HIV Infections
Conditions
Keywords
myPEEPS, Mobile Intervention, Human Immunodeficiency Virus (HIV), Men who have sex with men (MSM)
Brief summary
The proposed MyPEEPS Mobile intervention is a novel and evidence-driven intervention using mobile technology to deliver HIV prevention information specifically developed for at-risk young men who have sex with men (YMSM). This will be the one of the first studies to test the efficacy of a scaled-up, mobile version of an existing human immunodeficiency virus (HIV) prevention intervention originally developed for, designed by, and piloted for, a diverse group of YMSM. MyPEEPS Mobile will be tested in an randomized controlled trial with racially and ethnically diverse HIV-negative or unknown status YMSM aged 13-18 at four geographically diverse sites: Birmingham, Chicago, New York City, and Seattle, allowing for increased generalizability of findings.
Detailed description
Men who have sex with men (MSM) bear a greater burden of HIV/AIDS than any other population group in the US, comprising only 2% of the population but 56% of individuals living with HIV/AIDS. Although much of the increased incidence in HIV has been reported among YMSM, especially among racial and ethnic minority groups, and is linked to high-risk sexual behavior, there remains a dearth of evidence-based HIV prevention interventions for YMSM - and none that address racially/ethnically diverse YMSM. To address this need, this study leverages mobile technology and MyPEEPS, an existing theory-driven, multi-ethnic, group-level, evidence-based intervention for diverse YMSM. MyPEEPS is a manualized curriculum, comprised of 6 modules focusing on key intermediate social and personal factors, including knowledge (e.g., correct way to use a condom), self-efficacy for safer sex, interpersonal communication skills and behavioral skills. MyPEEPS is one of the only HIV prevention interventions in the literature that focuses on diverse adolescent MSM. Long-term sustainability of face-to face, group-level behavioral interventions, such as MyPEEPS, have been problematic for dissemination in at-risk populations, particularly among young racial and ethnic minority groups. In response to this challenge, the investigators propose to translate MyPEEPS from a face-to-face, group-based curriculum to a mobile, responsive-driven web-based platform, accessible by smartphone or other web-enabled devices, to increase accessibility and scalability for diverse YMSM. The ubiquitous nature of mobile phones in daily life, especially among 13-18 year olds, has created opportunities for health interventions in a portable format with enhanced privacy. Using a participatory approach, this study will incorporate user-centered design in the translation of the MyPEEPS intervention onto a mobile platform.
Interventions
BEHAVIORALMyPEEPS Mobile
Mobile technology to deliver HIV prevention information specifically developed for at-risk YMSM.
Sponsors
University of Washington
New York Blood Center
University of Alabama at Birmingham
Ann & Robert H Lurie Children's Hospital of Chicago
National Institute on Minority Health and Health Disparities (NIMHD)
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
13 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* Self-identify as male, nonbinary, or genderqueer * Male sex assigned at birth * Understand and read English * Live in the United States or its territories * Own or have access to a mobile device (e.g., smartphone or tablet) * Same-sex attraction and either kissed another guy or intending to engage in sexual activity with another guy in next year * Self-report HIV-negative or unknown status
Exclusion criteria
* HIV+
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Self-Reported Sexually Transmitted Infection (STI) Testing | Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group) | Participants were asked to report past 3-month testing for sexually transmitted infections (STIs) at each timepoint. |
| Number of Condomless Anal Sex Partners | Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group) | The number of condomless anal sex (CAS) partners will be evaluated at all time points using the AIDS-Risk Behavior Assessment (ARBA) adapted for YMSM. Participants are asked to report the number of insertive and receptive anal sex partners with whom condoms were not used in their lifetime at the baseline timepoint and then asked to report the number of insertive and receptive anal sex partners with whom condoms were not used in the past 3 months at each of the follow-up timepoints. |
| Number of Anal Sex Acts Under the Influence of Drugs/Alcohol | Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group) | The number of anal sex acts under the influence of drugs/alcohol will be evaluated at all time points using the AIDS-Risk Behavior Assessment (ARBA) adapted for YMSM. At each timepoint, participants were asked to report the past 3 month number of insertive and receptive anal sex acts during which they had been drinking alcohol or using drugs. |
