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.Apply for RFA AI 20 069
- 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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Frequently Asked Questions (FAQs)
What is the title and identifier of this NIH funding opportunity?
The funding opportunity is titled "Innovative Models for Delivering PrEP and STI Services to Stop HIV in the United States (R61/R33 Clinical Trial Optional)" and is identified as RFA-AI-20-069.
What is the main purpose of this opportunity?
The purpose is to support projects that expand access to HIV pre-exposure prophylaxis (PrEP) by integrating or strengthening PrEP delivery within sexually transmitted infection (STI) service settings. The focus is on practical, effective strategies that help people using STI or sexual health services learn about PrEP, start PrEP, and stay on PrEP.
What types of settings are the projects expected to focus on?
The opportunity centers on STI service settings and related sexual health touchpoints. Examples mentioned include STI clinics, sexual health clinics, public health department STI programs, and other service settings where STI testing and treatment occur.
Who is the intended population or audience for these interventions?
The interventions are intended for people who use STI clinics or related sexual health services, particularly individuals at increased risk for HIV who are already seeking care in these settings.
What are "high priority jurisdictions" and why do they matter in this opportunity?
What is the overall public health goal of this funding opportunity?
The overall goal is to reduce new HIV infections in the United States by improving prevention reach and PrEP uptake and persistence in settings where people at increased risk for HIV are already accessing care.
What funding mechanism does this FOA use?
This FOA uses the NIH R61/R33 phased innovation mechanism, which supports a staged project structure with an early phase focused on development and feasibility (R61), followed by a later phase intended for more rigorous implementation and evaluation (R33).
How does the R61 phase differ from the R33 phase?
The R61 phase is described as an early, time-limited phase focused on development, refinement, feasibility, and readiness activities. The R33 phase is intended as an expansion or more definitive phase to more rigorously implement and evaluate the intervention model.
Is continued funding into the later phase automatic?
No. Continued support into later years is not automatic. Funding for years four and five is tied to meeting negotiated milestones and "go/no-go" criteria. Applicants are expected to define measurable benchmarks and demonstrate adequate progress to advance.
What are "go/no-go" milestones in this opportunity?
Does the project have to include a clinical trial?
No. The FOA is labeled "Clinical Trial Optional," meaning a clinical trial may be included if appropriate, but it is not required.
What kinds of study approaches are allowed under "Clinical Trial Optional"?
Based on the description, projects may range from implementation and service delivery model testing to hybrid effectiveness-implementation work, depending on what best fits the proposed approach. Clinical trials may be included if appropriate, but are not mandatory.
What types of innovations is NIH looking for in this opportunity?
NIH is looking for innovative approaches that fit real-world clinical and public health workflows and can be adopted through STI clinical and public health infrastructure. The emphasis is on scalable service delivery innovations that increase PrEP uptake and persistence.
What barriers to PrEP delivery does the FOA specifically mention?
The FOA highlights 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 challenges navigating insurance coverage or medication access.
What does the FOA mean by improving "PrEP uptake and persistence"?
Within the context provided, "uptake" refers to increasing the number of people who start PrEP, and "persistence" refers to helping people stay on PrEP over time through improved follow-up, adherence support, and continuity of care.
What kinds of outputs or outcomes are projects expected to produce?
Projects are expected to generate evidence and implementation insights that health systems and public health agencies can adopt, with measurable progress and readiness to scale if early phase milestones are met.
Who administers this funding opportunity?
The opportunity is administered by the National Institutes of Health (NIH).
What funding activity category is this opportunity associated with?
The program is positioned in the education and health funding activity category.
What CFDA numbers are associated with this opportunity?
The CFDA numbers listed are 93.242, 93.279, and 93.855.
What was the closing date listed for this opportunity?
The original closing date listed is October 13, 2021.
Even though the closing date has passed, what does the summary indicate NIH was seeking to fund?
The summary emphasizes 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 prevention improvements can have outsized impact.
What organizations are eligible to apply?
Eligibility is broad. 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 eligible, as are nonprofits with or without 501(c)(3) status (with the noted condition described in the FOA summary). For-profit organizations (other than small businesses) and small businesses may also apply, along with other eligible entities as defined by NIH. The FOA also identifies faith-based or community-based organizations, minority-serving institutions (including HBCUs, Hispanic-serving institutions, TCCUs, Alaska Native and Native Hawaiian Serving Institutions, and AANAPISIs), regional organizations, and U.S. territories or possessions as eligible.
Are nonprofits eligible even if they do not have 501(c)(3) status?
Yes. The summary indicates nonprofits with or without 501(c)(3) status are eligible, subject to the condition stated that they are not institutions of higher education in those categories.
Are for-profit organizations eligible?
Yes. For-profit organizations (other than small businesses) and small businesses are both listed as eligible applicants.
Are minority-serving institutions specifically mentioned as eligible?
Yes. The FOA highlights multiple categories of minority-serving institutions as eligible, including 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).
Can faith-based or community-based organizations apply?
Yes. The FOA explicitly highlights faith-based or community-based organizations among eligible applicants.
Can U.S. territories or possessions apply?
Yes. U.S. territories or possessions are identified as eligible.
Are foreign (non-U.S.) organizations eligible to apply as the applicant?
No. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply as the applicant organization.
Are non-domestic components of U.S. organizations eligible to apply?
No. The summary states that non-domestic components of U.S. organizations are also not eligible to apply.
Are any international activities allowed at all?
Yes, in a limited way. While foreign organizations cannot be the applicant and non-domestic components cannot apply, "foreign components" as defined by the NIH Grants Policy Statement are allowed when included by a U.S.-based applicant and appropriately justified.
What is the geographic emphasis of the work supported by this FOA?
The work is primarily aimed at stopping HIV in the United States, with particular emphasis on high priority jurisdictions identified under the Ending the HIV Epidemic initiative.
What is the central implementation idea behind this FOA?
The central idea is to develop and test practical service delivery strategies that make it easier for people engaging with STI services to be screened for PrEP needs, initiate PrEP, and remain engaged in PrEP care over time.
How should proposed approaches fit into existing systems?
The FOA emphasizes innovative approaches that fit real-world clinical and public health workflows, suggesting projects should be designed to work within typical STI clinic and public health program operations rather than relying on unrealistic or hard-to-sustain processes.
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