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RECRUITING Not applicable ClinicalTrials.gov

P3 Trial: Estimating the Impact of a Multilevel, Multicomponent Intervention to Increase Uptake of HIV Testing and Biomedical HIV Prevention

Sponsor: Columbia University • ClinicalTrials.gov ID: NCT06785376

Registry updated: 2026-08-31
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Description

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.

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.

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

Conditions

HIV Testing PrEP Uptake

Locations

  • Columbia University — New York, New York, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record