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 20: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Neutral | 7.69 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 20: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Disagree | 23.08 percentage of participants |
p-value: 0.5369Fisher Exact
Primary
Perceived HIV Risk Reduction at Week 20: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: The availability of PrEP makes me less worried about having unprotected sex.
Time frame: Week 20
Population: Not all participants answered every question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 20: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Agree | 0.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 20: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Neutral | 8.33 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 20: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Strongly Disagree | 66.67 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 20: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Disagree | 25.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 20: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Strongly Agree | 0.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 20: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Neutral | 7.14 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 20: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Strongly Disagree | 78.57 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 20: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Disagree | 14.29 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 20: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Agree | 0.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 20: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Strongly Agree | 0.00 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 20: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Strongly Agree | 0.00 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 20: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Agree | 7.69 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 20: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Strongly Disagree | 53.85 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 20: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Neutral | 15.38 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 20: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Disagree | 23.08 percentage of participants |
p-value: 0.8243Fisher Exact
Primary
Perceived HIV Risk Reduction at Week 20: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex.
Time frame: Week 20
Population: Not all participants answered every question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 20: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Agree | 0.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 20: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Neutral | 0.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 20: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Strongly Disagree | 75.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 20: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Disagree | 25.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 20: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Strongly Agree | 0.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 20: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Neutral | 7.14 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 20: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Strongly Disagree | 78.57 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 20: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Disagree | 7.14 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 20: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Agree | 7.14 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 20: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Strongly Agree | 0.00 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 20: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Strongly Agree | 7.69 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 20: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Agree | 23.08 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 20: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Strongly Disagree | 38.46 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 20: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Neutral | 15.38 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 20: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Disagree | 15.38 percentage of participants |
p-value: 0.1934Fisher Exact
Primary
Perceived HIV Risk Reduction at Week 20: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I have already risked getting infected with HIV through unsafe sex while I've been in this study.
Time frame: Week 20
Population: Not all participants answered every question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 20: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Neutral | 8.33 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 20: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Disagree | 8.33 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 20: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Agree | 0.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 20: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Strongly Disagree | 75.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 20: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Strongly Agree | 8.33 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 20: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Neutral | 0.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 20: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Strongly Disagree | 71.43 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 20: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Disagree | 21.43 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 20: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Agree | 7.14 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 20: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Strongly Agree | 0.00 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 20: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Strongly Agree | 7.69 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 20: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Agree | 7.69 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 20: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Neutral | 7.69 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 20: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Disagree | 15.38 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 20: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Strongly Disagree | 61.54 percentage of participants |
p-value: 0.9363Fisher Exact
Primary
Perceived HIV Risk Reduction at Week 20: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am more willing to take a chance of getting infected now that I am in this PrEP study.
Time frame: Week 20
Population: Not all participants answered every question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 20: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Strongly Disagree | 91.67 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 20: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Disagree | 8.33 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 20: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Agree | 0.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 20: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Strongly Agree | 0.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 20: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Neutral | 0.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 20: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Neutral | 0.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 20: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Strongly Disagree | 92.86 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 20: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Strongly Agree | 0.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 20: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Agree | 0.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 20: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Disagree | 7.14 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 20: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Agree | 0.00 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 20: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Neutral | 7.69 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 20: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Disagree | 30.77 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 20: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Strongly Disagree | 61.54 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 20: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Strongly Agree | 0.00 percentage of participants |
p-value: 0.2235Fisher Exact
Primary
Perceived HIV Risk Reduction at Week 24: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am less concerned about having unprotected anal sex now that I am in this PrEP study.
Time frame: Week 24
Population: Not all participants answered every question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 24: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Agree | 0.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 24: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Neutral | 0.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 24: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Strongly Disagree | 60.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 24: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Disagree | 40.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 24: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Strongly Agree | 0.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 24: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Neutral | 0.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 24: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Strongly Disagree | 83.33 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 24: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Disagree | 16.67 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 24: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Agree | 0.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 24: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Strongly Agree | 0.00 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 24: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Strongly Agree | 7.69 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 24: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Agree | 7.69 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 24: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Strongly Disagree | 46.15 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 24: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Neutral | 23.08 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 24: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Disagree | 15.38 percentage of participants |
p-value: 0.1524Fisher Exact
Primary
Perceived HIV Risk Reduction at Week 24: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: The availability of PrEP makes me less worried about having unprotected sex.
