Health Outcomes around Pregnancy and Exposure to HIV/ARV (HOPE):

The Women’s HOPE Study (“Health Outcomes around Pregnancy and Exposure to HIV/ARV [HOPE]: Extending the Reach of PHACS to Examine Women’s Health”) will establish a dynamic cohort of 2000 young women living with HIV (WLHIV), including those with perinatally acquired HIV, to address critical scientific questions in the clinical course of HIV infection during the preconception to post-partum cascade of care. The cohort will build on the unique research infrastructure of the well-established Pediatric HIV/AIDS Cohort Study (PHACS), allowing further understanding of the long-term health of WLHIV and their children and addressing the missions of the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Dental and Craniofacial Research. WLHIV of reproductive age will be co-enrolled in HOPE and PHACS from 22 sites across the United States and Puerto Rico during pregnancy or up to 5 years postpartum with their children to address questions regarding engagement in HIV care, and reproductive, psychosocial and oral health over five years. In addition, a biorepository of specimens will be established to prepare for future investigations of pregnancy and other long-term health outcomes. Data collection will occur twice during pregnancy and at the time of their child’s annual or biannual PHACS visit, and will include biologic specimen collection (blood, saliva, placenta, cord blood, oral and vaginal swabs), psychosocial, reproductive and sexual health questionnaires, medical chart data abstraction (virologic and immunologic data, blood pressures, body measurement index, antiretroviral and other medications, and medical and psychiatric diagnoses), anthropometric measurements and oral exams. Novel approaches to data harmonization and digital photography to evaluate gingival inflammation will be used, and data analysis will be performed by the well-established PHACS team of epidemiologists and statisticians at the Harvard T.H. Chan School of Public Health. The HOPE study will create a platform to explore mechanistic and psychosocial factors that may influence the short and longer-term health of WLHIV during their reproductive years. In addition, the HOPE cohort with its biorepository will serve as a resource for future multidisciplinary studies in the areas of genetics/epigenetics, microbiome/virome/proteomes, immune activation, cardiovascular and metabolic health and other domains.