PrEP for HIV Prevention among Substance Using Populations (R01 Clinical Trial Optional) | RFA DA 20 013

Opportunity Information: Apply for RFA DA 20 013

The National Institute on Drug Abuse (NIDA), within the National Institutes of Health (NIH), offered this R01 grant opportunity to support research on HIV pre-exposure prophylaxis (PrEP) specifically among people who use substances. The central purpose is to close major evidence gaps about how PrEP works in real-world settings for substance-using populations, and to use that evidence to improve both clinical management of PrEP and practical implementation strategies. While U.S. Public Health Service PrEP guidelines already recommend PrEP for people who inject drugs (PWID) and note that alcohol and illicit drug use can complicate clinical management, the research base for these recommendations is thin. The notice highlights that only one clinical trial had evaluated PrEP among PWID at the time, and that systematic data on broader PrEP use across substance-using groups were limited, creating an urgent need for more rigorous, targeted research.

A core emphasis of the opportunity is understanding how substance use may influence PrEP effectiveness and outcomes. This includes studying the ways alcohol or drug use might affect adherence (taking PrEP consistently), persistence (staying on PrEP over time), and retention in care (continuing to engage with clinical services for follow-up testing and monitoring). NIDA is signaling that the clinical question is not just whether PrEP can biologically prevent HIV in these populations, but how well it can be delivered, managed, and supported given the realities of substance use, including periods of instability, co-occurring mental health conditions, housing insecurity, or involvement with the justice system. Research responsive to this opportunity would therefore often combine biomedical, behavioral, and implementation science approaches to identify barriers and test solutions.

The opportunity also calls attention to potential unintended consequences or secondary effects of PrEP use that could be unique or particularly relevant to people who use substances. One example raised is the possibility of changes in harm reduction practices, such as altered needle-sharing behaviors, syringe service program engagement, condom use, or other risk-reduction routines once someone starts PrEP. Another concern is that substance use can contribute to higher-risk sexual behaviors, which may lead to increases in sexually transmitted infections (STIs) even if HIV risk declines due to PrEP. In other words, NIDA is encouraging applicants to look beyond the single endpoint of HIV incidence and to examine a fuller set of health outcomes and behaviors, including STI trends, risk compensation dynamics, and the interaction between substance use patterns and sexual or injection-related risks.

Mechanistically, this was an R01 funding opportunity (clinical trial optional), meaning applicants could propose either observational, interventional, or implementation-focused studies, and clinical trials were allowed but not required. The broad intent is to generate systematic, generalizable evidence that can inform future PrEP guidelines and improve delivery models tailored to substance-using populations. Projects could reasonably include studies that characterize real-world PrEP uptake among people who use drugs, test adherence support strategies, integrate PrEP into substance use treatment or harm reduction settings, or evaluate care models that address the clinical management challenges raised by ongoing alcohol or illicit drug use.

In terms of eligibility, the announcement was wide-ranging and included many organization types that commonly apply for NIH grants. Eligible applicants listed in the source data include state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories); for-profit organizations (other than small businesses) as well as small businesses; and other applicant types. It also explicitly welcomed applications from a number of mission-relevant or underserved-serving institutions and organizations, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, non-domestic (non-U.S.) entities (foreign organizations), Indian/Native American Tribal Governments other than federally recognized, and U.S. territories or possessions. This breadth reflects the expectation that meaningful PrEP research for substance-using populations may require partnerships across academic centers, community organizations, public health agencies, and service delivery sites.

Key administrative details from the source information include the funding opportunity title "PrEP for HIV Prevention among Substance Using Populations (R01 Clinical Trial Optional)," funding opportunity number RFA-DA-20-013, and CFDA number 93.279. The opportunity category is discretionary and the funding instrument is a grant. The original closing date listed was 2019-11-08, with a creation date of 2019-05-16. Award ceiling and expected awards were not specified in the provided source data excerpt.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "PrEP for HIV Prevention among Substance Using Populations (R01 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.279.
• This funding opportunity was created on 2019-05-16.
• Applicants must submit their applications by 2019-11-08. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

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