Are stage-based health information messages effective and good value for money in improving maternal newborn and child health outcomes in India? Protocol for an individually randomized controlled trial

Abstract

Background: Evidence is limited on the effectiveness of mobile health programs which provide stage-based health information messages to pregnant and postpartum women. Kilkari is an outbound service that delivers weekly, stage-based audio messages about pregnancy, childbirth, and childcare directly to families in 13 states across India on their mobile phones. In this protocol we outline methods for measuring the effectiveness and cost-effectiveness of Kilkari.

Methods: The study is an individually randomized controlled trial (iRCT) with a parallel, partially concurrent, and unblinded design. Five thousand pregnant women will be enrolled from four districts of Madhya Pradesh and randomized to an intervention or control arm. The women in the intervention arm will receive Kilkari messages while the control group will not receive any Kilkari messages as part of the study. Women in both arms will be followed from enrollment in the second and early third trimesters of pregnancy until one year after delivery. Differences in primary outcomes across study arms including early and exclusive breastfeeding and the adoption of modern contraception at 1 year postpartum will be assessed using intention to treat methodology. Surveys will be administered at baseline and endline containing modules on phone ownership, geographical and demographic characteristics, knowledge, practices, respectful maternity care, and coverage for antenatal care, delivery, and postnatal care. In-depth interviews and focus group discussions will be carried out to understand user perceptions of Kilkari, and more broadly, experiences providing phone numbers and personal health information to health care providers. Costs and consequences will be estimated from a societal perspective for the 2018-2019 analytic time horizon.

Discussion: Kilkari is the largest maternal messaging program, in terms of absolute numbers, currently being implemented globally. Evaluations of similar initiatives elsewhere have been small in scale and focused on summative outcomes, presenting limited evidence on individual exposure to content. Drawing upon system-generated data, we explore linkages between successful receipt of calls, user engagement with calls, and reported outcomes. This is the first study of its kind in India and is anticipated to provide the most robust and comprehensive evidence to date on maternal messaging programs globally.

Trial registration: Clinicaltrials.gov, 90075552, NCT03576157 . Registered on 22 June 2018.

Keywords: India; Maternal messaging; Mobile health; Pregnant women; mHealth.

Conflict of interest statement

Ethics approval and consent to participate

Ethical approval to carry out this research has been obtained by the Johns Hopkins School of Public Health Institutional Review Board in Baltimore, MD, USA, Sigma in Delhi India, and the University of Cape Town in South Africa.

Consent for publication

All others approved the final publication.

Competing interests

The authors declare that they have no competing interests.

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Figures

Fig. 1

Theory of change for assessing the impact of Kilkari

Fig. 2

Overview of enrolment and study design over time

Fig. 3

Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Checklist