Tuberculosis
Conditions
Interventions
Standard of care
Intervention
Sponsors
University of California San Francisco
Makerere University College of Health Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. (Site-level) Use standard (multi-day) sputum smear microscopy as the primary method of TB diagnosis 2. (Site-level) Participate in NTP-sponsored external quality assurance (EQA) for sputum smear microscopy 3. (Site-level) Send samples to a district or regional hospital/health center for Xpert testing 4. (Patient-level) Initiate evaluation for active TB at a study health center
Exclusion criteria
Exclusion criteria: 1. (Site-level) Do not agree to be randomized to standard-of-care vs. intervention arms 2. (Site-level) Perform sputum smear examination on <150 patients per year (based on 2015 data) 3. (Site-level) Diagnose <15 smear-positive TB cases per year (based on 2015 data) 4. (Patient-level) Have sputum collected for monitoring of response to anti-TB therapy 5. (Patient-level) Have sputum collected as part of active, community-based case finding (e.g., contact tracing, community outreach campaign) 6. (Patient-level) Referred to a study health center for TB treatment after a diagnosis is established elsewhere 7. (Patient-level) Started on TB treatment for extra-pulmonary TB only
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number treated for microbiologically-confirmed TB within two weeks of referral for sputum-based TB testing ;Proportion treated for microbiologically-confirmed TB within two weeks of initial sputum submission | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion completing testing;Proportion completing testing;Number diagnosed with microbiologically-confirmed TB;Proportion diagnosed with microbiologically-confirmed TB;Number diagnosed with RIF-resistant TB;Proportion diagnosed with RIF-resistant TB;Time to microbiologically-confirmed TB;Number treated for TB;Proportion treated for TB;Number treated for microbiologically-confirmed TB;Proportion treated for microbiologically-confirmed TB;Proportion with microbiologically-confirmed TB treated;Time to treatment of microbiologically-confirmed TB;Number with microbiologically-confirmed TB completing treatment;Proportion with microbiologically-confirmed TB completing treatment;Number who died within 6 months ;Proportion who died within 6 months;Patient costs (total costs, direct costs, indirect costs);Patient satisfaction with care survey (general satisfaction with care, convenience of services, health facility environment, provider interpersonal skills, provider technical competence);Provider survey (intention, attitudes/beliefs, social norms/expectations, self-efficacy/behavioral control);Intervention arm process metrics;Variation in and barriers to intervention strategy uptake;Incremental cost per DALY averted;Incremental health system cost per DALY averted;Incremental patient cost per DALY averted;Projected reduction in TB incidence over 10 years;Projected reduction in TB mortality over 10 years;Proportion completing testing;Proportion completing testing;Number diagnosed with microbiologically-confirmed TB;Proportion diagnosed with microbiologically-confirmed TB;Number diagnosed with RIF-resistant TB;Proportion diagnosed with RIF-resistant TB;Time to microbiologically-confirmed TB;Number treated for TB;Proportion treated for TB;Number treated for microbiologically-confirmed TB;Proportion treated for microbiologically-confirmed TB;Proportion with microbiologically-confirmed TB treated;Time to treatment of microbiologically-confirmed TB;Number with microbiologically-c | — |
Countries
Uganda
Contacts
Public ContactKatherine Farr
Research Associate
Outcome results
None listed