| Number of Participants With Self-reported Pre-exposure Prophylaxis (PrEP) Use | Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group) | Participants were asked if they have ever used Pre-exposure Prophylaxis (PrEP) at baseline, if they have used PrEP in the prior 3 months at all timepoints, and if they are currently using PrEP at the time of study visit at all timepoints. |
| Number of Participants With Self-reported Non-occupational Post-Exposure Prophylaxis (nPEP) Use | Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group) | Participants were asked if they've ever used Non-occupational Post-Exposure Prophylaxis (nPEP) at baseline and if they've used nPEP in the 3 months prior to each study visit timepoint. |
| Number of Participants With Self-Reported HIV Testing | Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group) | Participants were asked to report how many times they've ever been tested for HIV at baseline and at each follow-up timepoint they were asked how many times they've tested for HIV in the prior 3 months. |
| Number of Condomless Anal Sex Acts | Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group) | The number of condomless anal sex acts (CASA) will be evaluated at all time points using the AIDS-Risk Behavior Assessment (ARBA) adapted for YMSM. At each timepoint, participants were asked to report the past 3 month number of insertive and receptive anal sex acts during which condoms were not used. |
| Number of Anal Sex Partners | Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group) | The number of anal sex partners will be evaluated at all time points using the AIDS-Risk Behavior Assessment (ARBA) adapted for YMSM. Participants are asked to report the number of insertive and receptive anal sex partners in their lifetime at the baseline timepoint and then asked to report the number of insertive and receptive anal sex partners in the past 3 months at each of the follow-up timepoints. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intent to Have Anal Sex | Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group) | Participants were presented with the statement During the next 3 months, I am not planning to have anal sex with response options ranging from 1=Very true to 4=Very untrue. The mean value was calculated per group and per timepoint. |
| Intent to Always Use Condoms During Anal Sex With All Sex Partners | Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group) | Participants responded to the statement During the next 3 months, I plan to always use condoms during anal sex with all of my sex partners with response options ranging from 1=Very true to 4=Very untrue. Mean values were calculated by group for each timepoint. |
| Intent to Use PrEP as a Strategy to Reduce HIV Infection Risk | Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group) | Participants responded to the statement I plan to use PrEP as a strategy to reduce my risk for HIV infection during the next three months with response values ranging from 1=Very true to 4=Very untrue. Mean values were calculated for each group at each timepoint. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Condom Use Errors | Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group) | The condom errors survey is a 12-item questionnaire was adapted to reflect a 6-week recall period. A sample question is when you used condoms during the last six weeks, how often was the condom put on the wrong side up so that it had to be flipped over? Response options ranged from 0=Never to 2=Always. Question scores ranged 0-2, values averaged and total scores ranged from 0 to 2, with lower values indicating fewer condom use errors. |
| Self-efficacy for Safer Sex and Situational Temptation for Unsafe Sex | Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group) | Participants were asked to respond to 10 questions assessing self-efficacy in practicing condom use and safer sex communication with a partner. A sample item is if I didn't want to have sex with my partner, I would be able to say no. Response options ranged from 1=Strongly agree to 4=Strongly disagree. Question scores ranged 1-4, values averaged and total scores ranged from 1 to 4, with lower values indicating higher self-efficacy |
Countries
United States
Participant flow
Pre-assignment details
One participant was enrolled in error (ineligible age) and withdrawn from the study prior to randomization
Participants by arm
| Arm | Count |
|---|---|
| Immediate Intervention Study participants randomized to the immediate intervention arm will have access to the MyPEEPS Mobile from the baseline visit to 3-month follow-up visit. They will continue with follow-up visits at 6 months and 9 months, but will no longer have access to the MyPEEPS Mobile past the 3-month follow-up visit.
MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk YMSM. | 379 |
| Delayed Intervention Study participants randomized to the delayed intervention arm will complete visits at baseline, 3 months, 6 months, 9 months, and 12 months. They will have access to the MyPEEPS Mobile from the 9-month follow-up visit until the 12-month follow-up visit.
MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk YMSM. | 381 |
| Total | 760 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 73 | 64 |
| Overall Study | Withdrawal by Investigator | 0 | 2 |
| Overall Study | Withdrawal by Subject | 6 | 5 |
Baseline characteristics
| Characteristic | Immediate Intervention | Delayed Intervention | Total |
|---|---|---|---|
| Age, Continuous | 16.23 years STANDARD_DEVIATION 1.4 | 16.20 years STANDARD_DEVIATION 1.4 | 16.22 years STANDARD_DEVIATION 1.4 |
| Any Anal Sex Acts With Another Male | 203 Participants | 192 Participants | 395 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 169 Participants | 142 Participants | 311 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 210 Participants | 239 Participants | 449 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 20 Participants | 23 Participants | 43 Participants |
| Race (NIH/OMB) Asian | 36 Participants | 36 Participants | 72 Participants |
| Race (NIH/OMB) Black or African American | 75 Participants | 83 Participants | 158 Participants |
| Race (NIH/OMB) More than one race | 55 Participants | 39 Participants | 94 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 6 Participants | 5 Participants | 11 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 55 Participants | 43 Participants | 98 Participants |
| Race (NIH/OMB) White | 132 Participants | 152 Participants | 284 Participants |
| Region of Enrollment United States | 379 Participants | 381 Participants | 760 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 379 Participants | 381 Participants | 760 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 382 | 0 / 381 |
| other Total, other adverse events | 0 / 382 | 0 / 381 |
| serious Total, serious adverse events | 0 / 382 | 0 / 381 |
Outcome results
Primary
Number of Anal Sex Acts Under the Influence of Drugs/Alcohol
The number of anal sex acts under the influence of drugs/alcohol will be evaluated at all time points using the AIDS-Risk Behavior Assessment (ARBA) adapted for YMSM. At each timepoint, participants were asked to report the past 3 month number of insertive and receptive anal sex acts during which they had been drinking alcohol or using drugs.
Time frame: Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
Population: The analytic sample included 760 of the 764 participants enrolled because 1 participant was enrolled in error (ineligible age) and withdrawn from the study prior to randomization and 3 participants were excluded from the analytic sample due to missing or invalid data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Intervention | Number of Anal Sex Acts Under the Influence of Drugs/Alcohol | Baseline | 0.33 Anal sex acts under the influence | Standard Error 0.09 |
| Immediate Intervention | Number of Anal Sex Acts Under the Influence of Drugs/Alcohol | 3-Month Follow-up | 0.35 Anal sex acts under the influence | Standard Error 0.16 |
| Immediate Intervention | Number of Anal Sex Acts Under the Influence of Drugs/Alcohol | 6-Month Follow-up | 0.35 Anal sex acts under the influence | Standard Error 0.18 |
| Immediate Intervention | Number of Anal Sex Acts Under the Influence of Drugs/Alcohol | 9-Month Follow-up | 0.41 Anal sex acts under the influence | Standard Error 0.11 |
| Delayed Intervention | Number of Anal Sex Acts Under the Influence of Drugs/Alcohol | 9-Month Follow-up | 0.54 Anal sex acts under the influence | Standard Error 0.12 |
| Delayed Intervention | Number of Anal Sex Acts Under the Influence of Drugs/Alcohol | 6-Month Follow-up | 0.43 Anal sex acts under the influence | Standard Error 0.09 |
| Delayed Intervention | Number of Anal Sex Acts Under the Influence of Drugs/Alcohol | Baseline | 0.45 Anal sex acts under the influence | Standard Error 0.11 |
| Delayed Intervention | Number of Anal Sex Acts Under the Influence of Drugs/Alcohol | 12-Month Follow-up | 0.53 Anal sex acts under the influence | Standard Error 0.16 |
| Delayed Intervention | Number of Anal Sex Acts Under the Influence of Drugs/Alcohol | 3-Month Follow-up | 0.42 Anal sex acts under the influence | Standard Error 0.14 |
Primary
Number of Anal Sex Partners
The number of anal sex partners will be evaluated at all time points using the AIDS-Risk Behavior Assessment (ARBA) adapted for YMSM. Participants are asked to report the number of insertive and receptive anal sex partners in their lifetime at the baseline timepoint and then asked to report the number of insertive and receptive anal sex partners in the past 3 months at each of the follow-up timepoints.
