Pediatric HIV/AIDS Cohort Study (PHACS) (U19 Clinical Trial Not Allowed)

The National Institutes of Health (NIH) invites applications for the Pediatric HIV/AIDS Cohort Study (PHACS) under a U19 cooperative agreement mechanism. The purpose of this funding opportunity is to support an adaptable, comprehensive research program focused on individuals with HIV, specifically perinatally acquired cases, emphasizing youth and young adults within the United States. The study aims to investigate the developmental and clinical trajectories of these populations, examining long-term outcomes of antiretroviral therapy (ART) and associated health challenges, including impacts on fertility, co-morbidities, and other health markers. Research under PHACS is expected to contribute to a better understanding of the health needs and interventions for individuals aging with HIV, with findings relevant to similar global populations. This funding opportunity will prioritize research on various health outcomes affected by HIV and ART, such as reproductive health, cardiovascular and metabolic systems, neurodevelopment, and mental health. Notably, the program also includes a strong focus on syndemics with other conditions, including sexually transmitted infections like syphilis, chlamydia, and HPV, which often coincide with HIV in high-risk populations. The program will support a diverse range of research activities, including cohort studies, health impact analyses, and pilot sub-studies to explore emerging scientific questions. Recruitment of participants, including pregnant individuals, adolescents, and children at high risk for or living with HIV, will be essential to ensure a broad, representative sample. Funding for this initiative includes up to $5.5 million in direct costs per year, with a total project period of five years. The program structure mandates a Scientific Administrative Core (SAC) and a Data Management and Analysis Core (DMAC) to ensure effective coordination, data handling, and resource sharing across research projects. The SAC will manage the program, coordinate communication among teams, and support a range of activities, including outreach and data-sharing efforts. The DMAC, responsible for data integrity and compliance with NIH data-sharing policies, will facilitate data access, sample management, and integration with external datasets, such as the NICHD Data and Specimen Hub (DASH). Eligible applicants include U.S.-based public and private higher education institutions, nonprofits, and state and local governments, as well as federally recognized tribal entities and certain faith- or community-based organizations. Applicants must submit a Plan for Enhancing Diverse Perspectives (PEDP), outlining strategies to promote inclusivity and collaboration among research teams and subjects. This plan will be reviewed as part of the application’s scientific and technical merit. The PEDP is intended to advance equity and participation from diverse backgrounds and regions, particularly among underrepresented groups. Applications are due by December 11, 2024, with an earliest start date projected for July 2025. Interested applicants are encouraged to submit a Letter of Intent by November 5, 2024, which should include basic project and personnel details to assist the NIH in preparing for the review process. All applications must adhere to NIH’s "Multi-Project (M) Instructions" in the SF424 (R&R) Application Guide and conform to specific page limits and structural requirements outlined for each component of the U19 cooperative agreement. Submissions require compliance with NIH’s Data Management and Sharing Policy, necessitating a clear plan for data stewardship and dissemination. Additionally, the NIH expects applicants to have completed several key registrations, including SAM.gov and eRA Commons, before applying. The NIH ASSIST system or an institutional system-to-system solution must be used for application submission.