Client-Centered Care Coordination for Black Men Who Have Sex With Men

Not Applicable

Recruiting

• Conditions: HIV Prevention; HIV Pre-exposure Prophylaxis
• Interventions: Behavioral: Client Centered Care Coordination

• Registration Number: NCT06056544
• Lead Sponsor: University of Maryland, Baltimore

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-05
• Study First Submitted QC: 2023-09-20
• Study First Posted: 2023-09-28
• Status Verified: 2025-03
• Study Start: 2025-03-21
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-04-02
• Primary Completion: 2027-12
• Study Completion: 2028-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 350

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Client Centered Care Coordination	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.).

Primary Outcome Measures

Name	Time	Method
PrEP Adherence	6, 12, 18 months	Number of participants with tenofovir-diphosphate (fmol/punch) of greater than 700 using dried blood spots analyzing peripheral blood mononuclear cells (PBMCs) and plasma concentration assay for tenofovir-diphosphate (TFV-DF) and emtricitabine-triphosphate (FTC-TP).

Trial Locations

Locations (1)

Us Helping Us, People Into Living Inc.; 🇺🇸 Washington, District of Columbia, United States