RecruitingNot ApplicableNCT06785376

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

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


Sponsor

Columbia University

Enrollment

480 participants

Start Date

Dec 19, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 65 Years

Inclusion Criteria5

  • assigned biological male sex at birth;
  • years of age;
  • self-identify as: Black, African-American, Afro-Caribbean, Black African, Afro-Latino or multiethnic Black;
  • reside in the NYC metro area; (5) not HIV-positive (tested before randomization);
  • \) report insertive or receptive anal intercourse with another man in the past six months; 7) not currently on PEP or PrEP; 8) communicate in English or Spanish; 9) provide informed consent for the study.

Exclusion Criteria2

  • Sexual identity is not an exclusion criterion
  • potential participants who self-identify as Latino must also identify as Black (as per above) to be included

Interventions

BEHAVIORALDIY (Do It Yourself)

DIY is 3-session program that promotes empowerment, autonomy, stigma coping/resistance and social support to promote sexual health and pleasure and HIV prevention.

BEHAVIORALTRUST

TRUST is a single-session HIV self-testing training with facilitator

BEHAVIORALSOC

standard of care single-session, low threshold peer/near-peer navigation to PrEP.


Locations(1)

Columbia University

New York, New York, United States

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NCT06785376


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