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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FAQs: NIH "Formative and Pilot Intervention Research for Prevention and Treatment of HIV/AIDS (R34 Clinical Trial Optional)" (PA-18-276)

What is this funding opportunity?

This National Institutes of Health (NIH) funding opportunity supports early-stage, developmental research to create, refine, and preliminarily test interventions that address HIV prevention and/or HIV treatment. It uses the R34 mechanism and is titled "Formative and Pilot Intervention Research for Prevention and Treatment of HIV/AIDS (R34 Clinical Trial Optional)" (Funding Opportunity Number PA-18-276).

What is the main purpose of the R34 mechanism in this FOA?

The R34 mechanism is intended for formative research, intervention development, and pilot testing. The goal is to generate foundational, decision-ready evidence about whether an intervention is practical and promising enough to justify a larger-scale study later, rather than funding a full-scale efficacy trial at this stage.

Is a clinical trial required?

No. Clinical trials are allowed but not required under this FOA ("Clinical Trial Optional"). Applicants can propose a pilot clinical trial if appropriate, or focus on other formative and pilot research activities depending on the maturity of the intervention and research plan.

What kinds of interventions does NIH consider eligible under this announcement?

NIH defines "intervention" broadly for this FOA. Eligible approaches include behavioral, social, and structural interventions, as well as combination approaches that integrate biomedical components with behavioral, social, or structural strategies.

What are examples of behavioral interventions that fit this FOA?

Behavioral interventions may include counseling strategies, adherence supports, risk-reduction programs, and mental health or substance use components that are linked to HIV outcomes.

What are examples of social interventions that fit this FOA?

Social interventions may include peer navigation, family-based supports, and community engagement strategies designed to improve HIV prevention or treatment outcomes.

What are examples of structural interventions that fit this FOA?

Structural interventions may include changes to systems, policies, service delivery models, or environmental barriers that shape HIV risk and care outcomes.

Can a project combine biomedical and behavioral/social/structural components?

Yes. The FOA explicitly welcomes combination approaches that integrate biomedical components with behavioral, social, or structural strategies.

Does the FOA support HIV prevention, HIV treatment, or both?

It supports interventions aimed at preventing HIV acquisition and transmission, improving clinical outcomes for people living with HIV, or addressing prevention and treatment together, which may reflect real-world service settings.

What stage of research is this FOA meant to fund?

This FOA is meant for projects that are not yet ready for large-scale efficacy trials. It is designed for early-stage work such as formative research, intervention development or adaptation, and pilot testing.

What scientific priorities does NIH emphasize for these projects?

The core priorities focus on whether an intervention is feasible, tolerable, acceptable, and safe for the target population and in real-world settings.

What does "feasibility" mean in the context of this FOA?

Feasibility generally means the intervention can realistically be delivered as intended. Examples include whether recruitment approaches work, procedures are implementable, retention is reasonable, and staff can deliver the program with fidelity.

What do "acceptability" and "tolerability" mean here?

Acceptability and tolerability address whether participants and stakeholders are willing to engage with the intervention and whether participants can realistically stick with it without undue burden.

How is "safety" considered for different types of interventions?

Safety is especially important for interventions with biomedical components, but it can also apply to behavioral, social, and structural approaches. Potential risks may include stigma, privacy concerns, intimate partner conflict, or other social harms that should be anticipated and monitored.

What is the award ceiling for this opportunity?

The posted award ceiling is $225,000, reflecting the program's intent to support small, focused projects that generate evidence to guide next steps rather than fund full-scale trials.

What is the activity category and CFDA number listed?

The activity category is Health, and the CFDA number listed is 93.242.

When was this opportunity created, and what is the closing date shown?

The opportunity was created on 2017-11-29. The original closing date shown in the provided source data is 2020-01-07.

Should applicants verify whether the FOA is still open or has been updated?

Yes. Because the closing date shown in the provided information is in the past (2020-01-07), anyone interested should verify the current status and look for reissued or updated NIH announcements before planning an application.

Who is eligible to apply?

Eligibility is broad and spans public, private, and nonprofit sectors. Examples include various levels of government (state, county, city/township, and special district), independent school districts, institutions of higher education (public/state-controlled and private), tribal governments and organizations, public housing authorities, nonprofits (with or without 501(c)(3) status, outside of higher education), for-profit organizations (other than small businesses), and small businesses.

Are tribal entities eligible?

Yes. The eligibility list includes federally recognized Native American tribal governments, Native American tribal organizations, and other tribal governments that are not federally recognized.

Are foreign organizations eligible?

Yes. The FOA includes non-U.S. entities (foreign organizations) and regional organizations among eligible applicants.

Are U.S. territories or possessions eligible?

Yes. U.S. territories or possessions are included among eligible applicants.

Are faith-based and community-based organizations eligible?

Yes. The FOA highlights faith-based and community-based organizations as eligible applicants.

Are minority-serving institutions included in the eligibility list?

Yes. The FOA highlights 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), and Tribally Controlled Colleges and Universities (TCCUs).

What types of projects are likely to be competitive under this FOA?

Strong projects typically propose a clearly defined intervention concept, explain the HIV prevention and/or treatment gap being addressed, describe how the intervention will be developed or adapted for a specific population and setting, and include a pilot study designed to produce concrete evidence on implementation and early outcomes.

What kinds of measures or evidence does NIH expect from pilot work?

The FOA emphasizes evidence related to feasibility, acceptability, tolerability, and safety in the target population and real-world settings. Competitive proposals often assess feasibility and acceptability using mixed methods and specify how safety or potential harms will be monitored.

Does the FOA expect applicants to define criteria for moving to a larger study?

Yes. The provided description indicates that the most competitive proposals would specify clear criteria that will be used to decide whether to advance to a larger trial or broader implementation study.

Why does NIH emphasize real-world settings for this opportunity?

The FOA emphasizes feasibility and implementation realities, reflecting that promising HIV interventions must be deliverable with fidelity, acceptable to participants and stakeholders, and safe in the contexts where prevention and treatment services are actually provided.

Browse more opportunities from the same agency: National Institutes of Health

Browse more opportunities from the same category: Health

Next opportunity: Targeted Implementation Science to Achieve 90/90/90 Goals for HIV/AIDS Prevention and Treatment (R01 Clinical Trial Optional)

Previous opportunity: Contraception Research Centers Program (U54)

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