Clinical trial NCT06056544: Client-Centered Care Coordination for Black Men Who Have Sex With Men
Official title: A Randomized Clinical Trial of Client-centered Care Coordination to Improve Preexposure Prophylaxis Use for Black Men Who Have Sex With Men
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Prevention
HIV Pre-exposure Prophylaxis
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Yale University
name: George Washington University
name: Us Helping Us, People Into Living, Inc.
First posted: 2023-09-28
Enrollment: 350
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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. 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 criteria: 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

Primary outcomes:
measure: PrEP Adherence
timeFrame: 6, 12, 18 months
measure: PrEP Adherence
timeFrame: 6, 12, 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Us Helping Us, People Into Living Inc.
state: District of Columbia
Study officials:
References: