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Enrolling by Invitation

NCT Number: NCT06056544

Client-Centered Care Coordination 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.

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Key information

Conditions

HIV Prevention HIV Pre-Exposure Prophylaxis

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Us Helping Us, People Into Living Inc.

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. PrEP Adherence

    Time frame: 6, 12, 18 months

    Count of doses of PrEP missed in the last 30 days by self report

  2. PrEP Adherence

    Time frame: 6, 12, 18 months

    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

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Sep 28, 2023
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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