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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
University of Maryland, Baltimore
Study ID
NCT06056544
Status
Enrolling By Invitation

Conditions

  • HIV Pre-exposure Prophylaxis
  • HIV Prevention

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Client Centered Care Coordination — BEHAVIORAL
    During the initial C4 sessions, participants will be offered PrEP. For participants who initiate PrEP, C4 staff will provide an individualized PrEP initiation plan. During subsequent C4 sessions, C4 staff will review the prevention plan and goals with participants and use autonomy supportive counseling to address the barriers that are identified by participants that impact their motivation to use PrEP and adhere to PrEP through referrals to support services (e.g, PrEP access programs, addiction medicine services, housing, and job resources). In addition, the C4 staff will ensure any medical issues related to PrEP adherence are addressed by the site medical providers.

Study Details

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.

Key Dates

Start date
Dec 21, 2025
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Aug 31, 2028

Study Design

Enrollment
350 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Intervention Group
    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.).
  • No Intervention: Control Group
    Individuals in the control group will receive standard of care for PrEP use at each clinic. The standard of care is PrEP clinical care includes identifying and engaging patients in need of PrEP, conducting necessary exams and lab tests and prescribing PrEP for the patients, as well as ongoing patient monitoring with follow-up visits and prescriptions-for as long as the patient needs PrEP.

Primary Outcome Measure

PrEP Adherence [ Time Frame: 6, 12, 18 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Us Helping Us, People Into Living Inc.Washington D.C.District of Columbia20009-

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Us Helping Us, People Into Living Inc.· Washington D.C., DC

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