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Self-Reported Antiretroviral Adherence: Association with Maternal Viral Load Suppression in Postpartum Women Living with HIV-1 from Promoting Maternal and Infant Survival Everywhere (PROMISE), a Randomized Controlled Trial in Sub-Saharan Africa and India
Journal of Acquired Immune Deficiency Syndrome
Optimal adherence to antiretroviral therapy (ART) is crucial to promoting maternal–infant health.
Fourteen sites in 7 countries within sub-Saharan Africa and India.
The multicomponent, open-label strategy PROMISE trial enrolled breastfeeding mother–infant pairs not meeting in-country criteria for maternal ART (mART) initiation in the postpartum component within 5 days of delivery. Randomization was to mART versus infant NVP (iNVP) prophylaxis. Infants in the mART arm also received 6 weeks of iNVP. Self-reported adherence was assessed in a secondary analysis. Time-to-event analyses were performed to explore the association between adherence and maternal viral load (mVL) in the mART arm.
Two thousand four hundred thirty-one mother–infant pairs were enrolled between 2011 and 2014; the baseline maternal median CD4 was 686 (IQR 553–869), and the median mVL was 322 copies/mL (IQR 40–1422). Self-reported adherence was lower in the mART arm compared with the iNVP arm (no missed doses within 4 weeks of all study visits: 66% vs 83%; within 2 weeks: 71% vs 85%; P < 0.0001). The iNVP adherence at week 6 was high in both arms: 97% in mART arm; 95% in iNVP arm. Time-to-event analyses showed that adherence to mART was associated with time to first mVL ≥400 copies/mL (P < 0.0001). Missing 1 full day of doses over 3 days was associated with a 66% risk of mVL ≥1000 copies/mL (HR: 1.66; 95% CI: 1.37, 1.99).
Postpartum women were less adherent to their own ART than mothers providing their infant's nevirapine prophylaxis. The self-reported missed mART doses were associated with high mVL. Strategies to optimize postpartum mART adherence are urgently needed.
Clinical Trial Number:
ClinicalTrials.gov: NCT01061151; closed to follow-up.
Nevrekar N, Butler K, Shapiro DE, Atuhaire P, Taha TE, Makanani B, Chinula L, Owor M, Moodley D, Chipato T, McCarthy K, Flynn PM, Currier J, Fowler MG, Gupta A, Suryavanshi N. Self-reported Antiretroviral Adherence: Association With Maternal Viral Load Suppression in Postpartum Women Living With HIV-1 From Promoting Maternal and Infant Survival Everywhere, a Randomized Controlled Trial in Sub-Saharan Africa and India. J Acquir Immune Defic Syndr. 2023 Jan 1;92(1):76-83. doi: 10.1097/QAI.0000000000003102. Epub 2022 Sep 28. PMID: 36170749; PMCID: PMC9722360.