Abstract
Two reasons for the lack of success of programs or interventions are poor alignment of interventions with the causes of the problem targeted by the intervention, leading to poor efficacy (theory failure), and failure to implement interventions as designed (program failure). These failures are important for both public health programs and randomized trials. In the Sanitation Hygiene and Infant Nutrition Efficacy (SHINE) Trial, we utilize the program impact pathway (PIP) approach to track intervention implementation and behavior uptake. In this article, we present the SHINE PIP including definitions and measurements of key mediating domains, and discuss the implications of this approach for randomized trials. Operationally, the PIP can be used for monitoring and strengthening intervention delivery, facilitating course-correction at various stages of implementation. Analytically, the PIP can facilitate a richer understanding of the mediating and modifying determinants of intervention impact than would be possible from an intention-to-treat analysis alone.
Highlights
The emergence of implementation science over the past decade has advanced understanding of the many possible impediments to delivery and utilization that can limit the potential impacts of proven health and nutrition interventions [1,2,3]
One area in which its added value is most apparent is through embedding theorydriven process evaluation directly into evaluation studies, including randomized trials [4, 5]. This typically entails conceptually articulating how an intervention has been designed to work and elucidating and measuring intermediate outcomes that need to be achieved for it to work as intended [6,7,8]. Such theorydriven approaches can provide generalizable knowledge aMembers of the SHINE Trial Team are shown in SHINE Trial Team, “The Sanitation Hygiene Infant Nutrition Efficacy (SHINE) trial: rationale, design, and methods,” Clin Infect Dis 2015; 61(suppl 7):S685–702
Consistent with the linkages laid out in the a priori program theory and strengthening the plausibility of the results, the authors demonstrated that better health center implementation of the intervention positively influenced caregiver exposure, which was in turn positively associated with caregiver message recall, which was in turn positively associated with key feeding behaviors [22]
Summary
The emergence of implementation science over the past decade has advanced understanding of the many possible impediments to delivery and utilization that can limit the potential impacts of proven health and nutrition interventions [1,2,3]. One area in which its added value is most apparent is through embedding theorydriven process evaluation directly into evaluation studies, including randomized trials [4, 5] This typically entails conceptually articulating how an intervention has been designed to work (ie, the program theory) and elucidating and measuring intermediate outcomes that need to be achieved for it to work as intended [6,7,8]. A theory-driven process evaluation confirmed that there were no differences in visits, deliveries of the study foods, message recall, or rates of consumption of study foods between the treatment groups [25] This process evaluation, and high fidelity of implementation observed, increased confidence that the trial’s null finding was not due to differences or inconsistencies in protocol implementation. The SHINE Trial is acomplex intervention within a complex system [27,28,29].Evaluating and understanding the impact of such an intervention is challenging because the pathways to impact are multiple and subject to effect modification [8]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
