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NCT06056544 · ClinicalTrials.gov registry record · NA
Client-Centered Care Coordination for Black Men Who Have Sex With Men
A NA study of HIV Prevention and HIV Pre-exposure Prophylaxis, sponsored by University of Maryland, Baltimore.
- Recruiting
- Registry status
- NA
- Development phase
- 350
- Enrollment target
- 1
- Study location
NCT06056544 is a NA study of HIV Prevention and HIV Pre-exposure Prophylaxis that is actively recruiting participants, run by University of Maryland, Baltimore. The registered enrollment target is 350 participants, roughly in line with the 371-participant average among 32 other HIV Prevention trials with a reported enrollment target. The trial reports 1 study location across 1 state.
The verdict
NCT06056544, a NA study of HIV Prevention and HIV Pre-exposure Prophylaxis, is actively recruiting participants, sponsored by University of Maryland, Baltimore.
- RECRUITING
- Registry status
- NA
- Development phase
- 350 participants
- Enrollment target
- 1
- Study location
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 |
Interested in This Trial?
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, categorized as NA. The registered enrollment target is 350 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 371-participant average among 32 other HIV Prevention trials with a reported enrollment target. The listed sponsor is University of Maryland, Baltimore, which has 560 total studies on file at ClinicalTrials.gov.
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.
NCT06056544 reports 1 study location spanning 1 distinct geographic area - top geographies include District of Columbia.
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.
What interventions are being tested in trial NCT06056544?
The interventions under investigation include: Client Centered Care Coordination (BEHAVIORAL).
Who is sponsoring clinical trial NCT06056544?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
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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