Atom | Formative and Pilot Intervention Research to Optimize HIV Prevention and Care Continuum Outcomes (R34 Clinical Trial Optional)

Due Dates: September 9, 2025 (AIDS applications) | January 9, 2026 (AIDS applications)

Funding Amounts: Up to $225,000 direct costs/year, max $450,000 direct costs over 3 years (R34 mechanism)

Summary: Supports formative research, intervention development, and pilot-testing of novel or adapted interventions to improve HIV prevention and care outcomes.

Key Information: Only AIDS-related applications are accepted; non-AIDS applications are not eligible under this FOA.

Description

This opportunity, offered by the National Institutes of Health (NIH) through the National Institute of Mental Health (NIMH), supports formative and pilot intervention research to optimize outcomes along the HIV prevention and care continuum. The focus is on developing, adapting, and pilot-testing interventions—behavioral, social, structural, or combination biomedical/behavioral approaches—that address feasibility, acceptability, tolerability, and safety for HIV prevention or treatment.

The R34 mechanism is intended for early-stage, pilot, or formative research, including:

Initial development and pilot testing of innovative interventions.
Formative implementation research to adapt evidence-based interventions.
Development or selection of implementation strategies to improve uptake and effectiveness of HIV prevention and care.

Projects should align with NIMH Division of AIDS Research (DAR) priorities and are encouraged to address multi-level factors (individual, contextual, structural) that impact HIV outcomes, including mental health, stigma, social determinants, and disparities.

Due Dates

Next deadlines:
- September 9, 2025 (AIDS applications)
- January 9, 2026 (AIDS applications)
All applications are due by 5:00 PM local time of the applicant organization.
Expiration date: January 10, 2026

Note: Only AIDS-related applications are accepted for this FOA.

Funding Amount

Direct costs: Up to $225,000 per year
Total direct costs: Not to exceed $450,000 over a maximum 3-year project period
Project period: Up to 3 years
Number of awards: Contingent on NIH appropriations and the number of meritorious applications

Eligibility

Eligible applicants include:

Public and private institutions of higher education (U.S. and foreign)
Nonprofits (with or without 501(c)(3) status)
For-profit organizations (including small businesses)
State, county, city, township, and special district governments
Native American tribal governments and organizations (federally recognized and other)
Independent school districts
Public housing authorities/Indian housing authorities
Faith-based and community-based organizations
Regional organizations
U.S. territories and possessions
Non-domestic (non-U.S.) entities and components of U.S. organizations

Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to apply.

Application Process

Application method: Submit electronically via Grants.gov, NIH ASSIST, or an institutional system-to-system solution.
Required registrations: SAM, eRA Commons, Grants.gov, and (for foreign organizations) NCAGE code.
Application forms: Use SF424 (R&R) with FORMS-H.
Instructions: Follow the SF424 (R&R) Application Guide and the full FOA instructions.
Data sharing: All funded investigators are expected to share data via the NIMH Data Archive.
Human subjects: Applications involving human subjects must include appropriate protections and data and safety monitoring plans.
Clinical trials: This FOA accepts applications that propose or do not propose clinical trials (clinical trial optional).

Additional Information

Scope: Projects should focus on feasibility, acceptability, and safety of interventions, not on formal efficacy testing or effect size estimation.
Community engagement: Strongly encouraged to include community members and relevant organizations in the research team and advisory groups.
Alignment: Applicants should review current NIMH Division of AIDS Research Notices of Special Interest (NOSIs) and consult with a Program Officer before submission.
Companion opportunities: For larger-scale or more advanced studies, consider the companion R01 (PAR-23-062) or R21 (PAR-23-061) mechanisms.

External Links

Contact Information

Contact Type	Name/Program/Unit	Email	Phone
Scientific/Research Contacts	Gregory Greenwood, Ph.D. (HIV Testing & Social Determinants)	gregory.greenwood@nih.gov	240-669-5532
	Susannah Allison, Ph.D. (Infant, Child, & Adolescent HIV)	allisonsu@mail.nih.gov	240-627-3861
	Pim Brouwers, Ph.D. (Clinical Neuroscience of HIV)	ebrouwer@nih.gov	301-640-6143
	Chris Gordon, Ph.D. (Implementation Science)	cgordon1@nih.gov	240-627-3867
	Suzy Pollard, Ph.D. (Health Equity for HIV)	suzy.pollard@nih.gov	301-761-6869
	Lori Scott-Sheldon, Ph.D. (Data Science & Methodologies)	lori.scott-sheldon@nih.gov	301-792-2309
	Teri Senn, Ph.D. (Psychosocial Comorbidities)	teri.senn@nih.gov	301-605-4146
	Michael Stirratt, Ph.D. (Adherence to HIV Treatment)	stirrattm@nih.gov	240-627-3875
Peer Review Contact	See eRA Commons account for assignment
Financial/Grants Management	Rita Sisco (NIMH)	siscor@mail.nih.gov	301-443-2805
General Grants Info	NIH Grants Information	GrantsInfo@nih.gov	301-480-7075
Application Submission	eRA Service Desk		301-402-7469 or 866-504-9552
Grants.gov Support	Grants.gov Customer Support	support@grants.gov	800-518-4726