Time frame: Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
Population: The analytic sample included 760 of the 764 participants enrolled because 1 participant was enrolled in error (ineligible age) and withdrawn from the study prior to randomization and 3 participants were excluded from the analytic sample due to missing or invalid data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Intervention | Number of Anal Sex Partners | Baseline | 0.95 Anal sex partners | Standard Error 0.11 |
| Immediate Intervention | Number of Anal Sex Partners | 3-Month Follow-up | 0.86 Anal sex partners | Standard Error 0.13 |
| Immediate Intervention | Number of Anal Sex Partners | 6-Month Follow-up | 0.90 Anal sex partners | Standard Error 0.11 |
| Immediate Intervention | Number of Anal Sex Partners | 9-Month Follow-up | 1.00 Anal sex partners | Standard Error 0.13 |
| Delayed Intervention | Number of Anal Sex Partners | 9-Month Follow-up | 0.77 Anal sex partners | Standard Error 0.08 |
| Delayed Intervention | Number of Anal Sex Partners | 6-Month Follow-up | 0.84 Anal sex partners | Standard Error 0.1 |
| Delayed Intervention | Number of Anal Sex Partners | Baseline | 0.87 Anal sex partners | Standard Error 0.09 |
| Delayed Intervention | Number of Anal Sex Partners | 12-Month Follow-up | 1.27 Anal sex partners | Standard Error 0.21 |
| Delayed Intervention | Number of Anal Sex Partners | 3-Month Follow-up | 0.71 Anal sex partners | Standard Error 0.09 |
Primary
Number of Condomless Anal Sex Acts
The number of condomless anal sex acts (CASA) will be evaluated at all time points using the AIDS-Risk Behavior Assessment (ARBA) adapted for YMSM. At each timepoint, participants were asked to report the past 3 month number of insertive and receptive anal sex acts during which condoms were not used.
Time frame: Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
Population: The analytic sample included 760 of the 764 participants enrolled because 1 participant was enrolled in error (ineligible age) and withdrawn from the study prior to randomization and 3 participants were excluded from the analytic sample due to missing or invalid data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Intervention | Number of Condomless Anal Sex Acts | Baseline | 1.53 condomless anal sex acts | Standard Error 0.29 |
| Immediate Intervention | Number of Condomless Anal Sex Acts | 3-Month Follow-up | 1.04 condomless anal sex acts | Standard Error 0.26 |
| Immediate Intervention | Number of Condomless Anal Sex Acts | 6-Month Follow-up | 1.68 condomless anal sex acts | Standard Error 0.47 |
| Immediate Intervention | Number of Condomless Anal Sex Acts | 9-Month Follow-up | 1.70 condomless anal sex acts | Standard Error 0.36 |
| Delayed Intervention | Number of Condomless Anal Sex Acts | 9-Month Follow-up | 1.65 condomless anal sex acts | Standard Error 0.33 |
| Delayed Intervention | Number of Condomless Anal Sex Acts | 6-Month Follow-up | 1.21 condomless anal sex acts | Standard Error 0.25 |
| Delayed Intervention | Number of Condomless Anal Sex Acts | Baseline | 1.45 condomless anal sex acts | Standard Error 0.27 |
| Delayed Intervention | Number of Condomless Anal Sex Acts | 12-Month Follow-up | 1.47 condomless anal sex acts | Standard Error 0.36 |
| Delayed Intervention | Number of Condomless Anal Sex Acts | 3-Month Follow-up | 1.63 condomless anal sex acts | Standard Error 0.38 |
Primary
Number of Condomless Anal Sex Partners
The number of condomless anal sex (CAS) partners will be evaluated at all time points using the AIDS-Risk Behavior Assessment (ARBA) adapted for YMSM. Participants are asked to report the number of insertive and receptive anal sex partners with whom condoms were not used in their lifetime at the baseline timepoint and then asked to report the number of insertive and receptive anal sex partners with whom condoms were not used in the past 3 months at each of the follow-up timepoints.
Time frame: Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
Population: The analytic sample included 760 of the 764 participants enrolled because 1 participant was enrolled in error (ineligible age) and withdrawn from the study prior to randomization and 3 participants were excluded from the analytic sample due to missing or invalid data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Intervention | Number of Condomless Anal Sex Partners | 9-Month Follow-up | 0.63 Condomless anal sex partners | Standard Error 0.11 |
| Immediate Intervention | Number of Condomless Anal Sex Partners | Baseline | 0.53 Condomless anal sex partners | Standard Error 0.08 |
| Immediate Intervention | Number of Condomless Anal Sex Partners | 3-Month Follow-up | 0.50 Condomless anal sex partners | Standard Error 0.08 |
| Immediate Intervention | Number of Condomless Anal Sex Partners | 6-Month Follow-up | 0.43 Condomless anal sex partners | Standard Error 0.06 |
| Delayed Intervention | Number of Condomless Anal Sex Partners | 6-Month Follow-up | 0.47 Condomless anal sex partners | Standard Error 0.06 |
| Delayed Intervention | Number of Condomless Anal Sex Partners | 3-Month Follow-up | 0.38 Condomless anal sex partners | Standard Error 0.06 |
| Delayed Intervention | Number of Condomless Anal Sex Partners | 12-Month Follow-up | 0.72 Condomless anal sex partners | Standard Error 0.17 |
| Delayed Intervention | Number of Condomless Anal Sex Partners | 9-Month Follow-up | 0.40 Condomless anal sex partners | Standard Error 0.05 |
| Delayed Intervention | Number of Condomless Anal Sex Partners | Baseline | 0.42 Condomless anal sex partners | Standard Error 0.05 |
Primary
Number of Participants With Self-Reported HIV Testing
Participants were asked to report how many times they've ever been tested for HIV at baseline and at each follow-up timepoint they were asked how many times they've tested for HIV in the prior 3 months.
