Clinical trial NCT03167606: A Pragmatic Clinical Trial of MyPEEPS Mobile to Improve HIV Prevention Behaviors in Diverse Adolescent MSM
Official title: A Pragmatic Clinical Trial of MyPEEPS Mobile to Improve HIV Prevention Behaviors in Diverse Adolescent MSM
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: myPEEPS
Mobile Intervention
Human Immunodeficiency Virus (HIV)
Men who have sex with men (MSM)
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: University of Washington
name: New York Blood Center
name: University of Alabama at Birmingham
name: Ann & Robert H Lurie Children's Hospital of Chicago
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2017-05-30
Enrollment: 764
Sex: MALE
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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+

Primary outcomes:
measure: Number of Condomless Anal Sex Acts
timeFrame: Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
measure: Number of Anal Sex Partners
timeFrame: Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
measure: Number of Condomless Anal Sex Partners
timeFrame: Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
measure: Number of Anal Sex Acts Under the Influence of Drugs/Alcohol
timeFrame: Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
measure: Number of Participants With Self-reported Pre-exposure Prophylaxis (PrEP) Use
timeFrame: Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
measure: Number of Participants With Self-reported Non-occupational Post-Exposure Prophylaxis (nPEP) Use
timeFrame: Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
measure: Number of Participants With Self-Reported HIV Testing
timeFrame: Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
measure: Number of Participants With Self-Reported Sexually Transmitted Infection (STI) Testing
timeFrame: Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
Secondary outcomes:
measure: Intent to Have Anal Sex
timeFrame: Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
measure: Intent to Always Use Condoms During Anal Sex With All Sex Partners
timeFrame: Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
measure: Intent to Use PrEP as a Strategy to Reduce HIV Infection Risk
timeFrame: Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
Other outcomes:
measure: Self-efficacy for Safer Sex and Situational Temptation for Unsafe Sex
timeFrame: Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
measure: Condom Use Errors
timeFrame: Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
Locations:
city: Birmingham
country: United States
facility: Birmingham Aids Outreach
state: Alabama
city: Chicago
country: United States
facility: Lurie Children's Hospital
state: Illinois
city: New York
country: United States
facility: Columbia University School of Nursing
state: New York
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Columbia University School of Nursing
name: Rebecca Schnall, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schnall R, Kuhns LM, Pearson C, Batey DS, Bruce J, Hidalgo MA, Hirshfield S, Janulis P, Jia H, Radix A, Belkind U, Rodriguez RG, Garofalo R. Efficacy of MyPEEPS Mobile, an HIV Prevention Intervention Using Mobile Technology, on Reducing Sexual Risk Among Same-Sex Attracted Adolescent Males: A Randomized Clinical Trial. JAMA Netw Open. 2022 Sep 1;5(9):e2231853. doi: 10.1001/jamanetworkopen.2022.31853.
citation: Diaz JE, Sandh S, Schnall R, Garofalo R, Kuhns LM, Pearson CR, Bruce J, Batey DS, Radix A, Belkind U, Hidalgo MA, Hirshfield S. Predictors of Past-Year Health Care Utilization Among Young Men Who Have Sex with Men Using Andersen's Behavioral Model of Health Service Use. LGBT Health. 2022 Oct;9(7):471-478. doi: 10.1089/lgbt.2021.0488. Epub 2022 Jul 22.
citation: Cordoba E, Kuizon CM, Garofalo R, Kuhns LM, Pearson C, Batey DS, Bruce J, Radix A, Belkind U, Hidalgo MA, Hirshfield S, Jia H, Schnall R. Are State-Level HIV Testing Policies for Minors Associated With HIV Testing Behavior and Awareness of Home-Based HIV Testing in Young Men Who Have Sex With Men? J Adolesc Health. 2022 Jun;70(6):902-909. doi: 10.1016/j.jadohealth.2021.12.023. Epub 2022 Feb 28.
citation: Cordoba E, Garofalo R, Kuhns LM, Pearson C, Bruce J, Batey DS, Radix A, Belkind U, Hidalgo MA, Hirshfield S, Garibay Rodriguez R, Schnall R. Risk-taking behaviors in adolescent men who have sex with men (MSM): An association between homophobic victimization and alcohol consumption. PLoS One. 2021 Dec 2;16(12):e0260083. doi: 10.1371/journal.pone.0260083. eCollection 2021.
citation: Kuhns LM, Garofalo R, Hidalgo M, Hirshfield S, Pearson C, Bruce J, Batey DS, Radix A, Belkind U, Jia H, Schnall R. A randomized controlled efficacy trial of an mHealth HIV prevention intervention for sexual minority young men: MyPEEPS mobile study protocol. BMC Public Health. 2020 Jan 15;20(1):65. doi: 10.1186/s12889-020-8180-4.