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

NCT03167606 | Completed Results DMC

• 2 other identifiers: AAAQ6500U01MD011279
• Study Type: interventional
• Target: 764
• Locations: 1 country
• Sites: 4

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.

Conditions

HIV Infections

Keywords

myPEEPS; Mobile Intervention; Human Immunodeficiency Virus (HIV); Men who have sex with men (MSM)

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (3)

• Intent to Have Anal Sex

  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

  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

  Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)

Other Outcomes (2)

• 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)

• Condom Use Errors

  Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)

Study Arms (2)

Immediate Intervention

EXPERIMENTAL

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

Delayed Intervention

EXPERIMENTAL

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

Interventions

MyPEEPS Mobile BEHAVIORAL

Mobile technology to deliver HIV prevention information specifically developed for at-risk YMSM.

Delayed Intervention; Immediate Intervention

Eligibility Criteria

• Age: 13 Years - 18 Years
• Gender Eligibility Details: Participants must identify as male, nonbinary, or genderqueer
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• HIV+

Sponsors & Collaborators

• Columbia University: lead
• University of Washington: collaborator
• New York Blood Center: collaborator
• University of Alabama at Birmingham: collaborator
• Ann & Robert H Lurie Children's Hospital of Chicago: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (4)

Birmingham Aids Outreach

Birmingham, Alabama, 35233, United States

Location

Lurie Children's Hospital

Chicago, Illinois, 60611, United States

Location

Columbia University School of Nursing

New York, New York, 10032, United States

Location

University of Washington

Seattle, Washington, 98105, United States

Location

Related Publications (6)

• Cordoba E, Garofalo R, Kuhns LM, Pearson CR, Batey DS, Bruce J, Radix A, Belkind U, Hidalgo MA, Hirshfield S, Schnall R. A Cross-sectional Study of Perceived Stress and Racial Discrimination Among a National Sample of Young Men Who Have Sex With Men. J Assoc Nurses AIDS Care. 2023 May-Jun 01;34(3):226-237. doi: 10.1097/JNC.0000000000000407.

  PMID: 37129475 DERIVED

• 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.

  PMID: 36129712 DERIVED

• 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.

  PMID: 35867076 DERIVED

• 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.

  PMID: 35241362 DERIVED

• 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.

  PMID: 34855787 DERIVED

• 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.

  PMID: 31941475 DERIVED

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; Homosexuality

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Sexuality; Sexual Behavior; Behavior

Results Point of Contact

• Title: Dr. Rebecca Schnall, RN, MPH, PhD, Professor of Disease Prevention and Health Promotion (in Nursing)
• Organization: Columbia University

rb897@cumc.columbia.edu

212-342-6886

Study Officials

• Rebecca Schnall, PhD

  Columbia University School of Nursing

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mary Dickey Lindsay Assistant Professor of Disease Prevention and Health Promotion in the Faculty of Nursing

Study Record Dates

• First Submitted: May 11, 2017
• First Posted: May 30, 2017
• Study Start: June 1, 2018
• Primary Completion: May 13, 2021
• Study Completion: May 13, 2021
• Last Updated: February 23, 2023
• Results First Posted: February 23, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)