Clinical trial NCT06741618: MyPEEPS Mobile Plus: A Multi-Level HIV Prevention Intervention for Young MSM
Official title: MyPEEPS Mobile Plus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV/AIDS
Keywords: PrEP
care navigation
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Ann & Robert H Lurie Children's Hospital of Chicago
name: Callen-Lorde Community Health Center
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2024-12-19
Enrollment: 500
Sex: MALE
Minimum age (years): 17
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* 17-25 years of age
* identify as male, non-binary, or genderqueer
* 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
* Transgender identity
* currently report consistent use of PrEP

Primary outcomes:
measure: PrEP Initiation:
timeFrame: Baseline, 6-month follow-up, 12-month follow-up
Secondary outcomes:
measure: PrEP Adherence
timeFrame: Baseline, 6-month follow-up, 12-month follow-up
measure: PrEP Persistence
timeFrame: Baseline, 6-month follow-up, 12-month follow-up
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University
state: New York
Study officials:
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
name: Robert Garofalo, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
name: Lisa Kuhns, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: