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

Lancet HIV. 2016 Apr;3(4):e175-82. doi: 10.1016/S2352-3018(16)00008-4. Epub 2016 Mar 9.


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.

Publication types

  • Observational Study
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, Non-P.H.S.
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adolescent
  • Adult
  • Anti-HIV Agents / therapeutic use*
  • Breast Feeding
  • Cohort Studies
  • Female
  • HIV Infections / drug therapy*
  • HIV Infections / prevention & control
  • HIV Infections / transmission
  • Humans
  • Infectious Disease Transmission, Vertical / prevention & control*
  • Lost to Follow-Up*
  • Malawi
  • Maternal-Child Health Services / statistics & numerical data
  • Medication Adherence / statistics & numerical data
  • Odds Ratio
  • Patient Dropouts / statistics & numerical data*
  • Pregnancy
  • Pregnancy Complications, Infectious / drug therapy*
  • Proportional Hazards Models
  • Risk Factors
  • Young Adult


  • Anti-HIV Agents