Abstract

BackgroundSouth Africa is home to more people living with HIV than any other country, including nearly one in three pregnant women attending antenatal care. Access to antiretroviral therapy (ART) has increased substantially since the start of the national ART program in 2004, with > 95% ART coverage during pregnancy and delivery, and vertical transmission of HIV greatly reduced. However, women who initiate ART during pregnancy are at heightened risk of dropping out of care, particularly after delivery, leading to the potential for viral transmission, morbidity and mortality. It is difficult to evaluate the success of policies of expanded access to ART care, and assess continuity of care, due to the lack of a national longitudinal HIV care database. Also, patient movement between unlinked facilities. For the first time on a national level, we propose to utilize routinely-collected laboratory data to develop and validate a cohort of pregnant women living with HIV in South Africa in a way that is uniquely robust to facility transfer.MethodsUsing laboratory test data matched to facility type, we will identify entry to antenatal care to build the cohort, then describe key treatment milestones, including 1) engagement in antenatal care, 2) initiation of ART, 3) HIV viremia, and 4) continuity of HIV care in the postpartum period. Second, we will measure the effect of system-wide factors impacting continuity of care among pregnant women. We will assess policies of expanded treatment access on continuity of care using regression-discontinuity analyses. We then will assess mobility and its effect on continuity of care during and after pregnancy. Third, we will identify individual-level risk factors for loss from HIV care in order to develop targeted interventions to improve engagement in HIV care.DiscussionThis work will create the world’s largest national cohort of pregnant women living with HIV. This novel cohort will be a powerful tool available to policymakers, clinicians and researchers for improving our understanding of engagement in care among pregnant women in South Africa and assessing the performance of the South African national ART program in caring for pregnant women living with HIV.Trial registrationN/A (not a clinical trial).

Highlights

  • South Africa is home to more people living with Human immunodeficiency virus (HIV) than any other country, including nearly one in three pregnant women attending antenatal care

  • We will build a national-level pregnancy cohort and describe key treatment milestones in the care of pregnant women living with HIV in South Africa: 1) engagement in antenatal care, 2) initiation of antiretroviral therapy (ART), 3) HIV viremia and 4) continuity of HIV care in the postpartum period, a period of high LTFU

  • Data collection and analysis plan Aim 1: develop and validate a novel national cohort of pregnant women accessing HIV care We propose to utilize the National Health Laboratory Service (NHLS) National HIV Cohort to create and validate a national, longitudinal, patientlevel cohort of pregnant women accessing HIV care in South Africa dating to the beginning of the national ART program in 2004, as follows:

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Summary

Introduction

South Africa is home to more people living with HIV than any other country, including nearly one in three pregnant women attending antenatal care. Since 2016, South Africa has implemented a “treat all” policy, providing ART to all HIV-positive people, regardless of CD4 cell count [3]. This rapid-scale up has undoubtedly had a positive effect on morbidity and mortality due to HIV, as well as HIV transmission: there was an estimated life expectancy gain of 11.3 years between 2003 and 2011 due to ART [4] and a 77% decrease in HIV transmission in stable serodiscordant couples [5]. HIV and tuberculosis (usually exacerbated by HIV) are the top two causes of death among women ages 15–44 in South Africa [18], demonstrating that a focus on sustained engagement in care must continue after pregnancy ends

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