RecruitingNot ApplicableNCT06056544

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


Sponsor

University of Maryland, Baltimore

Enrollment

350 participants

Start Date

Mar 21, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a care coordination program to help Black men who have sex with men (MSM) who are at high risk for HIV start and stay on PrEP (a daily pill that prevents HIV infection). **You may be eligible if...** - You are 18 years or older - You identify as Black, African American, Afro-Caribbean, or Black-Latino - You are a cisgender male - You have never taken PrEP or stopped taking it prematurely - You do not have HIV (confirmed by testing) - You consider yourself at high risk for acquiring HIV - You are not currently enrolled in another HIV prevention study **You may NOT be eligible if...** - You tested positive for HIV at screening or are known to be HIV-positive - You identify as transgender - You have used PrEP or post-exposure prophylaxis in the last 60 days - You are currently participating in another research study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALClient Centered Care Coordination

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.


Locations(1)

Us Helping Us, People Into Living Inc.

Washington D.C., District of Columbia, United States

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NCT06056544


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