TY - JOUR
T1 - Study of Treatment and Reproductive Outcomes among Reproductive-Age Women with HIV Infection in the Southern United States
T2 - Protocol for a Longitudinal Cohort Study
AU - Sheth, Anandi N.
AU - Adimora, Adaora A.
AU - Golub, Elizabeth Topper
AU - Kassaye, Seble G.
AU - Rana, Aadia
AU - Westreich, Daniel
AU - Cyriaque, Jennifer Webster
AU - Parish, Carrigan
AU - Konkle-Parker, Deborah
AU - Jones, Deborah L.
AU - Kempf, Mirjam Colette
AU - Ofotokun, Igho
AU - Kanthula, Ruth M.
AU - Donohue, Jessica
AU - Raccamarich, Patricia
AU - Tisdale, Tina
AU - Ramirez, Catalina
AU - Warren-Jeanpiere, Lari
AU - Tien, Phyllis C.
AU - Alcaide, Maria L.
N1 - Funding Information:
The STAR is funded by the NIH through the Eunice Kennedy Shriver National Institute of Child Health and Human Development, with supplemental funding from the National Institute of Dental and Craniofacial Research and the Centers for Disease Control and Prevention. This research is supported by the NIH grant R01HD101352. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH. The STAR data collection is also supported by the Miami Center for AIDS Research (P30AI073961), Miami Center for HIV and Research in Mental Health (P30MH116867), Birmingham Center for AIDS Research (P30AI027767), and Emory Center for AIDS Research (P30AI050409).
Funding Information:
The authors would like to thank the principal investigators and the Executive Committee of the Multicenter AIDS Cohort Study/Women's Interagency HIV Study Combined Cohort Study (MWCCS), the Study of Treatment and Reproductive Outcomes (STAR) Scientific Advisory Group members, and MWCCS science leaders for their support and input in the study development. The authors would also like to thank the study staff and community partners at all the sites, along with the National Institutes of Health (NIH) representatives for their work in developing this study. The authors also thank the following investigators who supported the future use of the STAR data and specimens for research focused on reproductive-age women with HIV: Nadia Roan, PhD; Nicole Klatt, PhD; Mimi Ghosh, PhD, MS; M Bradley Drummond, MD, MHS; Leah Rubin, PhD, MPH; Gretchen Neigh, PhD; Italo Mocchetti, PhD; Bradley Aouizerat, MS, PhD; Janet Turan, PhD, MPH; Sheri Weiser, MD, MPH; and Lisa Haddad, MD, MD, MPH. The STAR Scientific Advisory Group members are Susan Cohn, MD, MPH; Pamina Gorbach, MHS, DrPH; Lynne Mofenson, MD; Phyllis Tien, MD; and Markella Zanni, MD. The STAR is funded by the NIH through the Eunice Kennedy Shriver National Institute of Child Health and Human Development, with supplemental funding from the National Institute of Dental and Craniofacial Research and the Centers for Disease Control and Prevention. This research is supported by the NIH grant R01HD101352. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH. The STAR data collection is also supported by the Miami Center for AIDS Research (P30AI073961), Miami Center for HIV and Research in Mental Health (P30MH116867), Birmingham Center for AIDS Research (P30AI027767), and Emory Center for AIDS Research (P30AI050409).
Publisher Copyright:
© Anandi N Sheth, Adaora A Adimora, Elizabeth Topper Golub, Seble G Kassaye, Aadia Rana, Daniel Westreich, Jennifer Webster Cyriaque, Carrigan Parish, Deborah Konkle-Parker, Deborah L Jones, Mirjam-Colette Kempf, Igho Ofotokun, Ruth M Kanthula, Jessica Donohue, Patricia Raccamarich, Tina Tisdale, Catalina Ramirez, Lari Warren-Jeanpiere, Phyllis C Tien, Maria L Alcaide. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 20.12.2021. This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.
