Impact evaluation of a community engagement intervention in improving childhood immunization coverage: a cluster randomized controlled trial in Assam, India

Abstract

BackgroundTo improve immunization coverage, most interventions that are part of the national immunization program in India address supply-side challenges. But, there is growing evidence that addressing demand-side factors can potentially contribute to improvement in childhood vaccination coverage in low- and middle-income countries. Participatory engagement of communities can address demand-side barriers while also mobilizing the community to advocate for better service delivery. The objective of this study is to evaluate the impact of a novel community engagement approach in improving immunization coverage. In our proposed intervention, we go a step beyond merely engaging the community and strive towards increasing ‘ownership’ by the communities.Methods/DesignWe adopt a cluster randomized design with two groups to evaluate the intervention in Assam, a state in the northeast region of India. To recruit villages and participants at baseline, we used a two-stage stratified random sampling method. We stratified villages; our unit of randomization, based on census data and randomly selected villages from each of the four strata. At the second-stage, we selected random sub-sample of eligible households (having children in the age group of 6–23 months) from each selected village. The study uses a repeated cross sectional design where we track the same sampled villages but draw independent random samples of households at baseline and endline. Total number of villages required for the study is 180 with 15 eligible HHs from each village. Post-baseline survey, we adopt a stratified randomization strategy to achieve better balance in intervention and control groups, leveraging information from the extensive baseline survey.DiscussionThe proposed intervention can help identify barriers to vaccination at the local level and potentially lead to more sustainable solutions over the long term. Our sampling design, sample size calculation, and randomization strategy address internal validity of our evaluation design. We believe that it would allow us to causally relate any observed changes in immunization coverage to the intervention.Trial registrationThe trial has been registered on 7th February, 2017 under the Clinical Trials Registry- India (CTRI), hosted at the ICMR’s National Institute of Medical Statistics, having registration number CTRI/2017/02/007792. This is the original study protocol.

A qualitative analysis of vaccine decision-makers’ conceptualization and fostering of ‘community engagement’ in India

“…Correspondingly, community engagement (CE) for vaccinations is increasingly been recognized and proposed by decisionmakers [4] as a core component of working toward health equity, with a focus on community-based participatory research [5][6][7]. CE is lauded for its methodological gains in translating research ndings [8] and fostering positive perceptions of vaccines and immunization-related interventions [9], while decreasing the likelihood of therapeutic misconception [10]. Also, CE is recognized for its assertion that research and interventions with people and without their inputs is unethical [11].…”

Indian vaccine decision-makers’ conceptualization and fostering of ‘community engagement’: A qualitative analysis of elite interviews

“…This study included nation-level vaccine decision-makers who were policy-makers, program heads and/or associates in the government, private sector, non-governmental organizations, and country-o ces of international donor and UN agencies -because by virtue of their knowledge and position they could give a big-picture perspective [18] about CE strategizing and implementation during the Decade of Vaccines (2010-2020). In keeping with the assumptions and beliefs of social phenomenology, a two-step participatory approach for data collection was used: (1) semi-structured 'elite interviews' followed by (2) member check-in meeting [19].…”

“…Community engagement (CE) is increasingly recognized by public health decision-makers for its assertion that research and interventions with people without their input is unethical, and for its methodological gains in invigorating translation of research ndings [1] and fostering positive public perceptions of public health interventions [2], while decreasing the likelihood of therapeutic misconception [3]. Some scholars have referred to this political will to embed CE in biomedical policies and programs as 'governmentalization of CE' [4].…”

A qualitative analysis of vaccine decision makers’ conceptualization and fostering of ‘community engagement’ in India

“…Correspondingly, community engagement (CE) for vaccinations has increasingly been recognized by decision makers [ 4 ] as a core component of working toward health equity, with a focus on community-based participatory research [ 5 – 7 ]. CE has been lauded for its facilitation of research translation [ 8 ] and for fostering positive perceptions of vaccines and immunization-related interventions [ 9 ], while decreasing the likelihood of therapeutic misconception [ 10 ]. CE also has been recognized for its assertion that research and interventions with people but without their input is unethical [ 11 ].…”