Optimizing knowledge and behavioral intention of women and their partners in the perinatal period in South Africa: a randomized control trial study protocol in the Tshwane district, Gauteng province, South Africa

Abstract

Background: Maternal knowledge that motivates improvements in critical perinatal health behaviors has the potential to significantly reduce maternal and neonatal mortality. However, evidence-based health information often fails to reach mothers and their partners. mHealth video micro-messages, which disseminate evidence-based perinatal health messages, have the potential to address this gap.

Methods: The study will make use of a mixed method design, using both qualitative and quantitative methods. The study consists of two phases. During Phase 1, qualitative in-depth interviews will be used as part of a human-centered design approach to co-create 10 videos on priority perinatal behaviors. During Phase 2, quantitative methods (a randomized control trial) will be used to test the effectiveness of the videos in improving maternal knowledge and intended behavioral change.

Discussion: We hypothesize that by engaging mothers and their partners through emotive, resonant narratives and visuals, we can facilitate the delivery of evidence-based health messages at the foundation of perinatal health, thereby motivating life-saving improvements in health behaviors during the perinatal period.

Trial registration: This trial has been prospectively registered on the Pan African Clinical Trials Registry (PACTR), with the registration number PACTR202203673222680 . Registration date: 14 March 2022. TRIAL REGISTRATION WHO DATA SET: Registry - Pan African Clinical Trials Registry (PACTR). Date: 14 March 2022. Secondary identification number - grant number: GCCSOAFMNH1. Source of support: Science for Africa Foundation. Primary sponsor - Clinton Health Access Initiative South Africa. Secondary sponsor - Stanford University School of Medicine and Heidelberg University. Contact for public & scientific queries: amandlamamasa@clintonhealthaccess.org ; +27 123,426,911; 1166 Francis Baard St, Hatfield, Pretoria, 0028. Public title - Amandla Mama. Scientific title - Optimizing knowledge and behavioral intention of women and their partners in the perinatal period in South Africa. Countries of recruitment - South Africa. Health conditions - antenatal care. Intervention - Amandla Mama mHealth videos, short 2D animated health promotional videos that promote healthy behavior in expectant mothers. Inclusion and exclusion criteria - Expectant mothers and their partners must be 18 years and older. Study type - randomized control trial. Date of first enrollment - 14 March 2021. Sample size - plan to enrol 450 participants, participants enrolled 29 participants. Recruitment Status - suspended. Primary outcome - improving knowledge. Secondary outcome - intended behavioral change. Ethics review - Approved on 24 January 2022 by Pharma-Ethics, contact Mrs. Marzelle Haskins, marzelle@pharma-ethics.co.za . Completion date - N/A. Summary results - N/A. IPD sharing statement - yes, through the publication of results in a journal article.

Keywords: Human centered design; Maternal health; Randomized controlled trial; South Africa; Study protocol; mHealth.