Time frame: Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
Population: The analytic sample included 760 of the 764 participants enrolled because 1 participant was enrolled in error (ineligible age) and withdrawn from the study prior to randomization and 3 participants were excluded from the analytic sample due to missing or invalid data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Immediate Intervention | Number of Participants With Self-Reported HIV Testing | Baseline | 63 Participants |
| Immediate Intervention | Number of Participants With Self-Reported HIV Testing | 3-Month Follow-up | 90 Participants |
| Immediate Intervention | Number of Participants With Self-Reported HIV Testing | 6-Month Follow-up | 84 Participants |
| Immediate Intervention | Number of Participants With Self-Reported HIV Testing | 9-Month Follow-up | 93 Participants |
| Delayed Intervention | Number of Participants With Self-Reported HIV Testing | 9-Month Follow-up | 69 Participants |
| Delayed Intervention | Number of Participants With Self-Reported HIV Testing | 6-Month Follow-up | 69 Participants |
| Delayed Intervention | Number of Participants With Self-Reported HIV Testing | Baseline | 55 Participants |
| Delayed Intervention | Number of Participants With Self-Reported HIV Testing | 12-Month Follow-up | 71 Participants |
| Delayed Intervention | Number of Participants With Self-Reported HIV Testing | 3-Month Follow-up | 79 Participants |
Primary
Number of Participants With Self-reported Non-occupational Post-Exposure Prophylaxis (nPEP) Use
Participants were asked if they've ever used Non-occupational Post-Exposure Prophylaxis (nPEP) at baseline and if they've used nPEP in the 3 months prior to each study visit timepoint.
Time frame: Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
Population: The analytic sample included 760 of the 764 participants enrolled because 1 participant was enrolled in error (ineligible age) and withdrawn from the study prior to randomization and 3 participants were excluded from the analytic sample due to missing or invalid data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Immediate Intervention | Number of Participants With Self-reported Non-occupational Post-Exposure Prophylaxis (nPEP) Use | Baseline | 4 Participants |
| Immediate Intervention | Number of Participants With Self-reported Non-occupational Post-Exposure Prophylaxis (nPEP) Use | 3-Month Follow-up | 3 Participants |
| Immediate Intervention | Number of Participants With Self-reported Non-occupational Post-Exposure Prophylaxis (nPEP) Use | 6-Month Follow-up | 5 Participants |
| Immediate Intervention | Number of Participants With Self-reported Non-occupational Post-Exposure Prophylaxis (nPEP) Use | 9-Month Follow-up | 1 Participants |
| Delayed Intervention | Number of Participants With Self-reported Non-occupational Post-Exposure Prophylaxis (nPEP) Use | 9-Month Follow-up | 3 Participants |
| Delayed Intervention | Number of Participants With Self-reported Non-occupational Post-Exposure Prophylaxis (nPEP) Use | 6-Month Follow-up | 8 Participants |
| Delayed Intervention | Number of Participants With Self-reported Non-occupational Post-Exposure Prophylaxis (nPEP) Use | Baseline | 6 Participants |
| Delayed Intervention | Number of Participants With Self-reported Non-occupational Post-Exposure Prophylaxis (nPEP) Use | 12-Month Follow-up | 3 Participants |
| Delayed Intervention | Number of Participants With Self-reported Non-occupational Post-Exposure Prophylaxis (nPEP) Use | 3-Month Follow-up | 4 Participants |
Primary
Number of Participants With Self-reported Pre-exposure Prophylaxis (PrEP) Use
Participants were asked if they have ever used Pre-exposure Prophylaxis (PrEP) at baseline, if they have used PrEP in the prior 3 months at all timepoints, and if they are currently using PrEP at the time of study visit at all timepoints.
