Next Generation Multipurpose Prevention Technologies (NGM) (R01 Clinical Trial Optional)

The National Institutes of Health (NIH), through its National Institute of Allergy and Infectious Diseases (NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), and National Institute of Mental Health (NIMH), has reissued a funding opportunity (NOFO PAR-23-180) for research on Next Generation Multipurpose Prevention Technologies (NGM). This initiative aims to support innovative research to develop new multipurpose prevention technologies (MPTs) that address needs for both contraception and prevention of HIV, STIs, or multiple non-HIV STIs. Targeted MPTs could range from on-demand and event-driven to long-acting systemic and non-systemic options for both cis and trans individuals across various age groups. Research may cover pharmacokinetics, pharmacodynamics, safety profiles, and drug-drug interaction studies. Proposals may also include biobehavioral research to explore the physical characteristics and social factors that influence MPT adoption and adherence. The goal of this funding opportunity is to foster innovative MPT products that can meet user needs for effective protection against pregnancy and STIs, improve adoption rates, and support ongoing adherence. Key research areas of interest include the development of MPTs designed for specific high-risk populations, such as adolescents, individuals in sero-discordant partnerships, and those at elevated risk due to their sexual behaviors. MPTs may integrate both contraceptive and anti-HIV/STI components, available in various formulations like microarray patches, biodegradable implants, or intravaginal rings. The NOFO emphasizes products that enhance user convenience and safety while encouraging greater utilization. Funding is provided in the form of R01 research project grants, with budgets to be determined by the project’s scope and needs, extending up to five years. Proposals should outline clinical or non-clinical milestones and timelines for activities, focusing on user-driven features to ensure broader acceptance and adherence. Research priorities for NIAID include episodic and extended-release formulations that provide up to seven days of protection from a single dose. NICHD’s focus is on MPTs suitable for young adults and pregnant individuals, while NIMH encourages studies examining behavioral components that influence MPT preferences and adherence in HIV prevention contexts. Eligibility extends to various organizations, including public and private higher education institutions, nonprofits, government entities, and for-profit organizations. Foreign institutions and non-domestic components of U.S.-based organizations may also apply. Specific eligibility and registration requirements are outlined, and applicants are encouraged to engage with NIH staff prior to submission. Only applications with scientifically distinct objectives are accepted from the same organization, and each proposal must follow the instructions within the SF424 (R&R) Application Guide. Applications are due by December 7, 2023, for the first cycle, with additional submissions accepted through December 2024. Submission should be conducted via NIH ASSIST, Grants.gov Workspace, or institutional system-to-system solutions. Adherence to application guidelines is strictly enforced; incomplete or non-compliant applications will not be reviewed. Applicants are encouraged to apply early to ensure the opportunity to correct any submission errors. Applications will be evaluated for scientific merit using NIH’s peer review system, which considers factors such as significance, investigator qualifications, innovation, approach, and environment. Reviewers will assess the feasibility and potential impact of the proposed MPT strategies, emphasizing collaboration across disciplines and alignment with end-user needs. The overall impact score will reflect the likelihood that the project will substantially influence the field, with award decisions contingent on scientific merit, program priorities, and available funds.