PROJECT SUMMARY
This R01 application proposes conducting 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. We 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.