NCT06056544Enrolling by invitation
Client-Centered Care Coordination 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
Source: ClinicalTrials.gov · Last updated 1 May 2026
Brief summary (registry, in English)
The goal of this clinical trial is to determine the efficacy of a client-center care coordination intervention (C4) in improving pre-exposure prophylaxis (PrEP) adherence in Black men who have sex with men (MSM). The main aims of the study are: 1. Determine the efficacy of C4 for increasing PrEP adherence among Black MSM. 2. Identify the optimal dose of C4 implementation for maximizing its effect on PrEP adherence. 3. Describe the acceptability and feasibility of C4 implementation in community settings. Participants in the clinical trial will be randomized to receive the intervention or standard of care for PrEP in two sites. Researchers will compare administration of C4 to standard of care to see if C4 improves adherence to PrEP. C4 is a longitudinal intervention which provides individualized client-centered HIV prevention and support services designed to address health and psychosocial needs that impact the success of PrEP use and adherence (i.e., co-morbidities, substance use, mental health, housing, etc.). The intervention pulls from the Centers for Disease Control and Prevention (CDC) Comprehensive Risk Counseling and Services (CRCS) and Self-Determination Theory (SDT) to support client-identified HIV prevention goals to promote, adopt, and maintain PrEP use. CRCS is a public health strategy to assist persons in developing behavioral goals to reduce HIV acquisition and transmission. In this intervention, the HIV prevention plan element of CRCS will be the foundation of the C4 intervention. After the initial prevention plan is developed, elements of SDT will be used to implement a client-centered care approach to assist in addressing issues which many arise which impede successful PrEP adherence.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 350 (estimated)
- First submitted
- 5 Sept 2023
- Start date
- 21 Dec 2025
- Primary completion date
- Dec 2027
- Lead sponsor
- University of Maryland, Baltimore
- Diseases
- HIV
- NCT number
- NCT06056544
What you commit to
- Study type: Interventional
- Planned participants: 350
- From 21 Dec 2025 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Black MSM who received a reactive or positive HIV test at screening or self report HIV-positive
- Use of PrEP or post-exposure prophylaxis in the last 60 days prior to anticipated enrollment
Other
- Identifying as transgender
- Current participation in any research study via self-report
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Us Helping Us, People into Living Inc Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.