Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
MALE
Healthy Volunteers
NCT06785376

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

Led by Columbia University · Updated on 2025-01-21

480

Participants Needed

1

Research Sites

166 weeks

Total Duration

On this page

Sponsors

C

Columbia University

Lead Sponsor

N

National Institute of Mental Health (NIMH)

Collaborating Sponsor

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
MALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Assigned biological male sex at birth
  • Between 18 and 65 years of age
  • Self-identify as Black, African-American, Afro-Caribbean, Black African, Afro-Latino, or multiethnic Black
  • Reside in the New York City 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
  • Communicate in English or Spanish
  • Provide informed consent for the study
Not Eligible

You will not qualify if you...

  • Sexual identity is not an exclusion criterion
  • Participants who identify as Latino must also identify as Black to be included

AI-Screening

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Trial Site Locations

Total: 1 location

1

Columbia University

New York, New York, United States, 10027

Actively Recruiting

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Research Team

V

Victoria Frye, MPH, DrPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

PREVENTION

Number of Arms

4

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