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

MyPEEPS Mobile Plus

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06741618
Enrollment
500
Registered
2024-12-19
Start date
2026-04-20
Completion date
2029-06-30
Last updated
2026-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV/AIDS

Keywords

PrEP, care navigation

Brief summary

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

BEHAVIORALMyPEEPS Mobile

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

BEHAVIORALElectronic PrEP peer navigation

Electronic peer navigation to PreP services

Sponsors

Columbia University
Lead SponsorOTHER
Ann & Robert H Lurie Children's Hospital of Chicago
CollaboratorOTHER
Callen-Lorde Community Health Center
CollaboratorOTHER
National Institute on Minority Health and Health Disparities (NIMHD)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
MALE
Age
16 Years to 25 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
PrEP Initiation:Baseline, 6-month follow-up, 12-month follow-upParticipants will self-report attending at least one PrEP-related care visit to asess medical eligibility for PrEP initiation.

Secondary

MeasureTime frameDescription
PrEP AdherenceBaseline, 6-month follow-up, 12-month follow-upDaily oral PrEP users will report PrEP use in the past 7-days.
PrEP PersistenceBaseline, 6-month follow-up, 12-month follow-upQuestions will be measure visit constancy, i.e., self-report at least 1 PrEP related care visit in the past 6 months.

Countries

United States

Contacts

CONTACTRebecca Schnall, PhD, MPH
rb897@columbia.edu212-342-6886
PRINCIPAL_INVESTIGATORRobert Garofalo, MD, MPH

Ann & Robert H Lurie Children's Hospital of Chicago

PRINCIPAL_INVESTIGATORLisa Kuhns, PhD, MPH

Ann & Robert H Lurie Children's Hospital of Chicago

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 27, 2026