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

Frequently Asked Questions (FAQs)

1) What is this funding opportunity about?

This is an NIH/NIDA R01 grant opportunity focused on HIV pre-exposure prophylaxis (PrEP) research specifically among people who use substances. The emphasis is on closing major evidence gaps about how PrEP works in real-world settings for substance-using populations and using that evidence to improve clinical management and practical implementation strategies.

2) Which agency is offering the grant?

The opportunity was offered by the National Institute on Drug Abuse (NIDA), which is part of the National Institutes of Health (NIH).

3) What is the official title of the opportunity?

The official title is: "PrEP for HIV Prevention among Substance Using Populations (R01 Clinical Trial Optional)."

4) What is the funding opportunity number?

The funding opportunity number is RFA-DA-20-013.

5) What is the CFDA number listed for this opportunity?

The CFDA number provided is 93.279.

6) What kind of award mechanism is this?

This is an R01 funding opportunity and the funding instrument is a grant.

7) Is a clinical trial required?

No. The announcement is described as "Clinical Trial Optional," meaning applicants could propose studies that are observational, interventional, or implementation-focused, and clinical trials were allowed but not required.

8) Why is NIDA focusing on PrEP among people who use substances?

NIDA highlighted that while U.S. Public Health Service PrEP guidelines recommend PrEP for people who inject drugs (PWID) and note that alcohol and illicit drug use can complicate clinical management, the research base supporting these recommendations was described as thin. The notice pointed to limited trial and systematic data, creating an urgent need for more rigorous, targeted research.

9) What evidence gaps is the opportunity trying to address?

The opportunity aims to generate systematic, generalizable evidence about PrEP in substance-using populations, especially in real-world settings. It calls out limited prior research, including that only one clinical trial had evaluated PrEP among PWID at the time, and that broader systematic data on PrEP use across substance-using groups were limited.

10) What outcomes or issues does NIDA want researchers to study?

A core emphasis is understanding how substance use may influence PrEP effectiveness and outcomes in practice, including 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).

11) What does "real-world settings" mean in the context of this opportunity?

Based on the description, "real-world settings" refers to delivering and managing PrEP given the realities that may accompany substance use, such as periods of instability, co-occurring mental health conditions, housing insecurity, or involvement with the justice system, and how those factors may affect PrEP use and follow-up care.

12) Are implementation science approaches considered responsive?

Yes. The opportunity indicates that responsive research would often combine biomedical, behavioral, and implementation science approaches to identify barriers and test solutions for delivering and supporting PrEP among substance-using populations.

13) What types of studies could fit this R01 opportunity?

The notice suggests that applicants could propose observational, interventional, or implementation-focused studies. Examples described as reasonable include characterizing real-world PrEP uptake among people who use drugs, testing adherence support strategies, integrating PrEP into substance use treatment or harm reduction settings, or evaluating care models that address clinical management challenges associated with ongoing alcohol or illicit drug use.

14) Does the opportunity focus only on HIV incidence as an endpoint?

No. NIDA encouraged applicants to look beyond HIV incidence alone and examine a fuller set of outcomes and behaviors that may be relevant to people who use substances.

15) What "secondary effects" or unintended consequences are mentioned?

The opportunity specifically raises potential changes in harm reduction practices after starting PrEP, such as altered needle-sharing behaviors, syringe service program engagement, condom use, or other risk-reduction routines. It also flags concerns 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.

16) How does substance use relate to PrEP adherence and retention in care?

The notice emphasizes studying how alcohol or drug use might affect adherence, persistence, and retention in care, recognizing that substance use can complicate clinical management and ongoing engagement with follow-up testing and monitoring.

17) Are people who inject drugs (PWID) specifically included in the research focus?

Yes. The description references U.S. Public Health Service PrEP guidelines recommending PrEP for PWID and notes that, at the time referenced, only one clinical trial had evaluated PrEP among PWID, underscoring the need for additional research.

18) What kinds of organizations are eligible to apply?

Eligibility is broad and includes (as listed in the provided information): 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) and small businesses; and other applicant types.

19) Are specific institution types or underserved-serving organizations explicitly welcomed?

Yes. The opportunity explicitly welcomed applications from 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.

20) Can non-U.S. (foreign) organizations apply?

Yes. The eligibility list explicitly includes non-domestic (non-U.S.) entities (foreign organizations).

21) Does the opportunity expect partnerships across sectors?

The description notes that the breadth of eligible organizations reflects an expectation that meaningful PrEP research for substance-using populations may require partnerships across academic centers, community organizations, public health agencies, and service delivery sites.

22) What is the opportunity category and funding instrument?

The opportunity category is discretionary, and the funding instrument is a grant.

23) When was the opportunity created and when did it close?

The creation date listed is 2019-05-16. The original closing date listed is 2019-11-08.

24) Are award amounts, award ceiling, or expected number of awards provided?

Not in the provided source excerpt. The award ceiling and expected awards were not specified in the information provided.

25) What is the overall goal of the research supported by this opportunity?

The broad intent is to generate systematic, generalizable evidence that can inform future PrEP guidelines and improve delivery models tailored to substance-using populations, including improving clinical management and implementation strategies in real-world settings.