DOI: 10.5061/dryad.08kprr50c
title: Data from: Implementation of Option B and a fixed-dose combination antiretroviral regimen for prevention of mother-to-child transmission of HIV in South Africa: a model of uptake and adherence to care

description: Introduction Initiating and retaining pregnant women on antiretroviral
 therapy (ART) to prevent mother-to-child HIV transmission (PMTCT) remains
 a major challenge facing African HIV programs, particularly during the
 critical final months prior to delivery. In 2013, South Africa implemented
 its “Option B” PMTCT regimen (three-drug ART throughout pregnancy and
 breastfeeding, regardless of maternal CD4 count) and introduced once-daily
 fixed-dose combinations and lifelong ART. Currently, the uptake of Option
 B and its possible impact on adherence to PMTCT during the critical final
 months of pregnancy is unclear. Materials and Methods  We
 prospectively collected visit data from a cohort of adult, HIV-infected,
 pregnant women between July 2013-August 2014 to estimate three models of
 adherence to PMTCT during the final 16 weeks immediately preceding
 delivery. Adherence was defined according to possession of antiretroviral
 drugs, which was inferred from clinic visit records under varying
 assumptions in each model. We describe uptake of the PMTCT regimen,
 gestational age at initiation, and model possible scenarios of adherence
 through delivery after the implementation of Option B. Results Among 138
 women enrolled (median (IQR) age 28 years (24-32), median CD4 count 378
 cells/mm3), median (IQR) gestational age at initiation was 22 weeks
 (16-26). Estimates of adherence during the final 16 weeks of pregnancy
 prior to delivery ranged from 75% (52-89%) under the best case scenario
 assumptions to 52% (30-75%) under the worst case scenario assumptions.
 Estimates of the proportion of women who would achieve 80% adherence to
 PMTCT were &lt;50% across all models. Conclusions Despite the switch
 to Option B and once-daily dosing, South African women continue to
 initiate PMTCT late in pregnancy, and estimations of regimen adherence, as
 modelled using PMTCT visit attendance data, is poor, with &lt;50% of
 women reaching 80% adherence during final months of pregnancy across all
 models. Further guideline changes and interventions are needed to achieve
 vertical transmission goals. Trial Registration This study was nested
 within the original RapIT randomized controlled trial which was registered
 on ClinicalTrials.gov (Registration number) NCT01710397 on September 7,
 2012 and the South African National Clinical Trials Register
 DOH-27-0213-4177. The first participant in the RapIT study was enrolled on
 May 8th, 2013.
description: The data utilized in this study were collected at a public-sector
 primary health clinic (PHC) in Johannesburg, South Africa. It is located
 in an informal settlement on the edge of the city with a large population
 of immigrants from neighboring countries and patients from other South
 African provinces. It provides a full range of primary healthcare
 services, including antenatal care (ANC), maternal and child health, HIV
 testing and counseling, ART initiation, and ART management. Under South
 African guidelines (8), women are advised to make at least four antenatal
 care visits prior to delivery, starting at 14 weeks’ gestation. PMTCT
 guidelines increased the required number of visits, however, as clinics
 standard practice was to provide only one month of ARV medication at a
 time during the study period. The clinic does not have a delivery ward;
 referral for delivery was to either a nearby hospital or one of three
 maternal obstetric units (MOUs) located 4, 5.5, and 7 kilometers from the
 clinic, respectively. At least one antenatal clinic visit was needed for a
 woman to obtain an antenatal care card, which is required to assure access
 to a hospital or MOU for delivery.  We sequentially
 enrolled adult (≥18 years old), HIV-infected, pregnant women at the
 earliest clinic visit for a positive HIV test, provision of a blood sample
 for a CD4 count, or first ANC visit between July 4, 2013 and August 14,
 2014. Women who were already on ART for their own health or who indicated
 that they did not intend to seek the remainder of their antenatal care at
 the study clinic were excluded. After informed consent, the women were
 administered a questionnaire eliciting information about demographic and
 socioeconomic characteristics; previous pregnancies, health-seeking
 behavior and exposure to PMTCT; normal activities and employment, and the
 costs the patient incurred per clinic visit. Study patients were then
 followed by passive medical record review, using the site’s and delivery
 facility’s routine patient records, until delivery. These records included
 antenatal and labour ward registries as well as an electronic medical
 record system, TherapyEdge-HIVTM. Fields collected included dates of
 antenatal clinic visits, gravidity and parity, gestational age at first
 visit and predicted delivery date, date of HIV test, ARV regimen
 prescribed, and baseline CD4 count. Not all data for all study subjects
 could be found in the routine records maintained by the study site, nor
 could confirmation of all deliveries be found at the referral facilities.
 Viral load test results were not available for the majority of study
 participants, as most had spent fewer than 6 months on ART at the time of
 delivery