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

University of Maryland Baltimore (UMB)

Status: Enrolling

Conditions: HIV Prevention; HIV Pre-exposure Prophylaxis

Treatments: Behavioral: Client Centered Care Coordination

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06056544

1R01MH134721 (U.S. NIH Grant/Contract)

HP-00106408

Details and patient eligibility

About

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.

Enrollment: 350 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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350 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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.).

Treatment:

Behavioral: Client Centered Care Coordination

Control Group

No Intervention group

Description:

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.