Time frame: Week 24
Population: Not all participants answered every question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 24: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Agree | 10.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 24: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Neutral | 10.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 24: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Strongly Disagree | 50.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 24: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Disagree | 30.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 24: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Strongly Agree | 0.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 24: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Neutral | 8.33 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 24: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Strongly Disagree | 83.33 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 24: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Disagree | 8.33 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 24: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Agree | 0.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 24: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Strongly Agree | 0.00 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 24: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Strongly Agree | 0.00 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 24: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Agree | 15.38 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 24: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Strongly Disagree | 53.85 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 24: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Neutral | 15.38 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 24: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Disagree | 15.38 percentage of participants |
p-value: 0.6202Fisher Exact
Primary
Perceived HIV Risk Reduction at Week 24: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex.
Time frame: Week 24
Population: Not all participants answered every question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 24: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Agree | 0.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 24: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Neutral | 10.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 24: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Strongly Disagree | 50.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 24: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Disagree | 30.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 24: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Strongly Agree | 10.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 24: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Neutral | 0.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 24: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Strongly Disagree | 83.33 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 24: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Disagree | 16.67 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 24: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Agree | 0.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 24: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Strongly Agree | 0.00 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 24: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Strongly Agree | 0.00 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 24: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Agree | 15.38 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 24: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Strongly Disagree | 46.15 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 24: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Neutral | 23.08 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 24: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Disagree | 15.38 percentage of participants |
p-value: 0.2146Fisher Exact
Primary
Perceived HIV Risk Reduction at Week 24: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I have already risked getting infected with HIV through unsafe sex while I've been in this study.
Time frame: Week 24
Population: Not all participants answered every question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 24: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Strongly Agree | 20.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 24: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Neutral | 10.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 24: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Disagree | 10.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 24: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Agree | 10.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 24: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Strongly Disagree | 50.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 24: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Strongly Agree | 0.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 24: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Strongly Disagree | 66.67 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 24: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Disagree | 16.67 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 24: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Neutral | 8.33 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 24: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Agree | 8.33 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 24: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Strongly Disagree | 30.77 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 24: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Agree | 30.77 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 24: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Disagree | 15.38 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 24: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Strongly Agree | 7.69 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 24: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Neutral | 15.38 percentage of participants |
p-value: 0.6267Fisher Exact
Primary
Perceived HIV Risk Reduction at Week 24: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am more willing to take a chance of getting infected now that I am in this PrEP study.
Time frame: Week 24
Population: Not all participants answered every question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 24: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Neutral | 0.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 24: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Agree | 0.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 24: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Disagree | 20.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 24: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Strongly Agree | 0.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 24: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Strongly Disagree | 80.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 24: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Strongly Agree | 0.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 24: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Agree | 8.33 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 24: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Neutral | 0.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 24: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Disagree | 0.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 24: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Strongly Disagree | 91.67 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 24: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Agree | 0.00 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 24: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Strongly Disagree | 53.85 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 24: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Disagree | 23.08 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 24: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Neutral | 23.08 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 24: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Strongly Agree | 0.00 percentage of participants |
p-value: 0.0467Fisher Exact
Primary
Perceived HIV Risk Reduction at Week 4: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am less concerned about having unprotected anal sex now that I am in this PrEP study.
Time frame: Week 4
Population: Not all participants answered every question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 4: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Agree | 0.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 4: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Neutral | 15.79 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 4: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Strongly Disagree | 57.89 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 4: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Disagree | 26.32 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 4: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Strongly Agree | 0.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 4: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Neutral | 5.56 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 4: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Strongly Disagree | 66.67 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 4: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Disagree | 22.22 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 4: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Agree | 5.56 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 4: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Strongly Agree | 0.00 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 4: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Strongly Agree | 5.56 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 4: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Agree | 0.00 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 4: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Strongly Disagree | 50.00 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 4: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Neutral | 16.67 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 4: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Disagree | 27.78 percentage of participants |
p-value: 0.8351Fisher Exact
Primary
Perceived HIV Risk Reduction at Week 4: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: The availability of PrEP makes me less worried about having unprotected sex.
Time frame: Week 4
Population: Not all participants answered every question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 4: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Agree | 21.05 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 4: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Neutral | 10.53 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 4: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Strongly Disagree | 63.16 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 4: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Disagree | 5.26 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 4: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Strongly Agree | 0.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 4: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Neutral | 5.56 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 4: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Strongly Disagree | 66.67 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 4: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Disagree | 16.67 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 4: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Agree | 11.11 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 4: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Strongly Agree | 0.00 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 4: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Strongly Agree | 5.56 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 4: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Agree | 5.56 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 4: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Strongly Disagree | 55.56 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 4: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Neutral | 5.56 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 4: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Disagree | 27.78 percentage of participants |
p-value: 0.5317Fisher Exact
Primary
Perceived HIV Risk Reduction at Week 4: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex.