PY - 2021/12
Y1 - 2021/12
N2 - Background: Nearly a quarter of the 1.1 million individuals with HIV in the United States are women. Racial and ethnic minority women in the Southern United States are disproportionately impacted. Reproductive-age women with HIV are prone to poor HIV outcomes but remain underrepresented in HIV research. We will answer contemporary questions related to the health outcomes in this population by enrolling a prospective cohort of reproductive-age women with and without HIV in the Southern United States. Objective: The Study of Treatment and Reproductive Outcomes (STAR) will enroll and retain 2000 reproductive-age women with and without HIV. The STAR will leverage the infrastructure of the US-based Multicenter AIDS Cohort Study (MACS)/Women's Interagency HIV Study (WIHS) Combined Cohort Study, comprising the WIHS (a cohort of women with and at risk for HIV, which began in 1993), and the MACS (a cohort of gay and bisexual men with and at risk for HIV, which began in 1984). Although the advancing age of the participants enrolled in the MACS/WIHS Combined Cohort Study provides an opportunity to address the questions related to HIV and aging, the research questions pertinent to the reproductive years must also be addressed. The STAR will conduct high-priority scientific research in key areas with the overall aim of addressing the unique needs of reproductive-age women with HIV. Methods: The STAR is a prospective, observational cohort study that will be conducted at 6 sites in the United States-Atlanta, Georgia; Birmingham, Alabama; Jackson, Mississippi; Chapel Hill, North Carolina; Miami, Florida; and Washington, District of Columbia. Visits will occur semiannually for 2 years, with additional visits for up to 5 years. At each visit, the participating women will complete a structured interview for collecting key demographic, psychosocial, and clinical variables, and undergo biospecimen collection for laboratory testing and repositing (blood, urine, hair, vaginal, anal, and oral specimens). Pregnant women and infants will undergo additional study assessments. The initial scientific focus of the STAR is to understand the roles of key social determinants of health, depression, reproductive health, and oral health on HIV and pregnancy outcomes across the reproductive life span. Results: Enrollment in the STAR commenced in February 2021 and is ongoing. Conclusions: Through in-depth, longitudinal data and biospecimen collection, the newly initiated STAR cohort will create a platform to answer scientific questions regarding reproductive-age women with and without HIV. STAR will be uniquely positioned to enable investigators to conduct high-impact research relevant to this population. Building on the legacy of the MACS and WIHS cohorts, the STAR is designed to foster multidisciplinary collaborations to galvanize scientific discoveries to improve the health of reproductive-age women with HIV and ameliorate the effects of the HIV epidemic in this population in the United States.
AB - Background: Nearly a quarter of the 1.1 million individuals with HIV in the United States are women. Racial and ethnic minority women in the Southern United States are disproportionately impacted. Reproductive-age women with HIV are prone to poor HIV outcomes but remain underrepresented in HIV research. We will answer contemporary questions related to the health outcomes in this population by enrolling a prospective cohort of reproductive-age women with and without HIV in the Southern United States. Objective: The Study of Treatment and Reproductive Outcomes (STAR) will enroll and retain 2000 reproductive-age women with and without HIV. The STAR will leverage the infrastructure of the US-based Multicenter AIDS Cohort Study (MACS)/Women's Interagency HIV Study (WIHS) Combined Cohort Study, comprising the WIHS (a cohort of women with and at risk for HIV, which began in 1993), and the MACS (a cohort of gay and bisexual men with and at risk for HIV, which began in 1984). Although the advancing age of the participants enrolled in the MACS/WIHS Combined Cohort Study provides an opportunity to address the questions related to HIV and aging, the research questions pertinent to the reproductive years must also be addressed. The STAR will conduct high-priority scientific research in key areas with the overall aim of addressing the unique needs of reproductive-age women with HIV. Methods: The STAR is a prospective, observational cohort study that will be conducted at 6 sites in the United States-Atlanta, Georgia; Birmingham, Alabama; Jackson, Mississippi; Chapel Hill, North Carolina; Miami, Florida; and Washington, District of Columbia. Visits will occur semiannually for 2 years, with additional visits for up to 5 years. At each visit, the participating women will complete a structured interview for collecting key demographic, psychosocial, and clinical variables, and undergo biospecimen collection for laboratory testing and repositing (blood, urine, hair, vaginal, anal, and oral specimens). Pregnant women and infants will undergo additional study assessments. The initial scientific focus of the STAR is to understand the roles of key social determinants of health, depression, reproductive health, and oral health on HIV and pregnancy outcomes across the reproductive life span. Results: Enrollment in the STAR commenced in February 2021 and is ongoing. Conclusions: Through in-depth, longitudinal data and biospecimen collection, the newly initiated STAR cohort will create a platform to answer scientific questions regarding reproductive-age women with and without HIV. STAR will be uniquely positioned to enable investigators to conduct high-impact research relevant to this population. Building on the legacy of the MACS and WIHS cohorts, the STAR is designed to foster multidisciplinary collaborations to galvanize scientific discoveries to improve the health of reproductive-age women with HIV and ameliorate the effects of the HIV epidemic in this population in the United States.
KW - Depression
KW - HIV
KW - Longitudinal cohort study
KW - Oral health
KW - Women's health
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U2 - 10.2196/30398
DO - 10.2196/30398
M3 - Article
C2 - 34932006
AN - SCOPUS:85121981530
SN - 1929-0748
VL - 10
JO - JMIR Research Protocols
JF - JMIR Research Protocols
IS - 12
M1 - e30398
ER -