HIV Infection
Conditions
Keywords
HIV, PrEP, FTC/TDF, Truvada®
Brief summary
Approximately 200 HIV-uninfected young men who have sex with men (YMSM) at high risk of acquiring HIV infection, ages 18-22 years, inclusive, will be recruited across all participating Adolescent Medicine Trials Units (AMTU). The behavioral intervention will be assigned at the level of the site, which include Many Men, Many Voices (3MV) and Personalized Cognitive Counseling (PCC). Subjects will first complete the behavioral intervention offered at their respective site and then be provided with open label emtricitabine (FTC)/tenofovir (TDF) (Truvada®) as PrEP. Behavioral and biomedical data will be collected at baseline and 0, 4, 8, 12, 24, 36 and 48 weeks. Any subjects who become HIV infected during the course of the study will be discontinued from the study agent and followed for an additional 24 weeks after the study visit at which HIV infection is confirmed. Those subjects who meet specific bone or renal criteria at the Week 48 visit or the 24-Week HIV Seropositive visit will be followed for an additional 48 weeks in the Extension Phase to monitor longer-term outcomes of potential concerns.
Detailed description
The primary objectives of the study are to provide additional safety data regarding FTC/TDF (Truvada®) use as PrEP in YMSM, to examine acceptability, patterns of use, rates of adherence, measure levels of drug exposure and patterns of risk behavior when YMSM are provided open label FTC/TDF (Truvada®). The study will also examine information regarding safety and efficacy of FTC/TDF (Truvada®) as PrEP from prior studies.
Interventions
BEHAVIORAL3MV
Many Men, Many Voices (3MV) is based on Social Cognitive Theory and the Transtheoretical Model of Behavior Change. 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The other factors include cultural, social and religious norms, racial identity and degree of connectedness to communities, HIV/STI interactions, sexual relationship dynamics, and the social influences of racism and homophobia.
BEHAVIORALPCC
Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. Counselors ask the client to recall and describe in as much detail, a recent encounter of unprotected anal sex with another man of unknown or sero-discordant HIV status. The client then identifies and expresses thoughts, feelings, or attitudes that might have led to the high-risk behavior. The client and counselor examine and identify thoughts that may have led the client to decide to engage in high transmission risk sex. The client and counselor agree on strategies that can be used to deal with similar situations in the future.
All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Mental Health (NIMH)
University of North Carolina, Chapel Hill
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 22 Years
Healthy volunteers
Yes
Inclusion criteria
* Willing and able to provide written informed consent; * Male gender at birth; * Age 18 years and 0 days through 22 years and 364 days, inclusive, at the time of signed informed consent; * Self reports evidence of high risk for acquiring HIV infection including at least one of the following: * At least one episode of unprotected anal intercourse with an HIV-infected male partner or a male partner of unknown HIV status during the last 6 months; * Anal intercourse with 3 or more male sex partners during the last 6 months; * Exchange of money, gifts, shelter, or drugs for anal sex with a male partner during the last 6 months; * Sex with a male partner and has had a sexually transmitted infection (STI) during the last 6 months or at screening; * Sexual partner of an HIV-infected man with whom condoms were not consistently used in the last 6 months; or * At least one episode of anal intercourse where the condom broke or slipped off during the last 6 months; * Tests HIV antibody negative at time of screening; * Willing to provide locator information to study staff; * Willing to take pre-exposure prophylaxis (PrEP); * Willing to participate in behavioral intervention; * Reports intention not to relocate out of the Adolescent Medicine Trial Unit (AMTU) study area during the course of the study; and * Does not have a job or other obligations that would require long absences from the AMTU study area (greater than 4 weeks at a time).
Exclusion criteria
* Appears visibly distraught or presence of active serious psychiatric symptoms (e.g., active hallucinations, suicidal, homicidal, or exhibiting violent behavior) at the time of consent; * Intoxicated or under the influence of alcohol or other drugs at the time of consent; * Any significant uncontrolled, active or chronic disease process that, in the judgment of the site investigator, would make participation in the study inappropriate. (Appropriately managed conditions, like well-controlled diabetes, would not preclude enrollment; the site is encouraged to contact the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) 110 Protocol Team if they are having difficulty making the judgment.); * History of bone fractures not explained by trauma; * Acute or chronic hepatitis B infection as indicated by positive hepatitis B surface antigen (sAg) test at time of screening; * Confirmed renal dysfunction (Creatinine Clearance (CrCl) \< 75 ml/min, or serum creatinine ≥ upper limit of normal (ULN), or history of renal parenchymal disease or presence of only one kidney at time of screening; * Confirmed ≥ Grade 2 hypophosphatemia at time of screening; * Confirmed ≥ Grade 2 hematologic system abnormality (White Blood Count (WBC), Absolute Neutrophil Count (ANC), hemoglobin, or platelets) at time of screening; * Confirmed ≥ Grade 2 hepatobiliary system abnormality (Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), or bilirubin) at time of screening; * Confirmed proteinuria as indicated by urine dipstick result ≥ 1+ at time of screening, regardless of urine protein to creatinine ratio(UP/C); * UP/C \> 0.37 g/g at time of screening, regardless of urine dipstick protein result; * Confirmed normoglycemic glucosuria as indicated by urine dipstick result ≥ 1+ in the presence of normal serum glucose (\<120 mg/dL) at time of screening; * A confirmed Grade ≥ 3 toxicity on any screening evaluations; * Known allergy/sensitivity to the study agent or its components; * Concurrent participation in an HIV vaccine study or other investigational drug study, including oral or topical PrEP (microbicide) studies; * Use of disallowed medications ; or * Inability to understand spoken English.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serum Creatinine Event of Grade 1 or Higher | 48 Weeks | This measure addresses the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM Serum creatinine was tested at every study visit (Baseline through Week 48). The number of participants with a serum creatinine laboratory toxicity of Grade 1 or higher was assessed. Grade 1 (Mild) toxicity was defined as: 1.1 - 1.3 x ULN, where ULN is the Upper limit of normal. |
| Number of Participants With Decrease in Absolute Bone Mineral Density (BMD) From Baseline to Week 48 | 48 weeks | This outcome addresses the objective Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM. The total number of participants with dual-energy radiography absorptiometry scanning (DXA) data through Week 48 who experienced varying degrees of decrease in absolute BMD in at least one region (spine, hip, or whole body) between Baseline and Week 48. |
| Lumbar Spine Bone Mineral Density at Baseline and at Week 48 | Baseline, Week 48 | This outcome addresses the objective: Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM. Bone mineral density at Baseline and Week 48: data reported below for lumbar spine. |
| Femoral Neck Bone Mineral Density at Baseline and at Week 48 | Baseline, Week 48 | This outcome addresses the objective: Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM. Bone mineral density at Baseline and Week 48: data reported below for femoral neck. |
| Total Body Bone Mineral Density at Baseline and at Week 48 | Baseline, Week 48 | This outcome addresses the objective: Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM. Bone mineral density at Baseline and Week 48: data reported below for total body. |
| Total Hip Bone Mineral Density at Baseline and at Week 48 | Baseline, Week 48 | This outcome addresses the objective: Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM. Bone mineral density at Baseline and Week 48: data reported below for total hip. |
| Number of Participants With Unprotected Sex Acts | Baseline and 48 weeks | This outcome addresses the objective Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM, specifically behavioral disinhibition/risk compensation endpoints. Responses to the participant ACASI question referring to male partners in the past month/since the last survey: Of these males (male partners), how many did you have unprotected oral or anal sex with in the last month? (Baseline), or Of these males (male partners), how many did you have unprotected oral or anal sex with since the last time you took this survey? (Week 48) An event is defined as an answer of greater than 0. |
| Number of Sex Partners | Baseline and 48 weeks | This outcome addresses the objective Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM, specifically behavioral disinhibition/risk compensation endpoints. Responses to the participant ACASI question referring to number of male partners in the past month/since the last survey: During the past month, how many male partners have you had sexual contact with (oral or anal)? (Baseline), or Since the last time you took this survey, how many male partners have you had sexual contact with (oral or anal)? (Week 48) And responses to the participant ACASI question referring to number of HIV-positive male partners in the past month/since the last survey: Of those you had unprotected sex with, how many did you know were HIV positive? |
| Acceptability of PrEP: Distribution of Participant Feelings About Size of the Pill | Week 12 | This outcome addresses the objective: Acceptability When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies. Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions. This question reports on how the participants felt about the size of the pill. |
| Acceptability of PrEP: Distribution of Participant Feelings About Taste of the Pill | Week 12 | This outcome addresses the objective: Acceptability when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions. This specific outcome focuses on the question of how participants felt about the taste of the pill. |
| Acceptability of PrEP: Distribution of Participant Feelings About Color of the Pill | Week 12 | This outcome addresses the objective: Acceptability when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions. This specific outcome focuses on the question of how participants felt about the color of the pill. |
| Acceptability of PrEP: Distribution of Participant Feelings About Taking the Pill Every Day | Week 12 | This outcome addresses the objective: Acceptability when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies. Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions. This specific outcome focuses on the question of how participants felt about taking the pill every day. |
| Acceptability of PrEP: Distribution of Participant Feelings About Taking Part in the Study | Week 12 | This outcome addresses the objective Acceptability when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies. Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions. This specific outcome focuses on the question of how participants felt about taking part in the study. |
| Acceptability of PrEP: Distribution of Participant Feelings About HIV Test at Every Visit | Week 12 | This outcome addresses the objective: Acceptability When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies. Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions. This question reports on how the participants felt about having an HIV test at every visit. |
| Acceptability of PrEP: Distribution of Participant Feelings About Risk Reduction Counseling at Every Visit | Week 12 | This outcome addresses the objective: Acceptability When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies. Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions. This question reports on how the participants felt about having individual risk reduction counseling at every visit |
| Acceptability of PrEP: Distribution of Participant Feelings About Questions About Sexual Behavior | Week 12 | This outcome addresses the objective: Acceptability When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies. Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions. This question reports on how the participants felt about being asked questions about sexual behavior at every visit |
| Acceptability of PrEP: Distribution of Participant Feelings About Physician Exam | Week 12 | This outcome addresses the objective: Acceptability When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies. Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions. This question reports on how the participants felt about having a physician exam by a doctor |
| Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48 | This outcome addresses the objective: Patterns of Use, Rates of Adherence and Measured Levels of Drug Exposure When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies. PrEP medication levels were assessed via dried blood spot (DBS) collected at each visit to quantify intracellular TFV-DP and FTC-triphosphate concentrations. DBS results were translated into dosing categories previously used in PrEP trials with adult MSM. Dosing categories included below lower limit of quantitation (BLQ), lower limit of quantitation to 349 fmol per punch (fewer than 2 tablets per week), 350- 699 fmol per punch (2-3 tablets per week), 700-1250 fmol per punch (4 tablets per week), and \>1250 fmol per punch (daily). |
