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

Columbia University · with National Institute of Mental Health (NIMH) · NCT06785376

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–65 · Men only
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
480
US sites recruiting
1
Study start
December 19, 2024
Record last updated
August 31, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: DIY (Do It Yourself); TRUST; SOC

Conditions: HIV Testing; PrEP Uptake

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Columbia University

    New York, NY 10027

    Site contact: Victoria Frye, MPH, DrPH · 2128534490 · vaf5@columbia.edu

Study contacts (from the official record)

  • Victoria Frye, MPH, DrPH · 2128534490 · vaf5@columbia.edu
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P3 Trial: Estimating the Impact of a Multilevel, Multicomponent… (NCT06785376) | Bored Studies