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Client-Centered Care Coordination for Black Men Who Have Sex With Men
NCT06056544 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- BEHAVIORAL Client Centered Care Coordination
Study Locations (1)
District of Columbia
- Us Helping Us, People Into Living Inc. — Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 350 participants |
| Start Date | 2025-03-21 |
| Est. Completion | 2028-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06056544
The ClinicalTrials.gov registry entry for NCT06056544 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 350 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Maryland, Baltimore, which has 559 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with HIV Prevention appearing as the primary indexed condition, and to 1 intervention — of which Client Centered Care Coordination is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06056544 reports 1 study location spanning 1 distinct geographic area — top geographies include District of Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06056544 about?
NCT06056544 is a clinical study titled "Client-Centered Care Coordination for Black Men Who Have Sex With Men". 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 ad...
What is the current status of trial NCT06056544?
This trial is currently recruiting. It is a NA study. The enrollment target is 350 participants. The study started on 2025-03-21. Estimated completion is 2028-08.
What conditions does trial NCT06056544 study?
This clinical trial studies the following conditions: HIV Prevention, HIV Pre-exposure Prophylaxis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06056544?
The interventions under investigation include: Client Centered Care Coordination (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06056544?
This trial is sponsored by University of Maryland, Baltimore, which has 559 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06056544 being conducted?
This trial has 1 study location across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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