| Measured Levels of Drug Exposure (DBS RBC FTC-TP) When YMSM Are Provided Open Label FTC/TDF (Truvada®) | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48 | PrEP medication levels were assessed via dried blood spot (DBS) collected at each visit to quantify intracellular FTC-triphosphate concentrations. |
| Measured Levels of Drug Exposure (DBS RBC TFV-DP) When YMSM Are Provided Open Label FTC/TDF (Truvada®) | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48 | This outcome addresses the objective: Measured Levels of Drug Exposure (DBS RBC TFV-DP) When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies. PrEP medication levels were assessed via dried blood spot (DBS) collected at each visit to quantify intracellular TFV-DP concentrations. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability and Feasibility of Text Message Reminders: Number Discontinuing Text Messaging Reminders | 48 weeks | Number of subjects who discontinued receiving text message reminders while they were still on the study agent |
| Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 1: Away From Home) | 48 weeks | Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48. Question: In the past month, how often have you missed taking your study pills because you: Were away from home? |
| Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 2: Busy With Other Things) | 48 weeks | Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48. Question: In the past month, how often have you missed taking your study pills because you: Were too busy with other things? |
| Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 3: Simply Forgot) | 48 weeks | Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48. Question: In the past month, how often have you missed taking your study pills because you: Simply forgot? |
| Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 4: Too Many Pills) | 48 weeks | Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48. Question: In the past month, how often have you missed taking your study pills because you: Had too many study pills to take? |
| Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 6: Others Notice) | 48 weeks | Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48. Question: In the past month, how often have you missed taking your study pills because you: Did not want others to notice you taking meds? |
| Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 7: Routine Change) | 48 weeks | Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48. Question: In the past month, how often have you missed taking your study pills because you: Had a change in daily routine? |
| Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 8: Study Pill Harmful) | 48 weeks | Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48. Question: In the past month, how often have you missed taking your study pills because you: Felt like the study pill was toxic/harmful? |
| Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 9: Fell Asleep) | 48 weeks | Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48. Question: In the past month, how often have you missed taking your study pills because you: Fell asleep/slept through dose time? |
| Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 10: Felt Ill) | 48 weeks | Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48. Question: In the past month, how often have you missed taking your study pills because you: Felt sick or ill? |
| Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 11: Felt Depressed) | 48 weeks | Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48. Question: In the past month, how often have you missed taking your study pills because you: Felt depressed/overwhelmed? |
| Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 12: Ran Out of Pills) | 48 weeks | Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48. Question: In the past month, how often have you missed taking your study pills because you: Ran out of study pills? |
| Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 9 of 10: I Would Recommend This Workshop/Session to Others. | 48 weeks | Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session). Item 9 of 10: I would recommend this workshop/session to others. |
| Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 13: No Risky Sex) | 48 weeks | Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48. Question: In the past month, how often have you missed taking your study pills because you: Didn't think you needed it because you weren't having risk sex? |
| Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 1 of 10: I Learned a Lot From This Workshop/Session. | 48 weeks | Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session). Item 1 of 10: I learned a lot from this workshop/session |
| Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 2 of 10: I Will be Able to Apply What I Learned From This Workshop/Session in my Life. | 48 weeks | Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session). Item 2 of 10: I will be able to apply what I learned from this workshop/session in my life |
| Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 3 of 10: I Was Given an Opportunity to Participate and Discuss Information With Others. | 48 weeks | Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session). Item 3 of 10: I was given an opportunity to participate and discuss information with others |
| Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 4 of 10: The Workshop/Session Was Well Organized. | 48 weeks | Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session). Item 4 of 10: The workshop/session was well organized |
| Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 5 of 10: The Topic of This Workshop/Session Was Interesting. | 48 weeks | Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session). Item 5 of 10: The topic of this workshop/session was interesting |
| Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 6 of 10: The Presenter(s) Stimulated my Interest in the Material. | 48 weeks | Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session). Item 6 of 10: The presenter(s) stimulated my interest in the material |
| Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 7 of 10: The Topic of This Workshop/Session Was Relevant to my Life. | 48 weeks | Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session). Item 7 of 10: The topic of this workshop/session was relevant to my life |
| Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 8 of 10: The Workshop/Session Was Enjoyable. | 48 weeks | Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session). Item 8 of 10: The workshop/session was enjoyable. |
| Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 5: Side Effects) | 48 weeks | Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48. Question: In the past month, how often have you missed taking your study pills because you: Wanted to avoid side effects? |
| Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 10 of 10: I Felt Comfortable Participating in This Workshop/Session. | 48 weeks | Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session). Item 10 of 10: I felt comfortable participating in this workshop/session. |
| Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Age) | 48 weeks | Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use. PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not. This item concerns the subject's age at enrollment. |
| Explore Potential Demographic and/or Behavioral Differences Between Youth Who Are Interested in Participating in a PrEP Study Versus Those Who Are Not. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. | 48 weeks | — |
| Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Race, 5 Categories) | 48 weeks | Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use. PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not. This item concerns the subject's race (5 categories) |
| Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Race, 2 Categories) | 48 weeks | Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use. PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not. This item concerns the subject's race (2 categories) |
| Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Ethnicity, Hispanic vs. Non-Hispanic or Latino) | 48 weeks | Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use. PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not. This item concerns the subject's ethnicity, (Hispanic vs. Non-Hispanic or Latino) |
| Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (BMI, Categorical) | 48 weeks | Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use. PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not. This item concerns the subject's BMI (kg/m2), assessed categorically. |
| Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Log 10 Viral Load) | 48 weeks | Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use. PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not. This item concerns the subject's viral load, assessed here as Log 10 Viral Load (copies/ml) |
| Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (High Risk Sex Acts) | 48 weeks | Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use. PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not. This item concerns whether the subject reported any high risk sex acts with a male partner, defined as an answer of greater than 0 to the question Of these males (male partners), how many did you have unprotected oral or anal sex with since the last time you took this survey? |
| Acceptability and Feasibility of Text Message Reminders: Number Using Text Messaging Reminders | 48 weeks | Total number of subjects who signed up for text message reminders |
Countries
United States
Participant flow
Recruitment details
This research was conducted at 12 clinical sites. Accrual was open between July 2012 and September 2013.
Participants by arm
| Arm | Count |
|---|---|
| 3MV Behavioral Intervention Group 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks. | 128 |
| PCC Behavioral Intervention Group PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks. | 72 |
| Total | 200 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Behavioral Intervention (BL -3MV or PCC) | Inadvertent enrollment | 1 | 0 |
| Behavioral Intervention (BL -3MV or PCC) | Inelligible at rescreen | 2 | 1 |
| Behavioral Intervention (BL -3MV or PCC) | Lost to Follow-up | 1 | 0 |
| Behavioral Intervention (BL -3MV or PCC) | Moved out of area | 1 | 0 |
| Behavioral Intervention (BL -3MV or PCC) | Withdrawal by Subject | 1 | 1 |
| Behavioral Intervention (BL -3MV or PCC) | Wk 0 not completed, 30 days of baseline | 6 | 0 |
| Extension Phase (Visits 24,48wks Post tx | Became unavailable for study visits | 1 | 0 |
| Extension Phase (Visits 24,48wks Post tx | Lost to Follow-up | 6 | 5 |
| Extension Phase (Visits 24,48wks Post tx | Moved out of area | 2 | 2 |
| Extension Phase (Visits 24,48wks Post tx | Withdrawal by Subject | 1 | 2 |
| Treatment Phase (Week 0- Week 48) | Incarcerated | 1 | 0 |
| Treatment Phase (Week 0- Week 48) | Lost to Follow-up | 15 | 13 |
| Treatment Phase (Week 0- Week 48) | Moved out of area | 4 | 3 |
| Treatment Phase (Week 0- Week 48) | Suicide gesture/disruptive behavior | 1 | 0 |
| Treatment Phase (Week 0- Week 48) | Withdrawal by Subject | 6 | 1 |
| Treatment Phase (Week 0- Week 48) | Wk 0 not completed, 30 days of baseline | 1 | 1 |
Baseline characteristics
| Characteristic | Total | 3MV Behavioral Intervention Group | PCC Behavioral Intervention Group |
|---|---|---|---|
| Age, Continuous | 20.18 years STANDARD_DEVIATION 1.34 | 20.14 years STANDARD_DEVIATION 1.4 | 20.25 years STANDARD_DEVIATION 1.23 |
| BMI Normal (18.5-<25 kg/m^2) | 109 Participants | 71 Participants | 38 Participants |
| BMI Obese (=>30 kg/m^2) | 39 Participants | 29 Participants | 10 Participants |
| BMI Overweight (25.0-<30 kg/m^2) | 43 Participants | 25 Participants | 18 Participants |
| BMI Underweight (<18.5 kg/m^2) | 9 Participants | 3 Participants | 6 Participants |
| Race/Ethnicity, Customized Hispanic Ethnicity Hispanic | 53 Participants | 39 Participants | 14 Participants |
| Race/Ethnicity, Customized Hispanic Ethnicity Non-Hispanic | 145 Participants | 89 Participants | 56 Participants |
| Race/Ethnicity, Customized Hispanic Ethnicity Refused | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Race/ethnicity Asian/Pacific Islander | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/ethnicity Black/African American | 93 Participants | 55 Participants | 38 Participants |
| Race/Ethnicity, Customized Race/ethnicity Other/Mixed Race | 42 Participants | 30 Participants | 12 Participants |
| Race/Ethnicity, Customized Race/ethnicity White | 42 Participants | 26 Participants | 16 Participants |
| Race/Ethnicity, Customized Race/ethnicity White/Hispanic | 21 Participants | 15 Participants | 6 Participants |
| Region of Enrollment United States | 200 Participants | 128 Participants | 72 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 200 Participants | 128 Participants | 72 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 128 | 0 / 72 |
| other Total, other adverse events | 10 / 128 | 4 / 72 |
| serious Total, serious adverse events | 7 / 128 | 1 / 72 |
Outcome results
Primary
Acceptability of PrEP: Distribution of Participant Feelings About Color of the Pill
This outcome addresses the objective: Acceptability when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions. This specific outcome focuses on the question of how participants felt about the color of the pill.