Time frame: Week 4
Population: Not all participants answered every question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 4: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Strongly Agree | 5.56 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 4: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Neutral | 11.11 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 4: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Disagree | 5.56 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 4: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Agree | 11.11 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 4: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Strongly Disagree | 66.67 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 4: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Agree | 5.56 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 4: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Strongly Agree | 5.56 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 4: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Strongly Disagree | 55.56 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 4: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Neutral | 5.56 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 4: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Disagree | 27.78 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 4: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Strongly Agree | 0.00 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 4: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Strongly Disagree | 55.56 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 4: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Disagree | 11.11 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 4: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Neutral | 16.67 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 4: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Agree | 16.67 percentage of participants |
p-value: 0.6331Fisher Exact
Primary
Perceived HIV Risk Reduction at Week 4: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I have already risked getting infected with HIV through unsafe sex while I've been in this study.
Time frame: Week 4
Population: Not all participants answered every question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 4: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Agree | 21.05 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 4: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Neutral | 10.53 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 4: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Strongly Disagree | 63.16 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 4: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Disagree | 5.26 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 4: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Strongly Agree | 0.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 4: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Neutral | 0.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 4: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Strongly Disagree | 50.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 4: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Disagree | 16.67 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 4: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Agree | 27.78 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 4: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Strongly Agree | 5.56 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 4: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Strongly Agree | 5.56 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 4: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Agree | 22.22 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 4: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Strongly Disagree | 44.44 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 4: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Neutral | 22.22 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 4: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Disagree | 5.56 percentage of participants |
p-value: 0.47Fisher Exact
Primary
Perceived HIV Risk Reduction at Week 4: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am more willing to take a chance of getting infected now that I am in this PrEP study.
Time frame: Week 4
Population: Not all participants answered every question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 4: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Strongly Agree | 0.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 4: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Neutral | 10.53 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 4: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Disagree | 5.26 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 4: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Strongly Disagree | 84.21 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 4: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Agree | 0.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 4: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Disagree | 5.56 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 4: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Agree | 5.56 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 4: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Strongly Agree | 5.56 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 4: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Strongly Disagree | 83.33 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 4: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Neutral | 0.00 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 4: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Strongly Agree | 0.00 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 4: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Strongly Disagree | 94.44 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 4: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Disagree | 0.00 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 4: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Agree | 0.00 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 4: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Neutral | 5.56 percentage of participants |
p-value: 0.7847Fisher Exact
Primary
Perceived HIV Risk Reduction at Week 8: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am less concerned about having unprotected anal sex now that I am in this PrEP study.
Time frame: Week 8
Population: Not all participants answered every question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 8: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Agree | 0.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 8: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Neutral | 23.53 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 8: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Strongly Disagree | 47.06 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 8: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Disagree | 23.53 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 8: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Strongly Agree | 5.88 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 8: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Neutral | 5.56 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 8: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Strongly Disagree | 83.33 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 8: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Disagree | 11.11 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 8: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Agree | 0.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 8: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Strongly Agree | 0.00 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 8: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Strongly Agree | 0.00 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 8: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Agree | 0.00 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 8: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Strongly Disagree | 35.29 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 8: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Neutral | 23.53 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 8: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Disagree | 41.18 percentage of participants |
p-value: 0.0484Fisher Exact
Primary
Perceived HIV Risk Reduction at Week 8: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: The availability of PrEP makes me less worried about having unprotected sex.
Time frame: Week 8
Population: Not all participants answered every question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 8: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Strongly Disagree | 58.82 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 8: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Strongly Agree | 5.88 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 8: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Neutral | 17.65 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 8: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Agree | 0.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 8: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Disagree | 17.65 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 8: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Strongly Agree | 0.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 8: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Neutral | 16.67 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 8: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Agree | 5.56 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 8: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Strongly Disagree | 66.67 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 8: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Disagree | 11.11 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 8: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Disagree | 23.53 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 8: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Strongly Disagree | 35.29 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 8: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Neutral | 11.76 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 8: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Strongly Agree | 0.00 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 8: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Agree | 29.41 percentage of participants |
p-value: 0.1733Fisher Exact
Primary
Perceived HIV Risk Reduction at Week 8: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex.
Time frame: Week 8
Population: Not all participants answered every question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 8: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Agree | 5.88 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 8: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Neutral | 17.65 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 8: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Strongly Disagree | 47.06 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 8: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Disagree | 29.41 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 8: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Strongly Agree | 0.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 8: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Neutral | 27.78 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 8: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Strongly Disagree | 66.67 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 8: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Disagree | 5.56 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 8: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Agree | 0.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 8: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Strongly Agree | 0.00 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 8: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Agree | 17.65 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 8: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Strongly Disagree | 35.29 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 8: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Neutral | 11.76 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 8: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Disagree | 35.29 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 8: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Strongly Agree | 0.00 percentage of participants |
p-value: 0.0948Fisher Exact
Primary
Perceived HIV Risk Reduction at Week 8: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I have already risked getting infected with HIV through unsafe sex while I've been in this study.
Time frame: Week 8
Population: Not all participants answered every question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 8: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Agree | 5.88 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 8: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Neutral | 17.65 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 8: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Strongly Disagree | 52.94 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 8: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Disagree | 5.88 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 8: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Strongly Agree | 17.65 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 8: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Neutral | 5.56 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 8: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Strongly Disagree | 61.11 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 8: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Disagree | 11.11 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 8: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Agree | 5.56 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 8: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Strongly Agree | 16.67 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 8: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Strongly Agree | 17.65 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 8: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Agree | 17.65 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 8: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Strongly Disagree | 23.53 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 8: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Neutral | 23.53 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 8: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Disagree | 17.65 percentage of participants |
p-value: 0.4686Fisher Exact
Primary
Perceived HIV Risk Reduction at Week 8: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am more willing to take a chance of getting infected now that I am in this PrEP study.
Time frame: Week 8
Population: Not all participants answered every question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 8: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Strongly Disagree | 68.75 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 8: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Strongly Agree | 0.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 8: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Disagree | 25.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 8: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Agree | 0.00 percentage of participants |
| FTC/TDF as PrEP | Perceived HIV Risk Reduction at Week 8: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Neutral | 6.25 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 8: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Neutral | 0.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 8: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Agree | 0.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 8: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Strongly Agree | 0.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 8: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Strongly Disagree | 100.00 percentage of participants |
| Placebo Pill Control | Perceived HIV Risk Reduction at Week 8: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Disagree | 0.00 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 8: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Disagree | 29.41 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 8: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Strongly Disagree | 64.71 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 8: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Neutral | 5.88 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 8: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Strongly Agree | 0.00 percentage of participants |
| No Pill Control | Perceived HIV Risk Reduction at Week 8: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Agree | 0.00 percentage of participants |
p-value: 0.0288Fisher Exact
Primary
Perceived Risk of Becoming HIV Positive at Week 12
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: Because I am in this PrEP study, I am less concerned about becoming HIV positive.
Time frame: Week 12
Population: Not all participants answered every question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Perceived Risk of Becoming HIV Positive at Week 12 | Neutral | 20.00 percentage of participants |
| FTC/TDF as PrEP | Perceived Risk of Becoming HIV Positive at Week 12 | Disagree | 40.00 percentage of participants |
| FTC/TDF as PrEP | Perceived Risk of Becoming HIV Positive at Week 12 | Agree | 0.00 percentage of participants |
| FTC/TDF as PrEP | Perceived Risk of Becoming HIV Positive at Week 12 | Strongly Disagree | 40.00 percentage of participants |
| FTC/TDF as PrEP | Perceived Risk of Becoming HIV Positive at Week 12 | Strongly Agree | 0.00 percentage of participants |
| Placebo Pill Control | Perceived Risk of Becoming HIV Positive at Week 12 | Strongly Disagree | 75.00 percentage of participants |
| Placebo Pill Control | Perceived Risk of Becoming HIV Positive at Week 12 | Disagree | 6.25 percentage of participants |
| Placebo Pill Control | Perceived Risk of Becoming HIV Positive at Week 12 | Neutral | 6.25 percentage of participants |
| Placebo Pill Control | Perceived Risk of Becoming HIV Positive at Week 12 | Agree | 12.50 percentage of participants |
| Placebo Pill Control | Perceived Risk of Becoming HIV Positive at Week 12 | Strongly Agree | 0.00 percentage of participants |
| No Pill Control | Perceived Risk of Becoming HIV Positive at Week 12 | Agree | 6.25 percentage of participants |
| No Pill Control | Perceived Risk of Becoming HIV Positive at Week 12 | Disagree | 37.50 percentage of participants |
| No Pill Control | Perceived Risk of Becoming HIV Positive at Week 12 | Strongly Disagree | 31.25 percentage of participants |
| No Pill Control | Perceived Risk of Becoming HIV Positive at Week 12 | Neutral | 12.50 percentage of participants |
| No Pill Control | Perceived Risk of Becoming HIV Positive at Week 12 | Strongly Agree | 12.50 percentage of participants |
p-value: 0.042Fisher Exact
Primary
Perceived Risk of Becoming HIV Positive at Week 16
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: Because I am in this PrEP study, I am less concerned about becoming HIV positive.
