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

Abstract

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 summaryThe 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 DeW...

The Geshiyaro Project: a study protocol for developing a scalable model of interventions for moving towards the interruption of the transmission of soil-transmitted helminths and schistosome infections in the Wolaita zone of Ethiopia

“…These include a safe water supply, appropriately constructed and maintained sanitation infrastructure that ensures safe disposal of human excreta, the promotion of hygiene such as handwashing plus bathing, and the management of water in the home. Studies have shown that the provision of additional interventions should allow the suppression of the prevalence of STH and schistosomiasis infection to very low levels, achieved through MDA, to be sustained once transmission has deemed to be broken in defined settings such that MDA can cease in these settings [49–51]. The Geshiyaro Project is the first large-scale project, addressing a zone of 1.9 million inhabitants, to provide WaSH facilities combined with MDA within different study arms which permits, in principle, the assessment of the relative benefits of MDA targeted at the whole community, whole community MDA plus WaSH, and MDA targeted at SAC.…”

Targeting a highly repeated germline DNA sequence for improved real-time PCR-based detection of Ascaris infection in human stool

“…lumbricoides and the other STH infections. Such awareness has resulted in the expansion of infection and risk mapping efforts [4–9] and operational research studies intended to improve, expand, and more fully understand the impacts associated with interventions [10–15]. Similarly, due to exponential improvements in approaches to mathematical modelling, the roles played by these valuable tools for shaping and informing the STH programmatic decision making process continue to increase [5–6, 16–18].…”

Integrating Lean Thinking and Implementation Science Determinants Checklists for Quality Improvement: A Scoping Review

“…Two articles consisted of research protocols that had not yet reported on findings, and therefore, some of the items in the RATS tool could not be applied to assess the quality of these articles. 15,16 Additionally, 1 article 17 is a conference proceeding and 1 article 18 is an executive summary instead of a journal publication and therefore yielded a lower quality score based on the RATS assessment tool. Studies were assessed for quality independently by 2 researchers (TS and GDB), and any disagreements were resolved through discussion during an in-person meeting.…”

“…Of those 8 studies, 6 were reports of research study results [17][18][19][20][21][22] and 2 were protocols for studies. 15,16 Two publications were from the same study, 19,20 leaving 7 distinct studies included.…”

“…All the included studies were published after 2013; 5 were conducted in the United States, [17][18][19][20]22 2 took place in Africa, 15,21 and 1 in Asia. 16 Table 1 provides an overview of the 8 studies and their inclusion of various lean thinking tools and implementation science determinants frameworks or checklists. All included studies used CFIR, or a modified version, 23 as the implementation science determinants checklist.…”