GeneXpert Performance Evaluation for Linkage to Tuberculosis Care
- Conditions
- Rifampicin Resistant TuberculosisTuberculosis, Pulmonary
- Interventions
- Device: GeneXpert IBehavioral: Process re-designOther: Performance Feedback
- Registration Number
- NCT03044158
- Lead Sponsor
- University of California, San Francisco
- Brief Summary
The investigators' overall objective is to assess the effectiveness, implementation and costs of a streamlined TB diagnostic evaluation strategy based around rapid, onsite molecular testing. The intervention strategy was developed based on theory-informed assessment of barriers to TB diagnostic evaluation at community health centers in Uganda and a process of engagement with local stakeholders. It includes: 1) Point-of-care molecular testing using GeneXpert as a replacement for sputum smear microscopy; 2) Re-structuring of clinic-level procedures to facilitate same-day TB diagnosis and treatment; and 3) Quarterly feedback of TB evaluation metrics to health center staff. The investigators' central hypothesis is that the intervention strategy will have high uptake and increase the number of patients diagnosed with and treated for active pulmonary TB. To test this hypothesis, the investigators will conduct a pragmatic cluster-randomized trial at community health centers that provide TB microscopy services in Uganda in partnership with the National TB Program (NTP). The investigators utilize an effectiveness-implementation hybrid design in which, concurrent with the clinical trial, the investigators will conduct nested mixed methods, health economic and modeling studies to assess 1) whether the intervention strategy modifies targeted barriers to TB diagnostic evaluation; 2) fidelity of implementation of the intervention components (i.e, the degree to which intervention components were implemented as intended vs. adapted across sites); and 3) cost-effectiveness and public health impact.
- Detailed Description
Aim 1: To compare patient outcomes at health centers randomized to intervention vs. standard-of-care TB diagnostic evaluation strategies. The investigators will randomize 20 community health centers to continue standard TB evaluation (routine microscopy plus referral of patients for Xpert testing per existing processes of care) or to implement the intervention strategy (1. Onsite molecular testing; 2. Re-structuring clinic-level procedures to facilitate same-day TB diagnosis and treatment; and 3. Performance feedback). The investigators will compare reach and effectiveness based on the numbers and proportions of patients (N=5500) who complete TB testing, are found to have TB, and have treatment initiated within one week of specimen provision.
Aim 2: To identify processes and contextual factors that influence the effectiveness and fidelity of the intervention TB diagnostic evaluation strategy. The investigators will use quantitative process metrics to assess the adoption and maintenance over time of the core components of the intervention strategy. The investigators will also collect quantitative and qualitative data to describe the fidelity of implementation of each component and faithfulness to the conceptual model.
Aim 3: To compare the costs and epidemiological impact of intervention vs. standard-of-care TB diagnostic evaluation strategies. The investigators will model the incremental costs and cost-effectiveness of intervention relative to standard-of-care TB diagnostic evaluation from the health system and patient perspective. The investigators will then construct an epidemic model of the population-level impact of the intervention strategy on TB incidence and mortality.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10644
- Site-level: Use standard (multi-day) sputum smear microscopy as the primary method of TB diagnosis
- Site-level: Participate in NTP-sponsored external quality assurance (EQA) for sputum smear microscopy
- Site-level: Send samples to a district or regional hospital/health center for Xpert testing
- Patient-level: Initiate evaluation for active TB at a study health center
- Site-level: Do not agree to be randomized to standard-of-care vs. intervention arms
- Site-level: Perform sputum smear examination on <150 patients per year (based on 2015 data)
- Site-level: Diagnose <15 smear-positive TB cases per year (based on 2015 data)
- Patient-level: Have sputum collected for monitoring of response to anti-TB therapy
- Patient-level: Have sputum collected as part of active, community-based case finding (e.g., contact tracing, community outreach campaign)
- Patient-level: Referred to a study health center for TB treatment after a diagnosis is established elsewhere
- Patient-level: Started on TB treatment for extra-pulmonary TB only
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Performance Feedback Onsite molecular testing for TB with GeneXpert I + process redesign to facilitate same-day TB diagnosis and treatment + performance feedback Intervention Process re-design Onsite molecular testing for TB with GeneXpert I + process redesign to facilitate same-day TB diagnosis and treatment + performance feedback Intervention GeneXpert I Onsite molecular testing for TB with GeneXpert I + process redesign to facilitate same-day TB diagnosis and treatment + performance feedback
- Primary Outcome Measures
Name Time Method Number treated for microbiologically-confirmed TB within two weeks of referral for sputum-based testing Within 2 weeks of initial sputum submission Effectiveness outcome.
- Secondary Outcome Measures
Name Time Method Number diagnosed with microbiologically-confirmed TB Within 2 weeks of initial sputum submission Effectiveness outcome.
Number suspected/diagnosed with RIF-resistant TB Within 2 weeks of initial sputum submission Effectiveness outcome.
Time to microbiologically-confirmed TB Days from initial sputum submission to being diagnosed, up to 60 days. Effectiveness outcome. Time-to-diagnosis if microbiologically-confirmed TB.
Number diagnosed and treated for microbiologically-confirmed TB Within 2 weeks of initial sputum submission Effectiveness outcome.
Number diagnosed AND completing treatment Days from initial health center visit to treatment outcome, up to 2 years. Effectiveness outcome.
Number referred for TB testing Within 2 weeks of initial sputum submission Effectiveness outcome.
Number treated for TB Within 2 weeks of initial sputum submission Effectiveness outcome.
Number of patients enrolled Within 2 weeks of initial sputum submission Effectiveness outcome.
Time-to-treatment of microbiologically-confirmed TB Days from initial health center visit to initiation of treatment if diagnosed, up to 1 year. Effectiveness outcome. Time-to-treatment if microbiologically-confirmed TB and treated.
Number who died within 6 months Days from initial health center visit to treatment outcome, up to 6 months. Effectiveness outcome.
Trial Locations
- Locations (20)
Busesa Health Center IV
🇺🇬Busesa, Uganda
Kiganda Health Center IV
🇺🇬Kiganda, Uganda
Lugasa Health Center III
🇺🇬Lugala, Uganda
Mayuge Health Center III
🇺🇬Mayuge, Uganda
Busana Health Center III
🇺🇬Busana, Uganda
Kira Health Center III
🇺🇬Kira, Uganda
Namungalwe Health Center III
🇺🇬Namungalwe, Uganda
Buwama Health Center III
🇺🇬Buwama, Uganda
Iganga TC
🇺🇬Iganga, Uganda
Malongo Health Center III
🇺🇬Mayuge, Uganda
Wabulungu Health Center III
🇺🇬Mayuge, Uganda
Lwampanga Health Center III
🇺🇬Nakasongola, Uganda
Bukulula Health Center IV
🇺🇬Kalungu, Uganda
Bishop Asili Health Center
🇺🇬Luwero, Uganda
Malangala Health Center III
🇺🇬Mityana, Uganda
St Francis Njeru Health Center III
🇺🇬Buikwe, Uganda
Nazigo Health Center III
🇺🇬Kayunga, Uganda
Kinoni Health Center III
🇺🇬Lwengo, Uganda
Nankandulo Health Center IV
🇺🇬Nankandulo, Uganda
Kityerera Health Center IV
🇺🇬Mayuge, Uganda