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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: HIV Prevention; HIV Pre-exposure Prophylaxis
• Intervention / Treatment: Behavioral: Client Centered Care Coordination

• Study Type: Interventional
• Enrollment (Estimated): 350
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20009
      • Us Helping Us, People Into Living Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.).	Behavioral: Client 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PrEP Adherence	Count of doses of PrEP missed in the last 30 days by self report	6, 12, 18 months
PrEP Adherence	Number of participants with the following levels of PrEP using dried blood spots analyzing peripheral blood mononuclear cells (PBMCs) and plasma concentration assay for tenofovir-diphosphate (TDF), tenofovir alafenamide(TAF), lenavapavir, and cabotegravir. The drug assays with lower limit of quantification (LLoQ) are: Oral TAF/TDF Plasma: 1.0 ng/mL DBS: 0.3 ng/mL Injectables: CAB Plasma: 25 ng/mL (standard) DBS: 10 ng/mL (sensitive); 25 ng/mL (standard) Injectables: LEN Plasma: 0.5 ng/mL DBS: 1.0 ng/mL	6, 12, 18 months

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Collaborators: National Institute of Mental Health (NIMH); Yale University; George Washington University; Us Helping Us, People Into Living, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: September 5, 2023
• First Submitted That Met QC Criteria: September 20, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: HP-00106408; 1R01MH134721 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data sharing ensures the ability of translation of research results into knowledge, research products, and interventions to improve the health of communities. The research team commits to transparency through sharing the data generated by this project. All research data will be shared as requested in accordance with federal regulations and the Freedom of Information Act. The research team anticipates dissemination of results beginning in the 4th year of the award period. Sharing of the findings will involve a primary paper describing the effectiveness of the intervention on pre-exposure prophylaxis (PrEP) use and adherence and secondary papers reporting the qualitative findings and sub-analyses. Study findings will also be shared in the form of scientific and community presentations.
• IPD Sharing Time Frame: The final study data set will be shared through Inter-university Consortium for Political and Social Research (ICPSR) no later than the time of acceptance of the secondary paper on the qualitative findings on feasibility and acceptability of the intervention. Based on our study timeline, we expect this to be approximately spring of 2029, although the actual date could be earlier or later depending on the time for completing data analysis.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No