Abstract

BackgroundIn resource-poor settings, lack of awareness and low demand for services constitute important barriers to expanding the coverage of effective interventions. In India, childhood immunization is a priority health strategy with suboptimal uptake.ObjectiveTo assess study feasibility and key implementation outcomes for the Tika Vaani model, a new approach to educate and empower beneficiaries to improve immunization and child health.MethodsA cluster-randomized pilot trial with a 1:1 allocation ratio was conducted in rural Uttar Pradesh, India, from January to September 2018. Villages were randomly assigned to either the intervention or control group. In each participating village, surveyors conducted a complete enumeration to identify eligible households and requested participation before randomization. Interventions were designed through formative research using a social marketing approach and delivered over 3 months using strategies adapted to disadvantaged populations: (1) mobile health (mHealth): entertaining educational audio capsules (edutainment) and voice immunization reminders via mobile phone and (2) face-to-face: community mobilization activities, including 3 small group meetings offered to each participant. The control group received usual services. The main outcomes were prespecified criteria for feasibility of the main study (recruitment, randomization, retention, contamination, and adoption). Secondary endpoints tested equity of coverage and changes in intermediate outcomes. Statistical methods included descriptive statistics to assess feasibility, penalized logistic regression and ordered logistic regression to assess coverage, and generalized estimating equation models to assess changes in intermediate outcomes.ResultsAll villages consented to participate. Gaps in administrative data hampered recruitment; 14.0% (79/565) of recorded households were nonresident. Only 1.4% (8/565) of households did not consent. A total of 387 households (184 intervention and 203 control) with children aged 0 to 12 months in 26 villages (13 intervention and 13 control) were included and randomized. The end line survey occurred during the flood season; 17.6% (68/387) of the households were absent. Contamination was less than 1%. Participation in one or more interventions was 94.0% (173/184), 78.3% (144/184) for the face-to-face strategy, and 67.4% (124/184) for the mHealth strategy. Determinants including place of residence, mobile phone access, education, and female empowerment shaped intervention use; factors operated differently for face-to-face and mHealth strategies. For 11 of 13 intermediate outcomes, regression results showed significantly higher basic health knowledge among the intervention group, supporting hypothesized causal mechanisms.ConclusionsA future trial of a new intervention model is feasible. The interventions could strengthen the delivery of immunization and universal primary health care. Social and behavior change communication via mobile phones proved viable and contributed to standardization and scalability. Face-to-face interactions remain necessary to achieve equity and reach, suggesting the need for ongoing health system strengthening to accompany the introduction of communication technologies.Trial RegistrationInternational Standard Randomized Controlled Trial Number (ISRCTN) 44840759; https://doi.org/10.1186/ISRCTN44840759

Highlights

  • Background and RationaleExpanding coverage of effective interventions is a critical challenge for many low- and middle-income countries (LMICs)

  • A cluster design was chosen owing to the nature of the study interventions: face-to-face interventions are structured around communities rather than individuals, whereas mobile health (mHealth) interventions have a possibility of contamination

  • We originally sought to register the trial in the Clinical Trials Registry–India (CTRI), which is free of charge and has as the mission to enroll all clinical trials conducted in India

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Summary

Introduction

Background and RationaleExpanding coverage of effective interventions is a critical challenge for many low- and middle-income countries (LMICs). The immunization platform can potentially be used to strengthen the delivery of universal primary health care, universal health coverage, and meet other SDG targets [1]. This approach may be salient in areas where vaccination delivery systems function reliably, but important gaps exist in the delivery of other health services. In these contexts, increasing immunization coverage offers a potential pathway to expand the range and reach of health services and to advance a holistic health agenda. In India, childhood immunization is a priority health strategy with suboptimal uptake

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