Time frame: Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
Population: The analytic sample included 760 of the 764 participants enrolled because 1 participant was enrolled in error (ineligible age) and withdrawn from the study prior to randomization and 3 participants were excluded from the analytic sample due to missing or invalid data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Immediate Intervention | Number of Participants With Self-reported Pre-exposure Prophylaxis (PrEP) Use | Baseline | 10 Participants |
| Immediate Intervention | Number of Participants With Self-reported Pre-exposure Prophylaxis (PrEP) Use | 3-Month Follow-up | 14 Participants |
| Immediate Intervention | Number of Participants With Self-reported Pre-exposure Prophylaxis (PrEP) Use | 6-Month Follow-up | 20 Participants |
| Immediate Intervention | Number of Participants With Self-reported Pre-exposure Prophylaxis (PrEP) Use | 9-Month Follow-up | 13 Participants |
| Delayed Intervention | Number of Participants With Self-reported Pre-exposure Prophylaxis (PrEP) Use | 9-Month Follow-up | 14 Participants |
| Delayed Intervention | Number of Participants With Self-reported Pre-exposure Prophylaxis (PrEP) Use | 6-Month Follow-up | 16 Participants |
| Delayed Intervention | Number of Participants With Self-reported Pre-exposure Prophylaxis (PrEP) Use | Baseline | 10 Participants |
| Delayed Intervention | Number of Participants With Self-reported Pre-exposure Prophylaxis (PrEP) Use | 12-Month Follow-up | 25 Participants |
| Delayed Intervention | Number of Participants With Self-reported Pre-exposure Prophylaxis (PrEP) Use | 3-Month Follow-up | 14 Participants |
Primary
Number of Participants With Self-Reported Sexually Transmitted Infection (STI) Testing
Participants were asked to report past 3-month testing for sexually transmitted infections (STIs) at each timepoint.
Time frame: Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
Population: The analytic sample included 760 of the 764 participants enrolled because 1 participant was enrolled in error (ineligible age) and withdrawn from the study prior to randomization and 3 participants were excluded from the analytic sample due to missing or invalid data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Immediate Intervention | Number of Participants With Self-Reported Sexually Transmitted Infection (STI) Testing | 9-Month Follow-up | 59 Participants |
| Immediate Intervention | Number of Participants With Self-Reported Sexually Transmitted Infection (STI) Testing | 6-Month Follow-up | 56 Participants |
| Immediate Intervention | Number of Participants With Self-Reported Sexually Transmitted Infection (STI) Testing | 3-Month Follow-up | 63 Participants |
| Immediate Intervention | Number of Participants With Self-Reported Sexually Transmitted Infection (STI) Testing | Baseline | 73 Participants |
| Delayed Intervention | Number of Participants With Self-Reported Sexually Transmitted Infection (STI) Testing | 12-Month Follow-up | 53 Participants |
| Delayed Intervention | Number of Participants With Self-Reported Sexually Transmitted Infection (STI) Testing | 3-Month Follow-up | 49 Participants |
| Delayed Intervention | Number of Participants With Self-Reported Sexually Transmitted Infection (STI) Testing | Baseline | 65 Participants |
| Delayed Intervention | Number of Participants With Self-Reported Sexually Transmitted Infection (STI) Testing | 6-Month Follow-up | 44 Participants |
| Delayed Intervention | Number of Participants With Self-Reported Sexually Transmitted Infection (STI) Testing | 9-Month Follow-up | 44 Participants |
Secondary
Intent to Always Use Condoms During Anal Sex With All Sex Partners
Participants responded to the statement During the next 3 months, I plan to always use condoms during anal sex with all of my sex partners with response options ranging from 1=Very true to 4=Very untrue. Mean values were calculated by group for each timepoint.
