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The PROCESS study: a protocol to evaluate the implementation, mechanisms of effect and context of an intervention to enhance public health centres in Tororo, Uganda

Journal

Implementation Science

Category: Publications

Author: Clare IR Chandler, Deborah DiLiberto, Susan Nayiga, Lilian Taaka, Christine Nabirye, Miriam Kayendeke, Eleanor Hutchinson, James Kizito, Catherine Maiteki-Sebuguzi, Moses R Kamya and Sarah G Staedke

Published Date: 30 September 2013

Summary

Background: Despite significant investments into health improvement programmes in Uganda, health indicatorsand access to healthcare remain poor across the country. The PRIME trial aims to evaluate the impact of a complexintervention delivered in public health centres on health outcomes of children and management of malaria in ruralUganda. The intervention consists of four components: Health Centre Management; Fever Case Management;Patient- Centered Services; and support for supplies of malaria diagnostics and antimalarial drugs.

Methods: The PROCESS study will use mixed methods to evaluate the processes, mechanisms of change, andcontext of the PRIME intervention by addressing five objectives. First, to develop a comprehensive logic modelof the intervention, articulating the project’s hypothesised pathways to trial outcomes. Second, to evaluate theimplementation of the intervention, including health worker training, health centre management tools, andthe supply of artemether-lumefantrine (AL) and rapid diagnostic tests (RDTs) for malaria. Third, to understandmechanisms of change of the intervention components, including testing hypotheses and interpreting realitiesof the intervention, including resistance, in context. Fourth, to develop a contextual record over time of factorsthat may have affected implementation of the intervention, mechanisms of change, and trial outcomes, includingfactors at population, health centre and district levels. Fifth, to capture broader expected and unexpected impactsof the intervention and trial activities among community members, health centre workers, and private providers.Methods will include intervention logic mapping, questionnaires, recorded consultations, in-depth interviews, focusgroup discussions, and contextual data documentation.

Discussion: The findings of this PROCESS study will be interpreted alongside the PRIME trial results. This will enablea greater ability to generalise the findings of the main trial. The investigators will attempt to assess which methodsare most informative in such evaluations of complex interventions in low-resource settings.

Trial registration: Clinicaltrials.gov, NCT01024426

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