Effect of HIV and Substance Use Comorbidity on the Placenta and Maternal Outcomes (R01 Clinical Trial Optional)

The National Institute on Drug Abuse (NIDA) seeks applications for R01 research grants focusing on understanding how HIV, antiretroviral therapy (ART), and substance use affect placental development and maternal health outcomes. This notice of funding opportunity (NOFO), titled "Effect of HIV and Substance Use Comorbidity on the Placenta and Maternal Outcomes," specifically invites proposals investigating the interaction of HIV/ART and substance use on placental function and associated maternal health consequences. This opportunity targets studies to address gaps in understanding how these comorbidities may influence pregnancy outcomes, with a special focus on physiological, pharmacological, and other biological mechanisms. Key objectives of this NOFO include examining placental pathophysiology in individuals with both HIV and substance use and identifying the effects of placental abnormalities on maternal health in this population. Research areas of interest include studies on how comorbid HIV, ART, and substance use impact placental function, identifying biological mechanisms, and leveraging existing placental tissue repositories to analyze maternal outcomes related to placental health. Priority will be given to applications that incorporate transdisciplinary approaches and causal analysis methods. Applications should also include assessments of addictive substance use, focusing on substances such as opioids, nicotine, stimulants, prescription drugs, cannabinoids, or poly-substance use (excluding alcohol-only studies). This grant will support new applications only, with NIDA committing approximately $2 million in fiscal year 2025 to fund between two and five awards. There is no specified budget limit; however, proposed budgets should reflect the actual needs of the project. The project period may extend up to five years, and applicants are encouraged to discuss their project needs with the designated scientific contact. This NOFO permits clinical trials but does not mandate them. Eligible applicants include a wide range of institutions, such as higher education institutions, nonprofits, for-profit organizations, government entities, tribal governments, and foreign institutions. Foreign components and non-domestic entities are also eligible to apply. All applicants must complete necessary registrations with the System for Award Management (SAM), eRA Commons, and Grants.gov well in advance of submission. Each institution can submit multiple applications as long as each application is scientifically unique. Applications will undergo a standard NIH review process, focusing on criteria such as significance, investigator capability, innovation, approach, and research environment. For clinical trial applications, additional review will consider trial design, relevance, and potential to advance public health outcomes. Reviewers will also assess resource sharing plans, data management plans, and compliance with human subjects research and animal welfare standards where applicable. Letters of intent are due by October 15, 2024, and applications by November 15, 2024. Successful applications will receive Notices of Award, with projects expected to begin in July 2025. Recipients must comply with NIH data sharing and reporting policies, including regular Research Performance Progress Reports (RPPR) and final reports, as outlined in the NIH Grants Policy Statement.