Time frame: Week 16
Population: Not all participants answered every question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Perceived Risk of Becoming HIV Positive at Week 16 | Agree | 8.33 percentage of partcipants |
| FTC/TDF as PrEP | Perceived Risk of Becoming HIV Positive at Week 16 | Neutral | 8.33 percentage of partcipants |
| FTC/TDF as PrEP | Perceived Risk of Becoming HIV Positive at Week 16 | Strongly Disagree | 58.33 percentage of partcipants |
| FTC/TDF as PrEP | Perceived Risk of Becoming HIV Positive at Week 16 | Disagree | 16.67 percentage of partcipants |
| FTC/TDF as PrEP | Perceived Risk of Becoming HIV Positive at Week 16 | Strongly Agree | 8.33 percentage of partcipants |
| Placebo Pill Control | Perceived Risk of Becoming HIV Positive at Week 16 | Neutral | 6.67 percentage of partcipants |
| Placebo Pill Control | Perceived Risk of Becoming HIV Positive at Week 16 | Strongly Disagree | 80.00 percentage of partcipants |
| Placebo Pill Control | Perceived Risk of Becoming HIV Positive at Week 16 | Disagree | 13.33 percentage of partcipants |
| Placebo Pill Control | Perceived Risk of Becoming HIV Positive at Week 16 | Agree | 0.00 percentage of partcipants |
| Placebo Pill Control | Perceived Risk of Becoming HIV Positive at Week 16 | Strongly Agree | 0.00 percentage of partcipants |
| No Pill Control | Perceived Risk of Becoming HIV Positive at Week 16 | Strongly Agree | 14.29 percentage of partcipants |
| No Pill Control | Perceived Risk of Becoming HIV Positive at Week 16 | Agree | 0.00 percentage of partcipants |
| No Pill Control | Perceived Risk of Becoming HIV Positive at Week 16 | Strongly Disagree | 42.86 percentage of partcipants |
| No Pill Control | Perceived Risk of Becoming HIV Positive at Week 16 | Neutral | 21.43 percentage of partcipants |
| No Pill Control | Perceived Risk of Becoming HIV Positive at Week 16 | Disagree | 21.43 percentage of partcipants |
p-value: 0.4906Fisher Exact
Primary
Perceived Risk of Becoming HIV Positive at Week 20
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: Because I am in this PrEP study, I am less concerned about becoming HIV positive.
Time frame: Week 20
Population: Not all participants answered every question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Perceived Risk of Becoming HIV Positive at Week 20 | Agree | 16.67 percentage of participants |
| FTC/TDF as PrEP | Perceived Risk of Becoming HIV Positive at Week 20 | Neutral | 0.00 percentage of participants |
| FTC/TDF as PrEP | Perceived Risk of Becoming HIV Positive at Week 20 | Strongly Disagree | 66.67 percentage of participants |
| FTC/TDF as PrEP | Perceived Risk of Becoming HIV Positive at Week 20 | Disagree | 16.67 percentage of participants |
| FTC/TDF as PrEP | Perceived Risk of Becoming HIV Positive at Week 20 | Strongly Agree | 0.00 percentage of participants |
| Placebo Pill Control | Perceived Risk of Becoming HIV Positive at Week 20 | Neutral | 0.00 percentage of participants |
| Placebo Pill Control | Perceived Risk of Becoming HIV Positive at Week 20 | Strongly Disagree | 78.57 percentage of participants |
| Placebo Pill Control | Perceived Risk of Becoming HIV Positive at Week 20 | Disagree | 21.43 percentage of participants |
| Placebo Pill Control | Perceived Risk of Becoming HIV Positive at Week 20 | Agree | 0.00 percentage of participants |
| Placebo Pill Control | Perceived Risk of Becoming HIV Positive at Week 20 | Strongly Agree | 0.00 percentage of participants |
| No Pill Control | Perceived Risk of Becoming HIV Positive at Week 20 | Agree | 7.69 percentage of participants |
| No Pill Control | Perceived Risk of Becoming HIV Positive at Week 20 | Strongly Disagree | 30.77 percentage of participants |
| No Pill Control | Perceived Risk of Becoming HIV Positive at Week 20 | Neutral | 23.08 percentage of participants |
| No Pill Control | Perceived Risk of Becoming HIV Positive at Week 20 | Disagree | 23.08 percentage of participants |
| No Pill Control | Perceived Risk of Becoming HIV Positive at Week 20 | Strongly Agree | 15.38 percentage of participants |
p-value: 0.0544Fisher Exact
Primary
Perceived Risk of Becoming HIV Positive at Week 24
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: Because I am in this PrEP study, I am less concerned about becoming HIV positive.
