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Development and Testing of Novel Interventions to Improve HIV Prevention, Treatment, and Program Implementation for People Who Use Substances (R34 Clinical Trial Required)

US · US National Institutes of Health (NIH) grant open #PAR-24-329
Response due Mar 16, 2027 · 00:00 UTC

Summary

This NIH funding opportunity (PAR-24-329) solicits R34 clinical trial planning grant applications focused on developing and testing novel interventions to improve HIV prevention, treatment, and program implementation specifically for people who use substances. The R34 mechanism is designed to support the planning and development phase of clinical trials, including feasibility and pilot testing. Applicants must propose a clinical trial as part of their application. The opportunity is open from January 2025 through March 2027, reflecting a multi-cycle announcement typical of NIH Program Announcements with Review (PARs).

What they want

Applicants must develop and pilot-test novel interventions targeting HIV prevention, HIV treatment, and/or HIV program implementation for populations who use substances. Work must include the planning and early-stage development components required under the R34 Clinical Trial Required mechanism, encompassing protocol development, feasibility assessment, and preliminary data collection in support of a future full-scale clinical trial.
Deliverables
  • Pilot/feasibility clinical trial protocol
  • Preliminary data supporting intervention efficacy
  • Progress reports per NIH reporting requirements
  • Final project report
Technical requirements
  • Must propose a clinical trial (Clinical Trial Required mechanism)
  • Intervention must target HIV prevention, treatment, or program implementation
  • Target population must include people who use substances
  • R34 mechanism requires pilot/feasibility phase planning

How they evaluate

  • Scientific and technical merit (peer review by NIH study section)
  • Significance and innovation of proposed intervention
  • Approach and rigor of clinical trial design
  • Investigator qualifications and environment
  • Feasibility and potential for future full-scale trial
Submission: Electronic submission via Grants.gov and NIH eRA Commons

Eligibility & certifications

SAM registration (System for Award Management)Grants.gov registrationNIH eRA Commons registration

Risks & flags

  • No dollar value or award ceiling disclosed — budget limits unclear without reading full FOA
  • Multi-year open window (Jan 2025–Mar 2027) with multiple due dates typical of PAR — specific submission deadlines not enumerated in this synopsis
  • Full eligibility and scoring criteria not provided in synopsis; full FOA text required for complete assessment

Market context

inferred from NAICS
Professional, Scientific & Technical Services
NAICS 541714
US market size
$2.0T
Typical award
$25K – $50M
Typical buyers
All federal civilianDoDStates
Commonly required
8(a)WOSBSDVOSBPE/PMP

Sector-level estimate — full code lookup not yet in catalog.

Development and Testing of Novel Intervent…
Due Mar 16
Onboard