NCT06872307

Intervention to Enhance PrEP Persistence

Recruiting now NA Last updated 12 March 2025

What this trial tests

NA trial testing RAMP-It-Up Initiation, Adherence, and Retention Intervention in HIV Prevention in 300 participants. Currently enrolling.

Timeline

1 October 2024

Primary endpoint
31 July 2028

31 July 2028

Quick facts

Lead sponsor	Brown University
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	300
Start date	1 October 2024
Primary completion	31 July 2028
Estimated completion	31 July 2028
Sites	3 locations across United States

Drugs / interventions tested

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

Conditions studied

• HIV Prevention — all drugs for HIV Prevention →
• HIV Infection Primary — all drugs for HIV Infection Primary →

Sponsor

Brown University

Who can join

18 and older, male only, with HIV Prevention or HIV Infection Primary. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.