Innovative Models for Delivering PrEP and STI Services to Stop HIV in the United States (R61/R33 Clinical Trial Optional) | RFA AI 20 069

Opportunity Information: Apply for RFA AI 20 069

The NIH funding opportunity titled "Innovative Models for Delivering PrEP and STI Services to Stop HIV in the United States (R61/R33 Clinical Trial Optional)" (RFA-AI-20-069) supports projects aimed at expanding access to HIV pre-exposure prophylaxis (PrEP) by integrating or strengthening PrEP delivery within sexually transmitted infection (STI) service settings. The central idea is to develop and test practical, effective strategies that make it easier for people who use STI clinics or related sexual health services to learn about, start, and stay on PrEP, particularly in "high priority jurisdictions" identified under the national Ending the HIV Epidemic: A Plan for America initiative. The opportunity is designed for applicants who can propose innovative approaches that fit real-world clinical and public health workflows, with the overall goal of reducing new HIV infections in the United States by improving prevention reach in settings where people at increased risk for HIV are already seeking care.

This FOA uses the NIH R61/R33 phased innovation mechanism, which typically supports a staged project structure: an early, time-limited phase focused on development, refinement, feasibility, and readiness activities (R61), followed by an expansion or more definitive phase (R33) intended to more rigorously implement and evaluate the intervention model. A key feature is that continued support into later years is not automatic. Funding for years four and five is specifically tied to meeting negotiated milestones and "go/no-go" criteria, meaning applicants must define measurable benchmarks and demonstrate adequate progress and performance to advance. The FOA is labeled "Clinical Trial Optional," which means proposed studies may include clinical trials if appropriate, but a clinical trial is not required; projects can range from implementation and service delivery model testing to hybrid effectiveness-implementation work, depending on what best fits the proposed approach.

The program is positioned in the education and health funding activity category and is administered by the National Institutes of Health. The CFDA numbers associated with this opportunity are 93.242, 93.279, and 93.855, reflecting NIH program areas relevant to infectious diseases and related research. While the original closing date listed is October 13, 2021, the summary focus remains useful for understanding the type of work NIH sought to fund: scalable service delivery innovations that increase PrEP uptake and persistence through STI clinical and public health infrastructure, especially in locations where the HIV epidemic is most concentrated and where improved prevention delivery can have outsized impact.

Eligibility is broad and includes many types of organizations that could realistically build and evaluate PrEP models in STI service settings. Eligible applicants include state, county, and city/township governments; 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; and Native American tribal organizations that are not federally recognized. Public housing authorities and Indian housing authorities are also eligible, as are nonprofits with or without 501(c)(3) status (as long as they are not institutions of higher education in those categories). For-profit organizations (other than small businesses) and small businesses may apply as well, alongside other eligible entities as defined by NIH. The FOA also highlights additional eligible applicants such as faith-based or community-based organizations and several categories of minority-serving institutions, 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). Regional organizations and U.S. territories or possessions are also identified as eligible.

At the same time, the FOA draws clear boundaries around foreign involvement. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply as the applicant organization, and non-domestic components of U.S. organizations are also not eligible to apply. However, "foreign components" as defined by the NIH Grants Policy Statement are allowed, meaning a U.S.-based applicant can include certain international collaborations or activities if they meet NIH definitions and are appropriately justified, even though the funded work is primarily aimed at stopping HIV within the United States and in targeted U.S. jurisdictions.

In practical terms, the opportunity is about building better, more accessible pathways to PrEP through STI-focused touchpoints, which can include STI clinics, sexual health clinics, public health department STI programs, and other service settings where STI testing and treatment occur. The FOA encourages models that solve persistent barriers such as missed opportunities for PrEP screening, limited same-day initiation, fragmented linkage to ongoing PrEP care, gaps in follow-up and adherence support, stigma, workforce capacity constraints, and difficulties navigating insurance coverage or medication access. Projects supported under this FOA would be expected to produce evidence and implementation insights that can be adopted by health systems and public health agencies, with an emphasis on measurable progress and readiness to scale if the early phase milestones are met.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Innovative Models for Delivering PrEP and STI Services to Stop HIV in the United States (R61/R33 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, 93.279, 93.855.
• This funding opportunity was created on 2021-06-15.
• Applicants must submit their applications by 2021-10-13. (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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