Time frame: Week 24
Population: Not all participants answered every question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Perceived Risk of Becoming HIV Positive at Week 24 | Agree | 10.00 percentage of participants |
| FTC/TDF as PrEP | Perceived Risk of Becoming HIV Positive at Week 24 | Neutral | 0.00 percentage of participants |
| FTC/TDF as PrEP | Perceived Risk of Becoming HIV Positive at Week 24 | Strongly Disagree | 60.00 percentage of participants |
| FTC/TDF as PrEP | Perceived Risk of Becoming HIV Positive at Week 24 | Disagree | 20.00 percentage of participants |
| FTC/TDF as PrEP | Perceived Risk of Becoming HIV Positive at Week 24 | Strongly Agree | 10.00 percentage of participants |
| Placebo Pill Control | Perceived Risk of Becoming HIV Positive at Week 24 | Neutral | 16.67 percentage of participants |
| Placebo Pill Control | Perceived Risk of Becoming HIV Positive at Week 24 | Strongly Disagree | 75.00 percentage of participants |
| Placebo Pill Control | Perceived Risk of Becoming HIV Positive at Week 24 | Disagree | 8.33 percentage of participants |
| Placebo Pill Control | Perceived Risk of Becoming HIV Positive at Week 24 | Agree | 0.00 percentage of participants |
| Placebo Pill Control | Perceived Risk of Becoming HIV Positive at Week 24 | Strongly Agree | 0.00 percentage of participants |
| No Pill Control | Perceived Risk of Becoming HIV Positive at Week 24 | Strongly Agree | 15.38 percentage of participants |
| No Pill Control | Perceived Risk of Becoming HIV Positive at Week 24 | Agree | 7.69 percentage of participants |
| No Pill Control | Perceived Risk of Becoming HIV Positive at Week 24 | Strongly Disagree | 38.46 percentage of participants |
| No Pill Control | Perceived Risk of Becoming HIV Positive at Week 24 | Neutral | 15.38 percentage of participants |
| No Pill Control | Perceived Risk of Becoming HIV Positive at Week 24 | Disagree | 23.08 percentage of participants |
p-value: 0.5645Fisher Exact
Primary
Perceived Risk of Becoming HIV Positive at Week 4
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: Because I am in this PrEP study, I am less concerned about becoming HIV positive.
Time frame: Week 4
Population: Not all participants answered every question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Perceived Risk of Becoming HIV Positive at Week 4 | Agree | 15.79 percentage of participants |
| FTC/TDF as PrEP | Perceived Risk of Becoming HIV Positive at Week 4 | Neutral | 10.53 percentage of participants |
| FTC/TDF as PrEP | Perceived Risk of Becoming HIV Positive at Week 4 | Strongly Disagree | 52.63 percentage of participants |
| FTC/TDF as PrEP | Perceived Risk of Becoming HIV Positive at Week 4 | Disagree | 21.05 percentage of participants |
| FTC/TDF as PrEP | Perceived Risk of Becoming HIV Positive at Week 4 | Strongly Agree | 0.00 percentage of participants |
| Placebo Pill Control | Perceived Risk of Becoming HIV Positive at Week 4 | Neutral | 11.11 percentage of participants |
| Placebo Pill Control | Perceived Risk of Becoming HIV Positive at Week 4 | Strongly Disagree | 38.89 percentage of participants |
| Placebo Pill Control | Perceived Risk of Becoming HIV Positive at Week 4 | Disagree | 33.33 percentage of participants |
| Placebo Pill Control | Perceived Risk of Becoming HIV Positive at Week 4 | Agree | 11.11 percentage of participants |
| Placebo Pill Control | Perceived Risk of Becoming HIV Positive at Week 4 | Strongly Agree | 5.56 percentage of participants |
| No Pill Control | Perceived Risk of Becoming HIV Positive at Week 4 | Strongly Agree | 16.67 percentage of participants |
| No Pill Control | Perceived Risk of Becoming HIV Positive at Week 4 | Agree | 0.00 percentage of participants |
| No Pill Control | Perceived Risk of Becoming HIV Positive at Week 4 | Strongly Disagree | 33.33 percentage of participants |
| No Pill Control | Perceived Risk of Becoming HIV Positive at Week 4 | Neutral | 27.78 percentage of participants |
| No Pill Control | Perceived Risk of Becoming HIV Positive at Week 4 | Disagree | 22.22 percentage of participants |
p-value: 0.3176Fisher Exact
Primary
Perceived Risk of Becoming HIV Positive at Week 8
Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: Because I am in this PrEP study, I am less concerned about becoming HIV positive.
