RAMP-It-Up for HIV Prevention

Recruiting at 2 trial locations

Overseen By Dr. Amy Nunn, ScD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Brown University

Must be taking: PrEP

Disqualifiers: Under 18, Female, HIV-positive, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 12 months

300 Participants Needed

Trial Summary

What is the purpose of this trial?

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 Criteria

This trial is for Black/African American men who have sex with men (MSM) and are at risk of HIV. It aims to help them start, stick with, and continue using PrEP—a daily medication that can prevent HIV infection.

Inclusion Criteria

Identify as Black/African American

Meet the CDC eligibility criteria for PrEP

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

Exclusion Criteria

Does not identify as Black/African American

HIV-positive or inconclusive HIV status based on antibody testing at the time of enrollment

Does not meet CDC eligibility criteria for PrEP

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the RAMP-It-Up intervention, including personalized navigation, communication, and support for PrEP adherence and retention

12 months

Monthly check-ins (phone or text), in-person navigation session

Follow-up

Participants are monitored for PrEP adherence and retention in care, with assessments at 3, 6, 9, and 12 months

12 months

4 visits (in-person) at 3, 6, 9, and 12 months

Extension

Optional continuation of PrEP care and navigation support beyond the initial 12 months

Long-term

Treatment Details

Interventions

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

Trial Overview The study tests a patient navigation program called RAMP-IT-UP designed to improve the use of PrEP among participants. The effectiveness will be compared against standard care in community health centers through a randomized controlled trial.

Participant Groups

Group I: RAMP-It-Up intervention Experimental Treatment 1 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.

Group II: Standard of Care (Control Arm) Active Control 1 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)

Who Is Running the Clinical Trial?

Brown University

Lead Sponsor

Trials

480

Recruited

724,000+

University of Mississippi Medical Center

Collaborator

Trials

185

Recruited

200,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Whitman-Walker Institute

Collaborator

Trials

4

Recruited

1,800+

Rhode Island Public Health Institute

Collaborator

Trials

2

Recruited

500+