Time frame: Week 12
Population: Participants enrolled at Week 12 who provided a response to this question.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Study Participants | Acceptability of PrEP: Distribution of Participant Feelings About Color of the Pill | Did not like it at all | 3 Participants |
| All Study Participants | Acceptability of PrEP: Distribution of Participant Feelings About Color of the Pill | Did not like | 7 Participants |
| All Study Participants | Acceptability of PrEP: Distribution of Participant Feelings About Color of the Pill | Liked | 73 Participants |
| All Study Participants | Acceptability of PrEP: Distribution of Participant Feelings About Color of the Pill | Liked a lot | 18 Participants |
| PCC Behavioral Intervention Group | Acceptability of PrEP: Distribution of Participant Feelings About Color of the Pill | Liked a lot | 5 Participants |
| PCC Behavioral Intervention Group | Acceptability of PrEP: Distribution of Participant Feelings About Color of the Pill | Did not like it at all | 2 Participants |
| PCC Behavioral Intervention Group | Acceptability of PrEP: Distribution of Participant Feelings About Color of the Pill | Liked | 48 Participants |
| PCC Behavioral Intervention Group | Acceptability of PrEP: Distribution of Participant Feelings About Color of the Pill | Did not like | 6 Participants |
p-value: 0.3761Chi-squared
Primary
Acceptability of PrEP: Distribution of Participant Feelings About HIV Test at Every Visit
This outcome addresses the objective: Acceptability When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies. Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions. This question reports on how the participants felt about having an HIV test at every visit.
Time frame: Week 12
Population: Participants enrolled at Week 12 who provided a response to this question.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Study Participants | Acceptability of PrEP: Distribution of Participant Feelings About HIV Test at Every Visit | Did not like it at all | 1 Participants |
| All Study Participants | Acceptability of PrEP: Distribution of Participant Feelings About HIV Test at Every Visit | Did not like | 1 Participants |
| All Study Participants | Acceptability of PrEP: Distribution of Participant Feelings About HIV Test at Every Visit | Liked | 29 Participants |
| All Study Participants | Acceptability of PrEP: Distribution of Participant Feelings About HIV Test at Every Visit | Liked a lot | 71 Participants |
| PCC Behavioral Intervention Group | Acceptability of PrEP: Distribution of Participant Feelings About HIV Test at Every Visit | Liked a lot | 42 Participants |
| PCC Behavioral Intervention Group | Acceptability of PrEP: Distribution of Participant Feelings About HIV Test at Every Visit | Did not like it at all | 0 Participants |
| PCC Behavioral Intervention Group | Acceptability of PrEP: Distribution of Participant Feelings About HIV Test at Every Visit | Liked | 15 Participants |
| PCC Behavioral Intervention Group | Acceptability of PrEP: Distribution of Participant Feelings About HIV Test at Every Visit | Did not like | 4 Participants |
p-value: 0.1968Chi-squared
Primary
Acceptability of PrEP: Distribution of Participant Feelings About Physician Exam
This outcome addresses the objective: Acceptability When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies. Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions. This question reports on how the participants felt about having a physician exam by a doctor
Time frame: Week 12
Population: Participants enrolled at Week 12 who provided a response to this question.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Study Participants | Acceptability of PrEP: Distribution of Participant Feelings About Physician Exam | Did not like it at all | 1 Participants |
| All Study Participants | Acceptability of PrEP: Distribution of Participant Feelings About Physician Exam | Did not like | 13 Participants |
| All Study Participants | Acceptability of PrEP: Distribution of Participant Feelings About Physician Exam | Liked | 54 Participants |
| All Study Participants | Acceptability of PrEP: Distribution of Participant Feelings About Physician Exam | Liked a lot | 33 Participants |
| PCC Behavioral Intervention Group | Acceptability of PrEP: Distribution of Participant Feelings About Physician Exam | Liked a lot | 18 Participants |
| PCC Behavioral Intervention Group | Acceptability of PrEP: Distribution of Participant Feelings About Physician Exam | Did not like it at all | 1 Participants |
| PCC Behavioral Intervention Group | Acceptability of PrEP: Distribution of Participant Feelings About Physician Exam | Liked | 38 Participants |
| PCC Behavioral Intervention Group | Acceptability of PrEP: Distribution of Participant Feelings About Physician Exam | Did not like | 4 Participants |
p-value: 0.5285Chi-squared
Primary
Acceptability of PrEP: Distribution of Participant Feelings About Questions About Sexual Behavior
This outcome addresses the objective: Acceptability When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies. Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions. This question reports on how the participants felt about being asked questions about sexual behavior at every visit
Time frame: Week 12
Population: Participants enrolled at Week 12 who provided a response to this question.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Study Participants | Acceptability of PrEP: Distribution of Participant Feelings About Questions About Sexual Behavior | Did not like it at all | 1 Participants |
| All Study Participants | Acceptability of PrEP: Distribution of Participant Feelings About Questions About Sexual Behavior | Did not like | 8 Participants |
| All Study Participants | Acceptability of PrEP: Distribution of Participant Feelings About Questions About Sexual Behavior | Liked | 61 Participants |
| All Study Participants | Acceptability of PrEP: Distribution of Participant Feelings About Questions About Sexual Behavior | Liked a lot | 31 Participants |
| PCC Behavioral Intervention Group | Acceptability of PrEP: Distribution of Participant Feelings About Questions About Sexual Behavior | Liked a lot | 16 Participants |
| PCC Behavioral Intervention Group | Acceptability of PrEP: Distribution of Participant Feelings About Questions About Sexual Behavior | Did not like it at all | 1 Participants |
| PCC Behavioral Intervention Group | Acceptability of PrEP: Distribution of Participant Feelings About Questions About Sexual Behavior | Liked | 31 Participants |
| PCC Behavioral Intervention Group | Acceptability of PrEP: Distribution of Participant Feelings About Questions About Sexual Behavior | Did not like | 13 Participants |
p-value: 0.0994Chi-squared
Primary
Acceptability of PrEP: Distribution of Participant Feelings About Risk Reduction Counseling at Every Visit
This outcome addresses the objective: Acceptability When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies. Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions. This question reports on how the participants felt about having individual risk reduction counseling at every visit
Time frame: Week 12
Population: Participants enrolled at Week 12 who provided a response to this question.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Study Participants | Acceptability of PrEP: Distribution of Participant Feelings About Risk Reduction Counseling at Every Visit | Did not like it at all | 2 Participants |
| All Study Participants | Acceptability of PrEP: Distribution of Participant Feelings About Risk Reduction Counseling at Every Visit | Did not like | 1 Participants |
| All Study Participants | Acceptability of PrEP: Distribution of Participant Feelings About Risk Reduction Counseling at Every Visit | Liked | 38 Participants |
| All Study Participants | Acceptability of PrEP: Distribution of Participant Feelings About Risk Reduction Counseling at Every Visit | Liked a lot | 61 Participants |
| PCC Behavioral Intervention Group | Acceptability of PrEP: Distribution of Participant Feelings About Risk Reduction Counseling at Every Visit | Liked a lot | 32 Participants |
| PCC Behavioral Intervention Group | Acceptability of PrEP: Distribution of Participant Feelings About Risk Reduction Counseling at Every Visit | Did not like it at all | 1 Participants |
| PCC Behavioral Intervention Group | Acceptability of PrEP: Distribution of Participant Feelings About Risk Reduction Counseling at Every Visit | Liked | 23 Participants |
| PCC Behavioral Intervention Group | Acceptability of PrEP: Distribution of Participant Feelings About Risk Reduction Counseling at Every Visit | Did not like | 5 Participants |
p-value: 0.1226Chi-squared
Primary
Acceptability of PrEP: Distribution of Participant Feelings About Size of the Pill
This outcome addresses the objective: Acceptability When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies. Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions. This question reports on how the participants felt about the size of the pill.
