American Women: Assessing Risk Epidemiologically (AWARE) (R01 Clinical Trial Optional) | RFA AI 21 058

Opportunity Information: Apply for RFA AI 21 058

American Women: Assessing Risk Epidemiologically (AWARE) is an NIH R01 funding opportunity (RFA-AI-21-058) aimed at improving how the public health field understands and tracks HIV risk, prevention, transmission, and the earliest steps of the HIV care continuum for women in the United States. The core emphasis is on bringing together three toolkits that are often used separately: epidemiologic study design and measurement, modern digital technologies for recruitment and follow-up, and data science methods that can integrate and learn from complex, multi-source datasets. The opportunity is structured to strengthen the evidence base on why and how women remain vulnerable to HIV, and to generate practical insights that can be translated into future pilot interventions intended to reduce new HIV infections and other sexually transmitted infections.

A central requirement is that applicants focus on the front end of cohort science for women at behavioral vulnerability to HIV: how to find them, enroll them, and keep them engaged over time in research. In practice, this means proposing and testing recruitment, enrollment, and retention strategies that work in real-world contexts and across diverse communities of women in the US, including cisgender women, transgender women, and gender non-conforming women. The FOA is not just asking for descriptive epidemiology; it is asking investigators to build a sustainable and informative cohort approach that can capture changing risk patterns, prevention access (including but not limited to PrEP-related touchpoints), and early “care-cascade” milestones that occur around testing, diagnosis, and linkage to initial services.

The second required element is the creation of a “knowledgebase” built from cohort data and strengthened by linkage or augmentation with additional sources, including big data sources. The intent is to move beyond what a single study’s questionnaires and clinic visits can capture by combining cohort measures with other relevant information streams where appropriate, such as digital traces, geospatial and neighborhood-level indicators, health service utilization signals, or other large-scale datasets that can provide context on structural and social drivers of risk. This knowledgebase concept points to producing an analyzable resource that supports more powerful inference about patterns of vulnerability, prevention uptake, and early-care outcomes than would be possible with cohort-only data.

While the FOA is “Clinical Trial Optional,” its main deliverable is not a full-scale intervention trial. Instead, it prioritizes generating findings that clarify mechanisms and actionable leverage points, so that subsequent pilot interventions can be better targeted and more likely to succeed. In other words, the work funded here is meant to explain what is happening, where the gaps are, and which measurable factors predict prevention failures or missed opportunities early in the HIV care pathway, with an explicit expectation that the results will inform next-step intervention development to reduce HIV and STI incidence among the women included in the research scope.

Eligibility is broad and reflects NIH’s typical inclusion of many organizational types. Eligible applicants include state, county, city/township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofits with or without 501(c)(3) status (other than IHEs); for-profit organizations (other than small businesses); small businesses; public housing authorities/Indian housing authorities; and Native American tribal governments (federally recognized) as well as tribal organizations other than federally recognized tribal governments. The announcement also explicitly highlights a range of additional eligible applicant categories, including 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 (AANAPISIs), along with faith-based or community-based organizations, eligible federal agencies, regional organizations, and US territories or possessions. At the same time, it draws clear boundaries around foreign involvement: non-domestic (non-US) entities and non-domestic components of US organizations are not eligible to apply, although foreign components (as NIH defines them in its Grants Policy Statement) are allowed.

Administratively, this is a discretionary grant mechanism under NIH, categorized under education/health/income security and social services in the opportunity listing, and associated with multiple CFDA numbers (93.242, 93.273, 93.279, 93.313, 93.855, 93.865). The original closing date listed for the opportunity was December 9, 2021, and the award ceiling was not specified in the provided source information. Overall, the program is best understood as an effort to modernize and strengthen US-based HIV epidemiology for women by building better cohorts, using digital methods to improve reach and retention, and integrating cohort data with larger contextual datasets to produce insights that can directly shape the next generation of prevention and early-care interventions.

• The National Institutes of Health in the education, health, income security and social services sector is offering a public funding opportunity titled "American Women: Assessing Risk Epidemiologically (AWARE) (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): 93.242, 93.273, 93.279, 93.313, 93.855, 93.865.
• This funding opportunity was created on 2021-08-12.
• Applicants must submit their applications by 2021-12-09. (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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