We evaluated the effect of an option B-plus Enhanced Adherence Package (BEAP), on early ART uptake in a randomized controlled trial. HIV-positive, ART naïve pregnant women in Lusaka, Zambia, were randomized to receive BEAP (phone calls/home visits, additional counseling, male partner engagement and missed-visit follow-up) versus standard of care (SOC). The primary outcome was initiating and remaining on ART at 30 days. Analysis was by intention to treat (ITT) using logistic regression. Additional per protocol analysis was done. We enrolled 454 women; 229 randomized to BEAP and 225 to SOC. Within 30 days of eligibility, 445 (98.2%) initiated ART. In ITT analysis, 82.5% BEAP versus 80.4% SOC participants reached primary outcome (crude relative risk [RR] 1.03; 95% confidence interval [CI] 0.91–1.16; Wald test statistic = 0.44; p-value = 0.66). In per protocol analysis, (92 participants (40.2%) excluded), 91.9% BEAP versus 80.4% SOC participants reached primary outcome (crude RR 1.14; 95% CI 1.02–1.29; Wald test statistic = 2.23; p-value = 0.03). Early ART initiation in pregnancy was nearly universal but there was early drop out suggesting need for additional adherence support.
This trial was registered at ClinicalTrials.gov (trials number NCT02459678) on May 14, 2015.
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This research has been supported by the President’s Emergency Plan for AIDS Relief (PEPFAR) through the United States Centers for Disease Control and Prevention (CDC) under the terms of cooperative agreement number U01GH000530. Additional investigator support was provided by the National Institutes of Health (K24 AI120796). The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the funding agencies. The authors acknowledge the B-Plus study team for their work in participant recruitment and follow-up; and all the HIV infected pregnant women who participated in the study.
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Mubiana-Mbewe, M., Bosomprah, S., Kadota, J.L. et al. Effect of Enhanced Adherence Package on Early ART Uptake Among HIV-Positive Pregnant Women in Zambia: An Individual Randomized Controlled Trial. AIDS Behav 25, 992–1000 (2021). https://doi.org/10.1007/s10461-020-03060-4