Time frame: Week 12
Population: Participants enrolled at Week 12 who provided a response to this question.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Study Participants | Acceptability of PrEP: Distribution of Participant Feelings About Size of the Pill | Did not like it at all | 13 Participants |
| All Study Participants | Acceptability of PrEP: Distribution of Participant Feelings About Size of the Pill | Did not like | 26 Participants |
| All Study Participants | Acceptability of PrEP: Distribution of Participant Feelings About Size of the Pill | Liked | 60 Participants |
| All Study Participants | Acceptability of PrEP: Distribution of Participant Feelings About Size of the Pill | Liked a lot | 2 Participants |
| PCC Behavioral Intervention Group | Acceptability of PrEP: Distribution of Participant Feelings About Size of the Pill | Liked a lot | 2 Participants |
| PCC Behavioral Intervention Group | Acceptability of PrEP: Distribution of Participant Feelings About Size of the Pill | Did not like it at all | 5 Participants |
| PCC Behavioral Intervention Group | Acceptability of PrEP: Distribution of Participant Feelings About Size of the Pill | Liked | 36 Participants |
| PCC Behavioral Intervention Group | Acceptability of PrEP: Distribution of Participant Feelings About Size of the Pill | Did not like | 18 Participants |
p-value: 0.7513Chi-squared
Primary
Acceptability of PrEP: Distribution of Participant Feelings About Taking Part in the Study
This outcome addresses the objective Acceptability when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies. Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions. This specific outcome focuses on the question of how participants felt about taking part in the study.
Time frame: Week 12
Population: Participants enrolled at Week 12 who provided a response to this question.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Study Participants | Acceptability of PrEP: Distribution of Participant Feelings About Taking Part in the Study | Did not like | 2 Participants |
| All Study Participants | Acceptability of PrEP: Distribution of Participant Feelings About Taking Part in the Study | Liked | 35 Participants |
| All Study Participants | Acceptability of PrEP: Distribution of Participant Feelings About Taking Part in the Study | Liked a lot | 64 Participants |
| All Study Participants | Acceptability of PrEP: Distribution of Participant Feelings About Taking Part in the Study | Did not like it at all | 1 Participants |
| PCC Behavioral Intervention Group | Acceptability of PrEP: Distribution of Participant Feelings About Taking Part in the Study | Liked | 29 Participants |
| PCC Behavioral Intervention Group | Acceptability of PrEP: Distribution of Participant Feelings About Taking Part in the Study | Did not like it at all | 1 Participants |
| PCC Behavioral Intervention Group | Acceptability of PrEP: Distribution of Participant Feelings About Taking Part in the Study | Did not like | 1 Participants |
| PCC Behavioral Intervention Group | Acceptability of PrEP: Distribution of Participant Feelings About Taking Part in the Study | Liked a lot | 30 Participants |
p-value: 0.3801Chi-squared
Primary
Acceptability of PrEP: Distribution of Participant Feelings About Taking the Pill Every Day
This outcome addresses the objective: Acceptability when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies. Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions. This specific outcome focuses on the question of how participants felt about taking the pill every day.
Time frame: Week 12
Population: Participants enrolled at Week 12 who provided a response to this question.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Study Participants | Acceptability of PrEP: Distribution of Participant Feelings About Taking the Pill Every Day | Did not like it at all | 6 Participants |
| All Study Participants | Acceptability of PrEP: Distribution of Participant Feelings About Taking the Pill Every Day | Liked | 63 Participants |
| All Study Participants | Acceptability of PrEP: Distribution of Participant Feelings About Taking the Pill Every Day | Did not like | 24 Participants |
| All Study Participants | Acceptability of PrEP: Distribution of Participant Feelings About Taking the Pill Every Day | Liked a lot | 7 Participants |
| PCC Behavioral Intervention Group | Acceptability of PrEP: Distribution of Participant Feelings About Taking the Pill Every Day | Liked a lot | 8 Participants |
| PCC Behavioral Intervention Group | Acceptability of PrEP: Distribution of Participant Feelings About Taking the Pill Every Day | Did not like it at all | 4 Participants |
| PCC Behavioral Intervention Group | Acceptability of PrEP: Distribution of Participant Feelings About Taking the Pill Every Day | Did not like | 17 Participants |
| PCC Behavioral Intervention Group | Acceptability of PrEP: Distribution of Participant Feelings About Taking the Pill Every Day | Liked | 31 Participants |
p-value: 0.4359Chi-squared
Primary
Acceptability of PrEP: Distribution of Participant Feelings About Taste of the Pill
This outcome addresses the objective: Acceptability when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions. This specific outcome focuses on the question of how participants felt about the taste of the pill.
Time frame: Week 12
Population: Participants enrolled at Week 12 who provided a response to this question.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Study Participants | Acceptability of PrEP: Distribution of Participant Feelings About Taste of the Pill | Did not like it at all | 11 Participants |
| All Study Participants | Acceptability of PrEP: Distribution of Participant Feelings About Taste of the Pill | Did not like | 33 Participants |
| All Study Participants | Acceptability of PrEP: Distribution of Participant Feelings About Taste of the Pill | Liked | 53 Participants |
| All Study Participants | Acceptability of PrEP: Distribution of Participant Feelings About Taste of the Pill | Liked a lot | 3 Participants |
| PCC Behavioral Intervention Group | Acceptability of PrEP: Distribution of Participant Feelings About Taste of the Pill | Liked a lot | 1 Participants |
| PCC Behavioral Intervention Group | Acceptability of PrEP: Distribution of Participant Feelings About Taste of the Pill | Did not like it at all | 8 Participants |
| PCC Behavioral Intervention Group | Acceptability of PrEP: Distribution of Participant Feelings About Taste of the Pill | Liked | 29 Participants |
| PCC Behavioral Intervention Group | Acceptability of PrEP: Distribution of Participant Feelings About Taste of the Pill | Did not like | 23 Participants |
p-value: 0.8281Chi-squared
Primary
Femoral Neck Bone Mineral Density at Baseline and at Week 48
This outcome addresses the objective: Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM. Bone mineral density at Baseline and Week 48: data reported below for femoral neck.
Time frame: Baseline, Week 48
Population: Participants with DXA results. (Baseline N=197, Week 48 N=135). The primary objective Additional safety data regarding FTC/TDF (Truvada®) use does not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Study Participants | Femoral Neck Bone Mineral Density at Baseline and at Week 48 | Femoral neck BMD at baseline | 1.04 g/cm2 | Standard Deviation 0.18 |
| All Study Participants | Femoral Neck Bone Mineral Density at Baseline and at Week 48 | Femoral neck Week 48 | 1.03 g/cm2 | Standard Deviation 0.2 |
Primary
Lumbar Spine Bone Mineral Density at Baseline and at Week 48
This outcome addresses the objective: Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM. Bone mineral density at Baseline and Week 48: data reported below for lumbar spine.
Time frame: Baseline, Week 48
Population: Participants with DXA results. (Baseline N=197, Week 48 N=135). The primary objective Additional safety data regarding FTC/TDF (Truvada®) use does not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Study Participants | Lumbar Spine Bone Mineral Density at Baseline and at Week 48 | Lumbar spine BMD at baseline | 1.09 g/cm2 | Standard Deviation 0.15 |
| All Study Participants | Lumbar Spine Bone Mineral Density at Baseline and at Week 48 | Lumbar spine BMD Week 48 | 1.08 g/cm2 | Standard Deviation 0.14 |
Primary
Measured Levels of Drug Exposure (DBS RBC FTC-TP) When YMSM Are Provided Open Label FTC/TDF (Truvada®)
PrEP medication levels were assessed via dried blood spot (DBS) collected at each visit to quantify intracellular FTC-triphosphate concentrations.
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48
Population: Enrolled subjects (Individual row Ns vary due to the number of subjects per week enrolled at that time point and with DBS data) This primary objective did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Study Participants | Measured Levels of Drug Exposure (DBS RBC FTC-TP) When YMSM Are Provided Open Label FTC/TDF (Truvada®) | DBS RBC FTC-TP at Week 4 | 0.20 pmol/punch | Standard Deviation 0.11 |
| All Study Participants | Measured Levels of Drug Exposure (DBS RBC FTC-TP) When YMSM Are Provided Open Label FTC/TDF (Truvada®) | DBS RBC FTC-TP at Week 8 | 0.19 pmol/punch | Standard Deviation 0.12 |
| All Study Participants | Measured Levels of Drug Exposure (DBS RBC FTC-TP) When YMSM Are Provided Open Label FTC/TDF (Truvada®) | DBS RBC FTC-TP at Week 12 | 0.18 pmol/punch | Standard Deviation 0.12 |
| All Study Participants | Measured Levels of Drug Exposure (DBS RBC FTC-TP) When YMSM Are Provided Open Label FTC/TDF (Truvada®) | DBS RBC FTC-TP at Week 24 | 0.16 pmol/punch | Standard Deviation 0.12 |
| All Study Participants | Measured Levels of Drug Exposure (DBS RBC FTC-TP) When YMSM Are Provided Open Label FTC/TDF (Truvada®) | DBS RBC FTC-TP at Week 36 | 0.17 pmol/punch | Standard Deviation 0.13 |
| All Study Participants | Measured Levels of Drug Exposure (DBS RBC FTC-TP) When YMSM Are Provided Open Label FTC/TDF (Truvada®) | DBS RBC FTC-TP at Week 48 | 0.15 pmol/punch | Standard Deviation 0.13 |
Primary
Measured Levels of Drug Exposure (DBS RBC TFV-DP) When YMSM Are Provided Open Label FTC/TDF (Truvada®)
This outcome addresses the objective: Measured Levels of Drug Exposure (DBS RBC TFV-DP) When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies. PrEP medication levels were assessed via dried blood spot (DBS) collected at each visit to quantify intracellular TFV-DP concentrations.
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48
Population: Enrolled subjects (Individual row Ns vary due to the number of subjects per week enrolled at that time point and with DBS data) This primary objective did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Study Participants | Measured Levels of Drug Exposure (DBS RBC TFV-DP) When YMSM Are Provided Open Label FTC/TDF (Truvada®) | DBS RBC TFV-DP at Week 4 | 584.56 fmol/punch | Standard Deviation 365.37 |
| All Study Participants | Measured Levels of Drug Exposure (DBS RBC TFV-DP) When YMSM Are Provided Open Label FTC/TDF (Truvada®) | DBS RBC TFV-DP at Week 8 | 783.18 fmol/punch | Standard Deviation 505.67 |
| All Study Participants | Measured Levels of Drug Exposure (DBS RBC TFV-DP) When YMSM Are Provided Open Label FTC/TDF (Truvada®) | DBS RBC TFV-DP at Week 12 | 793.37 fmol/punch | Standard Deviation 548.87 |
| All Study Participants | Measured Levels of Drug Exposure (DBS RBC TFV-DP) When YMSM Are Provided Open Label FTC/TDF (Truvada®) | DBS RBC TFV-DP at Week 24 | 657.66 fmol/punch | Standard Deviation 619.06 |
| All Study Participants | Measured Levels of Drug Exposure (DBS RBC TFV-DP) When YMSM Are Provided Open Label FTC/TDF (Truvada®) | DBS RBC TFV-DP at Week 36 | 671.72 fmol/punch | Standard Deviation 678.37 |
| All Study Participants | Measured Levels of Drug Exposure (DBS RBC TFV-DP) When YMSM Are Provided Open Label FTC/TDF (Truvada®) | DBS RBC TFV-DP at Week 48 | 528.24 fmol/punch | Standard Deviation 570.8 |
Primary
Number of Participants With Decrease in Absolute Bone Mineral Density (BMD) From Baseline to Week 48
This outcome addresses the objective Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM. The total number of participants with dual-energy radiography absorptiometry scanning (DXA) data through Week 48 who experienced varying degrees of decrease in absolute BMD in at least one region (spine, hip, or whole body) between Baseline and Week 48.
Time frame: 48 weeks
Population: Enrolled subjects with DXA results for Baseline and Week 48 The primary objective Additional safety data regarding FTC/TDF (Truvada®) use did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Study Participants | Number of Participants With Decrease in Absolute Bone Mineral Density (BMD) From Baseline to Week 48 | Decrease in absolute BMD >=1% | 97 Participants |
| All Study Participants | Number of Participants With Decrease in Absolute Bone Mineral Density (BMD) From Baseline to Week 48 | Decrease in absolute BMD >=5% | 16 Participants |
| All Study Participants | Number of Participants With Decrease in Absolute Bone Mineral Density (BMD) From Baseline to Week 48 | Decrease in absolute BMD >10% | 1 Participants |
Primary
Number of Participants With Serum Creatinine Event of Grade 1 or Higher
This measure addresses the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM Serum creatinine was tested at every study visit (Baseline through Week 48). The number of participants with a serum creatinine laboratory toxicity of Grade 1 or higher was assessed. Grade 1 (Mild) toxicity was defined as: 1.1 - 1.3 x ULN, where ULN is the Upper limit of normal.
Time frame: 48 Weeks
Population: Participants with visit data through 48 weeks. The primary objective Additional safety data regarding FTC/TDF (Truvada®) use did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Study Participants | Number of Participants With Serum Creatinine Event of Grade 1 or Higher | 1 Participants |
Primary
Number of Participants With Unprotected Sex Acts
This outcome addresses the objective Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM, specifically behavioral disinhibition/risk compensation endpoints. Responses to the participant ACASI question referring to male partners in the past month/since the last survey: Of these males (male partners), how many did you have unprotected oral or anal sex with in the last month? (Baseline), or Of these males (male partners), how many did you have unprotected oral or anal sex with since the last time you took this survey? (Week 48) An event is defined as an answer of greater than 0.
Time frame: Baseline and 48 weeks
Population: Participants at Baseline/Week 48 providing a response to this question. The primary objective Additional safety data regarding FTC/TDF (Truvada®) use did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Study Participants | Number of Participants With Unprotected Sex Acts | Had unprotected oral/anal w/male (BL) | 143 Participants |
| All Study Participants | Number of Participants With Unprotected Sex Acts | Had unprotected oral/anal w/ male (Wk48) | 103 Participants |
Primary
Number of Sex Partners
This outcome addresses the objective Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM, specifically behavioral disinhibition/risk compensation endpoints. Responses to the participant ACASI question referring to number of male partners in the past month/since the last survey: During the past month, how many male partners have you had sexual contact with (oral or anal)? (Baseline), or Since the last time you took this survey, how many male partners have you had sexual contact with (oral or anal)? (Week 48) And responses to the participant ACASI question referring to number of HIV-positive male partners in the past month/since the last survey: Of those you had unprotected sex with, how many did you know were HIV positive?
Time frame: Baseline and 48 weeks
Population: Participants at Baseline/Week 48 providing a response to this question. The primary objective Additional safety data regarding FTC/TDF (Truvada®) use did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Study Participants | Number of Sex Partners | Male sexual partners last month (baseline) | 5.41 sexual partners | Standard Deviation 26.03 |
| All Study Participants | Number of Sex Partners | Male sexual partners since last survey (Wk 48) | 2.46 sexual partners | Standard Deviation 2.92 |
| All Study Participants | Number of Sex Partners | Number HIV+ male partners last month (baseline) | 1.65 sexual partners | Standard Deviation 16.77 |
| All Study Participants | Number of Sex Partners | Number HIV+ male partners since last survey(Wk48) | 0.15 sexual partners | Standard Deviation 0.38 |
Primary
Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure
This outcome addresses the objective: Patterns of Use, Rates of Adherence and Measured Levels of Drug Exposure When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies. PrEP medication levels were assessed via dried blood spot (DBS) collected at each visit to quantify intracellular TFV-DP and FTC-triphosphate concentrations. DBS results were translated into dosing categories previously used in PrEP trials with adult MSM. Dosing categories included below lower limit of quantitation (BLQ), lower limit of quantitation to 349 fmol per punch (fewer than 2 tablets per week), 350- 699 fmol per punch (2-3 tablets per week), 700-1250 fmol per punch (4 tablets per week), and \>1250 fmol per punch (daily).
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48
Population: Enrolled subjects (Individual row Ns vary due to the number of subjects per week enrolled at that time point and with DBS data) This primary objective did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| All Study Participants | Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure | Week 4 | Below level of quantification | 13 Participants |
| All Study Participants | Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure | Week 4 | <2 days | 35 Participants |
| All Study Participants | Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure | Week 4 | 2 days | 58 Participants |
| All Study Participants | Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure | Week 4 | 4 days | 59 Participants |
| All Study Participants | Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure | Week 4 | Daily | 8 Participants |
| All Study Participants | Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure | Week 8 | Below level of quantification | 7 Participants |
| All Study Participants | Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure | Week 8 | <2 days | 32 Participants |
| All Study Participants | Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure | Week 8 | 2 days | 30 Participants |
| All Study Participants | Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure | Week 8 | 4 days | 69 Participants |
| All Study Participants | Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure | Week 8 | Daily | 26 Participants |
| All Study Participants | Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure | Week 12 | Below level of quantification | 12 Participants |
| All Study Participants | Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure | Week 12 | <2 days | 32 Participants |
| All Study Participants | Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure | Week 12 | 2 days | 26 Participants |
| All Study Participants | Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure | Week 12 | 4 days | 55 Participants |
| All Study Participants | Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure | Week 12 | Daily | 34 Participants |
| All Study Participants | Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure | Week 24 | Below level of quantification | 28 Participants |
| All Study Participants | Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure | Week 24 | <2 days | 36 Participants |
| All Study Participants | Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure | Week 24 | 2 days | 14 Participants |
| All Study Participants | Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure | Week 24 | 4 days | 42 Participants |
| All Study Participants | Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure | Week 24 | Daily | 28 Participants |
| All Study Participants | Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure | Week 36 | Below level of quantification | 30 Participants |
| All Study Participants | Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure | Week 36 | <2 days | 27 Participants |
| All Study Participants | Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure | Week 36 | 2 days | 23 Participants |
| All Study Participants | Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure | Week 36 | 4 days | 26 Participants |
| All Study Participants | Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure | Week 36 | Daily | 28 Participants |
| All Study Participants | Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure | Week 48 | Below level of quantification | 37 Participants |
| All Study Participants | Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure | Week 48 | <2 days | 24 Participants |
| All Study Participants | Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure | Week 48 | 2 days | 18 Participants |
| All Study Participants | Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure | Week 48 | 4 days | 26 Participants |
| All Study Participants | Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure | Week 48 | Daily | 15 Participants |
Primary
Total Body Bone Mineral Density at Baseline and at Week 48
This outcome addresses the objective: Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM. Bone mineral density at Baseline and Week 48: data reported below for total body.
Time frame: Baseline, Week 48
Population: Participants with DXA results. (Baseline N=197, Week 48 N=135). The primary objective Additional safety data regarding FTC/TDF (Truvada®) use does not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Study Participants | Total Body Bone Mineral Density at Baseline and at Week 48 | Total body BMD at baseline | 1.20 g/cm2 | Standard Deviation 0.011 |
| All Study Participants | Total Body Bone Mineral Density at Baseline and at Week 48 | Total body BMD Week 48 | 1.18 g/cm2 | Standard Deviation 0.11 |
Primary
Total Hip Bone Mineral Density at Baseline and at Week 48
This outcome addresses the objective: Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM. Bone mineral density at Baseline and Week 48: data reported below for total hip.
Time frame: Baseline, Week 48
Population: Participants with DXA results. (Baseline N=197, Week 48 N=135). The primary objective Additional safety data regarding FTC/TDF (Truvada®) use does not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Study Participants | Total Hip Bone Mineral Density at Baseline and at Week 48 | Total hip BMD at baseline | 1.10 g/cm2 | Standard Deviation 0.16 |
| All Study Participants | Total Hip Bone Mineral Density at Baseline and at Week 48 | Total hip BMD Week 48 | 1.08 g/cm2 | Standard Deviation 0.17 |
Secondary
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 10: Felt Ill)
Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48. Question: In the past month, how often have you missed taking your study pills because you: Felt sick or ill?
