PrEP for HIV Prevention among Substance Using Populations (R01 - Clinical Trial Optional)

NIDA is interested in research that addresses research gaps related to PrEP and its use among substance users, with the goals of improving PrEP management and implementation. Current US Public Health Service PrEP guidelines recommend PrEP for people who inject drugs (PWID) and mention alcohol and illicit drug use as potential concerns for clinical management. Only one clinical trial has evaluated PrEP among PWID and systematic data regarding the broader use of PrEP among substance users are limited. There is a need to better understand the effects of substance use on PrEP effectiveness and better inform PrEP implementation among substance users. More systematic data are needed regarding the impact of substance use on PrEP management and adherence, along with investigating potential unintended consequences of PrEP use that may be unique to substance users. This RFA is restricted to projects conducted in the United States, although foreign components are permitted where they support domestic research in the United States. Applications are encouraged that propose research in states and counties identified in the US Governments Ending the HIV Epidemic (EtHE) initiative as described here: Ending the HIV Epidemic: A Plan for America https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview. Applications to work in locales that are not included in the EtHE initiative must provide an epidemiologic justification for their inclusion in the research.