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
| NCT ID | NCT06785376 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Columbia University |
| Condition | HIV Testing |
| Study Type | INTERVENTIONAL |
| Enrollment | 480 participants |
| Start Date | 2024-12-19 |
| Primary Completion | 2028-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 480 participants in total. It began in 2024-12-19 with a primary completion date of 2028-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. assigned biological male sex at birth; 2. 18-65 years of age; 3. self-identify as: Black, African-American, Afro-Caribbean, Black African, Afro-Latino or multiethnic Black; 4. reside in the NYC metro area; (5) not HIV-positive (tested before randomization); 6\) 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 Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06785376 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 65 Years, studying HIV Testing. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06785376 currently recruiting?
Yes, NCT06785376 is actively recruiting participants. Contact the research team at vaf5@columbia.edu for enrollment information.
Where is the NCT06785376 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06785376 clinical trial?
NCT06785376 is sponsored by Columbia University. The trial plans to enroll 480 participants.
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