Formative and Pilot Intervention Research for Prevention and Treatment of HIV/AIDS (R34 Clinical Trial Optional) | PA 20 141

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.

• 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.

Apply for PA 20 141

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: