Sheth Anandi N, Adimora Adaora A, Golub Elizabeth Topper, Kassaye Seble G, Rana Aadia, Westreich Daniel, Cyriaque Jennifer Webster, Parish Carrigan, Konkle-Parker Deborah, Jones Deborah L, Kempf Mirjam-Colette, Ofotokun Igho, Kanthula Ruth M, Donohue Jessica, Raccamarich Patricia, Tisdale Tina, Ramirez Catalina, Warren-Jeanpiere Lari, Tien Phyllis C, Alcaide Maria L
Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, GA, United States.
Infectious Diseases Program, Grady Health System, Atlanta, GA, United States.
JMIR Res Protoc. 2021 Dec 20;10(12):e30398. doi: 10.2196/30398.
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.
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.
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.
Enrollment in the STAR commenced in February 2021 and is ongoing.
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.
在美国110万艾滋病毒感染者中，近四分之一是女性。美国南部的少数族裔女性受影响的比例过高。处于生育年龄的艾滋病毒感染女性往往艾滋病毒治疗效果不佳，但在艾滋病毒研究中的代表性仍然不足。我们将招募一组美国南部有或没有艾滋病毒的育龄女性前瞻性队列，以回答与该人群健康结果相关的当代问题。
治疗与生殖结果研究（STAR）将招募并留住2000名有或没有艾滋病毒的育龄女性。STAR将利用美国多中心艾滋病队列研究（MACS）/妇女机构间艾滋病毒研究（WIHS）联合队列研究的基础设施，该联合队列研究包括WIHS（一组感染艾滋病毒及有感染风险的女性，始于1993年）和MACS（一组感染艾滋病毒及有感染风险的男同性恋和双性恋男性，始于1984年）。尽管参与MACS/WIHS联合队列研究的参与者年龄不断增长，为解决与艾滋病毒和衰老相关的问题提供了机会，但与生育年龄相关的研究问题也必须得到解决。STAR将在关键领域开展高优先级的科学研究，总体目标是满足感染艾滋病毒的育龄女性的独特需求。
STAR是一项前瞻性观察性队列研究，将在美国的6个地点进行——佐治亚州亚特兰大；阿拉巴马州伯明翰；密西西比州杰克逊；北卡罗来纳州教堂山；佛罗里达州迈阿密；以及哥伦比亚特区华盛顿。随访将每半年进行一次，为期2年，最多还会有5年的额外随访。每次随访时，参与研究的女性将完成一次结构化访谈，以收集关键的人口统计学、心理社会和临床变量，并进行生物样本采集，用于实验室检测和储存（血液、尿液、头发、阴道、肛门和口腔样本）。孕妇和婴儿将接受额外的研究评估。STAR最初的科学重点是了解关键的健康社会决定因素、抑郁症、生殖健康和口腔健康在整个生殖寿命中对艾滋病毒和妊娠结局的作用。
STAR于2021年2月开始招募，目前仍在进行中。
通过深入的纵向数据和生物样本采集，新启动的STAR队列将创建一个平台，以回答有关有或没有艾滋病毒的育龄女性的科学问题。STAR将具有独特的优势，使研究人员能够开展与该人群相关的高影响力研究。基于MACS和WIHS队列的遗产，STAR旨在促进多学科合作，激发科学发现，以改善感染艾滋病毒的育龄女性的健康状况，并减轻艾滋病毒在美国该人群中的流行影响。
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