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Table 1 Descriptions of key activities by study phases (XPEL study example)

From: Costing the implementation of public health interventions in resource-limited settings: a conceptual framework

Classification of activities Research or knowledge generation costsa Programmatic costs Shared research/program costs
Design phase
 Central • Ministry of Health (MoH), provincial, and district level approvals for the research study
• Institutional Review Board approvals
• Development of study CRFs (clinical outcomes)
• Development of research database (RedCap* program)
• Development of study protocols
• International collaborator site visits and periodic study calls
• Central procurement of GeneXpert machines, related equipment (e.g., solar panels and external batteries), Xpert Ultra cartridges, and associated supplies
• Development of SOPs* for Xpert testing, troubleshooting and QA/QC manuals, and management of testing equipment
• Recruitment of study staff
• Focus group discussions
 Site-specific • Site visits for site selection
• Review of clinical and laboratory data
• N/A • Sensitization meetings at district health office and potential study sites
• Pilot studies conducted at select potential study sites
Initiation phase
 Central • Establish clinical and laboratory data monitoring (including National TB Reference Laboratory)
• Management of regulatory processes with MoH
• Development of data collection plans for health economics study
• International collaborator site visits and periodic study calls
• Development of plans and organization of site visit and training
• Stock management (medical and laboratory consumables and Xpert cartridges)
• Study database management (clinical and programmatic)
• Data quality checks
• Weekly study call (implementation issues, study data checks, etc.)
 Site-specific • Management of provincial, district level regulatory processes • Installation of solar panel and GeneXpert equipment (including GX Alert system)
• Distribution of Xpert cartridges and laboratory consumables
• Training of laboratory personnel and technical support for Xpert testing
• Site sensitization meetings (w/ routine clinic staff) at both intervention and control sites
• Initial participant enrolment
• Establishment of data collection and follow-up plans
• Interim adjustments in implementation plans (including addition or exclusion of sites)
• Recruitment of study contact persons at each site (for data monitoring and study logistics purposes)
Maintenance phase
 Central • Management and monitoring of study data
• International collaborator site visits and periodic study calls
• Data analyses and reporting
• Stock management (medical and laboratory consumables and Xpert cartridges)
• Site visit organizations and communications
• Study database management (clinical and programmatic)
• Central database data review and quality checks
• Weekly study call (implementation issues, study data checks, etc.)
• Central study team human resource management
 Site-specific • Site-specific data issue troubleshooting • Ongoing technical support and troubleshooting (for GeneXpert and Solar panel equipment)
• Distribution of Xpert cartridges and laboratory consumables
• Procurement and replacement of key equipment (if broken)
• QA/QC of Xpert testing
• Review of GX Alert data
• Periodic EQA and re-training for Xpert testing
• Quarterly site visit
• Participant enrolment
• Adjustments in site-specific operations
• Ongoing human resource management at study sites
• Data monitoring and quality checks
  1. aResearch or knowledge generation costs that would be required for programmatic implementation in other settings (for example, ongoing monitoring and evaluation) should be clearly delineated and considered as programmatic costs in most analyses
  2. SOP Standard operation procedure, QA Quality assurance, QC Quality control, EQA External quality control, GX Alert System software system to centrally report site-specific Xpert testing statistics, equipment and testing troubleshooting, and testing operations