Behind the scenes of the PRIME intervention: designing a complex intervention to improve malaria care at public health centres in Uganda.
BACKGROUND
In Uganda, health system challenges limit access to good quality healthcare and contribute to slow progress on malaria control. We developed a complex intervention (PRIME), which was designed to improve quality of care for malaria at public health centres.


OBJECTIVE
Responding to calls for increased transparency, we describe the PRIME intervention's design process, rationale, and final content and reflect on the choices and challenges encountered during the design of this complex intervention.


METHODS
To develop the intervention, we followed a multistep approach, including the following: 1) formative research to identify intervention target areas and objectives; 2) prioritization of intervention components; 3) review of relevant evidence; 4) development of intervention components; 5) piloting and refinement of workshop modules; and 6) consolidation of the PRIME intervention theories of change to articulate why and how the intervention was hypothesized to produce desired outcomes. We aimed to develop an intervention that was evidence-based, grounded in theory, and appropriate for the study context; could be evaluated within a randomized controlled trial; and had the potential to be scaled up sustainably.


RESULTS
The process of developing the PRIME intervention package was lengthy and dynamic. The final intervention package consisted of four components: 1) training in fever case management and use of rapid diagnostic tests for malaria (mRDTs); 2) workshops in health centre management; 3) workshops in patient-centred services; and 4) provision of mRDTs and antimalarials when stocks ran low.


CONCLUSIONS
The slow and iterative process of intervention design contrasted with the continually shifting study context. We highlight the considerations and choices made at each design stage, discussing elements we included and why, as well as those that were ultimately excluded. Reflection on and reporting of 'behind the scenes' accounts of intervention design may improve the design, assessment, and generalizability of complex interventions and their evaluations.
Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK; deborah.diliberto@lshtm.ac.uk.
Deborah D
DD
DiLiberto
Department of Clinical Research, London School of Hygiene & Tropical Medicine, London, UK.|Infectious Diseases Research Collaboration, Kampala, Uganda.
Sarah G
SG
Staedke
Infectious Diseases Research Collaboration, Kampala, Uganda.
Florence
F
Nankya
Infectious Diseases Research Collaboration, Kampala, Uganda.
Catherine
C
Maiteki-Sebuguzi
Infectious Diseases Research Collaboration, Kampala, Uganda.
Lilian
L
Taaka
Infectious Diseases Research Collaboration, Kampala, Uganda.
Susan
S
Nayiga
Infectious Diseases Research Collaboration, Kampala, Uganda.|School of Medicine, Makerere University College of Health Sciences, Kampala, Uganda.
Moses R
MR
Kamya
Institute of Health and Society, University of Oslo, Oslo, Norway.
Ane
A
Haaland
Department of Global Health & Development, London School of Hygiene & Tropical Medicine, London, UK.
Clare I R
CI
Chandler
D003153:Community Health Services / Q000458:organization & administration* / Q000592:standards; D006288:Health Planning Organizations / Q000458:organization & administration*; D006297:Health Services Accessibility / Q000458:organization & administration; D006801:Humans; D007318:Inservice Training / Q000379:methods; D008288:Malaria / Q000175:diagnosis / Q000188:drug therapy / Q000628:therapy*; D018802:Patient-Centered Care; D011634:Public Health; D058996:Quality Improvement / Q000458:organization & administration*; D014454:Uganda
complex intervention; health centre management; health worker; intervention design; malaria; patient-centred services; quality of care; rapid diagnostic tests; theory of change; training