Time frame: Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
Population: The analytic sample included 760 of the 764 participants enrolled because 1 participant was enrolled in error (ineligible age) and withdrawn from the study prior to randomization and 3 participants were excluded from the analytic sample due to missing or invalid data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Intervention | Intent to Always Use Condoms During Anal Sex With All Sex Partners | Baseline | 3.38 units on a scale | Standard Error 0.04 |
| Immediate Intervention | Intent to Always Use Condoms During Anal Sex With All Sex Partners | 3-Month Follow-up | 3.45 units on a scale | Standard Error 0.05 |
| Immediate Intervention | Intent to Always Use Condoms During Anal Sex With All Sex Partners | 6-Month Follow-up | 3.34 units on a scale | Standard Error 0.05 |
| Immediate Intervention | Intent to Always Use Condoms During Anal Sex With All Sex Partners | 9-Month Follow-up | 3.42 units on a scale | Standard Error 0.05 |
| Delayed Intervention | Intent to Always Use Condoms During Anal Sex With All Sex Partners | 9-Month Follow-up | 3.38 units on a scale | Standard Error 0.04 |
| Delayed Intervention | Intent to Always Use Condoms During Anal Sex With All Sex Partners | 6-Month Follow-up | 3.37 units on a scale | Standard Error 0.05 |
| Delayed Intervention | Intent to Always Use Condoms During Anal Sex With All Sex Partners | Baseline | 3.41 units on a scale | Standard Error 0.04 |
| Delayed Intervention | Intent to Always Use Condoms During Anal Sex With All Sex Partners | 12-Month Follow-up | 3.35 units on a scale | Standard Error 0.05 |
| Delayed Intervention | Intent to Always Use Condoms During Anal Sex With All Sex Partners | 3-Month Follow-up | 3.44 units on a scale | Standard Error 0.04 |
Secondary
Intent to Have Anal Sex
Participants were presented with the statement During the next 3 months, I am not planning to have anal sex with response options ranging from 1=Very true to 4=Very untrue. The mean value was calculated per group and per timepoint.
Time frame: Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
Population: The analytic sample included 760 of the 764 participants enrolled because 1 participant was enrolled in error (ineligible age) and withdrawn from the study prior to randomization and 3 participants were excluded from the analytic sample due to missing or invalid data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Intervention | Intent to Have Anal Sex | Baseline | 2.35 score on a scale | Standard Error 0.06 |
| Immediate Intervention | Intent to Have Anal Sex | 3-Month Follow-up | 2.30 score on a scale | Standard Error 0.06 |
| Immediate Intervention | Intent to Have Anal Sex | 6-Month Follow-up | 2.33 score on a scale | Standard Error 0.06 |
| Immediate Intervention | Intent to Have Anal Sex | 9-Month Follow-up | 2.42 score on a scale | Standard Error 0.06 |
| Delayed Intervention | Intent to Have Anal Sex | 9-Month Follow-up | 2.40 score on a scale | Standard Error 0.06 |
| Delayed Intervention | Intent to Have Anal Sex | 6-Month Follow-up | 2.35 score on a scale | Standard Error 0.06 |
| Delayed Intervention | Intent to Have Anal Sex | Baseline | 2.40 score on a scale | Standard Error 0.05 |
| Delayed Intervention | Intent to Have Anal Sex | 12-Month Follow-up | 2.42 score on a scale | Standard Error 0.06 |
| Delayed Intervention | Intent to Have Anal Sex | 3-Month Follow-up | 2.36 score on a scale | Standard Error 0.06 |
Secondary
Intent to Use PrEP as a Strategy to Reduce HIV Infection Risk
Participants responded to the statement I plan to use PrEP as a strategy to reduce my risk for HIV infection during the next three months with response values ranging from 1=Very true to 4=Very untrue. Mean values were calculated for each group at each timepoint.
Time frame: Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
Population: The analytic sample included 760 of the 764 participants enrolled because 1 participant was enrolled in error (ineligible age) and withdrawn from the study prior to randomization and 3 participants were excluded from the analytic sample due to missing or invalid data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Intervention | Intent to Use PrEP as a Strategy to Reduce HIV Infection Risk | Baseline | 2.67 units on a scale | Standard Error 0.06 |
| Immediate Intervention | Intent to Use PrEP as a Strategy to Reduce HIV Infection Risk | 3-Month Follow-up | 2.82 units on a scale | Standard Error 0.06 |
| Immediate Intervention | Intent to Use PrEP as a Strategy to Reduce HIV Infection Risk | 6-Month Follow-up | 2.79 units on a scale | Standard Error 0.06 |
| Immediate Intervention | Intent to Use PrEP as a Strategy to Reduce HIV Infection Risk | 9-Month Follow-up | 2.74 units on a scale | Standard Error 0.06 |
| Delayed Intervention | Intent to Use PrEP as a Strategy to Reduce HIV Infection Risk | 9-Month Follow-up | 2.59 units on a scale | Standard Error 0.05 |
| Delayed Intervention | Intent to Use PrEP as a Strategy to Reduce HIV Infection Risk | 6-Month Follow-up | 2.66 units on a scale | Standard Error 0.06 |
| Delayed Intervention | Intent to Use PrEP as a Strategy to Reduce HIV Infection Risk | Baseline | 2.65 units on a scale | Standard Error 0.05 |
| Delayed Intervention | Intent to Use PrEP as a Strategy to Reduce HIV Infection Risk | 12-Month Follow-up | 2.83 units on a scale | Standard Error 0.06 |
| Delayed Intervention | Intent to Use PrEP as a Strategy to Reduce HIV Infection Risk | 3-Month Follow-up | 2.66 units on a scale | Standard Error 0.06 |
Other Pre-specified
Condom Use Errors
The condom errors survey is a 12-item questionnaire was adapted to reflect a 6-week recall period. A sample question is when you used condoms during the last six weeks, how often was the condom put on the wrong side up so that it had to be flipped over? Response options ranged from 0=Never to 2=Always. Question scores ranged 0-2, values averaged and total scores ranged from 0 to 2, with lower values indicating fewer condom use errors.
