A Patient-Centered, Combination Intervention to Support Adherence to HIV Pre-exposure Prophylaxis During Pregnancy and Breastfeeding: A Randomized Pilot Study in Malawi

Abstract

Background: Daily oral pre-exposure prophylaxis (PrEP) can reduce HIV incidence in pregnant and breastfeeding women, but adherence is essential. Methods: We conducted a pilot randomized trial to evaluate an intervention package to enhance antenatal and postnatal PrEP use in Lilongwe, Malawi. The intervention was based on patient-centered counseling adapted from prior PrEP studies, with the option of a participant-selected adherence supporter. Participants were locally eligible for PrEP and randomized 1:1 to intervention or standard counseling (i.e., control) and followed for six months. Participants received the intervention package or standard counseling at enrollment, one month, three months, and six months. Adherence was measured via plasma and intracellular tenofovir concentrations and scored using a published algorithm. Our primary outcome was retention in care with concentrations consistent with 4-7 doses/week. Results: From June to November 2020, we enrolled 200 pregnant women with median gestational age of 26 (IQR:19-33) weeks. Study retention was high at three months (89.5%) and six months (85.5%). In contrast, across the two timepoints, 32.8% had adherence scores consistent with 2-5 doses/week and 10.3% had scores consistent with daily dosing. For the composite primary endpoint, no substantial differences were observed between the intervention and control groups at three months (28.3% vs. 29.0%, probability difference [PD]:-0.7%, 95%CI:-13.3%, 11.8%) or at six months (22.0% vs. 26.3%, PD:-4.3%, 95%CI:-16.1%, 7.6%). Conclusions: In this randomized trial of PrEP adherence support, retention was high, but less than one-third of participants had pharmacologically confirmed adherence of >4 doses/week. Future research should focus on antenatal and postnatal HIV prevention needs and their alignment across the PrEP continuum, including uptake, persistence, and adherence.

Editorial: Improving the delivery of pre-exposure prophylaxis (PrEP) to eliminate vertical HIV transmission

“…Secondly, we learned about barriers and facilitators of the PrEP care continuum. Previous work has highlighted significant challenges with PrEP adherence which is critical for efficacy ( 11 ). Khadka et al found that over 80% of pregnant adolescent girls and young women initiated PrEP in the first antenatal care visit.…”