A Randomized Clinical Trial of Client-centered Care Coordination to Improve Preexposure Prophylaxis Use for Black Men Who Have Sex With Men

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
United States
Washington, D.c.
Us Helping Us, People Into Living Inc.
RECRUITING
Washington D.c.
Contact Information
Primary
Darren L Whitfield, PhD
darren.whitfield@ssw.umaryland.edu
410-706-6340
Time Frame
Start Date: 2025-03-21
Estimated Completion Date: 2028-08
Participants
Target number of participants: 350
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Yale University, National Institute of Mental Health (NIMH), Us Helping Us, People Into Living, Inc., George Washington University
Leads: University of Maryland, Baltimore

This content was sourced from clinicaltrials.gov