Retention in care during the first 3 years of antiretroviral therapy for women in Malawi's option B+ programme: an observational cohort study

Abstract

Background: Studies of Malawi's option B+ programme for HIV-positive pregnant and breastfeeding women have reported high loss to follow-up during pregnancy and at the start of antiretroviral therapy (ART), but few data exist about retention during breastfeeding and after weaning. We examined loss to follow-up and retention in care in patients in the option B+ programme during their first 3 years on ART.

Methods: We analysed two data sources: aggregated facility-level data about patients in option B+ who started ART between Oct 1, 2011, and June 30, 2012, at 546 health facilities; and patient-level data from 20 large facilities with electronic medical record system for HIV-positive women who started ART between Sept 1, 2011, and Dec 31, 2013, under option B+ or because they had WHO clinical stages 3 or 4 disease or had CD4 counts of less than 350 cells per μL. We used facility-level data to calculate representative estimates of retention and loss to follow-up. We used patient-level data to study temporal trends in retention, timing of loss to follow-up, and predictors of no follow-up and loss to follow-up. We defined patients who were more than 60 days late for their first follow-up visit as having no follow-up and patients who were more than 60 days late for a subsequent visit as being lost to follow-up. We calculated proportions and cumulative probabilities of patients who had died, stopped ART, had no follow-up, were lost to follow-up, or were retained alive on ART for 36 months. We calculated odds ratios and hazard ratios to examine predictors of no follow-up and loss to follow-up.

Findings: Analysis of facility-level data about patients in option B+ who had not transferred to a different facility showed retention in care to be 76·8% (20 475 of 26,658 patients) after 12 months, 70·8% (18,306 of 25,849 patients) after 24 months, and 69·7% (17,787 of 25,535 patients) after 36 months. Patient-level data included 29,145 patients. 14,630 (50·2%) began treatment under option B+. Patients in option B+ had a higher risk of having no follow-up and, for the first 2 years of ART, higher risk of loss to follow-up than did patients who started ART because they had CD4 counts less than 350 cells per μL or WHO clinical stage 3 or 4 disease. Risk of loss to follow-up during the third year was low and similar for patients retained for 2 years. Retention rates did not change as the option B+ programme matured.

Interpretation: Our data suggest that pregnant and breastfeeding women who start ART immediately after they are diagnosed with HIV can be retained on ART through the option B+ programme, even after many have stopped breastfeeding. Interventions might be needed to improve retention in the first year on ART in option B+.

Funding: Bill & Melinda Gates Foundation, Partnerships for Enhanced Engagement in Research Health, and National Institute of Allergy and Infectious Diseases.

Figure 1. Cumulative incidence of ART outcomes for patients at 20 large

Treatment outcomes are compared between three groups on the basis of indication for ART. Option B+ indication and ART started during pregnancy (top panel), Option B+ indication and ART started while breastfeeding (middle panel), and WHO stage 3 or 4 disease or CD4 cell count meeting the ART eligibility threshold (bottom panel). Estimates derived from competing-risk regression. ART=antiretroviral therapy.

Figure 2. Retention in care by indication for Option B+ and year of ART initiation

Data are for women who attended 20 large facilities with patient-level data. Kaplan-Meier curves show retention in care for pregnant or breastfeeding women in Option B+ who started ART in 2011, 2012, or 2013. In this analysis of temporal trends in retention, patients were classified as lost to follow-up if they were more than 150 days late for an appointment, even if they returned to care thereafter. ART=antiretroviral therapy.