Improving HIV prevention for Black men who have sex with men
A Randomized Clinical Trial of Client-centered Care Coordination to Improve Preexposure Prophylaxis Use for Black Men Who Have Sex With Men
NA · University of Maryland, Baltimore · NCT06056544
This study is testing a new support program to see if it helps Black men who have sex with men stick to their HIV prevention medication better than standard care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University of Maryland, Baltimore (other) |
| Locations | 1 site (Washington, District of Columbia) |
| Trial ID | NCT06056544 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a client-centered care coordination intervention (C4) in enhancing adherence to pre-exposure prophylaxis (PrEP) among Black men who have sex with men (MSM). Participants will be randomly assigned to receive either the C4 intervention or standard care for PrEP at two different sites. The study will assess how well C4 improves PrEP adherence, determine the optimal implementation of C4, and evaluate its acceptability and feasibility in community settings. The intervention focuses on providing tailored support to address the health and psychosocial factors affecting PrEP use.
Who should consider this trial
Good fit: Ideal candidates for this study are Black cisgender men aged 18 and older who are at high risk for acquiring HIV and have either never used PrEP or have stopped using it prematurely.
Not a fit: Patients who are HIV-positive or currently participating in another HIV prevention study may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could significantly improve PrEP adherence and reduce the risk of HIV among Black MSM.
How similar studies have performed: Other studies have shown promise in using client-centered approaches for improving adherence to HIV prevention methods, suggesting that this approach could be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age of 18 years of age * Identify as Black, African American, Black African, Afro-Caribbean, or Black-Latino * Cisgender male * PrEP naïve or who prematurely stopped PrEP * No prior HIV diagnosis confirmed through HIV testing * Self-reported high risk for acquiring HIV * Currently not enrolled in another HIV prevention study Exclusion Criteria: * Black MSM who received a reactive or positive HIV test at screening or self report HIV-positive * Identifying as transgender * Current participation in any research study via self-report * Use of PrEP or post-exposure prophylaxis in the last 60 days prior to anticipated enrollment
Where this trial is running
Washington, District of Columbia
- Us Helping Us, People Into Living Inc. — Washington, District of Columbia, United States (RECRUITING)
Study contacts
- Study coordinator: Darren L Whitfield, PhD
- Email: darren.whitfield@ssw.umaryland.edu
- Phone: 410-706-6340
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: HIV Prevention, HIV Pre-exposure Prophylaxis