RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-03-21
Study Completion:2028-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06056544

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age of 18 years of age
  2. * Identify as Black, African American, Black African, Afro-Caribbean, or Black-Latino
  3. * Cisgender male
  4. * PrEP naïve or who prematurely stopped PrEP
  5. * No prior HIV diagnosis confirmed through HIV testing
  6. * Self-reported high risk for acquiring HIV
  7. * Currently not enrolled in another HIV prevention study
  1. * Black MSM who received a reactive or positive HIV test at screening or self report HIV-positive
  2. * Identifying as transgender
  3. * Current participation in any research study via self-report
  4. * Use of PrEP or post-exposure prophylaxis in the last 60 days prior to anticipated enrollment

Contacts and Locations

Study Contact

Darren L Whitfield, PhD
CONTACT
410-706-6340
darren.whitfield@ssw.umaryland.edu

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of Maryland, Baltimore

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-21
Study Completion Date2028-08

Study Record Updates

Study Start Date2025-03-21
Study Completion Date2028-08

Terms related to this study

Additional Relevant MeSH Terms

  • HIV Prevention
  • HIV Pre-exposure Prophylaxis