GeneXpert Performance Evaluation for Linkage to Tuberculosis Care
Condition: Tuberculosis, Pulmonary; Rifampicin Resistant Tuberculosis
MeSH terms: Tuberculosis; Tuberculosis, Pulmonary
Study type: Interventional

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.
    

Intervention name(s): GeneXpert I; Process re-design; Performance Feedback
Intervention type(s): Device; Behavioral; Other
Intervention description(s): Onsite molecular testing with GeneXpert I as a replacement for microscopy; Research and Uganda NTLP staff will engage health center staff in a discussion of how to re-organize clinical, laboratory and pharmacy services to enable same-day TB diagnosis and treatment.; Feedback of TB diagnostic evaluation quality indicators to health center staff
Other intervention name(s): GeneXpert
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: tuberculosis; implementation science; point-of-care; diagnostics; GeneXpert; Uganda