Time frame: 48 weeks
Population: Participants enrolled at Week 48 providing a response to this question.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Study Participants | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 10: Felt Ill) | Never | 61 Participants |
| All Study Participants | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 10: Felt Ill) | Rarely | 9 Participants |
| All Study Participants | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 10: Felt Ill) | Sometimes | 3 Participants |
| All Study Participants | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 10: Felt Ill) | Often | 1 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 10: Felt Ill) | Often | 1 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 10: Felt Ill) | Never | 43 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 10: Felt Ill) | Sometimes | 4 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 10: Felt Ill) | Rarely | 1 Participants |
p-value: 0.0617Chi-squared
Secondary
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 11: Felt Depressed)
Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48. Question: In the past month, how often have you missed taking your study pills because you: Felt depressed/overwhelmed?
Time frame: 48 weeks
Population: Participants enrolled at Week 48 providing a response to this question.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Study Participants | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 11: Felt Depressed) | Never | 62 Participants |
| All Study Participants | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 11: Felt Depressed) | Sometimes | 1 Participants |
| All Study Participants | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 11: Felt Depressed) | Rarely | 10 Participants |
| All Study Participants | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 11: Felt Depressed) | Often | 1 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 11: Felt Depressed) | Rarely | 1 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 11: Felt Depressed) | Never | 43 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 11: Felt Depressed) | Often | 1 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 11: Felt Depressed) | Sometimes | 4 Participants |
p-value: 0.0868Chi-squared
Secondary
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 12: Ran Out of Pills)
Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48. Question: In the past month, how often have you missed taking your study pills because you: Ran out of study pills?
Time frame: 48 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Study Participants | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 12: Ran Out of Pills) | Never | 67 Participants |
| All Study Participants | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 12: Ran Out of Pills) | Rarely | 7 Participants |
| All Study Participants | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 12: Ran Out of Pills) | Sometimes | 0 Participants |
| All Study Participants | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 12: Ran Out of Pills) | Often | 0 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 12: Ran Out of Pills) | Often | 3 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 12: Ran Out of Pills) | Never | 44 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 12: Ran Out of Pills) | Sometimes | 1 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 12: Ran Out of Pills) | Rarely | 1 Participants |
p-value: 0.1847Chi-squared
Secondary
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 13: No Risky Sex)
Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48. Question: In the past month, how often have you missed taking your study pills because you: Didn't think you needed it because you weren't having risk sex?
Time frame: 48 weeks
Population: Participants enrolled at Week 48 providing a response to this question.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Study Participants | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 13: No Risky Sex) | Never | 58 Participants |
| All Study Participants | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 13: No Risky Sex) | Rarely | 12 Participants |
| All Study Participants | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 13: No Risky Sex) | Sometimes | 1 Participants |
| All Study Participants | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 13: No Risky Sex) | Often | 2 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 13: No Risky Sex) | Often | 1 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 13: No Risky Sex) | Never | 43 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 13: No Risky Sex) | Sometimes | 1 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 13: No Risky Sex) | Rarely | 4 Participants |
p-value: 0.0226Chi-squared
Secondary
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 1: Away From Home)
Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48. Question: In the past month, how often have you missed taking your study pills because you: Were away from home?
Time frame: 48 weeks
Population: Participants enrolled at Week 48 providing a response to this question.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Study Participants | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 1: Away From Home) | Never | 31 Participants |
| All Study Participants | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 1: Away From Home) | Rarely | 17 Participants |
| All Study Participants | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 1: Away From Home) | Sometimes | 19 Participants |
| All Study Participants | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 1: Away From Home) | Often | 7 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 1: Away From Home) | Often | 6 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 1: Away From Home) | Never | 22 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 1: Away From Home) | Sometimes | 10 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 1: Away From Home) | Rarely | 11 Participants |
p-value: 0.2193Chi-squared
Secondary
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 2: Busy With Other Things)
Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48. Question: In the past month, how often have you missed taking your study pills because you: Were too busy with other things?
Time frame: 48 weeks
Population: Participants enrolled at Week 48 providing a response to this question.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Study Participants | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 2: Busy With Other Things) | Often | 10 Participants |
| All Study Participants | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 2: Busy With Other Things) | Never | 33 Participants |
| All Study Participants | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 2: Busy With Other Things) | Rarely | 17 Participants |
| All Study Participants | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 2: Busy With Other Things) | Sometimes | 14 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 2: Busy With Other Things) | Sometimes | 11 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 2: Busy With Other Things) | Often | 4 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 2: Busy With Other Things) | Rarely | 10 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 2: Busy With Other Things) | Never | 24 Participants |
p-value: 0.1255Chi-squared
Secondary
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 3: Simply Forgot)
Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48. Question: In the past month, how often have you missed taking your study pills because you: Simply forgot?
Time frame: 48 weeks
Population: Participants enrolled at Week 48 providing a response to this question.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Study Participants | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 3: Simply Forgot) | Never | 28 Participants |
| All Study Participants | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 3: Simply Forgot) | Rarely | 18 Participants |
| All Study Participants | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 3: Simply Forgot) | Sometimes | 18 Participants |
| All Study Participants | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 3: Simply Forgot) | Often | 10 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 3: Simply Forgot) | Often | 5 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 3: Simply Forgot) | Never | 21 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 3: Simply Forgot) | Sometimes | 9 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 3: Simply Forgot) | Rarely | 14 Participants |
p-value: 0.0706Chi-squared
Secondary
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 4: Too Many Pills)
Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48. Question: In the past month, how often have you missed taking your study pills because you: Had too many study pills to take?
Time frame: 48 weeks
Population: Participants enrolled at Week 48 providing a response to this question.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Study Participants | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 4: Too Many Pills) | Never | 62 Participants |
| All Study Participants | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 4: Too Many Pills) | Rarely | 7 Participants |
| All Study Participants | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 4: Too Many Pills) | Sometimes | 2 Participants |
| All Study Participants | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 4: Too Many Pills) | Often | 2 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 4: Too Many Pills) | Often | 1 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 4: Too Many Pills) | Never | 46 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 4: Too Many Pills) | Sometimes | 1 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 4: Too Many Pills) | Rarely | 1 Participants |
p-value: 0.0088Chi-squared
Secondary
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 5: Side Effects)
Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48. Question: In the past month, how often have you missed taking your study pills because you: Wanted to avoid side effects?
Time frame: 48 weeks
Population: Participants enrolled at Week 48 providing a response to this question.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Study Participants | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 5: Side Effects) | Never | 64 Participants |
| All Study Participants | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 5: Side Effects) | Rarely | 7 Participants |
| All Study Participants | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 5: Side Effects) | Sometimes | 2 Participants |
| All Study Participants | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 5: Side Effects) | Often | 0 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 5: Side Effects) | Often | 2 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 5: Side Effects) | Never | 42 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 5: Side Effects) | Sometimes | 1 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 5: Side Effects) | Rarely | 4 Participants |
p-value: 0.2482Chi-squared
Secondary
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 6: Others Notice)
Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48. Question: In the past month, how often have you missed taking your study pills because you: Did not want others to notice you taking meds?
Time frame: 48 weeks
Population: Participants enrolled at Week 48 providing a response to this question.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Study Participants | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 6: Others Notice) | Never | 65 Participants |
| All Study Participants | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 6: Others Notice) | Rarely | 7 Participants |
| All Study Participants | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 6: Others Notice) | Sometimes | 1 Participants |
| All Study Participants | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 6: Others Notice) | Often | 1 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 6: Others Notice) | Often | 2 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 6: Others Notice) | Never | 43 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 6: Others Notice) | Sometimes | 1 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 6: Others Notice) | Rarely | 3 Participants |
p-value: 0.1647Chi-squared
Secondary
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 7: Routine Change)
Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48. Question: In the past month, how often have you missed taking your study pills because you: Had a change in daily routine?
Time frame: 48 weeks
Population: Participants enrolled at Week 48 providing a response to this question.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Study Participants | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 7: Routine Change) | Never | 51 Participants |
| All Study Participants | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 7: Routine Change) | Rarely | 9 Participants |
| All Study Participants | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 7: Routine Change) | Sometimes | 10 Participants |
| All Study Participants | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 7: Routine Change) | Often | 4 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 7: Routine Change) | Often | 6 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 7: Routine Change) | Never | 31 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 7: Routine Change) | Sometimes | 7 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 7: Routine Change) | Rarely | 5 Participants |
p-value: 0.688Chi-squared
Secondary
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 8: Study Pill Harmful)
Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48. Question: In the past month, how often have you missed taking your study pills because you: Felt like the study pill was toxic/harmful?
Time frame: 48 weeks
Population: Participants enrolled at Week 48 providing a response to this question.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Study Participants | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 8: Study Pill Harmful) | Never | 71 Participants |
| All Study Participants | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 8: Study Pill Harmful) | Rarely | 3 Participants |
| All Study Participants | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 8: Study Pill Harmful) | Sometimes | 0 Participants |
| All Study Participants | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 8: Study Pill Harmful) | Often | 0 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 8: Study Pill Harmful) | Often | 2 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 8: Study Pill Harmful) | Never | 45 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 8: Study Pill Harmful) | Sometimes | 1 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 8: Study Pill Harmful) | Rarely | 1 Participants |
p-value: 0.2881Chi-squared
Secondary
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 9: Fell Asleep)
Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48. Question: In the past month, how often have you missed taking your study pills because you: Fell asleep/slept through dose time?
