Pilot and Feasibility Studies in Preparation for Substance Use and HIV Prevention Intervention and Services Research Trials (R34 Clinical Trial Optional)

Solicitation PAR-28-093 is a Notice of Funding Opportunity issued by the National Institutes of Health under the Department of Health and Human Services to support pilot and feasibility studies. The program focuses on informing the design of future efficacy and services research trials in three primary areas: interventions to prevent substance use and substance use disorders, research into prevention, treatment, and recovery services for comorbid pain and mental health disorders, and HIV eradication research within substance use populations. Eligible applicants include small businesses and other for-profit organizations, provided they maintain active registrations in the System for Award Management and eRA Commons. The funding allows for total direct costs of up to 450,000 dollars over a three-year project period. Awards are determined through a two-level review process based on scientific and technical merit, availability of funds, and relevance to program priorities. Evaluation focuses on the importance of the research, specifically its innovation, as well as the rigor and feasibility of the proposed approach. Recipients must adhere to strict regulatory frameworks, including 42 CFR Part 52, and comply with cybersecurity incident reporting requirements, IRB/IEC approval for human subjects, and ClinicalTrials.gov registration for applicable trials. Application deadlines occur semi-annually through June 2029.