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. Electronic supplementary material The online version of this article (10.1186/s13063-019-3369-5) contains supplementary material, which is available to authorized users.

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IntroductionAs part of an investment by the Bill & Melinda Gates Foundation to support the Government of Bihar to improve reproductive, maternal, newborn and child health and nutrition (RMNCHN) statewide, BBC Media Action implemented multiple communication tools to support front-line worker (FLW) outreach. We analyse the impacts of a package of mHealth audio messaging and paper-based job aids used by FLWs during government-sponsored village health, sanitation and nutrition days (VHSNDs) on knowledge and practices of childbearing women across the RMNCHN continuum of care.MethodsData from two surveys collected between July and September 2016 were analysed using logistic regression to compare health-related knowledge and behaviours between women who had been exposed at VHSNDs to the mHealth GupShup Potli (GSP) audio recordings or interpersonal communication (IPC) tools versus those who were unexposed.ResultsExposure to GSP recordings (n=2608) was associated with improved knowledge across all continuum-of-care domains, as well as improved health-related behaviours in some domains. The odds of having taken iron-folic acid (IFA) tablets were significantly higher in exposed women (OR 1.5, 95% CI 1.1 to 2.2), as was contraceptive use (OR 2.0, 95% CI 1.2 to 3.2). There were no differences in birth preparedness or complementary feeding practices between groups. Exposure to IPC paper-based tools (n=2002) was associated with a twofold increased odds of IFA consumption (OR 2.3, 95% CI 1.7 to 3.2) and contraceptive use (OR 1.8, 95% CI 1.2 to 2.8). Women exposed to both tools were generally at least twice as likely to subsequently discuss the messages with others.ConclusionBBC Media Action’s mHealth audio messaging job aids and paper-based IPC tools were associated with improved knowledge and practices of women who were exposed to them across multiple domains, suggesting their important potential for improving health outcomes for beneficiaries at scale in low-resource settings.Trial registration numberNCT02726230.

BackgroundDirect-to-beneficiary communication mobile programmes are among the few examples of digital health programmes to have scaled widely in low-resource settings. Yet, evidence on their impact at scale is limited. This study aims to assess whether exposure to mobile health information calls during pregnancy and postpartum improved infant feeding and family planning practices.MethodsWe conducted an individually randomised controlled trial in four districts of Madhya Pradesh, India. Study participants included Hindi speaking women 4–7 months pregnant (n=5095) with access to a mobile phone and their husbands (n=3842). Women were randomised to either an intervention group where they received up to 72 Kilkari messages or a control group where they received none. Intention-to-treat (ITT) and instrumental variable (IV) analyses are presented.ResultsAn average of 65% of the 2695 women randomised to receive Kilkari listened to ≥50% of the cumulative content of calls answered. Kilkari was not observed to have a significant impact on the primary outcome of exclusive breast feeding (ITT, relative risk (RR): 1.04, 95% CI 0.88 to 1.23, p=0.64; IV, RR: 1.10, 95% CI 0.67 to 1.81, p=0.71). Across study arms, Kilkari was associated with a 3.7% higher use of modern reversible contraceptives (RR: 1.12, 95% CI 1.03 to 1.21, p=0.007), and a 2.0% lower proportion of men or women sterilised since the birth of the child (RR: 0.85, 95% CI 0.74 to 0.97, p=0.016). Higher reversible method use was driven by increases in condom use and greatest among those women exposed to Kilkari with any male child (9.9% increase), in the poorest socioeconomic strata (15.8% increase), and in disadvantaged castes (12.0% increase). Immunisation at 10 weeks was higher among the children of Kilkari listeners (2.8% higher; RR: 1.03, 95% CI 1.00 to 1.06, p=0.048). Significant differences were not observed for other maternal, newborn and child health outcomes assessed.ConclusionStudy findings provide evidence to date on the effectiveness of the largest mobile health messaging programme in the world.Trial registration numberTrial registration clinicaltrials.gov; ID 90075552, NCT03576157.

There has been exponential growth in the numbers of ‘digital development’ programmes seeking to leverage technology to solve systemic challenges. However, despite promising results and a shift from pilots to scale-ups, many have failed to realise their full potential. This paper reflects on lessons learnt from scaling and transitioning one of the largest mobile health programmes in the world to the Indian government. The complementary suite of services was designed by BBC Media Action to strengthen families’ reproductive, maternal, neonatal and child health behaviours. Mobile Academy was a training course to refresh frontline health workers’ (FLHWs) knowledge and improve their interpersonal communication skills. Mobile Kunji was a job aid to support FLHWs’ interactions with families. Kilkari delivered weekly audio information to families’ phones to reinforce FLHWs’ counselling. As of April 2019, when Mobile Academy and Kilkari were transitioned to the government, 206 000 FLHWs had graduated and Kilkari had reached 10 million subscribers. Lessons learnt include the following: (1) private sector business models are challenging in low-resource settings; (2) you may pilot ‘apples’ but scale ‘oranges’; (3) trade-offs are required between ideal solution design and affordability; (4) programme components should be reassessed before scaling; (5) operational viability at scale is a prerequisite for sustainability; (6) consider the true cost of open-source software; (7) taking informed consent in low-resource settings is challenging; (8) big data offer promise, but social norms and SIM change constrain use; (9) successful government engagements require significant capacity; (10) define governance structures and roadmaps up front.