Menu
Recruiting NCT06741618

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

No phase Interventional HIV/AIDS

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MyPEEPS Mobile, Electronic PrEP peer navigation.
Who it may be relevant to
Registry conditions: HIV/AIDS. Basic parameters: 16 years — 25 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

MyPEEPS Mobile Plus

Overview

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.

Detailed description

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.

Interventions

  • Behavioral MyPEEPS Mobile
    An evidence-based, digitally delivered mHealth sexual risk reduction intervention on HIV incidence
  • Behavioral Electronic PrEP peer navigation
    Electronic peer navigation to PreP services

Primary outcome measures

  • PrEP Initiation: [Time frame: Baseline, 6-month follow-up, 12-month follow-up]
Secondary outcome measures (2)
  • PrEP Adherence [Time frame: Baseline, 6-month follow-up, 12-month follow-up]
  • PrEP Persistence [Time frame: Baseline, 6-month follow-up, 12-month follow-up]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • Columbia University — New York

Identifiers

NCT: NCT06741618 · AAAU8894 · R01MD019181

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