Time frame: Week 8
Population: Not all participants answered every question
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FTC/TDF as PrEP | Perceived Risk of Becoming HIV Positive at Week 8 | Agree | 23.53 percentage of participants |
| FTC/TDF as PrEP | Perceived Risk of Becoming HIV Positive at Week 8 | Neutral | 23.53 percentage of participants |
| FTC/TDF as PrEP | Perceived Risk of Becoming HIV Positive at Week 8 | Strongly Disagree | 29.41 percentage of participants |
| FTC/TDF as PrEP | Perceived Risk of Becoming HIV Positive at Week 8 | Disagree | 17.65 percentage of participants |
| FTC/TDF as PrEP | Perceived Risk of Becoming HIV Positive at Week 8 | Strongly Agree | 5.88 percentage of participants |
| Placebo Pill Control | Perceived Risk of Becoming HIV Positive at Week 8 | Neutral | 0.00 percentage of participants |
| Placebo Pill Control | Perceived Risk of Becoming HIV Positive at Week 8 | Strongly Disagree | 66.67 percentage of participants |
| Placebo Pill Control | Perceived Risk of Becoming HIV Positive at Week 8 | Disagree | 27.78 percentage of participants |
| Placebo Pill Control | Perceived Risk of Becoming HIV Positive at Week 8 | Agree | 5.56 percentage of participants |
| Placebo Pill Control | Perceived Risk of Becoming HIV Positive at Week 8 | Strongly Agree | 0.00 percentage of participants |
| No Pill Control | Perceived Risk of Becoming HIV Positive at Week 8 | Strongly Agree | 5.88 percentage of participants |
| No Pill Control | Perceived Risk of Becoming HIV Positive at Week 8 | Agree | 11.76 percentage of participants |
| No Pill Control | Perceived Risk of Becoming HIV Positive at Week 8 | Strongly Disagree | 58.82 percentage of participants |
| No Pill Control | Perceived Risk of Becoming HIV Positive at Week 8 | Neutral | 11.76 percentage of participants |
| No Pill Control | Perceived Risk of Becoming HIV Positive at Week 8 | Disagree | 11.76 percentage of participants |
p-value: 0.1348Fisher Exact
Primary
Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Baseline
Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (\<10 ng/mL) were included in this count.
Time frame: Baseline
Population: Only two subjects in the Placebo Pill Control arm were randomly selected for tenofovir plasma concentration testing at baseline. All subjects in the FTC/TDF as PrEP arm had tenofovir plasma concentration testing and no subjects in the No Pill arm had tenofovir plasma concentration testing at baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FTC/TDF as PrEP | Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Baseline | 0 percentage of participants |
| Placebo Pill Control | Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Baseline | 0 percentage of participants |
Primary
Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 12
Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (\<10 ng/mL) were included in this count.
Time frame: Week 12
Population: One subject in the Placebo Pill Control arm was randomly selected for tenofovir plasma concentration testing at Week 12. 15 subjects in the FTC/TDF as PrEP arm had tenofovir plasma concentration testing and 1 subject in the No Pill arm had tenofovir plasma concentration testing at Week 12.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FTC/TDF as PrEP | Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 12 | 60 percentage of participants |
| Placebo Pill Control | Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 12 | 0 percentage of participants |
| No Pill Control | Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 12 | 0 percentage of participants |
Primary
Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 16
Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (\<10 ng/mL) were included in this count.
Time frame: Week 16
Population: 13 subjects in the Placebo Pill Control arm were randomly selected for tenofovir plasma concentration testing at Week 16. 13 subjects in the FTC/TDF as PrEP arm had tenofovir plasma concentration testing and 14 subjects in the No Pill arm had tenofovir plasma concentration testing at Week 16.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FTC/TDF as PrEP | Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 16 | 53.8 percentage of participants |
| Placebo Pill Control | Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 16 | 0 percentage of participants |
| No Pill Control | Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 16 | 0 percentage of participants |
Primary
Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 20
Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (\<10 ng/mL) were included in this count.
Time frame: Week 20
Population: One subject in the Placebo Pill Control arm was randomly selected for tenofovir plasma concentration testing at Week 20. 12 subjects in the FTC/TDF as PrEP arm had tenofovir plasma concentration testing and no subjects in the No Pill arm had tenofovir plasma concentration testing at Week 20.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FTC/TDF as PrEP | Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 20 | 41.7 percentage of participants |
| Placebo Pill Control | Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 20 | 0 percentage of participants |
Primary
Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 24
Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (\<10 ng/mL) were included in this count.
