PrEP for HIV Prevention among Substance Using Populations (R01 - Clinical Trial Optional) | RFA DA 21 024

Opportunity Information: Apply for RFA DA 21 024

This NIH/National Institute on Drug Abuse (NIDA) funding opportunity, RFA-DA-21-024, supports U.S.-based research focused on improving how pre-exposure prophylaxis (PrEP) for HIV prevention is managed and implemented among people who use substances. The central problem it targets is a clear evidence gap: 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 specific to substance-using populations is still thin. In fact, the opportunity highlights that only one clinical trial has evaluated PrEP among PWID, and that broader, systematic data on PrEP use across substance-using groups remain limited. NIDA is looking for studies that can fill those gaps so providers, health systems, and public health programs have stronger guidance on how to deliver PrEP effectively to people who use drugs and/or alcohol.

The research emphasis is on understanding how substance use intersects with PrEP in real-world settings, including whether and how different patterns of use affect PrEP effectiveness, adherence, persistence, and clinical monitoring. This includes practical issues clinicians and programs regularly face, such as whether substance use contributes to missed doses, interrupted care, reduced follow-up lab monitoring, or challenges with medication management. Alongside adherence and management questions, the announcement also calls attention to the need to investigate potential unintended consequences of PrEP that may be unique or more pronounced among substance-using populations. In other words, the opportunity is not only about increasing PrEP uptake, but also about generating evidence that anticipates and addresses risks, complications, or downstream effects that could emerge when PrEP is implemented at scale among people with active substance use.

The grant mechanism is an R01 (research project grant), and clinical trials are optional, meaning applicants may propose either clinical trial research or non-trial studies as long as the work directly addresses the stated PrEP and substance use research gaps. The overall goal is to strengthen PrEP delivery and outcomes for populations at elevated HIV risk due to injection drug use and other substance use, and to produce findings that improve implementation strategies, clinical decision-making, and public health impact.

Geographically, projects must be conducted in the United States. However, the opportunity allows foreign components when they meaningfully support the domestic U.S. research (as defined under the NIH Grants Policy Statement). At the same time, non-U.S. entities (foreign institutions) are not eligible to apply as applicants, and non-U.S. components of U.S. organizations are not eligible to apply as applicants either, even though a foreign component may be included within an otherwise eligible U.S.-led application.

A strong programmatic preference is given to research conducted in states and counties prioritized under the federal Ending the HIV Epidemic (EtHE) initiative. Applicants proposing work in EtHE jurisdictions are explicitly encouraged. If an application proposes a study location outside the EtHE-identified areas, it must justify that choice using epidemiologic evidence (for example, data showing high or rising HIV incidence, clusters of transmission, elevated risk among local substance-using populations, or other compelling local HIV burden indicators).

Eligibility is broad and includes many types of U.S. organizations and government entities. Eligible applicants include state, county, city, township, and special district governments; federally recognized tribal governments; tribal organizations (including those other than federally recognized governments); public housing authorities/Indian housing authorities; independent school districts; public and private institutions of higher education; nonprofits with or without 501(c)(3) status (other than higher education institutions); for-profit organizations (other than small businesses); and small businesses. The announcement also explicitly calls out additional eligible applicant types such as faith-based or community-based organizations, regional organizations, and U.S. territories or possessions, as well as several categories of minority-serving institutions and tribal colleges, including Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), and Tribally Controlled Colleges and Universities (TCCUs).

Administratively, the opportunity is a discretionary grant in the health and education activity category under CFDA 93.279, offered by the National Institutes of Health (NIH), with NIDA as the sponsoring institute. The original closing date listed is November 12, 2020, and the funding record does not specify an award ceiling or expected number of awards in the provided source details.

• 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 2020-06-29.
• Applicants must submit their applications by 2020-11-12. (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.

Apply for RFA DA 21 024

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