Time frame: 48 weeks
Population: Participants enrolled at Week 48 providing a response to this question.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Study Participants | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 9: Fell Asleep) | Never | 52 Participants |
| All Study Participants | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 9: Fell Asleep) | Rarely | 13 Participants |
| All Study Participants | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 9: Fell Asleep) | Sometimes | 5 Participants |
| All Study Participants | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 9: Fell Asleep) | Often | 4 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 9: Fell Asleep) | Often | 1 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 9: Fell Asleep) | Never | 35 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 9: Fell Asleep) | Sometimes | 7 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 9: Fell Asleep) | Rarely | 6 Participants |
p-value: 0.2223Chi-squared
Secondary
Acceptability and Feasibility of Text Message Reminders: Number Discontinuing Text Messaging Reminders
Number of subjects who discontinued receiving text message reminders while they were still on the study agent
Time frame: 48 weeks
Population: Total number of subjects signed up for text message reminders This objective did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®) and were eligible to receive text messages. As a result, this outcome was not assessed separately for each group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Study Participants | Acceptability and Feasibility of Text Message Reminders: Number Discontinuing Text Messaging Reminders | 3 Participants |
Secondary
Acceptability and Feasibility of Text Message Reminders: Number Using Text Messaging Reminders
Total number of subjects who signed up for text message reminders
Time frame: 48 weeks
Population: This objective did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®) and were eligible to receive text messages. As a result, this outcome was not assessed separately for each group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Study Participants | Acceptability and Feasibility of Text Message Reminders: Number Using Text Messaging Reminders | 76 Participants |
Secondary
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 10 of 10: I Felt Comfortable Participating in This Workshop/Session.
Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session). Item 10 of 10: I felt comfortable participating in this workshop/session.
Time frame: 48 weeks
Population: Participants providing a response to this question on the Session Evaluation Form
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Study Participants | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 10 of 10: I Felt Comfortable Participating in This Workshop/Session. | Strongly agree | 54 Participants |
| All Study Participants | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 10 of 10: I Felt Comfortable Participating in This Workshop/Session. | Agree | 9 Participants |
| All Study Participants | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 10 of 10: I Felt Comfortable Participating in This Workshop/Session. | Disagree | 2 Participants |
| All Study Participants | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 10 of 10: I Felt Comfortable Participating in This Workshop/Session. | Strongly Disagree | 3 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 10 of 10: I Felt Comfortable Participating in This Workshop/Session. | Strongly Disagree | 0 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 10 of 10: I Felt Comfortable Participating in This Workshop/Session. | Strongly agree | 55 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 10 of 10: I Felt Comfortable Participating in This Workshop/Session. | Disagree | 5 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 10 of 10: I Felt Comfortable Participating in This Workshop/Session. | Agree | 23 Participants |
p-value: 0.029Chi-squared
Secondary
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 1 of 10: I Learned a Lot From This Workshop/Session.
Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session). Item 1 of 10: I learned a lot from this workshop/session
Time frame: 48 weeks
Population: Participants providing a response to this question on the Session Evaluation Form
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Study Participants | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 1 of 10: I Learned a Lot From This Workshop/Session. | Strongly agree | 47 Participants |
| All Study Participants | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 1 of 10: I Learned a Lot From This Workshop/Session. | Agree | 16 Participants |
| All Study Participants | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 1 of 10: I Learned a Lot From This Workshop/Session. | Disagree | 2 Participants |
| All Study Participants | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 1 of 10: I Learned a Lot From This Workshop/Session. | Strongly Disagree | 3 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 1 of 10: I Learned a Lot From This Workshop/Session. | Strongly Disagree | 0 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 1 of 10: I Learned a Lot From This Workshop/Session. | Strongly agree | 32 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 1 of 10: I Learned a Lot From This Workshop/Session. | Disagree | 4 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 1 of 10: I Learned a Lot From This Workshop/Session. | Agree | 47 Participants |
p-value: 0.0001Chi-squared
Secondary
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 2 of 10: I Will be Able to Apply What I Learned From This Workshop/Session in my Life.
Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session). Item 2 of 10: I will be able to apply what I learned from this workshop/session in my life
Time frame: 48 weeks
Population: Participants providing a response to this question on the Session Evaluation Form
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Study Participants | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 2 of 10: I Will be Able to Apply What I Learned From This Workshop/Session in my Life. | Strongly agree | 50 Participants |
| All Study Participants | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 2 of 10: I Will be Able to Apply What I Learned From This Workshop/Session in my Life. | Agree | 13 Participants |
| All Study Participants | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 2 of 10: I Will be Able to Apply What I Learned From This Workshop/Session in my Life. | Disagree | 2 Participants |
| All Study Participants | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 2 of 10: I Will be Able to Apply What I Learned From This Workshop/Session in my Life. | Strongly Disagree | 3 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 2 of 10: I Will be Able to Apply What I Learned From This Workshop/Session in my Life. | Strongly Disagree | 0 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 2 of 10: I Will be Able to Apply What I Learned From This Workshop/Session in my Life. | Strongly agree | 48 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 2 of 10: I Will be Able to Apply What I Learned From This Workshop/Session in my Life. | Disagree | 1 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 2 of 10: I Will be Able to Apply What I Learned From This Workshop/Session in my Life. | Agree | 34 Participants |
p-value: 0.0098Chi-squared
Secondary
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 3 of 10: I Was Given an Opportunity to Participate and Discuss Information With Others.
Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session). Item 3 of 10: I was given an opportunity to participate and discuss information with others
Time frame: 48 weeks
Population: Participants providing a response to this question on the Session Evaluation Form
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Study Participants | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 3 of 10: I Was Given an Opportunity to Participate and Discuss Information With Others. | Strongly agree | 55 Participants |
| All Study Participants | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 3 of 10: I Was Given an Opportunity to Participate and Discuss Information With Others. | Agree | 10 Participants |
| All Study Participants | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 3 of 10: I Was Given an Opportunity to Participate and Discuss Information With Others. | Disagree | 0 Participants |
| All Study Participants | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 3 of 10: I Was Given an Opportunity to Participate and Discuss Information With Others. | Strongly Disagree | 3 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 3 of 10: I Was Given an Opportunity to Participate and Discuss Information With Others. | Strongly Disagree | 2 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 3 of 10: I Was Given an Opportunity to Participate and Discuss Information With Others. | Strongly agree | 55 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 3 of 10: I Was Given an Opportunity to Participate and Discuss Information With Others. | Disagree | 4 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 3 of 10: I Was Given an Opportunity to Participate and Discuss Information With Others. | Agree | 21 Participants |
p-value: 0.0766Chi-squared
Secondary
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 4 of 10: The Workshop/Session Was Well Organized.
Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session). Item 4 of 10: The workshop/session was well organized
Time frame: 48 weeks
Population: Participants providing a response to this question on the Session Evaluation Form
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Study Participants | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 4 of 10: The Workshop/Session Was Well Organized. | Strongly agree | 49 Participants |
| All Study Participants | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 4 of 10: The Workshop/Session Was Well Organized. | Agree | 13 Participants |
| All Study Participants | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 4 of 10: The Workshop/Session Was Well Organized. | Disagree | 4 Participants |
| All Study Participants | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 4 of 10: The Workshop/Session Was Well Organized. | Strongly Disagree | 2 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 4 of 10: The Workshop/Session Was Well Organized. | Strongly Disagree | 0 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 4 of 10: The Workshop/Session Was Well Organized. | Strongly agree | 66 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 4 of 10: The Workshop/Session Was Well Organized. | Disagree | 1 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 4 of 10: The Workshop/Session Was Well Organized. | Agree | 15 Participants |
p-value: 0.1581Chi-squared
Secondary
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 5 of 10: The Topic of This Workshop/Session Was Interesting.
Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session). Item 5 of 10: The topic of this workshop/session was interesting
Time frame: 48 weeks
Population: Participants providing a response to this question on the Session Evaluation Form
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Study Participants | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 5 of 10: The Topic of This Workshop/Session Was Interesting. | Strongly agree | 47 Participants |
| All Study Participants | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 5 of 10: The Topic of This Workshop/Session Was Interesting. | Agree | 16 Participants |
| All Study Participants | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 5 of 10: The Topic of This Workshop/Session Was Interesting. | Disagree | 2 Participants |
| All Study Participants | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 5 of 10: The Topic of This Workshop/Session Was Interesting. | Strongly Disagree | 2 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 5 of 10: The Topic of This Workshop/Session Was Interesting. | Strongly Disagree | 0 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 5 of 10: The Topic of This Workshop/Session Was Interesting. | Strongly agree | 56 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 5 of 10: The Topic of This Workshop/Session Was Interesting. | Disagree | 3 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 5 of 10: The Topic of This Workshop/Session Was Interesting. | Agree | 23 Participants |
p-value: 0.43Chi-squared
Secondary
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 6 of 10: The Presenter(s) Stimulated my Interest in the Material.
Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session). Item 6 of 10: The presenter(s) stimulated my interest in the material
Time frame: 48 weeks
Population: Participants providing a response to this question on the Session Evaluation Form
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Study Participants | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 6 of 10: The Presenter(s) Stimulated my Interest in the Material. | Strongly agree | 50 Participants |
| All Study Participants | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 6 of 10: The Presenter(s) Stimulated my Interest in the Material. | Agree | 14 Participants |
| All Study Participants | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 6 of 10: The Presenter(s) Stimulated my Interest in the Material. | Disagree | 1 Participants |
| All Study Participants | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 6 of 10: The Presenter(s) Stimulated my Interest in the Material. | Strongly Disagree | 3 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 6 of 10: The Presenter(s) Stimulated my Interest in the Material. | Strongly Disagree | 0 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 6 of 10: The Presenter(s) Stimulated my Interest in the Material. | Strongly agree | 54 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 6 of 10: The Presenter(s) Stimulated my Interest in the Material. | Disagree | 2 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 6 of 10: The Presenter(s) Stimulated my Interest in the Material. | Agree | 26 Participants |
p-value: 0.1201Chi-squared
Secondary
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 7 of 10: The Topic of This Workshop/Session Was Relevant to my Life.
Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session). Item 7 of 10: The topic of this workshop/session was relevant to my life
Time frame: 48 weeks
Population: Participants providing a response to this question on the Session Evaluation Form
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Study Participants | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 7 of 10: The Topic of This Workshop/Session Was Relevant to my Life. | Strongly agree | 50 Participants |
| All Study Participants | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 7 of 10: The Topic of This Workshop/Session Was Relevant to my Life. | Agree | 13 Participants |
| All Study Participants | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 7 of 10: The Topic of This Workshop/Session Was Relevant to my Life. | Disagree | 1 Participants |
| All Study Participants | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 7 of 10: The Topic of This Workshop/Session Was Relevant to my Life. | Strongly Disagree | 4 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 7 of 10: The Topic of This Workshop/Session Was Relevant to my Life. | Strongly Disagree | 0 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 7 of 10: The Topic of This Workshop/Session Was Relevant to my Life. | Strongly agree | 65 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 7 of 10: The Topic of This Workshop/Session Was Relevant to my Life. | Disagree | 1 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 7 of 10: The Topic of This Workshop/Session Was Relevant to my Life. | Agree | 17 Participants |
p-value: 0.1682Chi-squared
Secondary
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 8 of 10: The Workshop/Session Was Enjoyable.
Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session). Item 8 of 10: The workshop/session was enjoyable.
Time frame: 48 weeks
Population: Participants providing a response to this question on the Session Evaluation Form
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Study Participants | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 8 of 10: The Workshop/Session Was Enjoyable. | Strongly agree | 47 Participants |
| All Study Participants | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 8 of 10: The Workshop/Session Was Enjoyable. | Agree | 14 Participants |
| All Study Participants | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 8 of 10: The Workshop/Session Was Enjoyable. | Disagree | 5 Participants |
| All Study Participants | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 8 of 10: The Workshop/Session Was Enjoyable. | Strongly Disagree | 2 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 8 of 10: The Workshop/Session Was Enjoyable. | Strongly Disagree | 1 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 8 of 10: The Workshop/Session Was Enjoyable. | Strongly agree | 49 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 8 of 10: The Workshop/Session Was Enjoyable. | Disagree | 4 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 8 of 10: The Workshop/Session Was Enjoyable. | Agree | 28 Participants |
p-value: 0.2747Chi-squared
Secondary
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 9 of 10: I Would Recommend This Workshop/Session to Others.
Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session). Item 9 of 10: I would recommend this workshop/session to others.
Time frame: 48 weeks
Population: Participants providing a response to this question on the Session Evaluation Form
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Study Participants | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 9 of 10: I Would Recommend This Workshop/Session to Others. | Strongly agree | 49 Participants |
| All Study Participants | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 9 of 10: I Would Recommend This Workshop/Session to Others. | Agree | 10 Participants |
| All Study Participants | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 9 of 10: I Would Recommend This Workshop/Session to Others. | Disagree | 6 Participants |
| All Study Participants | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 9 of 10: I Would Recommend This Workshop/Session to Others. | Strongly Disagree | 3 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 9 of 10: I Would Recommend This Workshop/Session to Others. | Strongly Disagree | 0 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 9 of 10: I Would Recommend This Workshop/Session to Others. | Strongly agree | 47 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 9 of 10: I Would Recommend This Workshop/Session to Others. | Disagree | 4 Participants |
| PCC Behavioral Intervention Group | Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 9 of 10: I Would Recommend This Workshop/Session to Others. | Agree | 31 Participants |
p-value: 0.0046Chi-squared
Secondary
Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Age)
Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use. PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not. This item concerns the subject's age at enrollment.
Time frame: 48 weeks
Population: Enrolled subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Study Participants | Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Age) | 20.28 years | Standard Deviation 1.32 |
| PCC Behavioral Intervention Group | Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Age) | 19.93 years | Standard Deviation 1.36 |
p-value: 0.107Kruskal-Wallis
Secondary
Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (BMI, Categorical)
Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use. PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not. This item concerns the subject's BMI (kg/m2), assessed categorically.
Time frame: 48 weeks
Population: Enrolled subjects
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Study Participants | Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (BMI, Categorical) | Underweight (<18.5) | 6 Participants |
| All Study Participants | Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (BMI, Categorical) | Normal (18.5- <25) | 78 Participants |
| All Study Participants | Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (BMI, Categorical) | Overweight (25.0 - <30) | 31 Participants |
| All Study Participants | Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (BMI, Categorical) | Obese (>=30) | 26 Participants |
| PCC Behavioral Intervention Group | Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (BMI, Categorical) | Obese (>=30) | 13 Participants |
| PCC Behavioral Intervention Group | Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (BMI, Categorical) | Underweight (<18.5) | 3 Participants |
| PCC Behavioral Intervention Group | Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (BMI, Categorical) | Overweight (25.0 - <30) | 12 Participants |
| PCC Behavioral Intervention Group | Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (BMI, Categorical) | Normal (18.5- <25) | 31 Participants |
p-value: 0.9037Fisher Exact
Secondary
Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Ethnicity, Hispanic vs. Non-Hispanic or Latino)
Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use. PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not. This item concerns the subject's ethnicity, (Hispanic vs. Non-Hispanic or Latino)
Time frame: 48 weeks
Population: Enrolled subjects
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Study Participants | Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Ethnicity, Hispanic vs. Non-Hispanic or Latino) | Hispanic or Latino | 36 Participants |
| All Study Participants | Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Ethnicity, Hispanic vs. Non-Hispanic or Latino) | Non-Hispanic | 103 Participants |
| All Study Participants | Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Ethnicity, Hispanic vs. Non-Hispanic or Latino) | Refused to answer | 2 Participants |
| PCC Behavioral Intervention Group | Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Ethnicity, Hispanic vs. Non-Hispanic or Latino) | Hispanic or Latino | 17 Participants |
| PCC Behavioral Intervention Group | Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Ethnicity, Hispanic vs. Non-Hispanic or Latino) | Non-Hispanic | 42 Participants |
| PCC Behavioral Intervention Group | Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Ethnicity, Hispanic vs. Non-Hispanic or Latino) | Refused to answer | 0 Participants |
p-value: 0.8643Fisher Exact
Secondary
Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (High Risk Sex Acts)
Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use. PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not. This item concerns whether the subject reported any high risk sex acts with a male partner, defined as an answer of greater than 0 to the question Of these males (male partners), how many did you have unprotected oral or anal sex with since the last time you took this survey?
Time frame: 48 weeks
Population: Participants providing ACASI data for these questions
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Study Participants | Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (High Risk Sex Acts) | Yes (Had high risk sex acts w/ male partner) | 101 Participants |
| All Study Participants | Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (High Risk Sex Acts) | No (no high risk sex acts w/ male partner) | 22 Participants |
| PCC Behavioral Intervention Group | Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (High Risk Sex Acts) | Yes (Had high risk sex acts w/ male partner) | 42 Participants |
| PCC Behavioral Intervention Group | Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (High Risk Sex Acts) | No (no high risk sex acts w/ male partner) | 12 Participants |
p-value: 0.5369Fisher Exact
Secondary
Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Log 10 Viral Load)
Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use. PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not. This item concerns the subject's viral load, assessed here as Log 10 Viral Load (copies/ml)
Time frame: 48 weeks
Population: Enrolled subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Study Participants | Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Log 10 Viral Load) | 1.22 copies/ml | Standard Deviation 0.6 |
| PCC Behavioral Intervention Group | Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Log 10 Viral Load) | 1.14 copies/ml | Standard Deviation 0.15 |
p-value: 0.5279Kruskal-Wallis
Secondary
Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Race, 2 Categories)
Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use. PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not. This item concerns the subject's race (2 categories)
Time frame: 48 weeks
Population: Enrolled subjects
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Study Participants | Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Race, 2 Categories) | Black/African-American | 84 Participants |
| All Study Participants | Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Race, 2 Categories) | Non-Black/African-American | 57 Participants |
| PCC Behavioral Intervention Group | Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Race, 2 Categories) | Black/African-American | 25 Participants |
| PCC Behavioral Intervention Group | Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Race, 2 Categories) | Non-Black/African-American | 34 Participants |
p-value: 0.0298Fisher Exact
Secondary
Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Race, 5 Categories)
Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use. PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not. This item concerns the subject's race (5 categories)
Time frame: 48 weeks
Population: Enrolled subjects
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Study Participants | Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Race, 5 Categories) | Black/African American | 71 Participants |
| All Study Participants | Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Race, 5 Categories) | White/Hispanic | 15 Participants |
| All Study Participants | Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Race, 5 Categories) | White | 25 Participants |
| All Study Participants | Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Race, 5 Categories) | Other/Mixed Race | 28 Participants |
| All Study Participants | Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Race, 5 Categories) | Asian/Pacific Islander | 2 Participants |
| PCC Behavioral Intervention Group | Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Race, 5 Categories) | Other/Mixed Race | 14 Participants |
| PCC Behavioral Intervention Group | Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Race, 5 Categories) | Asian/Pacific Islander | 0 Participants |
| PCC Behavioral Intervention Group | Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Race, 5 Categories) | Black/African American | 22 Participants |
| PCC Behavioral Intervention Group | Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Race, 5 Categories) | White | 17 Participants |
| PCC Behavioral Intervention Group | Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Race, 5 Categories) | White/Hispanic | 6 Participants |
p-value: 0.2991Fisher Exact
Secondary
Explore Potential Demographic and/or Behavioral Differences Between Youth Who Are Interested in Participating in a PrEP Study Versus Those Who Are Not. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared.
Time frame: 48 weeks
Population: Data not collected