A Pragmatic Clinical Trial of MyPEEPS Mobile to Improve HIV Prevention Behaviors in Diverse Adolescent MSM

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Pragmatic Clinical Trial of MyPEEPS Mobile to Improve HIV Prevention Behaviors in Diverse Adolescent MSM

Conditions
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HIV Infections

Intervention / Treatment
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* Behavioral: MyPEEPS Mobile


Participation Criteria
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Eligibility Criteria
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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+

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Intervention<br>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. | Behavioral: MyPEEPS Mobile<br>* Mobile technology to deliver HIV prevention information specifically developed for at-risk YMSM.<br>|
| Experimental: Delayed Intervention<br>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. | Behavioral: MyPEEPS Mobile<br>* Mobile technology to deliver HIV prevention information specifically developed for at-risk YMSM.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group) | 
| 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. | Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group) | 
| 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. | Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group) | 
| 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. | Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group) | 
| 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. | Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group) | 
| 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. | Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group) | 
| 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. | Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group) | 
| 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. | Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group) | 
| 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. | Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group) | 
| 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. | Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myPEEPS, Mobile Intervention, Human Immunodeficiency Virus (HIV), Men who have sex with men (MSM)