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Table 1 Mixed methods evaluation strategy, sample, goal, data collection timing, and analysis

From: Study protocol: a cluster randomized trial to evaluate the effectiveness and implementation of onsite GeneXpert testing at community health centers in Uganda (XPEL-TB)

StrategySampleGoalData collectionAnalysis
Process metricsAll patients referred for TB diagnostic evaluation at intervention sitesExamine variability in adoption of and fidelity to intervention components across sitesEntire post-randomization periodMultivariate regression models
Surveys1) Health workers involved in TB evaluation at all sites*
2) Sixty patients per site (20 patients/site, 400 total pre-randomization; 40 patients/site, 800 total post-randomization)**
Examine whether the XPEL TB strategy modifies targeted barriers to TB diagnostic evaluationOnce before and once after trial is completedMultivariate regression models
Focus groupsHealth workers involved in TB evaluation at intervention sites*Assess acceptability of each component of the intervention strategy.After trial is completedThematic interpretation
In-depth interviewsPurposive: 20–30 health workers at high- and low-performing intervention strategy sites (2–3/site)Understand reasons for variability in adoption and implementation of the XPEL TB strategyAfter trial is completedThematic interpretation
  1. *Based on prior experience, we anticipate 5–10 staff members will be involved in TB diagnostic services at each health center (50–100 each at intervention and control health centers)
  2. **Patients will be selected randomly within strata based on gender and timing of health center visit (undergoing TB testing vs. completed testing/initiating TB treatment)