HIV Prevention and Alcohol (R01 Clinical Trials Optional) | RFA AA 21 016

FAQs: NIH RFA-AA-21-016 - HIV Prevention and Alcohol (R01 Clinical Trials Optional)

What is the funding opportunity?

This opportunity is the National Institutes of Health (NIH) funding opportunity announcement (FOA) RFA-AA-21-016, titled "HIV Prevention and Alcohol (R01 Clinical Trials Optional)." It supports R01 research project grants focused on strengthening and broadening HIV prevention approaches for people and communities affected by alcohol use.

What is the main goal of this FOA?

The FOA aims to support research that improves HIV prevention by directly addressing alcohol use as a factor that can increase vulnerability to HIV acquisition. It emphasizes integrating proven HIV prevention and HIV treatment strategies within a clear prevention framework focused on reducing new infections.

How does alcohol use relate to HIV vulnerability in this announcement?

The FOA describes alcohol use as increasing vulnerability to HIV acquisition through behavioral pathways (such as increased sexual risk-taking or reduced adherence to prevention routines) and biological pathways (such as alcohol-related effects on immune function or inflammation). It includes episodic patterns (for example, binge drinking) as well as long-term and chronic alcohol use.

Does the FOA only support studies that examine alcohol and HIV risk side by side?

No. The FOA encourages projects that go beyond examining alcohol and HIV risk in parallel. It emphasizes integrating alcohol-related intervention approaches with proven HIV prevention and HIV treatment strategies, with the intent to improve prevention outcomes and reduce new infections.

What type of grant mechanism is used?

The mechanism is an R01 research project grant.

Are clinical trials required?

No. Clinical trials are optional. Applicants may propose clinical trials if appropriate for the research aims, but clinical trials are not required.

What kinds of research does the FOA encourage?

The FOA prioritizes research that develops, tests, and supports the practical deployment of interventions that address alcohol use in the context of HIV prevention. This includes creating new interventions, adapting and expanding interventions with evidence, and studying how to implement these approaches effectively in real-world settings.

What does the FOA mean by "cross-cutting" research?

The FOA is interested in research that is informative across multiple HIV prevention strategies, including mechanisms, strategies, and delivery models that improve prevention outcomes across different populations and contexts rather than focusing only on a narrow niche.

What are the priority research areas identified in the FOA?

The FOA highlights six priority research areas: (1) PrEP utilization research; (2) treatment as prevention (TasP); (3) integration of preventive intervention strategies; (4) prevention-related cross-cutting research; (5) syndemic approaches; and (6) implementation and operations research.

What does the FOA prioritize related to PrEP?

PrEP utilization research is a priority, including questions about PrEP initiation, adherence, persistence over time, and how alcohol use patterns interfere with PrEP outcomes or can be addressed to improve PrEP use and effectiveness.

What does the FOA prioritize related to treatment as prevention (TasP)?

TasP is a focus area, including research on improving HIV testing, linkage to care, retention in care, and sustained viral suppression, particularly where alcohol use creates barriers to adherence or consistent engagement with care.

What does "integration of preventive intervention strategies" mean in this FOA?

This area includes combining alcohol-related interventions with other prevention components, such as biomedical prevention (like PrEP), behavioral risk reduction, or clinical service delivery, in ways that make prevention packages more effective and easier to access.

What is included under "prevention-related cross-cutting research"?

The FOA encourages research on shared drivers of prevention success or failure, measurement and methodological advances, and studies that can inform multiple prevention modalities at once.

What does the FOA mean by "syndemic approaches"?

Syndemic approaches reflect that alcohol-related HIV vulnerability often clusters with other conditions and challenges. The FOA highlights co-occurring conditions such as depression, trauma exposure, intimate partner violence, stimulant or opioid use, housing instability, and stigma, and supports work that addresses interacting epidemics together rather than treating alcohol use in isolation.

What does the FOA emphasize regarding implementation and operations research?

Implementation and operations research is a key priority, supporting studies on how to deliver integrated prevention interventions in diverse settings, how to scale effective models, how to improve reach and equity, and how to address barriers such as workforce capacity, stigma, and fragmented services.

What settings are mentioned for implementation research?

The FOA mentions diverse settings such as clinics, community organizations, justice settings, and other service systems where integrated prevention interventions could be delivered and scaled.

What is the activity category for this opportunity?

The activity category listed is health.

What CFDA number is associated with this opportunity?

The CFDA number listed is 93.273.

Who published this funding opportunity?

The opportunity was published by the National Institutes of Health (NIH).

What is the creation date and original closing date listed?

The creation date is August 20, 2021, and the original closing date is December 16, 2021.

What is the maximum award amount listed?

The award ceiling shown in the source data is $500,000, indicating the maximum award amount under the posting.

Which organizations are eligible to apply?

Eligibility is broad. Eligible applicants include state, county, city or township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding higher education institutions in those nonprofit categories); for-profit organizations other than small businesses; small businesses; and other organizations as allowed by NIH policy.

Are minority-serving institutions specifically mentioned as eligible?

Yes. The FOA explicitly notes additional eligible applicants such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISISs).

Are faith-based and community-based organizations eligible?

Yes. The FOA explicitly includes faith-based or community-based organizations among eligible applicants.

Can federal agencies apply?

Yes. The FOA notes eligible federal agencies among additional eligible applicants.

Are US territories and regional organizations eligible?

Yes. The FOA includes regional organizations and US territories or possessions as eligible applicants.

Are non-US (foreign) entities eligible to apply?

Yes. The FOA indicates non-US entities (foreign organizations) are eligible.

What is the overall focus of proposed projects expected to be?

Proposed projects are expected to focus on HIV prevention in the context of alcohol use, with an emphasis on interventions and delivery approaches that can lower new infections. The FOA highlights integration with proven HIV prevention and HIV treatment strategies and encourages work that can inform multiple prevention strategies and real-world implementation.