Improving Choice, Use, and Equitable Implementation of Biomedical HIV Prevention for Women (R21 Clinical Trial Optional) | RFA MH 24 331

Opportunity Information: Apply for RFA MH 24 331

The National Institutes of Health (NIH) is offering a discretionary grant opportunity titled "Improving Choice, Use, and Equitable Implementation of Biomedical HIV Prevention for Women (R21 Clinical Trial Optional)" under Funding Opportunity Number RFA-MH-24-331. This call supports exploratory, early-stage research (R21) focused on improving real-world uptake and sustained use of the biomedical HIV prevention vaginal ring among women, with an emphasis on equitable access and practical delivery outside tightly controlled clinical trial settings. Clinical trials are allowed but not required, giving applicants flexibility to propose observational, behavioral, mixed-methods, or implementation-focused projects depending on the research question.

The central goal is to address persistent knowledge gaps about why women do or do not start using the vaginal ring, how consistently they use it once they start, and what influences whether they continue using it over time (persistence). NIH is specifically looking for studies that move beyond clinical or open-label extension trials and examine what happens in everyday contexts such as community clinics, public health programs, family planning settings, or other routine care environments. This includes understanding how personal beliefs and experiences, relationship dynamics, community norms, and broader structural conditions shape decision-making and sustained use.

The opportunity encourages research across multiple levels of influence. At the individual level, proposed studies could examine factors like risk perception, product preferences, side effect concerns, comfort with insertion and removal, privacy, stigma, trust in healthcare systems, and practical challenges such as remembering replacement schedules. At the interpersonal level, applicants might investigate partner influence, communication and negotiation in relationships, reproductive goals, social support, or fear of disclosure. At the structural and systems level, NIH is interested in barriers and facilitators such as clinic workflows, provider knowledge and attitudes, counseling practices, service integration (for example with contraception or STI services), cost and coverage, supply chain and stocking, transportation, appointment availability, and policy or regulatory constraints. Equity is a core theme, so projects that directly address disparities in access and outcomes for populations disproportionately affected by HIV are particularly aligned with the intent of the announcement.

A major emphasis is on developing and testing behavioral interventions designed to improve three key outcomes: uptake (starting the ring), adherence (using it as intended), and persistence (continuing use over time). Interventions could include counseling approaches, peer or community health worker support, digital or mobile adherence supports, tailored education and risk communication, partner or couples-based strategies where appropriate, and approaches that reduce stigma or improve confidence and skills for consistent use. NIH is looking for rigorous but appropriately scoped R21 projects that generate actionable insights, feasibility data, and signals of promise that can be scaled or tested in larger follow-on studies.

In addition, the announcement highlights implementation science studies aimed at improving delivery and distribution of the ring. This includes identifying real-world implementation barriers and facilitators and testing strategies to optimize delivery, such as provider training models, differentiated service delivery, pharmacy-based distribution, community-based access points, integration into reproductive health services, and strategies to improve follow-up and continuity. Projects might evaluate implementation outcomes like reach, acceptability, feasibility, adoption, fidelity, sustainability, and cost considerations, with attention to how implementation strategies perform across different settings and populations.

Eligibility is broad and includes many types of U.S. organizations and government entities, such as state, county, and city governments; public and private institutions of higher education; independent school districts; special district governments; tribal governments (federally recognized) and tribal organizations (including those other than federally recognized tribal governments); public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses. The announcement also explicitly calls out additional eligible applicants to encourage diverse leadership and community-rooted implementation, 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). Faith-based or community-based organizations, eligible federal agencies, U.S. territories or possessions, regional organizations, and non-U.S. (foreign) entities are also listed as eligible, reflecting an interest in partnerships and settings that can credibly study real-world delivery and equity challenges.

Key administrative details include an award ceiling of $275,000 and an original closing date of November 22, 2023, with the opportunity created on September 20, 2023. The activity category is Health, Income Security, and Social Services, and the CFDA numbers associated with the funding include 93.242, 93.310, 93.313, and 93.865. Overall, this opportunity is designed to strengthen the evidence base for how the vaginal ring can be offered and supported in ways that are practical, acceptable, and equitable, so that more women who could benefit from it are able to access it, choose it, and use it consistently over time in real-world conditions.

• The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Improving Choice, Use, and Equitable Implementation of Biomedical HIV Prevention for Women (R21 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, 93.310, 93.313, 93.865.
• This funding opportunity was created on 2023-09-20.
• Applicants must submit their applications by 2023-11-22. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $275,000.00 in funding.
• 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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