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Abstract
Introduction Over 265 000 women are living with HIV in the USA, but limited research has investigated the physical, mental and behavioural health outcomes among women living with HIV of reproductive age. Health status during the reproductive years before, during and after pregnancy affects pregnancy outcomes and long-term health. Understanding health outcomes among women living with HIV of reproductive age is of substantial public health importance, regardless of whether they experience pregnancy. The Health Outcomes around Pregnancy and Exposure to HIV/Antiretrovirals (HOPE) study is a prospective observational cohort study designed to investigate physical and mental health outcomes of young women living with HIV as they age, including HIV disease course, engagement in care, reproductive health and choices and cardiometabolic health. We describe the HOPE study design, and characteristics of the first 437 participants enrolled as of 1 January 2024.
Methods and analysis The HOPE study seeks to enrol and follow 1630 women living with HIV of reproductive age, including those with perinatally-acquired HIV, at 12 clinical sites across 9 US states and Puerto Rico. HOPE studies multilevel dynamic determinants influencing physical, mental and social well-being and behaviours of women living with HIV across the reproductive life course (preconception, pregnancy, post partum, not or never-pregnant), informed by the socioecological model. Key research areas include the clinical course of HIV, relationship of HIV and antiretroviral medications to reproductive health, pregnancy outcomes and comorbidities and the influence of racism and social determinants of health. HOPE began enrolling in April 2022.
Ethics and dissemination The HOPE study received approval from the Harvard Longwood Campus Institutional Review Board, the single institutional review board of record for all HOPE sites. Results will be disseminated through conference presentations, peer-reviewed journals and lay summaries.
- HIV & AIDS
- Postpartum Women
- Pregnant Women
- Health Equity
- Observational Study
- MENTAL HEALTH
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Collaborators The Health Outcomes around Pregnancy and Exposure to HIV/ARVs (HOPE) Study Team: Ann & Robert H. Lurie Children’s Hospital of Chicago: Jennifer Jao, Lela Lartey, Kathleen Malee; Baylor College of Medicine: Mary Paul, Alejandra Martinez, Lynnette Harris; BronxCare Health System: Murli Purswani, Martha Cavallo, Mahoobullah Mirza Baig, Alma Villegas-Schwalenberg; Children's Diagnostic & Treatment Center: Lisa-Gaye Robinson, Kierra Archer, Alan Bernegger, Patricia Garvie; St. Jude Children's Research Hospital: Katherine Knapp, Chloe Burkhead, Gheri Terry, Megan Wilkins; Tulane University School of Medicine: Margarita Silio, Dornese Jones, Medea Gabriel, Patricia Sirois; University of Alabama, Birmingham: Cecelia Hutto, Paige Hickman, Dan Marullo; University of Colorado, Denver: Elizabeth McFarland, Carrie Chambers, Robin McEvoy; University of Florida, Center for HIV/AIDS Research, Education and Service: Mobeen Rathore, Saniyyah Mahmoudi, Staci Routman; University of Miami: Gwendolyn Scott, Lorena Bracho, Anai Cuadra; University of Puerto Rico School of Medicine, Medical Science Campus: Zoe M. Rodriguez, Lizmarie Torres, Nydia Scalley; University of Southern California: Toniette Frederick, Mariam Davtyan, Cristina Hernandez, Guadalupe Morales Avendano
Contributors DK wrote the manuscript, was integrally involved in the conception and design of the protocol, co-directed its implementation and oversaw the analysis. KMP and PLW were integrally involved in the conception and design of the protocol and data collection instruments, co-directed protocol implementation and provided critical input on the organisation and content of the manuscript. LMY and EGC were integrally involved in the conception and design of the protocol and data collection instruments, co-directed protocol implementation, were involved in the acquisition of data and provided critical input on the organisation and content of the manuscript. JJ and SS were integrally involved in the conception and design of the protocol and data collection instruments, were involved in the acquisition of data and provided critical input on the organisation and content of the manuscript. LBH, KMM and A-BM were integrally involved in the conception and design of the protocol, were involved in the development of the data collection instruments and provided important revisions to the manuscript. T-JY is the protocol statistician, was integrally involved in the conception and design of the protocol, the development of the data collection instruments and provided important revisions to the manuscript. JL was involved in the development of the protocol and data collection instruments, conducted the analysis for the manuscript and provided important revisions to the manuscript. MD was involved in the development of the protocol and data collection instruments, was involved in the acquisition of data and provided important revisions to the manuscript. L-GR was involved in the development of the data collection instruments, was involved in the acquisition of data and provided important revisions to the manuscript. CAB, KS and RAS were involved in the development of the protocol and data collection instruments, provided important revisions to the manuscript, led the formation of the HOPE CAB and facilitate partnership between the research team and the HOPE CAB and Task Force members. EAB, AD, AF, LH, DLJ, AK, TJ-T, KP and LS were involved in the development of the protocol and data collection instruments, and provided important revisions to the manuscript. JG and TW were integrally involved in the design and implementation of the protocol, and reviewed and provided important revisions to the manuscript.
Funding The study was supported by the Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD), through award R01HD101351 to the Harvard T.H. Chan School of Public Health (Principal Investigators: PLW, EGC, DK, KMP; Protocol Co-Chairs: DK, KMP, LMY; Senior Project Manager: Natalie Lewis-Vass). The study was also supported through the Pediatric HIV/AIDS Cohort Study (PHACS) 2020 award P01HD103133.
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Competing interests None declared.
Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.
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