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