# mWACh-PrEP: A SMS-based Support Intervention to Enhance PrEP Adherence during Pregnancy and Breastfeeding

> **NIH NIH R01** · UNIVERSITY OF WASHINGTON · 2021 · $575,224

## Abstract

In high HIV prevalence regions, women are at high risk for HIV during pregnancy and breastfeeding. To protect
women and reach elimination of mother-to-child HIV transmission, the World Health Organization recommends
offering oral tenofovir (TFV)-based pre-exposure prophylaxis (PrEP) to HIV-negative pregnant and postpartum
women in high-burden settings. Although most pregnant Kenyan women with HIV risk factors accept PrEP when
offered, >50% discontinue PrEP within 30 days of initiation and sub-optimal adherence is common. To date, no
intervention studies to improve PrEP adherence include pregnant or postpartum women. We adapted an SMS
communication platform (mWACh) to send PrEP-tailored, theory-based SMS to facilitate adherence among
pregnant women who initiate PrEP. In a non-randomized pilot, we found that mWACh-PrEP recipients were more
likely to persist with PrEP use and to self-report high adherence. We propose a randomized trial to determine
the effect of the mWACh-PrEP tool on PrEP adherence during pregnancy through the postpartum period. We
will also gather data on cost and delivery using the Proctor Implementation Outcomes Framework to expedite
translation into routine practice. Our overarching hypothesis is that mWACh-PrEP will improve PrEP adherence
among mothers at-risk for HIV, be acceptable to patients and providers, and be cost-effective. By leveraging our
team’s research infrastructure in Western Kenya, we are uniquely positioned to execute the following AIMS:
Aim 1- To determine the effect of the mWACh-PrEP tool on PrEP adherence during pregnancy through the
postpartum period among women who initiate PrEP within ANC-PrEP. We will conduct a 2-arm randomized trial
comparing mWACh-PrEP vs standard of care (SOC, i.e. in-clinic adherence counseling) among HIV-uninfected
pregnant women with high HIV acquisition risk (defined by validated risk score) who initiate PrEP. The primary
outcome will be adherence at 6 months postpartum (TFV hair levels >0.038 ng/mg; consistent with 7 pills/ week).
Secondary outcomes will include STI incidence, adherence cofactors, and prevention-effective adherence (time-
varying alignment of adherence with risk behaviors). Exploratory outcomes will include HIV incidence and
perinatal outcomes by arm. Hypothesis: mWACh-PrEP will increase PrEP adherence compared to SOC.
Aim 2– Evaluate barriers and facilitators of mWACh-PrEP implementation within routine ANC. Using the Proctor
framework, we assess acceptability and feasibility by conducting interviews and focus-groups with ANC-PrEP
users, providers, and health planners. Hypothesis: Indications for readiness of mWACh-PrEP will be identified.
Aim 3– Estimate the cost-effectiveness of implementing mWACh-PrEP within ANC-PrEP, per HIV infection and
disability-adjusted life-year (DALY) averted. We use data from Aims 1 and conduct micro-costing and time-and-
motion studies to estimate the cost of mWACh-PrEP from a payer perspective. The incremental cost-
effectiveness r...

## Key facts

- **NIH application ID:** 10266133
- **Project number:** 5R01NR019220-02
- **Recipient organization:** UNIVERSITY OF WASHINGTON
- **Principal Investigator:** John Kinuthia
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $575,224
- **Award type:** 5
- **Project period:** 2020-09-18 → 2025-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10266133

## Citation

> US National Institutes of Health, RePORTER application 10266133, mWACh-PrEP: A SMS-based Support Intervention to Enhance PrEP Adherence during Pregnancy and Breastfeeding (5R01NR019220-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10266133. Licensed CC0.

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