Study Protocol for a type 2 hybrid effectiveness-implementation evaluation of a multisite community-based participatory project to achieve full childhood immunization coverage in Mozambique and Malawi (Let’s talk about vaccines project)

Abstract

Background Full coverage of childhood vaccines is a persistent challenge in low- and middle-income countries, with the emergence of the COVID-19 pandemic further worsening the situation. The complementary use of community-based participatory research (CBPR) and human-centered design (HCD) approaches has the potential to effectively create tailored solutions (interventions) to improve public health outcomes. The Let’s talk about vaccines! project is a multisite community-based participatory project by VillageReach which uses the human- centered design approach to identify the barriers and co-create solutions to address under- two routine immunization access and uptake in Malawi and Mozambique. There are a few examples of evaluations of interventions created through human-centered design. This manuscript outlines a study protocol describing the evaluation of VillageReach’s participatory solution development and solution implementation (intervention-Let’s talk about vaccines Project). Methods Guided by the RE-AIM (Reach Effectiveness Adoption Implementation Maintenance) framework, this three-year evaluation adopts an effectiveness-implementation type 2 hybrid approach that prospectively evaluates the effectiveness (on under-two immunization coverage) of VillageReach’s intervention and processes of implementation (reach, adoption, implementation and maintenance) in two districts in Mozambique and two in Malawi. This paper will also describe the theory of change for VillageReach’s intervention. Thematic analysis will be used to analyze the qualitative data, and interrupted time series analysis used to analyze the intervention’s effectiveness on specific under-two immunization outcomes. Complex systems thinking with consideration of constructs inherent in health systems strengthening will be applied in the overall analysis. Findings will inform the development of a comprehensive framework to guide scalability of community-based approaches on childhood immunization uptake and access into similar contexts. Discussion This study is among the few studies to evaluate a public health intervention (solution) created through CBPR and HCD. This protocol provides examples of methods to evaluate the use of these novel approaches in low- and middle-income countries. The evaluation will be fundamental in providing evidence of the solution impact as well as informing scalability of the solution(s) to similar contexts. It will also contribute to the evidence base on mechanisms that explain observed improvements in under- two immunization outcomes as a result of codesigned community-driven solutions.