Design and impact evaluation of a digital reproductive health program in Rwanda using a cluster randomized design: study protocol

Abstract

Background: Rwandan adolescents have limited access to high-quality family planning and reproductive health (FP/RH) information and care to prevent unplanned pregnancy and HIV/STIs. In addition to the immediate implications for health and well-being, teenage pregnancy is a significant cause of school drop-out, limiting girls' future potential and employment opportunities. This study introduces a direct-to-consumer digital education program that uses storytelling to deliver age-appropriate FP/RH information and economic empowerment training to adolescents. It also facilitates access to high-quality, youth-friendly FP/RH care and products. We evaluate two different school-based models of its implementation to understand how to optimize the uptake of contraception and HIV testing among adolescents.

Methods: The study consists of two distinct phases. The first formative intervention design phase, conducted from 2016 to 2019, used a human-centered design methodology to develop the intervention alongside over 600 Rwandan adolescents, their parents, teachers, and healthcare providers. Through this methodology, we sought to maximize the fit between evidence-based practices (uptake of modern contraception and HIV testing) and the implementation context of adolescents in Rwanda. The second phase is an impact evaluation, in which we will use a Hybrid Trial Type 2 Effectiveness-Implementation study design to determine the overall effectiveness of this digital intervention as well as the relative effectiveness of the two different school-based implementation models. This takes the form of a 3-arm cluster-randomized non-inferiority trial, with a sample of 6000 youth aged 12-19 in 60 schools across 8 districts in Rwanda. Primary outcome measures include use of modern contraception, delayed initiation of childbearing, and uptake of HIV testing.

Discussion: This study will yield insights into not only whether this digital intervention is successful in achieving the intended sexual and reproductive health outcomes, but also which mechanisms are likely to drive this effectiveness. The methodologies used are broadly applicable to the design, implementation, and evaluation of other behavior-based health programs in low and middle-income countries.

Trial registration: ClinicalTrials.gov Identifier: NCT04198272 . Prospectively registered 13 December 2019.

Keywords: Adolescent sexual and reproductive health; Cluster randomized controlled trial; Digital health; Family planning and reproductive health; Human-centered design; Hybrid type 2 effectiveness-implementation study; Rwanda; Uptake of modern contraceptive methods.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1

Design Principles. Design principles derived from initial design research and used to inform prototype development

Fig. 2

The Prototype Development Process. Steps involved in prototyping both youth (a - c) and provider-facing (d - f) solutions ranged from co-designing key elements of the solution to low- and high-fidelity testing of prototype solutions. a: Youth Co-Design - Mapping site content based on young people’s key questions; b: Youth Low-Fidelity Prototyping - Testing paper prototypes of content and visual design; c: Youth High-Fidelity Prototyping - Testing wireframe prototypes of the app; d: Provider Co-Design - Exploring gamified approaches to learning with providers; e: Provider Low-Fidelity Prototyping - Testing pre-screening methods to expedite care for youth; f: Provider High-Fidelity Prototyping - Testing an interactive digital prototype of the training game

Fig. 3

Behavioral pathway leading to increased contraceptive use. Example behavioral pathway defined by the Theory of Planned Behavior, from knowledge to behavior change in usage of modern contraceptive methods

Fig. 4

CyberRwanda Intervention Design. a: Schematic describing the components of the CyberRwanda digital intervention including the youth-facing web application and pharmacist portal; b-e: Images of the youth-facing web application pages [‘Home’ (b); ‘Learn’ (c); ‘Shop’ (d); ‘Ask’ (e)]; f: Image of the pharmacist portal. Images are the property of YLabs and published with permission of author and YLabs Executive Director Rebecca Hope

Fig. 5

Cluster Randomized Hybrid Effectiveness-Implementation Trial Study Design. Schematic of the study design