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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03167606
• Other study ID #: AAAQ6500
• Secondary ID: U01MD011279
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: May 13, 2021

Study information

• Verified date: February 2023
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 764
• Est. completion date: May 13, 2021
• Est. primary completion date: May 13, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 13 Years to 18 Years

Eligibility

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+

Related Conditions & MeSH terms

• HIV Infections

Intervention

Behavioral:
• MyPEEPS Mobile
Mobile technology to deliver HIV prevention information specifically developed for at-risk YMSM.

Locations

Country	Name	City	State
United States	Birmingham Aids Outreach	Birmingham	Alabama
United States	Lurie Children's Hospital	Chicago	Illinois
United States	Columbia University School of Nursing	New York	New York
United States	University of Washington	Seattle	Washington

Sponsors (6)

Lead Sponsor	Collaborator
Columbia University	Ann & Robert H Lurie Children's Hospital of Chicago, National Institute on Minority Health and Health Disparities (NIMHD), New York Blood Center, University of Alabama at Birmingham, University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
Other	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.	Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
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.	Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
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.	Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
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.	Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
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.	Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
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.	Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
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.	Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
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.	Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
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.	Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
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.	Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
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.	Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
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.	Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)