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

Funding has been awarded to principal investigator Dr. Jillian Pintye by the National Institutes of Health for "mWACh-PrEP: A SMS-based Support Intervention to Enhance PrEP Adherence during Pregnancy and Breastfeeding."

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 preventioneffective 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 will 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 ratio (ICER) per HIV infection and DALY averted compared to SOC will be calculated. Hypothesis: Incorporating data on PrEP and ANC outcomes with improve ICERs for mWACh-PrEP.

Sponsor Award Number: 1R01NR019220-01A1