Effects of long-term antiretroviral therapy in reproductive-age women in sub-Saharan Africa (the PEPFAR PROMOTE study): a multi-country observational cohort study

Background We report the long-term impact of ART in women of reproductive age (15-49 years) in Africa who have been using ART for up to 10 years. We assess outcomes of retention, adherence, maternal health, fertility intentions, and safety. Methods This longitudinal, multicountry study (PROMOTE) enrolled women who initiated ART in an earlier perinatal clinical trial, PROMISE. PROMISE occurred from 2011 to 2016 and PROMOTE follow-up started in 2016 and is ongoing. The PROMOTE study was done at eight sites in four countries: Malawi (Blantyre and Lilongwe), South Africa (Durban and Soweto), Uganda (Kampala), and Zimbabwe (Harare, Seke North, and St Mary's). After baseline enrolment, women and their children are followed up every 6 months to collect information on medical history, antiretroviral therapy (ART) use, adherence, and health information, and to do physical examinations and laboratory tests. Obesity was defined as a body-mass index of 30 kg/m(2) or more. Data analyses were restricted to summaries of the main long-term outcomes (retention, adherence, maternal health, fertility intentions, and safety). We used descriptive and stratified analyses, and estimated rates using person-years of follow-up and computed probabilities based on Kaplan-Meier methods. Findings PROMOTE enrolled 1987 mothers and 2522 children. The median follow-up time for mothers was 41 center dot 8 (IQR 35 center dot 8-42 center dot 0) months and for children was 35 center dot 7 (23 center dot 8-42 center dot 0) months. Overall retention rates were 96 center dot 5% for mothers and 94 center dot 3% for children at 12 months, and, at 42 months, were 88 center dot 9% for mothers and 85 center dot 4% for children. 1115 (89 center dot 1%) of 1252 women had an undetectable viral load at 42 months, which varied by site (81 center dot 7-93 center dot 8%). Reported maternal health improved over time, with the proportion of women with excellent to very good health increasing from 67 center dot 5% at baseline to 87 center dot 5% at 42 months, the proportion of unwell participants who visited a health centre declining from 14 center dot 7% to 2 center dot 8%, and the proportion of those admitted to hospital declining from 1 center dot 5% to 1 center dot 0%. The desire to have more children was consistently high at some sites. The proportion of women with obesity was high in South Africa and increased over time from 40 center dot 2% at baseline to 52 center dot 8% at 42 months. The overall pregnancy rate was 17 center dot 6 (95% CI 16 center dot 5-18 center dot 7) per 100 women-years, and mortality rates were 2 center dot 4 (1 center dot 4-3 center dot 9) per 1000 person-years for mothers and 3 center dot 4 (2 center dot 2-5 center dot 10) per 1000 person-years for children (0-9 years). Interpretation The findings from this multicountry study are reassuring. These findings show that African women can consistently use ART for a long period after initiation, and long-term benefits can be maintained. Services to support maternal HIV care, treatment, and reproductive health should be strengthened. Copyright (c) 2022 Elsevier Ltd. All rights reserved.