Opportunity Information: Apply for PA 20 141
The National Institutes of Health (NIH) funding opportunity titled "Formative and Pilot Intervention Research for Prevention and Treatment of HIV/AIDS (R34 Clinical Trial Optional)" (Funding Opportunity Number PA-20-141) supports early-stage work to design, refine, and preliminarily test interventions aimed at preventing HIV acquisition and transmission and/or improving health outcomes for people living with HIV. This FOA is centered on formative research, intervention development, and pilot testing, meaning it is meant for projects that are not yet ready for a full-scale efficacy or effectiveness trial but need careful groundwork to show that an approach is workable and promising.
The main scientific emphasis is on generating practical, decision-ready evidence about whether a new or adapted intervention is feasible, tolerable, acceptable, and safe in the populations and settings where it is intended to be used. In practice, that can include questions like whether participants will enroll and stay engaged, whether the procedures can be delivered consistently, whether the intervention fits community and clinical realities, whether there are any safety or unintended harms, and whether implementation logistics (staffing, training, workflow, confidentiality, recruitment, data capture) are realistic. While the FOA allows clinical trials to be included ("Clinical Trial Optional"), the spirit of the mechanism is pilot-level testing rather than large definitive trials.
For this announcement, "intervention" is defined broadly. It includes behavioral approaches (for example, counseling, skills-building, adherence support, risk reduction programs), social interventions (peer navigation, social support models), and structural interventions (changes to service delivery, policy or system-level strategies that reduce barriers to prevention or care). It also explicitly includes combination approaches that blend biomedical strategies with behavioral, social, or structural components, reflecting how HIV prevention and treatment often require integrated solutions rather than single-component programs. The target outcomes can include preventing new infections, reducing transmission risk, improving engagement in HIV care, supporting viral suppression, and improving other clinical outcomes among people living with HIV.
The opportunity is categorized as discretionary funding and uses a grant funding instrument under the health activity category (CFDA 93.242). It is open to a wide range of applicant organizations. Eligible applicants include many types of U.S. government entities (state, county, city/township, and special district governments), independent school districts, public housing authorities/Indian housing authorities, and Native American tribal governments (federally recognized) as well as tribal organizations that are not federally recognized. Higher education institutions are eligible, including public/state-controlled and private institutions. Nonprofits are eligible whether or not they have 501(c)(3) status, and for-profit organizations (other than small businesses) and small businesses can also apply. The FOA also highlights additional eligible applicant categories 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 (AANAPISIs). Faith-based and community-based organizations are included, along with eligible federal agencies, U.S. territories or possessions, and non-U.S. entities (foreign organizations) and regional organizations, which signals NIH interest in a broad set of partnerships and settings, including international contexts where appropriate.
Key administrative details provided in the source data include an award ceiling of $225,000. The record lists an original closing date of 2023-01-07 and a creation date of 2020-03-19. The listing does not specify the expected number of awards in the provided fields. Overall, the FOA is best suited for teams that have a strong intervention concept and a clear public health need, but who still need rigorous formative work and pilot data to justify and shape a later, larger-scale study.Apply for PA 20 141
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Formative and Pilot Intervention Research for Prevention and Treatment of HIV/AIDS (R34 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.
- This funding opportunity was created on 2020-03-19.
- Applicants must submit their applications by 2023-01-07. (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 $225,000.00 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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Frequently Asked Questions (FAQs)
What is this NIH funding opportunity?
This opportunity is the National Institutes of Health (NIH) funding announcement titled "Formative and Pilot Intervention Research for Prevention and Treatment of HIV/AIDS (R34 Clinical Trial Optional)" with Funding Opportunity Number (FON) PA-20-141. It supports early-stage research to design, refine, and preliminarily test interventions related to HIV prevention and HIV treatment outcomes.
What is the main purpose of PA-20-141?
The purpose is to fund formative research, intervention development, and pilot testing that helps determine whether an intervention is workable and promising. The focus is on generating practical, decision-ready evidence that can justify and shape a later, larger-scale study.
Is this funding intended for large, definitive clinical trials?
No. The mechanism is designed for pilot-level testing and careful groundwork. While clinical trials may be included (the FOA is "Clinical Trial Optional"), the intent is not to support large, definitive efficacy or effectiveness trials.
What types of research activities does this FOA emphasize?
The FOA emphasizes formative research, intervention development, and pilot testing. In practice, that includes the kinds of activities needed to design or refine an intervention and to run preliminary studies that assess whether it can be delivered as intended and whether it appears feasible and acceptable in real-world settings.
What does NIH mean by "intervention" in this announcement?
"Intervention" is defined broadly. It can include behavioral approaches, social interventions, structural interventions, or combination approaches that integrate biomedical strategies with behavioral, social, or structural components.
What are examples of behavioral interventions that fit this FOA?
Examples described include counseling, skills-building, adherence support, and risk reduction programs.
What are examples of social interventions that fit this FOA?
Examples described include peer navigation and social support models.
What are examples of structural interventions that fit this FOA?
Examples described include changes to service delivery and policy or system-level strategies that reduce barriers to HIV prevention or HIV care.
Can combination interventions be supported?
Yes. The FOA explicitly includes combination approaches that blend biomedical strategies with behavioral, social, or structural components, reflecting the integrated nature of many HIV prevention and treatment solutions.
What HIV-related goals or outcomes are within scope?
Supported outcomes can include preventing new HIV infections, reducing transmission risk, improving engagement in HIV care, supporting viral suppression, and improving other clinical outcomes among people living with HIV.
What stage of evidence is NIH looking for under this mechanism?
NIH is looking for practical, decision-ready pilot evidence about whether an intervention is feasible, tolerable, acceptable, and safe in the populations and settings where it is intended to be used.
What kinds of feasibility questions can a project address?
The FOA highlights feasibility topics such as whether participants will enroll and remain engaged, whether procedures can be delivered consistently, whether the intervention fits community and clinical realities, and whether implementation logistics are realistic.
What implementation logistics are specifically mentioned as relevant?
Examples listed include staffing, training, workflow, confidentiality, recruitment, data capture, and the overall practicality of delivering the intervention in the intended setting.
Does the FOA consider safety and unintended harms?
Yes. The scientific emphasis includes assessing safety and identifying any unintended harms as part of determining whether an intervention is suitable to move forward to larger studies.
Are clinical trials allowed under this opportunity?
Yes. The FOA is labeled "Clinical Trial Optional," meaning a clinical trial can be included when appropriate, but the overall intent remains focused on formative and pilot-stage work rather than large trials.
What is the funding instrument and activity category?
The opportunity uses a grant funding instrument and is listed under the health activity category.
What is the CFDA (assistance listing) number associated with this opportunity?
The CFDA number listed is 93.242.
What is the maximum award amount (award ceiling) listed?
The record lists an award ceiling of $225,000.
Does the listing state how many awards NIH expects to make?
No. The provided fields do not specify an expected number of awards.
Who is eligible to apply?
The opportunity is open to a wide range of applicant organizations. Eligible applicants include multiple types of U.S. governmental entities, educational institutions, nonprofits, for-profits, small businesses, tribal entities, faith-based and community-based organizations, eligible federal agencies, U.S. territories or possessions, and non-U.S. entities (foreign organizations) and regional organizations.
Which U.S. government entities are listed as eligible?
Eligible U.S. government entities include state governments, county governments, city or township governments, special district governments, independent school districts, and public housing authorities/Indian housing authorities.
Are Native American tribal governments and tribal organizations eligible?
Yes. The FOA includes Native American tribal governments (federally recognized) and also includes tribal organizations that are not federally recognized.
Are colleges and universities eligible?
Yes. Higher education institutions are eligible, including public/state-controlled institutions and private institutions.
Are nonprofits eligible even if they do not have 501(c)(3) status?
Yes. The FOA states that nonprofits are eligible whether or not they have 501(c)(3) status.
Are for-profit organizations eligible?
Yes. For-profit organizations (other than small businesses) are listed as eligible, and small businesses are also listed as eligible.
Are faith-based and community-based organizations eligible?
Yes. The FOA includes faith-based and community-based organizations among eligible applicants.
Are U.S. territories or possessions eligible to apply?
Yes. U.S. territories or possessions are included in the eligible applicant categories.
Are foreign (non-U.S.) organizations eligible?
Yes. The eligibility description includes non-U.S. entities (foreign organizations) and regional organizations, signaling that international participation may be appropriate.
Does the FOA encourage participation from specific institution types (e.g., minority-serving institutions)?
The FOA highlights 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).
What is the original closing date shown in the record?
The record lists an original closing date of 2023-01-07.
What is the creation date shown for this opportunity record?
The record lists a creation date of 2020-03-19.
What kinds of teams or projects are a good fit for this FOA?
This FOA is best suited for teams with a strong intervention concept and a clear public health need who still require rigorous formative work and pilot data to demonstrate that the approach is feasible, acceptable, and promising before pursuing a larger-scale study.
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