Abstract
BackgroundThe PROMOTE study aims to measure long-term antiretroviral treatment (ART) safety and adherence; compare HIV disease progression; assess subsequent adverse pregnancy outcomes; evaluate effect of ART exposure on growth and development in HIV-exposed uninfected children; and assess long-term survival of mothers and children. This report primarily describes cohort characteristics at baseline to better understand long-term outcomes.Methods and findingsThis is a prospective study. HIV-infected mothers and their children originally recruited in a multisite randomized clinical trial for prevention of perinatal HIV transmission were re-enrolled in PROMOTE. A total of 1987 mothers and 1784 children were enrolled from eight sites in Uganda, Malawi, Zimbabwe and South Africa. Most women (≥75%) reported being married in Malawi and Zimbabwe compared to low proportions in South Africa (4.4% in Durban and 15% in Soweto), and 43.5% in Uganda (p<0.001). There were variabilities in contraceptive practices: injectable contraceptive was the commonest reported method (40.9% overall); implant was the second commonest (15.7% overall); oral contraceptives were common in Zimbabwe; and tubal ligation was common in Malawi and South Africa. At baseline, 97.8% of women reported currently using ART; 96.4% were in WHO clinical class 1 or 2; median CD4 cell count was 825 cells per uL; and viral load was undetectable in 1637 (~85%) of the women. Approximately, 14% of women did not inform their primary partners of their own HIV status, 18% reported that they knew their partners were not HIV tested, and 9% did not know if partner was tested. Overall mean age of children at enrollment was 3.5 years; and 5.7% and 25.0% had weight-for-age and height-for-age z-scores <2 standard deviations, respectively.ConclusionsThese baseline data show high adherence to ART use. However, issues of HIV disclosure and reproductive intentions remain important. In addition to ART and ensuring high adherence, other preventive measures should be included.
Highlights
HIV-infected mothers and their children originally recruited in a multisite randomized clinical trial for prevention of perinatal HIV transmission were re-enrolled in PROMise Ongoing Treatment Evaluation (PROMOTE)
The Promoting Maternal and Infant Survival Everywhere (PROMISE) multi-country randomized trial showed that perinatal HIV transmission can be reduced to ~0.5% when antiretroviral treatment (ART) is used during pregnancy and likewise post-partum continuation of maternal ART or infant prophylaxis can lead to very low rates of transmission during breastfeeding [1, 2]
We describe the PROMOTE study design, baseline data on women and children who enrolled in PROMOTE, and discuss the significance of the study
Summary
The Promoting Maternal and Infant Survival Everywhere (PROMISE) multi-country randomized trial showed that perinatal HIV transmission can be reduced to ~0.5% when antiretroviral treatment (ART) is used during pregnancy and likewise post-partum continuation of maternal ART or infant prophylaxis can lead to very low rates of transmission during breastfeeding [1, 2]. Despite huge reductions in perinatal HIV transmission, the roll-out of ART has resulted in millions of HIV-exposed, uninfected infants and children, being exposed to approximately 30 months of ART This includes both in utero from as early as conception through up to 18–24 months of breastfeeding during a period of rapid brain and somatic physical growth. Most ART drugs have limited research safety data on dosing and safety in pregnant or breastfeeding women and in children This includes pregnancy outcomes and later pediatric growth and development [7]. The PROMOTE study aims to measure long-term antiretroviral treatment (ART) safety and adherence; compare HIV disease progression; assess subsequent adverse pregnancy outcomes; evaluate effect of ART exposure on growth and development in HIV-exposed uninfected children; and assess long-term survival of mothers and children. This report primarily describes cohort characteristics at baseline to better understand long-term outcomes
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