Clinical trial NCT06872307: Intervention to Enhance PrEP Persistence
Official title: Intervention to Enhance Prep Persistence Among African American Men Who Have Sex with Men
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Prevention
HIV Infection Primary
Keywords: pre-exposure prophylaxis
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: Whitman-Walker Institute
name: Rhode Island Public Health Institute
name: University of Mississippi Medical Center
name: National Institute of Mental Health (NIMH)
First posted: 2025-03-12
Enrollment: 300
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: PrEP Adherence - Pharmacy Fill Data
timeFrame: 3 and 12 Month Follow Ups
measure: PrEP Adherence - Drug Levels
timeFrame: 3 and 12 Month Follow Ups
Secondary outcomes:
measure: PrEP Initiation
timeFrame: 3 and 12 Month Follow Ups
measure: PrEP Retention in Care
timeFrame: 3 and 12 Month Follow Ups
Other outcomes:
Locations:
city: Washington
country: United States
facility: Whitman Walker Health
state: District of Columbia
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Providence
country: United States
facility: The Rhode Island Public Health Institute
state: Rhode Island
Study officials:
References: