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

NCT06056544 | Enrolling By Invitation DMC

• 2 other identifiers: HP-001064081R01MH134721
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief 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. 1.Determine the efficacy of C4 for increasing PrEP adherence among Black MSM.
2. 2.Identify the optimal dose of C4 implementation for maximizing its effect on PrEP adherence.
3. 3.Describe the acceptability and feasibility of C4 implementation in community settings.

Conditions

HIV Pre-exposure Prophylaxis; HIV Prevention

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Us Helping Us, People Into Living Inc.

Washington D.C., District of Columbia, 20009, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 28, 2023
• Study Start: December 21, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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.

Locations

US (1)