BMJ Open (Jul 2024)
Health Outcomes around Pregnancy and Exposure to HIV/Antiretrovirals (HOPE) study protocol: a prospective observational cohort study of reproductive-aged women living with HIV
- Jessica Lee,
- Kathleen M Powis,
- Alejandra Martinez,
- Jennifer Green,
- Paige L Williams,
- Cristina Hernández,
- Lisa B Haddad,
- Anna-Barbara Moscicki,
- Lynn M Yee,
- Kunjal Patel,
- Deborah Kacanek,
- Suzanne Siminski,
- Mariam Davtyan,
- Tzy-Jyun Yao,
- Denise L Jacobson,
- Tamarra James-Todd,
- Ellen G Chadwick,
- Emily A Barr,
- Claire A Berman,
- Alex DiPerna,
- Amanda Flores,
- Laurie Hyzy,
- Jennifer Jao,
- Anisa Khadraoui,
- Kathleen M Malee,
- Lisa-Gaye Robinson,
- Liz Salomon,
- Kimbrae Sanders,
- Renee A Smith,
- Tracy Wolbach,
- Lela Lartey,
- Kathleen Malee,
- Mary Paul,
- Lynnette Harris,
- Murli Purswani,
- Martha Cavallo,
- Mahoobullah Mirza Baig,
- Alma Villegas-Schwalenberg,
- Kierra Archer,
- Alan Bernegger,
- Patricia Garvie,
- Katherine Knapp,
- Chloe Burkhead,
- Gheri Terry,
- Megan Wilkins,
- Margarita Silio,
- Dornese Jones,
- Medea Gabriel,
- Patricia Sirois,
- Cecelia Hutto,
- Paige Hickman,
- Dan Marullo,
- Elizabeth McFarland,
- Carrie Chambers,
- Robin McEvoy,
- Mobeen Rathore,
- Saniyyah Mahmoudi,
- Staci Routman,
- Gwendolyn Scott,
- Lorena Bracho,
- Anai Cuadra,
- Zoe M. Rodriguez,
- Lizmarie Torres,
- Nydia Scalley,
- Toniette Frederick,
- Guadalupe Morales Avendano
Affiliations
- Jessica Lee
- 1 Center for Biostatistics in AIDS Research, Harvard University T H Chan School of Public Health, Boston, Massachusetts, USA
- Kathleen M Powis
- 17 Departments of Internal Medicine and Pediatrics, Massachusetts General Hospital, Boston, Massachusetts, USA
- Alejandra Martinez
- Centre de Recherches en Cancérologie de Toulouse INSERM UMR1037, Toulouse, France
- Jennifer Green
- 9 Westat Inc, Rockville, Maryland, USA
- Paige L Williams
- 4 Departments of Epidemiology and Biostatistics, Harvard University T H Chan School of Public Health, Boston, Massachusetts, USA
- Cristina Hernández
- Lisa B Haddad
- 10 Population Council Center for Biomedical Research, New York City, New York, USA
- Anna-Barbara Moscicki
- 13 University of California Los Angeles, Los Angeles, California, USA
- Lynn M Yee
- 2 Department of Obstetrics and Gynecology, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA
- Kunjal Patel
- 6 Department of Epidemiology, Harvard University T H Chan School of Public Health, Boston, Massachusetts, USA
- Deborah Kacanek
- 1 Center for Biostatistics in AIDS Research, Harvard University T H Chan School of Public Health, Boston, Massachusetts, USA
- Suzanne Siminski
- 8 Frontier Science Foundation, Amherst, New York, USA
- Mariam Davtyan
- 7 Department of Pediatrics, University of Southern California Keck School of Medicine, Los Angeles, California, USA
- Tzy-Jyun Yao
- 1 Center for Biostatistics in AIDS Research, Harvard University T H Chan School of Public Health, Boston, Massachusetts, USA
- Denise L Jacobson
- 1 Center for Biostatistics in AIDS Research, Harvard University T H Chan School of Public Health, Boston, Massachusetts, USA
- Tamarra James-Todd
- 6 Department of Epidemiology, Harvard University T H Chan School of Public Health, Boston, Massachusetts, USA
- Ellen G Chadwick
- 3 Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA
- Emily A Barr
- 5 The University of Texas Health Science Center at Houston Cizik School of Nursing, Houston, Texas, USA
- Claire A Berman
- 6 Department of Epidemiology, Harvard University T H Chan School of Public Health, Boston, Massachusetts, USA
- Alex DiPerna
- 8 Frontier Science Foundation, Amherst, New York, USA
- Amanda Flores
- 6 Department of Epidemiology, Harvard University T H Chan School of Public Health, Boston, Massachusetts, USA
- Laurie Hyzy
- 8 Frontier Science Foundation, Amherst, New York, USA
- Jennifer Jao
- 11 Department of Internal Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA
- Anisa Khadraoui
- 6 Department of Epidemiology, Harvard University T H Chan School of Public Health, Boston, Massachusetts, USA
- Kathleen M Malee
- 12 Department of Psychiatry and Behavioral Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA
- Lisa-Gaye Robinson
- 14 Broward Health, Children’s Diagnostic and Treatment Center, Fort Lauderdale, Florida, USA
- Liz Salomon
- 6 Department of Epidemiology, Harvard University T H Chan School of Public Health, Boston, Massachusetts, USA
- Kimbrae Sanders
- 15 Baylor Texas Children’s Hospital, Houston, Texas, USA
- Renee A Smith
- 16 Department of Pediatrics, University of Illinois Chicago, Chicago, Illinois, USA
- Tracy Wolbach
- 9 Westat Inc, Rockville, Maryland, USA
- Lela Lartey
- Kathleen Malee
- Mary Paul
- Lynnette Harris
- Murli Purswani
- Martha Cavallo
- Mahoobullah Mirza Baig
- Alma Villegas-Schwalenberg
- Kierra Archer
- Alan Bernegger
- Patricia Garvie
- Katherine Knapp
- Chloe Burkhead
- Gheri Terry
- Megan Wilkins
- Margarita Silio
- Dornese Jones
- Medea Gabriel
- Patricia Sirois
- Cecelia Hutto
- Paige Hickman
- Dan Marullo
- Elizabeth McFarland
- Carrie Chambers
- Robin McEvoy
- Mobeen Rathore
- Saniyyah Mahmoudi
- Staci Routman
- Gwendolyn Scott
- Lorena Bracho
- Anai Cuadra
- Zoe M. Rodriguez
- Lizmarie Torres
- Nydia Scalley
- Toniette Frederick
- Guadalupe Morales Avendano
- DOI
- https://doi.org/10.1136/bmjopen-2024-084835
- Journal volume & issue
-
Vol. 14,
no. 7
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.
