Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
MALE
Healthy Volunteers
ID06785376

Evaluating a Combined Intervention to Increase HIV Testing and Prevention Uptake Among Black Gay, Bisexual, and Same-Gender Loving Men Including Peer Navigation, Self-Testing, and Media Campaigns

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

Researchers are evaluating a multi-component, multilevel HIV prevention program designed to overcome barriers and encourage HIV testing and PEP/PrEP uptake among Black men who have sex with men (MSM) aged 18 to 65 living in the New York City area. The study combines proven and new strategies integrated into a community-based organization's standard peer navigation care. It includes a social and print media campaign aimed at reducing HIV stigma and increasing testing and prevention demand in the community. The study uses a 2x2 factorial design to follow 480 eligible participants over 18 months. The interventions include TRUST, a one-session peer-led HIV self-testing program; DIY (Do It Yourself), a three-session program promoting empowerment, autonomy, stigma coping, and social support using "sexual self-care in-a-box" and peer training; and the standard of care (SOC) peer navigation program for PrEP access. Participants are randomized to one of four groups receiving different combinations of these interventions. The media campaign is launched midway through recruitment and delivered via social and print media to target geographic areas and Black MSM communities. Participants will be regularly assessed for HIV testing and PrEP uptake over the study period. Data will be collected through self-report, medical records, and urine tests measuring medication adherence. The study will also evaluate consistent HIV testing, PEP uptake, and adherence. Researchers will track exposure to the media campaign and analyze how combinations of interventions impact outcomes. Feedback on intervention feasibility, acceptability, and usability will be gathered using the Re-AIM framework, with an emphasis on implementation within the community-based organization.

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

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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Published Research Related To This Trial

Designing Pleasure-Centered, Culturally Relevant PrEP Messaging for Black Gay, Bisexual, Queer, Same-Gender-Loving, and Other Men Who have Sex with Men (SGL/MSM) in New York City.

Keosha T Bond, Porche M Williams, Mark Paige...

https://pubmed.ncbi.nlm.nih.gov/41995922