JMIR Publications

ABSTRACT

Background:

Nearly one quarter of the 1.1 million individuals living with HIV in the United States (US) are women, and racial/ethnic minority women in the Southern US are disproportionately impacted by the epidemic. Reproductive age women with HIV (WWH) are prone to poor HIV outcomes but remain underrepresented in HIV research. We will answer contemporary questions related to health outcomes in this population by enrolling a prospective cohort of reproductive age women with and without HIV in the Southern US.

Objective:

The Study of Treatment and Reproductive outcomes (STAR) will enroll and retain 2,000 reproductive-aged women with and without HIV into a longitudinal cohort study. STAR will leverage the US-based MACS/WIHS Combined Cohort Study (MWCCS), comprising the Women’s Interagency HIV Study (WIHS, a cohort of women with and at-risk for HIV, which began in 1993) and the Multicenter AIDS Cohort Study (MACS, a cohort of gay and bisexual men with and at-risk for HIV, which began in 1984). Although the advancing age of participants enrolled in MWCCS provides ample opportunity to address questions related to HIV infection and aging, research questions pertinent to the reproductive-aged years also must be addressed. STAR will conduct high priority science in key areas that contribute to poor health outcomes with the overall aim of addressing the unique needs of reproductive-aged WWH.

Methods:

STAR is a prospective, observational cohort study to be conducted in 6 US sites in Atlanta, GA; Birmingham, AL; Jackson, MS; Chapel Hill, NC; Miami, FL; and Washington, D.C. Visits will be conducted semiannually for 2 years, with additional annual visits for up to 5 years. At each visit, women will complete a structured interview to collect key demographic, psychosocial, and clinical variables; and undergo biospecimens collectionfor laboratory testing and repositing (serum, plasma, peripheral blood mononuclear cells, urine, hair, genital and anal mucosa, and oral specimens). Pregnant women and their infants will undergo additional study assessments. The initial scientific focus of STAR will be to understand the roles of key social determinants of health, depression, reproductive health, and oral health on critical HIV and pregnancy outcomes across the reproductive lifespan.

Results:

Enrollment in STAR began in February 2021 and is ongoing.

Conclusions:

Through in-depth, longitudinal collection of clinical, behavioral, and laboratory data, the newly initiated STAR cohort will create an important platform to answer scientific questions of relevance to reproductive age WWH, as well as demographically comparable HIV-seronegative women. This observational cohort will be uniquely positioned to enable investigators to conduct high impact research relevant to this population, including research related to pregnancy. Building on the legacy of the MACS and WIHS cohorts, STAR is designed to foster multidisciplinary collaborations to galvanize scientific discoveries to improve the health of reproductive age WWH and ameliorate the effects of the HIV epidemic in this population in the US. Clinical Trial: N/a