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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-65
SponsorColumbia University

About this trial

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.

Eligibility criteria

Qualifiers

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; (5) not HIV-positive (tested before randomization);

Disqualifiers

Sexual identity is not an exclusion criterion

potential participants who self-identify as Latino must also identify as Black (as per above) to be included

Trial design

Treatments tested in this trial

  • DIY (Do It Yourself)
  • TRUST
  • SOC

Treatment groups

480 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Columbia University

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator