Study of treatment and reproductive outcomes - one-fifth of the 1.1 million individuals living with HIV in the US are women, and there is a disproportionate impact on in the southern US

The National Institute of Allergy and Infectious Diseases awarded the University of Miami a $6.797 million cooperative agreement on September 12, 2025, to continue and expand the STAR (Study of Treatment and Reproductive Outcomes) cohort, the largest longitudinal research platform for reproductive-age women with HIV and demographically similar women without HIV in the United States. The award funds research, mentoring, and community engagement addressing HIV, reproductive health, and chronic disease outcomes in reproductive-age women, a population underrepresented in HIV research and disproportionately affected in the Southern United States.

The project operates through three core structures: a Scientific Administrative Core, a Data Management and Analysis Core, and a Community Engagement Core, coupled with two cohort-linked research projects addressing cardiovascular health and sexual and reproductive health. Work will expand participant recruitment and retention, conduct longitudinal data collection, support scientific and community engagement, and develop the next generation of HIV scientists by leveraging the STAR platform to investigate the intersecting effects of HIV, medical and non-medical factors, and reproductive transitions on health outcomes across the reproductive life course.

The award is funded under CFDA 93.279 (Drug Use and Addiction Research Programs) and carries a period of performance through August 31, 2030. Place of performance is Miami, Florida. Sub-recipients include Georgetown University and Emory University, both receiving sub-awards dated October 1, 2025, supporting STAR2-ASSIST vaccine research activities.

Reproductive age women with HIV are highly affected by worse HIV, reproductive, and chronic diseases outcomes, likely due to non-medical and biological factors that manifest differently across the reproductive life course. Despite experiencing poor outcomes and facing unique challenges, reproductive age women are underrepresented in HIV research. To address this GAP, STAR became the largest cohort of reproductive age women with HIV and demographically similar women without HIV in the US since its inaugural funding in 2019, and now serves as a robust platform to support high impact research and the development of early-stage investigators. In this U19 application, we propose to continue and expand STAR in this program project application to address the overarching goal of advancing high priority science in HIV, reproductive health, and chronic diseases for reproductive age women through research, mentoring, and community engagement. This program project will provide the structure for expanded recruitment, participant retention, longitudinal data collection, scientific and community engagement, and development of the next generation of HIV scientists - all components needed to optimally address science for this population. Through the scientific administrative core (SAC), data management and analysis core (DMAC), and community engagement core (CEC), coupled with cohort-linked, synergistic research projects (RP1 focused on cardiovascular health and RP2 focused on sexual and reproductive health), we propose to address the intersecting effects of HIV, medical and non-medical factors, and reproductive transitions on health. We will accomplish our goals by: (aim 1) expanding the STAR cohort as a platform for HIV science for reproductive age women; (aim 2) leveraging the resources of the STAR cores to promote rigorous patient-centered science; and (aim 3), testing a unifying hypothesis on the intersecting effects of HIV and reproductive transitions on two major health challenges - comorbidities and coinfections - via interlinked projects that leverage the STAR cores and utilize a shared framework, measures, and outcomes. Through the outstanding collaborative team assembled during the inaugural funding cycle, and by expanding based on lessons learned, the cohort will be rapidly established, effectively maintained, and will generate high quality longitudinal data with validated surveys, specimen procedures, and data management tools. This study is therefore poised to effectively engage, enable, and mentor scientists in a vast range of scientific areas aligned with NIH/OAR/orwh priorities, and to ultimately ameliorate the effects of the epidemic across populations. Narrative: HIV severely affects women of in the southern US and reproductive aged women with HIV have poor HIV and other health outcomes. The overarching goal of the study of treatment and reproductive outcomes (STAR) is to build upon our prior successes to advance high priority HIV science for reproductive age women with and without HIV through research, mentoring, and community engagement. In this application, we propose the establishment of a scientific administrative core, a data management and analysis core, and a community engagement core, to support the longitudinal STAR cohort and research projects that address the intersecting effects of HIV, and reproductive transitions on cardiovascular health (research project 1) and reproductive health and coinfections (research project 2).