P3 Trial: Estimating the Impact of a Multilevel, Multicomponent Intervention to Increase Uptake of HIV Testing and Biomedical HIV Prevention Among African-American/Black Gay, Bisexual, and Same-gender Loving Men

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT06785376
Status
Recruiting
Apply to this trial

Conditions

  • HIV Testing
  • PrEP Uptake

Eligibility Criteria

Sex
MALE
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • DIY (Do It Yourself) — BEHAVIORAL
    DIY is 3-session program that promotes empowerment, autonomy, stigma coping/resistance and social support to promote sexual health and pleasure and HIV prevention.
  • TRUST — BEHAVIORAL
    TRUST is a single-session HIV self-testing training with facilitator
  • SOC — BEHAVIORAL
    standard of care single-session, low threshold peer/near-peer navigation to PrEP.

Study Details

The major goal of this study is to evaluate a multi-component, multilevel HIV prevention intervention that targets theoretically-informed and empirically-identified barriers to and facilitators of both HIV testing and PEP/PrEP uptake by combining existing evidence-based and novel evidence-informed components and integrating them into a community-based organization's (CBO) standard of care (SOC) PEP/PrEP navigation program. The evaluation will apply use a 2x2 factorial design to randomize and follow for 18 months 480 PrEP-eligible Black MSM (aged 18-65) living in the NYC area to one of four combinations of interventions. The impact of the social/media campaign, delivered to both geographic (print media) and Black MSM communities (social media) and launched midway through recruitment, will be assessed through assessment of timing and length of exposure as covariates in analysis.

Key Dates

Start date
Dec 19, 2024
Status verified
Jan 2025
Primary completion
Feb 28, 2028
Completion
Feb 28, 2028

Study Design

Enrollment
480 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION

Arms

  • Active Comparator: A. SOC
    A. standard of care single-session, low threshold peer/near-peer navigation to PrEP.
  • Experimental: B. SOC & TRUST
    B. SOC standard of care single-session, low threshold peer/near-peer navigation to PrEP; TRUST single-session HIV self-testing training with facilitator
  • Experimental: C. SOC & DIY
    C. SOC standard of care single-session, low threshold peer/near-peer navigation to PrEP; DIY three-session sexual health promotion/HIV prevention training with facilitator
  • Experimental: D. SOC, TRUST & DIY
    D. SOC standard of care single-session, low threshold peer/near-peer navigation to PrEP; TRUST single-session HIV self-testing training with facilitator; DIY three-session sexual health promotion/HIV prevention training with facilitator

Primary Outcome Measure

P3M HIV testing [ Time Frame: past 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia UniversityNew YorkNew York10027
Victoria Frye, MPH, DrPH
[email protected]
2128534490
Victoria Frye, MPH, DrPH

Find similar trials in New York, NY

By research site
Columbia University· New York, NY

Related Studies