Formative and Pilot Intervention Research for Prevention and Treatment of HIV/AIDS (R34 Clinical Trial Optional) | PA 18 276

Opportunity Information: Apply for PA 18 276

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-18-276) supports early-stage research aimed at creating, refining, and preliminarily testing interventions that address HIV prevention and HIV treatment. It is designed for projects that are not yet ready for large-scale efficacy trials but need foundational work to establish whether an intervention is practical and promising enough to justify a bigger study later. The emphasis is on formative research, intervention development, and pilot testing, with clinical trials allowed but not required, which gives applicants flexibility depending on the maturity of their intervention and research plan.

The core scientific priorities focus on whether a new or adapted intervention is feasible, tolerable, acceptable, and safe in the target population and real-world settings. In this context, feasibility generally means the intervention can realistically be delivered as intended (for example, recruitment works, procedures are implementable, retention is reasonable, and staff can deliver the program with fidelity). Acceptability and tolerability speak to whether participants and stakeholders are willing to engage with the intervention and can realistically stick with it without undue burden. Safety is especially important where biomedical components exist, but it can also apply to behavioral, social, and structural approaches when there may be risks such as stigma, privacy concerns, intimate partner conflict, or other social harms that need to be anticipated and monitored.

NIH defines "intervention" broadly for this announcement. Eligible approaches include behavioral interventions (such as counseling strategies, adherence supports, risk-reduction programs, or mental health and substance use components linked to HIV outcomes), social interventions (peer navigation, family-based supports, community engagement strategies), and structural interventions (changes to systems, policies, service delivery models, or environmental barriers that shape HIV risk and care outcomes). The FOA also explicitly welcomes combination approaches that integrate biomedical components with behavioral, social, or structural strategies. The intervention goals can include preventing HIV acquisition and transmission, improving clinical outcomes for people living with HIV, or addressing both prevention and treatment together, which is increasingly relevant in real-world service settings.

Administratively, this is a discretionary grant opportunity using the NIH R34 mechanism, which is commonly used for developmental and pilot intervention research. The activity category is Health and the CFDA number listed is 93.242. The posted award ceiling is $225,000, indicating the program is meant to support small, focused projects that generate decision-ready evidence for next steps rather than fund full-scale trials. The opportunity was created on 2017-11-29, and the original closing date shown in the source data is 2020-01-07, so anyone interested should verify the current status and any reissued or updated NIH announcements before planning an application.

Eligibility is broad and includes many types of applicants across the public, private, and nonprofit sectors. Examples include state, county, city/township, and 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; Native American tribal organizations and other tribal governments that are not federally recognized; public housing authorities and Indian housing authorities; nonprofits with or without 501(c)(3) status (outside of higher education); for-profit organizations other than small businesses; and small businesses. The FOA also highlights additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based and community-based organizations, eligible federal agencies, U.S. territories or possessions, and non-U.S. entities (foreign organizations) and regional organizations. This breadth reflects the reality that effective HIV prevention and treatment interventions often depend on partnerships that span academia, health systems, community organizations, and government or tribal entities.

In practical terms, a strong project under this FOA would typically propose a clearly defined intervention concept, explain the HIV prevention and/or treatment gap it aims to address, describe how the intervention will be developed or adapted for a specific population and setting, and lay out a pilot study that produces concrete evidence on implementation and early outcomes. The most competitive proposals would be expected to show why the intervention is novel or meaningfully improved for the targeted context, how the research will assess feasibility and acceptability (often using mixed methods), how safety or potential harms will be monitored, and what specific criteria will be used to decide whether to advance to a larger trial or broader implementation 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 2017-11-29.
• Applicants must submit their applications by 2020-01-07. (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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