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NCT Number: NCT06741618

MyPEEPS Mobile Plus: A Multi-Level HIV Prevention Intervention for Young MSM

MyPEEPS Mobile Plus, a multi-level intervention for improving HIV prevention outcomes in YMSM, is a novel and evidence-driven approach using mobile technology to deliver HIV prevention information specifically developed for YMSM. Building on strong preliminary work, the proposed research is the next logical step in a body of work designed to assess whether refinement of this mobile intervention used in combination with virtual PrEP Peer Navigation will result in improvements in PrEP uptake and a reduction in HIV-related behavior. This is key to advancing HIV prevention among HIV-negative US persons at extremely high-risk for HIV seroconversion.

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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

16 year–25 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University

New York, 10032, United States

Location status: Recruiting

Location contact

Rebecca Schnall

CONTACT

[email protected]

212-342-6886

About this study

This study expands MyPEEPS Mobile to develop MyPEEPS Mobile Plus, a multi-level intervention comprised of MyPEEPS Mobile with added PrEP content (based upon expert advisory and youth feedback) + PrEP E-Peer Navigation to overcome the challenges of PrEP initiation, adherence, and persistence among YMSM. Peer navigation is an evidence-based, widely recommended intervention for reaching youth and MSM for HIV-related care outcomes, with evidence of acceptability among racial/ethnic minority YMSM for PrEP. Peer navigation addresses common reasons for failing to begin or maintain PrEP use, including low perceived risk, structural or logistic barriers to care engagement, and anticipated side effects. Relative to in-person and group-based HIV prevention programs, behavioral interventions with digital and virtual components can have vast reach and present unique potential to rapidly scale delivery to very large and hidden groups. Therefore, the investigators propose to conduct a randomized controlled trial to test the efficacy of MyPEEPS Mobile Plus (a multi-level intervention comprised of MyPEEPS Mobile + PrEP E-Peer Navigation) for promoting initiation, adherence, and persistence of PrEP and decreased HIV risk behavior in YMSM. Building upon the team's demonstrated ability to enroll large numbers of young racially and ethnically diverse YMSM and extensive experience developing mobile health interventions, the proposed study will test the efficacy of this expanded, multi-level mobile HIV prevention intervention emphasizing PrEP. If efficacious, it will increase PrEP initiation, adherence, and persistence and decrease overall HIV risk in diverse YMSM in the US.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 16-25 years of age
  • identify as male or non-binary
  • male sex assigned at birth
  • understand and read English
  • own a smartphone
  • report condomless anal sex with a male in the past year
  • HIV-negative (OraQuick verified)

Exclusion criteria

  • HIV Positive
  • If study staff determine participant unable to consent due to obvious and severe cognitive impairment or under the influence of drugs or alcohol
  • currently report consistent use of PrEP
  • currently enrolled in another HIV prevention study

Treatment and study plan

MyPEEPS Mobile

Behavioral

An evidence-based, digitally delivered mHealth sexual risk reduction intervention on HIV incidence

Electronic PrEP peer navigation

Behavioral

Electronic peer navigation to PreP services

Primary outcomes

  1. PrEP Initiation:

    Time frame: Baseline, 6-month follow-up, 12-month follow-up

    Participants will self-report attending at least one PrEP-related care visit to asess medical eligibility for PrEP initiation.

Secondary outcomes

  1. PrEP Adherence

    Time frame: Baseline, 6-month follow-up, 12-month follow-up

    Daily oral PrEP users will report PrEP use in the past 7-days.

  2. PrEP Persistence

    Time frame: Baseline, 6-month follow-up, 12-month follow-up

    Questions will be measure visit constancy, i.e., self-report at least 1 PrEP related care visit in the past 6 months.

Study contacts

Contact information is provided by the study sponsor or research team.

Rebecca Schnall, PhD, MPH

CONTACT

[email protected]

212-342-6886

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Ann & Robert H Lurie Children's Hospital of Chicago
  • Callen-Lorde Community Health Center
  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

MyPEEPS Mobile Plus

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Dec 19, 2024
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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