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P3 Trial: Estimating the Impact of a Multilevel, Multicomponent Intervention to Increase Uptake of HIV Testing and Biomedical HIV Prevention
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
Who can join
Ages 18 to 65 · Men · Healthy volunteers welcome
Full eligibility criteria
Inclusion Criteria: * Assigned biological male sex at birth * 18-65 years of age * Self-identify as: Black, African-American, Afro-Caribbean, Black African, Afro-Latino or multiethnic Black * Reside in the NYC metro area * Not HIV-positive (tested before randomization) * Report insertive or receptive anal intercourse with another man in the past six months * Not currently on PEP or PrEP * Can communicate in English or Spanish * Provide informed consent for the study * Any sexual identity Exclusion Criteria: * Unable to conduct a rapid HIV-self test to confirm self-reported HIV-negative status
About the study
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.
What is being tested
- DIY (Do It Yourself) (behavioral)
- TRUST (behavioral)
- SOC (behavioral)
Sponsor: Columbia University · Participants: 480 · Started: Dec 19, 2024
Contact the study team
- Victoria Frye, MPH, DrPH · Phone: 2128534490
Official record on ClinicalTrials.gov — NCT06785376
Locations in the U.S.
| New York | Columbia University, New York |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.