Actively Recruiting
Led by Columbia University · Updated on 2025-01-21
480
Participants Needed
1
Research Sites
N/A
Total Duration
C
Columbia University
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
Researchers are evaluating a multi-component, multilevel HIV prevention program aimed at overcoming barriers to HIV testing and the use of PEP/PrEP among Black men who have sex with men (MSM) aged 18 to 65 living in the New York City area. This research combines proven and new strategies within a community-based organization's standard care program, using a 2x2 factorial design to study 480 participants over 18 months. The study also looks at the impact of a social and print media campaign launched midway through recruitment to reduce HIV stigma and encourage testing and prevention uptake. The study compares four groups receiving different combinations of interventions: the standard of care peer navigation alone, standard of care plus TRUST (a single-session HIV self-testing training), standard of care plus DIY (a three-session sexual health and HIV prevention program), and standard of care with both TRUST and DIY. The media campaign targets both geographic and Black MSM communities through print and social media. Each intervention aims to increase recent HIV testing and PrEP uptake. Participants will be followed for 18 months with regular assessments including self-reported HIV testing and PrEP use, medical record reviews, and urine tests to monitor adherence to medication. Researchers will evaluate outcomes such as recent HIV testing, time to PrEP uptake, consistent testing over nine months, PEP uptake, and adherence to PrEP and PEP. The study also examines the feasibility and acceptability of the interventions as implemented by the community organization.
CONDITIONS
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
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 sessions for DIY component or single sessions for other components, over a few weeks
Participants receive behavioral interventions that include a single-session peer navigation to PrEP, a single-session HIV self-testing training, and/or a three-session sexual health promotion and HIV prevention training with a facilitator depending on their assigned group.
1 to 3 visits depending on assigned intervention components
Duration - Up to 18 months
Participants are followed for up to 18 months to assess HIV testing, PrEP and PEP uptake, and adherence through self-report, medical records, and urine testing.
Periodic visits throughout the follow-up period to collect outcome data
Total: 1 location
1
Columbia University
New York, New York, United States, 10027
Actively Recruiting
V
Victoria Frye, MPH, DrPH
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
PREVENTION
Number of Arms
4
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Keosha T Bond, Porche M Williams, Mark Paige...
https://pubmed.ncbi.nlm.nih.gov/41995922