Funding has been awarded to principal investigator Elizabeth K. Harrinton, MD, MPH by the Eunice Kennedy Shriver National Institute of Child Health and Human Development
(1R01HD119094-01A1 ) to optimize a novel, person-centered, tablet-based contraceptive decision support app tailored for AGYW (the Mara Divas app) in the pharmacy setting and conduct a hybrid effectiveness-implementation trial to evaluate clinical contraceptive and implementation outcomes of the Mara Divas app in parallel.
Abstract
Adolescent girls and young women (AGYW; age 15-24) globally are disproportionately affected by poor sexual and reproductive health (SRH) outcomes related to unintended pregnancy, with profound health consequences. Clinic-based SRH programs struggle to reach AGYW, and up to 50% of AGYW in East Africa seek contraception outside of formal clinic facilities, primarily at community pharmacies. Yet, pharmacists lack the time and training to engage AGYW in accurate contraceptive counseling that aligns with preferences, limiting quality and benefit.
We developed a novel, tablet-based mobile application (the Mara Divas app) to provide AGYW with person- centered contraceptive decision support in pharmacies. Iteratively co-designed with Kenyan AGYW and pharmacists, the Mara Divas app features adolescent-prioritized content with an Information-Motivation- Behavioral Skills-guided approach in 3 languages, including audio text narration and videos. In a feasibility study among AGYW seeking contraception at pharmacies (n=100), participants engaged with the app for a median of 26 min., 37% chose a different method post-app engagement, and AGYW reported significantly lower decision conflict after app engagement.
Expanding on this successful pilot, we propose a cluster RCT at 22 community pharmacies to test the effectiveness of the Mara Divas app to support contraceptive use among AGYW. Applying the Consolidated Framework on Implementation Research (CFIR) to inform implementation strategies and the Proctor model to measure implementation outcomes, this hybrid effectiveness-implementation trial is designed to promote scalability of the Mara Divas app by evaluating clinical contraceptive and implementation outcomes in parallel. Aim 1 will optimize pharmacy-based implementation of the Mara Divas app by iteratively refining implementation strategies through collaborative engagement with stakeholders. Aim 2 will determine the effect of the Mara Divas app on contraceptive use among AGYW in pharmacies through a 2-arm cluster RCT among AGYW (n=1940) seeking contraception at 22 community pharmacies in Kisumu, Kenya. Pharmacy providers will deliver the app. Primary outcomes are modern contraceptive use and preference-aligned fertility management (PFM) at 6 months. Secondary outcomes include method mix, decision conflict, and sexual and reproductive empowerment. Participants will be followed at 3 and 6 months after enrollment. Guided by the Proctor model and the CFIR, Aim 3 will conduct a qualitative and costing evaluation to examine implementation outcomes (feasibility, acceptability, appropriateness, fidelity, cost) and determinants of incorporating the Mara Divas app into pharmacy-based contraceptive delivery for AGYW.
Our study will be the first to examine an intervention to provide person-centered contraceptive decision support for AGYW in pharmacies, generating key evidence to guide implementation of contraceptive care in low-barrier community-based settings to improve SRH outcomes and support reproductive autonomy.