Intervention to Enhance Prep Persistence Among African American Men Who Have Sex with Men

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The investigators will conduct a fully powered randomized controlled trial (RCT) to test the effect of a patient navigation intervention for Black/African American (B/AA) men who have sex with men (MSM) on PrEP initiation, adherence and retention in care. B/AA men who have sex with men (MSM) are disproportionately impacted by the HIV/AIDS epidemic in the United States. Pre-exposure prophylaxis (PrEP), a once daily medication, can dramatically reduce HIV acquisition risk. However, social and structural barriers have contributed to suboptimal PrEP initiation, adherence, and retention in care among B/AA MSM. Our prior NIH-funded pilot study (R34MH109371; MPI: Nunn, Chan, Mena) developed and evaluated an Intervention to Retain and Adhere MSM in PrEP (RAMP-IT-UP), a brief strengths-based patient navigation program to enhance PrEP care outcomes among young B/AA MSM. The intervention was found to be highly acceptable among B/AA MSM and demonstrated preliminary effectiveness. Compared to control participants, RAMP-IT-UP participants were statistically more likely to initiate PrEP and adhere to PrEP based on pharmacy fill data and PrEP blood levels. Additionally, RAMP-IT-UP participants were more likely to be retained in PrEP care at the 3-month and 6-month clinical visits. Specific Aim #1 of this study will conduct a fully powered randomized controlled trial (RCT to estimate the effectiveness of RAMP-IT-UP in improving PrEP adherence and care outcomes among B/AA MSM in real-world community health center settings (CHCs). Specific Aim #2 will estimate the cost-effectiveness of RAMP-IT-UP among B/AA MSM attending CHCs compared to standard of care. The investigators will also determine the cost-effectiveness of differing levels of intensity of navigation services to prevent HIV based on data collected in Specific Aim #1. Our goal is to develop a cost-effective intervention that enhances PrEP care outcomes and reduces HIV incidence for B/AA MSM which will be relevant for CHCs across the US. The long-term goal of this work is to decrease HIV incidence among B/AA MSM, which aligns with federal Ending the HIV Epidemic and National HIV/AIDS Strategy goals. This application is led by an experienced team of investigators with a proven track record conducting HIV, PrEP and disparities research in real-world clinical settings.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: t
View:

• Aged 18 years and older

• Assigned male sex at birth

• Identify as Black/African American

• Report at least one male sex partner in the past 12 months

• Meet the CDC eligibility criteria for PrEP

• Have not taken PrEP for at least 30 days

• Are HIV-negative based on antibody testing at the time of enrollment

• Understand and speak English

• Able to provide informed consent

• Agree to authorize study access to their EHR and pharmacy fill data. Eligible patients who are interested in participating will be consented and enrolled into the study.

Locations
United States
Washington, D.c.
Whitman Walker Health
RECRUITING
Washington D.c.
Mississippi
University of Mississippi Medical Center
RECRUITING
Jackson
Rhode Island
The Rhode Island Public Health Institute
RECRUITING
Providence
Contact Information
Primary
Dr. Amy Nunn, ScD
amy_nunn@brown.edu
401-863-6568
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2028-07-31
Participants
Target number of participants: 300
Treatments
No_intervention: Standard of Care (Control Arm)
Standard of care (access to a financial advocate and clinical staff to support, facilitate, and assist in linkage to the established PrEP clinic at study sites and to facilitate initiation of, and obtaining, PrEP medications)
Experimental: RAMP-It-Up intervention
The RAMP-It-Up intervention focuses on personalized navigation informed by strengths-based case management. RAMP-It-Up consists of a brief in-person patient navigation session, ongoing bidirectional communication as needed, short (10-minute) phone or text message check-ins with the navigator, strengths-based case management strategies to overcome barriers, optional daily medication text reminders, transportation assistance to clinical visits as needed, and monthly calls to patients' pharmacies to assess prescription pick-up, allowing the navigator to provide real-time support in addressing barriers to PrEP initiation, adherence, and retention in care.
Related Therapeutic Areas
Sponsors
Collaborators: Whitman-Walker Institute, University of Mississippi Medical Center, National Institute of Mental Health (NIMH), Rhode Island Public Health Institute
Leads: Brown University

This content was sourced from clinicaltrials.gov