Evaluating the sustainability, scalability, and replicability of an STH transmission interruption intervention: The DeWorm3 implementation science protocol

Hybrid trials that include both clinical and implementation science outcomes are increasingly relevant for public health researchers that aim to rapidly translate study findings into evidence-based practice. The DeWorm3 Project is a series of hybrid trials testing the feasibility of interrupting the transmission of soil transmitted helminths (STH), while conducting implementation science research that contextualizes clinical research findings and provides guidance on opportunities to optimize delivery of STH interventions. The purpose of DeWorm3 implementation science studies is to ensure rapid and efficient translation of evidence into practice. DeWorm3 will use stakeholder mapping to identify individuals who influence or are influenced by school-based or community-wide mass drug administration (MDA) for STH and to evaluate network dynamics that may affect study outcomes and future policy development. Individual interviews and focus groups will generate the qualitative data needed to identify factors that shape, contextualize, and explain DeWorm3 trial outputs and outcomes. Structural readiness surveys will be used to evaluate the factors that drive health system readiness to implement novel interventions, such as community-wide MDA for STH, in order to target change management activities and identify opportunities for sustaining or scaling the intervention. Process mapping will be used to understand what aspects of the intervention are adaptable across heterogeneous implementation settings and to identify contextually-relevant modifiable bottlenecks that may be addressed to improve the intervention delivery process and to achieve intervention outputs. Lastly, intervention costs and incremental cost-effectiveness will be evaluated to compare the efficiency of community-wide MDA to standard-of-care targeted MDA both over the duration of the trial and over a longer elimination time horizon.Author summary: The DeWorm3 Project is a series of randomized clinical trials testing the feasibility of interrupting the transmission of soil-transmitted helminths. We have integrated implementation science research questions into the trials in order to optimize delivery of trial interventions as well as to speed the translation of study evidence into relevant policy and practice. DeWorm3 implementation science research will take place at baseline (formative research), midline (process research), and endline (summative research). DeWorm3 will use stakeholder mapping and network analysis, qualitative data collection via individual interviews and focus groups, structural readiness surveys, process mapping, and economic evaluation methods to assess opportunities to maximize intervention effectiveness, evaluate the efficiency of the intervention relative to the standard-of-care, and identify strategies for sustaining, scaling, and replicating effective components of trial interventions. The implementation science research described in this protocol will be helpful to policy makers and program implementers who aim to use DeWorm3 findings to inform guidelines and routine programmatic activities. The DeWorm3 implementation science protocol is also relevant to researchers interested in incorporating implementation hypotheses into their own clinical research studies.