RAMP-It-Up for HIV Prevention

Recruiting at 3 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a patient navigation program designed to help Black/African American men who have sex with men (MSM) start and maintain PrEP, a medication that reduces the risk of HIV. The RAMP-It-Up Initiation, Adherence, and Retention Intervention program provides personalized support, such as check-ins and transportation assistance, to minimize barriers to accessing PrEP. The trial compares this program to standard care to determine which is more effective and cost-efficient. The study seeks HIV-negative Black/African American men who have had a male partner in the past year and are interested in starting PrEP but have not taken it in the last 30 days. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance access to HIV prevention for the community.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on starting PrEP for HIV prevention, so it's best to discuss your current medications with the trial team.

What prior data suggests that the RAMP-It-Up intervention is safe for improving PrEP care outcomes?

Research shows that the RAMP-It-Up program is safe and well-liked by participants. Previous studies found it very acceptable among Black/African American men who have sex with men (B/AA MSM). Participants in these studies were more likely to start and continue taking their PrEP (pre-exposure prophylaxis) medication compared to those who didn’t receive the program. This indicates the program is both effective and safe for participants. No specific negative effects or safety issues have been reported, which is encouraging for anyone considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the RAMP-It-Up intervention for HIV prevention because it offers a personalized approach to help people start and stick with PrEP, a medication that can prevent HIV. Unlike standard care, which mainly provides access to a clinic and medication, RAMP-It-Up includes personalized patient navigation, regular communication, and strengths-based case management to tackle individual barriers. This approach also offers daily medication reminders and transportation assistance, ensuring patients receive the support they need to maintain their treatment. By focusing on personalized care and real-time support, this intervention aims to improve adherence and retention, potentially leading to better outcomes in HIV prevention.

What evidence suggests that the RAMP-It-Up intervention is effective for improving PrEP care outcomes among B/AA MSM?

Research has shown that the RAMP-It-Up program, which participants in this trial may receive, is promising in helping Black/African American men who have sex with men (B/AA MSM) start and continue taking their PrEP medication, which helps prevent HIV. In previous studies, participants in the RAMP-It-Up program were much more likely to begin and maintain PrEP use compared to those who didn't participate. Specifically, 93% of RAMP-It-Up participants started PrEP, while only 63% in the non-participating group did. They also adhered better to their medication schedule, taking their pills as directed. This program offers support like personalized advice, regular check-ins, and medication reminders, which significantly aid in sticking with PrEP. These findings suggest that RAMP-It-Up could effectively lower HIV risk among B/AA MSM. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06872307

NCT06872307 | Intervention to Enhance PrEP Persistence The investigators hypothesize that, compared to ETAU, RAMP-It-Up will significantly improve PrEP initiation, adherence, and retention in care ...

2. reporter.nih.gov reporter.nih.gov/search/OADbLE3qG0y4l19zsVwmiA/project-details/10700346

nunn, amy stewart 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 ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/condition/179/hiv-infections

Hiv Infections Clinical Research Trials 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 ...

4. ajpmonline.org ajpmonline.org/article/S0749-3797(21)00358-5/fulltext

Pre-exposure Prophylaxis Uptake, Adherence, and ... Overall, 216 (92%) patients received a prescription for PrEP, and executed adherence was reasonably high, with 57% (138 of 159) reporting not having missed a ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03256435

Retention in PrEP Care for African American MSM ... The ADAPT_ITT approach will be used to develop and pilot test a RAMP intervention that aims to promote PrEP adherence and retention in care in Jackson, MS and ...

6. withpower.com withpower.com/trial/ramp-it-up-for-hiv-prevention-5b8e8

RAMP-It-Up for HIV Prevention The intervention was found to be highly acceptable among B/AA MSM and demonstrated preliminary effectiveness. Compared to control participants, RAMP-IT-UP ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0749379721003585

Pre-exposure Prophylaxis Uptake, Adherence, and ... In MSM, ≥4 doses per week has been shown to reduce the risk of HIV infection by 90%. Data are less robust in women, although modeling analyses suggest that as ...

8. nimh.nih.gov nimh.nih.gov/health/trials/hiv-aids

HIV/AIDS - National Institute of Mental Health (NIMH) - NIH 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 ...