Theory-Driven Process Evaluation of the SHINE Trial Using a Program Impact Pathway Approach

Mduduzi N N Mbuya, Andrew D Jones, Robert Ntozini, Jean H Humphrey, Lawrence H Moulton, Rebecca J Stoltzfus, John A Maluccio, Sanitation Hygiene Infant Nutrition Efficacy (SHINE) Trial Team, Mduduzi N N Mbuya, Andrew D Jones, Robert Ntozini, Jean H Humphrey, Lawrence H Moulton, Rebecca J Stoltzfus, John A Maluccio, Sanitation Hygiene Infant Nutrition Efficacy (SHINE) Trial Team

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.

Keywords: intention to treat; per protocol; process evaluation; program impact pathway.

© The Author 2015. Published by Oxford University Press for the Infectious Diseases Society of America.

Figures

Figure 1.
Figure 1.
Program impact pathway linking village health worker (VHW) treatment allocation with stunting and anemia outcomes. Boldface text denotes those constructs that differ in accordance with the randomized design.

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