Time frame: Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
Population: The analytic sample included 760 of the 764 participants enrolled because 1 participant was enrolled in error (ineligible age) and withdrawn from the study prior to randomization and 3 participants were excluded from the analytic sample due to missing or invalid data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Intervention | Condom Use Errors | Baseline | 0.60 units on a scale | Standard Error 0.01 |
| Immediate Intervention | Condom Use Errors | 3-Month Follow-up | 0.68 units on a scale | Standard Error 0.01 |
| Immediate Intervention | Condom Use Errors | 6-Month Follow-up | 0.67 units on a scale | Standard Error 0.01 |
| Immediate Intervention | Condom Use Errors | 9-Month Follow-up | 0.62 units on a scale | Standard Error 0.01 |
| Delayed Intervention | Condom Use Errors | 9-Month Follow-up | 0.57 units on a scale | Standard Error 0.01 |
| Delayed Intervention | Condom Use Errors | 6-Month Follow-up | 0.58 units on a scale | Standard Error 0.01 |
| Delayed Intervention | Condom Use Errors | Baseline | 0.61 units on a scale | Standard Error 0.01 |
| Delayed Intervention | Condom Use Errors | 12-Month Follow-up | 0.64 units on a scale | Standard Error 0.02 |
| Delayed Intervention | Condom Use Errors | 3-Month Follow-up | 0.59 units on a scale | Standard Error 0.01 |
Other Pre-specified
Self-efficacy for Safer Sex and Situational Temptation for Unsafe Sex
Participants were asked to respond to 10 questions assessing self-efficacy in practicing condom use and safer sex communication with a partner. A sample item is if I didn't want to have sex with my partner, I would be able to say no. Response options ranged from 1=Strongly agree to 4=Strongly disagree. Question scores ranged 1-4, values averaged and total scores ranged from 1 to 4, with lower values indicating higher self-efficacy
Time frame: Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
Population: The analytic sample included 760 of the 764 participants enrolled because 1 participant was enrolled in error (ineligible age) and withdrawn from the study prior to randomization and 3 participants were excluded from the analytic sample due to missing or invalid data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Intervention | Self-efficacy for Safer Sex and Situational Temptation for Unsafe Sex | Baseline | 1.51 units on a scale | Standard Error 0.02 |
| Immediate Intervention | Self-efficacy for Safer Sex and Situational Temptation for Unsafe Sex | 3-Month Follow-up | 1.44 units on a scale | Standard Error 0.02 |
| Immediate Intervention | Self-efficacy for Safer Sex and Situational Temptation for Unsafe Sex | 6-Month Follow-up | 1.50 units on a scale | Standard Error 0.02 |
| Immediate Intervention | Self-efficacy for Safer Sex and Situational Temptation for Unsafe Sex | 9-Month Follow-up | 1.47 units on a scale | Standard Error 0.02 |
| Delayed Intervention | Self-efficacy for Safer Sex and Situational Temptation for Unsafe Sex | 9-Month Follow-up | 1.55 units on a scale | Standard Error 0.02 |
| Delayed Intervention | Self-efficacy for Safer Sex and Situational Temptation for Unsafe Sex | 6-Month Follow-up | 1.52 units on a scale | Standard Error 0.02 |
| Delayed Intervention | Self-efficacy for Safer Sex and Situational Temptation for Unsafe Sex | Baseline | 1.52 units on a scale | Standard Error 0.02 |
| Delayed Intervention | Self-efficacy for Safer Sex and Situational Temptation for Unsafe Sex | 12-Month Follow-up | 1.44 units on a scale | Standard Error 0.02 |
| Delayed Intervention | Self-efficacy for Safer Sex and Situational Temptation for Unsafe Sex | 3-Month Follow-up | 1.54 units on a scale | Standard Error 0.02 |