Intervention to Enhance PrEP Persistence

NCT06872307 | Recruiting DMC

• 2 other identifiers: STUDY000000871R01MH131475-01A1
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

HIV Prevention; HIV Infection Primary

Keywords

pre-exposure prophylaxis

Outcome Measures

Primary Outcomes (2)

• PrEP Adherence - Pharmacy Fill Data

  The primary outcome will be PrEP adherence, given adherence is the definitive marker associated with protection from HIV infection. Adherence will be measured using pharmacy fill data in order to determine whether participants have picked up their prescription on a monthly basis.

  3 and 12 Month Follow Ups

• PrEP Adherence - Drug Levels

  The primary outcome will be PrEP adherence, given adherence is the definitive marker associated with protection from HIV infection. Adherence will be assessed by dried blood spot sampling for PrEP drug levels.

  3 and 12 Month Follow Ups

Secondary Outcomes (2)

• PrEP Initiation

  3 and 12 Month Follow Ups

• PrEP Retention in Care

  3 and 12 Month Follow Ups

Study Arms (2)

Standard of Care (Control Arm)

NO INTERVENTION

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)

RAMP-It-Up intervention

EXPERIMENTAL

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.

Behavioral: RAMP-It-Up Initiation, Adherence, and Retention Intervention

Interventions

RAMP-It-Up Initiation, Adherence, and Retention Intervention BEHAVIORAL

The intervention arm will receive facilitated strengths-based case management (SBCM)-delivered by trained interventionists-to help navigate the PrEP medical care system and support the participant and health care staff in meeting the challenges faced with obtaining PrEP medication (e.g., overcoming insurance barriers or barriers with co-pays). This also includes facilitated integration into the PrEP clinic and obtaining monthly PrEP prescription refills

RAMP-It-Up intervention

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Under the age of 18
• Assigned female sex at birth
• Does not identify as Black/African American
• Has not had a male sex partner in the past 12 months
• Does not meet CDC eligibility criteria for PrEP
• Has taken PrEP within the last 30 days
• HIV-positive or inconclusive HIV status based on antibody testing at the time of enrollment
• Does not understand or speak English
• Unable to provide informed consent
• Does not agree to authorize study access to their EHR and pharmacy fill data.

Sponsors & Collaborators

• Brown University: lead
• Whitman-Walker Institute: collaborator
• Rhode Island Public Health Institute: collaborator
• University of Mississippi Medical Center: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (3)

Whitman Walker Health

Washington D.C., District of Columbia, 20005, United States

RECRUITING

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

RECRUITING

The Rhode Island Public Health Institute

Providence, Rhode Island, 02907, United States

RECRUITING

Central Study Contacts

Dr. Amy Nunn, ScD

CONTACT

401-863-6568; amy_nunn@brown.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Public Health and Medicine at Brown University; Executive Director of the Rhode Island Public Health Institute

Model Details: All eligible participants will be randomly assigned to either the RAMP-It-Up intervention or control condition with a 1:1 ratio stratified by study site. Randomization will occur immediately following participants' completion of baseline activities. Block randomization (with random block size of 4 or 6) will be used to achieve a nearly balanced number of participants in the intervention and control arms at any given time point at each site.121 Each study site will receive a list of random treatment assignments generated by a statistical algorithm.

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: March 12, 2025
• Study Start: October 1, 2024
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: March 12, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)