Time frame: Week 24
Population: No subjects in the Placebo Pill Control arm were randomly selected for tenofovir plasma concentration testing at Week 24. 10 subjects in the FTC/TDF as PrEP arm had tenofovir plasma concentration testing and no subjects in the No Pill arm had tenofovir plasma concentration testing at Week 24.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FTC/TDF as PrEP | Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 24 | 20 percentage of participants |
Primary
Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 4
Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (\<10 ng/mL) were included in this count.
Time frame: Week 4
Population: Only two subjects in the Placebo Pill Control arm were randomly selected for tenofovir plasma concentration testing at Week 4. 19 subjects in the FTC/TDF as PrEP arm had tenofovir plasma concentration testing and no subjects in the No Pill arm had tenofovir plasma concentration testing at Week 4.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FTC/TDF as PrEP | Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 4 | 63.2 percentage of participants |
| Placebo Pill Control | Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 4 | 0 percentage of participants |
Primary
Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 8
Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (\<10 ng/mL) were included in this count.
Time frame: Week 8
Population: 18 subjects in the Placebo Pill Control arm were randomly selected for tenofovir plasma concentration testing at Week 8. 17 subjects in the FTC/TDF as PrEP arm had tenofovir plasma concentration testing and 17 subjects in the No Pill arm had tenofovir plasma concentration testing at Week 8.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FTC/TDF as PrEP | Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 8 | 47.1 percentage of participants |
| Placebo Pill Control | Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 8 | 0 percentage of participants |
| No Pill Control | Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 8 | 0 percentage of participants |
Secondary
Number of Participants Reporting No High-Risk Man With Man Sex Acts at Baseline
A high-risk sex act was defined as an answer of greater than 0 to any of the following questions: With your male HIV positive male partners during the past month: How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?
Time frame: Baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FTC/TDF as PrEP | Number of Participants Reporting No High-Risk Man With Man Sex Acts at Baseline | 11 participants |
| Placebo Pill Control | Number of Participants Reporting No High-Risk Man With Man Sex Acts at Baseline | 11 participants |
| No Pill Control | Number of Participants Reporting No High-Risk Man With Man Sex Acts at Baseline | 12 participants |
p-value: 0.8722Fisher Exact
Secondary
Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 12
A high-risk sex act was defined as an answer of greater than 0 to any of the following questions: With your male HIV positive male partners during the past month: How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?
Time frame: Week 12
Population: Not all participants answered every question.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FTC/TDF as PrEP | Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 12 | 13 participants |
| Placebo Pill Control | Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 12 | 14 participants |
| No Pill Control | Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 12 | 12 participants |
p-value: 0.5778Fisher Exact
Secondary
Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 16
A high-risk sex act was defined as an answer of greater than 0 to any of the following questions: With your male HIV positive male partners during the past month: How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?
Time frame: Week 16
Population: Not all participants answered every question.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FTC/TDF as PrEP | Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 16 | 11 participants |
| Placebo Pill Control | Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 16 | 13 participants |
| No Pill Control | Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 16 | 12 participants |
p-value: 0.9881Fisher Exact
Secondary
Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 20
A high-risk sex act was defined as an answer of greater than 0 to any of the following questions: With your male HIV positive male partners during the past month: How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?
Time frame: Week 20
Population: Not all participants answered every question
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FTC/TDF as PrEP | Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 20 | 9 participants |
| Placebo Pill Control | Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 20 | 11 participants |
| No Pill Control | Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 20 | 10 participants |
p-value: 0.9771Fisher Exact
Secondary
Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 24
A high-risk sex act was defined as an answer of greater than 0 to any of the following questions: With your male HIV positive male partners during the past month: How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?
Time frame: Week 24
Population: Not all participants answered every question
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FTC/TDF as PrEP | Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 24 | 9 participants |
| Placebo Pill Control | Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 24 | 7 participants |
| No Pill Control | Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 24 | 10 participants |
p-value: 0.2301Fisher Exact
Secondary
Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 4
A high-risk sex act was defined as an answer of greater than 0 to any of the following questions: With your male HIV positive male partners during the past month: How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?
Time frame: Week 4
Population: Not all participants answered every question
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FTC/TDF as PrEP | Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 4 | 15 participants |
| Placebo Pill Control | Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 4 | 14 participants |
| No Pill Control | Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 4 | 12 participants |
p-value: 0.6434Fisher Exact
Secondary
Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 8
A high-risk sex act was defined as an answer of greater than 0 to any of the following questions: With your male HIV positive male partners during the past month: How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?
Time frame: Week 8
Population: Not all participants answered every question
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FTC/TDF as PrEP | Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 8 | 10 participants |
| Placebo Pill Control | Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 8 | 12 participants |
| No Pill Control | Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 8 | 10 participants |
p-value: 0.8582Fisher Exact