300 Participants Needed

RAMP-It-Up for HIV Prevention

Recruiting at 2 trial locations
DA
Overseen ByDr. Amy Nunn, ScD
Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: Brown University
Must be taking: PrEP
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

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
See 5 more

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
See 6 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: RAMP-It-Up interventionExperimental Treatment1 Intervention
Group II: Standard of Care (Control Arm)Active Control1 Intervention

Find a Clinic Near You

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+
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security