JMIR Publications

ABSTRACT

Background:

Cisgender women in Kenya are at elevated risk of HIV acquisition during pregnancy and the postpartum period. Acute HIV infection during pregnancy and breastfeeding accounts for approximately one-third of all vertical HIV transmissions. The World Health Organization recommends offering oral tenofovir (TFV)-based pre-exposure prophylaxis (PrEP) to HIV-negative pregnant and postpartum women at substantial and ongoing risk for HIV acquisition. PrEP delivery for pregnant and postpartum women is expanding within routine maternal child health (MCH) clinics in Kenya. However, approximately half of pregnant women discontinue PrEP within 30 days of initiation. Therefore, it is crucial to develop PrEP adherence strategies that enhance support for adherence when peripartum events and health issues pose challenges to sustaining PrEP adherence.

Objective:

We are conducting a randomized trial to determine the effect of a bi-directional communication platform (Mobile Solutions for Women’s and Children’s Health, mWACh) utilizing 2-way SMS dialogue between patients and remote nurses to support PrEP adherence and address maternal health concerns in real-time during the peripartum period.

Methods:

The mWACh-PrEP Study is a randomized trial designed to support PrEP adherence during the peripartum period by comparing mWACh-PrEP vs. standard of care (SOC, i.e., in-clinic adherence counseling) among HIV-negative women who initiate PrEP. Purposive sampling was used to select five facilities offering PrEP in antenatal clinics in Kisumu Counties, while block randomization will be used to divide participants into groups. Participants in the intervention arm will receive a custom-developed messaging curriculum via SMS targeted toward the particular perinatal stage. The primary outcome, PrEP adherence at 6 months postpartum, will be evaluated using log-binomial regression model, adjusting for imbalanced baseline characteristics. Based on a previous study of directly observed dosing conditions, we will use a hair tenofovir (TFV) concentration cut-off of 0.038 ng/mg (corresponding to 7 doses/week) as the primary adherence outcome measured at 6-months postpartum (binary outcome). Qualitative interviews and cost-effective analyses will be conducted to understand the feasibility, acceptability, and economic impact of the intervention.

Results:

Enrollment began in March 2022 and is projected to continue until July 2023, with follow-up through March 2024. The study results are expected to be reported in 2025.

Conclusions:

This trial will provide insights on using mobile health (mHealth) to enhance PrEP adherence among pregnant and postpartum mothers. Additionally, findings will have implications for using mHealth technology to improve adherence to other daily medications during the peripartum period. Clinical Trial: ClinicalTrials.gov (NCT04472884)