Intervention to Enhance PrEP Persistence

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

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.

Study Overview

• Status: Recruiting
• Conditions: HIV Prevention; HIV Infection Primary
• Intervention / Treatment: Behavioral: RAMP-It-Up Initiation, Adherence, and Retention Intervention

Detailed Description

Black/African American (B/AA) gay, bisexual, and other men who have sex with men (MSM) are at high risk for HIV acquisition in the United States (US). Although B/AA MSM account for less than 1% of the US population, they comprise 26% of new HIV infections. An estimated 41% of B/AA MSM acquire HIV during their lifetimes. HIV pre-exposure prophylaxis (PrEP) can dramatically reduce HIV incidence for B/AA MSM.

B/AA MSM have poorer outcomes at every stage of the PrEP care continuum. B/AA MSM are less likely to initiate PrEP, and be retained in care than non-Hispanic White MSM. PrEP care outcomes among B/AA MSM are influenced by complex social and structural factors, such as difficulty accessing culturally congruent healthcare services, insufficient health insurance, high out-of-pocket costs, and stigma associated with PrEP, sexual orientation, and HIV. The US Ending the HIV Epidemic (EtHE) initiative and the National HIV/AIDS Strategy call for expanding PrEP to B/AA MSM at community health centers (CHCs), but few interventions exist to overcome barriers and improve PrEP care outcomes in this setting. Moreover, access to PrEP navigation services in real-world settings is uneven. While some clinics offer PrEP navigation services, there is no standard or scientific consensus about how to enhance PrEP adherence and retention in care for B/AA MSM. There is also a lack of data on the degree of intensity and time for navigation services to achieve optimal PrEP outcomes for this population.

The investigator's NIH-funded pilot randomized controlled trial (RCT) (R34MH109371; MPI: Nunn, Chan, Mena) developed and evaluated the Retain and Adhere MSM on PrEP Intervention (RAMP-IT-UP), a strengths-based patient navigation program to enhance PrEP care outcomes among B/AA MSM at a CHC in Jackson, Mississippi. RAMP-IT-UP included one 60-minute personalized patient navigation session, bidirectional communication, scheduled short (10-minute) phone check-ins with navigators, tailored strengths-based strategies to overcome barriers, optional tailored daily medication reminders via text message, and transportation assistance as needed. RAMP-IT-UP also included monthly calls to patients' pharmacies to assess prescription pick-ups, allowing the navigator to connect with patients in a timely manner to understand why a PrEP prescription was not filled. RAMP-IT-UP provides real-time support to overcome social, structural and clinical barriers to PrEP initiation, retention, and adherence and was highly acceptable among B/AA MSM. Compared to control participants, RAMP-It-Up participants were much more likely to initiate PrEP (93% vs. 63%, p=0.01) and to adhere to PrEP based on pharmacy fill data (70% vs. 23%, p<0.01) and 3-month drug levels (83% vs. 50%, p=0.20). Additionally, RAMP-It-Up participants were more likely to be retained in PrEP care at 3-month (70% vs. 43%, p=0.05) and 6-month (37% vs. 27%, p=0.42) PrEP visits.

The objectives of the proposed study are to conduct a fully multi-site RCT to determine the effectiveness and cost-effectiveness of RAMP-It-Up for improving PrEP care outcomes among B/AA MSM in real-world CHC settings. The long-term goal of this work is to decrease HIV incidence among B/AA MSM, which aligns with EtHE and National HIV/AIDS Strategy goals. The investigators propose the following specific aims:

Specific Aim #1: Conduct a fully powered RCT to estimate the effectiveness of RAMP-It-Up among B/AA MSM attending CHCs. The investigators will enroll n=300 B/AA MSM who intend to initiate daily oral PrEP at CHCs in three US urban centers (N=100 each site): Jackson, Mississippi; Washington, District of Columbia; and Providence, Rhode Island. Block randomization will be used to randomize participants at each site to either RAMP-IT-UP or an attention-matched information/referral control condition (enhanced treatment-as usual [ETAU]). Quantitative research assessments will be conducted at baseline and 3-, 6-, 9-, and 12-months post-baseline. The primary outcome will be PrEP adherence, given that adherence is the definitive marker associated with protection from HIV infection. The investigators will measure adherence with pharmacy refill data and validate pharmacy refill data with PrEP drug levels. Secondary analyses will evaluate PrEP initiation and retention in care at clinical visits. The investigators hypothesize that, compared to ETAU, RAMP-It-Up will significantly improve PrEP initiation, adherence, and retention in care outcomes.

Specific Aim #2: Estimate the cost-effectiveness of RAMP-It-Up among B/AA MSM attending CHCs compared to ETAU. The investigators will employ intervention costing methods to evaluate costs of delivering RAMP-It-Up based on a comprehensive suite of tailored navigation services compared to ETAU. The investigators will then use a Markov state-transition model to estimate the cost-effectiveness of RAMP-It-Up compared to ETAU, in terms of cost-per-person initiating PrEP, adhering to PrEP, and being retained in PrEP 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. The ultimate goal is to develop a cost-effective intervention that enhances PrEP care outcomes and reduces HIV incidence among B/AA MSM that will be relevant for CHCs. This study is led by a highly successful research team with a long-standing history of collaboration on PrEP implementation studies in real-world settings. This proposal aligns with EtHE and National HIV/AIDS Strategy goals of scaling PrEP in real-world settings in geographic hotspots, with a focus on B/AA MSM.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr. Amy Nunn, ScD; Phone Number: 401-863-6568; Email: amy_nunn@brown.edu

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20005
      • Recruiting
      • Whitman Walker Health
      • Contact: Jowanna Malone, PhD, MSc; Phone Number: 202-207-2499; Email: jmalone@whitman-walker.org
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • Recruiting
      • University of Mississippi Medical Center
      • Contact: Thomas Dobbs, MD; Phone Number: (601) 984-5560; Email: tdobbs@umc.edu
  • Rhode Island
    • Providence, Rhode Island, United States, 02907
      • Recruiting
      • The Rhode Island Public Health Institute
      • Contact: Amy Nunn, ScD; Phone Number: 401-863-6568; Email: amy.nunn@riphi.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: RAMP-It-Up Initiation, Adherence, and Retention Intervention; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
PrEP Initiation	PrEP initiation will be measured as a secondary outcomes. This will be assessed by whether participants successfully obtained a PrEP prescription.	3 and 12 Month Follow Ups
PrEP Retention in Care	PrEP retention in care will be measured as a secondary outcome. Retention in care will be quantified by the number of PrEP clinical visits attended or missed in the 12 months after initiation.	3 and 12 Month Follow Ups

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: October 17, 2024
• First Submitted That Met QC Criteria: March 6, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 6, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: pre-exposure prophylaxis
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; HIV Infections
• Other Study ID Numbers: STUDY00000087; 1R01MH131475-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No