title: Theory-Driven Process Evaluation of the SHINE Trial Using a Program Impact Pathway Approach.
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.
authors.affiliation: Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe Division of Nutritional Sciences, Cornell University, Ithaca, New York Department of International Health, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
authors.forename: Mduduzi N N
authors.initials: MN
authors.lastname: Mbuya
authors.affiliation: School of Public Health, University of Michigan, Ann Arbor.
authors.forename: Andrew D
authors.initials: AD
authors.lastname: Jones
authors.affiliation: Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.
authors.forename: Robert
authors.initials: R
authors.lastname: Ntozini
authors.affiliation: Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe Department of International Health, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
authors.forename: Jean H
authors.initials: JH
authors.lastname: Humphrey
authors.affiliation: Department of International Health, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
authors.forename: Lawrence H
authors.initials: LH
authors.lastname: Moulton
authors.affiliation: Division of Nutritional Sciences, Cornell University, Ithaca, New York.
authors.forename: Rebecca J
authors.initials: RJ
authors.lastname: Stoltzfus
authors.affiliation: Department of Economics, Middlebury College, Vermont.
authors.forename: John A
authors.initials: JA
authors.lastname: Maluccio
mesh_terms: D000067576:Child Health; D005260:Female; D006801:Humans; D006920:Hygiene; D007223:Infant; D008297:Male; D015397:Program Evaluation; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D012424:Rural Population; D012499:Sanitation; D015030:Zimbabwe
keywords: intention to treat; per protocol; process evaluation; program impact pathway