PrEP for HIV Prevention among Substance Using Populations (R01 - Clinical Trial Optional) | RFA DA 22 017

Opportunity Information: Apply for RFA DA 22 017

This NIH/NIDA funding opportunity (RFA-DA-22-017) supports R01 research projects that fill key evidence gaps on HIV pre-exposure prophylaxis (PrEP) among people who use substances, with a strong emphasis on improving real-world PrEP clinical management and implementation for these populations. The core problem the RFA is trying to solve is that, while U.S. Public Health Service guidelines recommend PrEP for people who inject drugs (PWID) and flag alcohol and illicit drug use as potential complications for clinical care, the research base is still thin. In particular, only one clinical trial has evaluated PrEP among PWID, and there is limited systematic information on PrEP use across the broader range of substance-using groups. NIDA is looking for studies that can better explain how substance use affects PrEP effectiveness and day-to-day outcomes, and that can translate those findings into practical, evidence-based approaches for delivering and supporting PrEP among people who use drugs or alcohol.

A major focus is generating more rigorous, systematic data on how substance use influences PrEP adherence, persistence, and clinical management. Projects may examine how patterns of use (for example, intermittent versus daily use, polysubstance use, or use associated with high-risk contexts) affect a persons ability to start PrEP, take it as prescribed, stay engaged in follow-up care, and maintain protective medication levels. The opportunity also highlights the need to investigate unintended consequences of PrEP use that may be distinct in substance-using populations, which can include clinical, behavioral, or service-delivery issues that do not show up as clearly in other groups. Overall, the research is intended to strengthen implementation by identifying barriers and facilitators, testing strategies to improve uptake and adherence, and informing clinical guidance on how to manage PrEP when substance use is present.

The RFA is restricted to research conducted in the United States, but it allows foreign components when they directly support domestic U.S. research (as defined in the NIH Grants Policy Statement). At the same time, non-U.S. organizations are not eligible to apply as applicants, and non-domestic components of U.S. organizations are not eligible to apply; the main applicant entity must be U.S.-based and the project must be anchored in U.S. settings. NIDA also encourages applicants to conduct work in the specific states and counties prioritized under the U.S. Governments Ending the HIV Epidemic (EtHE) initiative. If a proposed study site is outside EtHE priority jurisdictions, the application is expected to justify that choice using epidemiologic reasoning, essentially showing why the selected locale is important for HIV prevention and relevant to the aims of the RFA.

In terms of who can apply, eligibility is broad and includes state, county, city/township, and special district governments; federally recognized tribal governments; tribal organizations; public housing authorities; public and private institutions of higher education; nonprofit organizations with or without 501(c)(3) status; for-profit organizations (other than small businesses) and small businesses; and other categories. The RFA explicitly notes interest in participation from a range of institution types and community-linked entities, including faith-based or community-based organizations, Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as U.S. territories or possessions. The funding mechanism is an NIH R01 (clinical trial optional), meaning applicants may propose studies that do or do not include a clinical trial component, depending on the research questions and design.

Administrative details provided in the source indicate this is a discretionary grant opportunity from the National Institutes of Health, categorized under education and health (CFDA 93.279). The original closing date listed is 2021-11-12, and the opportunity was created on 2021-06-16. The notice does not specify an award ceiling or expected number of awards in the provided excerpt, so applicants would typically need to consult the full funding announcement for budget expectations and any institute-specific limits or guidance.

• 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 2021-06-16.
• Applicants must submit their applications by 2021-11-12. (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 22 017

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