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XPEL-TB: GeneXpert Performance Evaluation for Linkage to Tuberculosis Care

Sponsor
University of California, San Francisco (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03044158
Collaborator
Makerere University (Other), Johns Hopkins Bloomberg School of Public Health (Other), London School of Hygiene and Tropical Medicine (Other), Yale University (Other), National Heart, Lung, and Blood Institute (NHLBI) (NIH)
10,644
Enrollment
20
Locations
2
Arms
47.3
Anticipated Duration (Months)
532.2
Patients Per Site
11.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: GeneXpert I
  • Behavioral: Process re-design
  • Other: Performance Feedback
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
10644 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
GeneXpert Performance Evaluation for Linkage to Tuberculosis Care: The XPEL-TB Trial
Actual Study Start Date :
Oct 22, 2018
Actual Primary Completion Date :
Mar 31, 2020
Anticipated Study Completion Date :
Sep 30, 2022

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control group

Onsite ZN or LED fluorescence microscopy + hub-based GeneXpert testing per existing protocols
Experimental: Intervention

Onsite molecular testing for TB with GeneXpert I + process redesign to facilitate same-day TB diagnosis and treatment + performance feedback

Device: GeneXpert I
Onsite molecular testing with GeneXpert I as a replacement for microscopy
Other Names:
  • GeneXpert

    • Behavioral: Process re-design
    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.

    Other: Performance Feedback
    Feedback of TB diagnostic evaluation quality indicators to health center staff

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Number referred for TB testing [Within 2 weeks of initial sputum submission]

      Effectiveness outcome.

    2. Number diagnosed with microbiologically-confirmed TB [Within 2 weeks of initial sputum submission]

      Effectiveness outcome.

    3. Number suspected/diagnosed with RIF-resistant TB [Within 2 weeks of initial sputum submission]

      Effectiveness outcome.

    4. 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.

    5. Number treated for TB [Within 2 weeks of initial sputum submission]

      Effectiveness outcome.

    6. Number of patients enrolled [Within 2 weeks of initial sputum submission]

      Effectiveness outcome.

    7. Number diagnosed and treated for microbiologically-confirmed TB [Within 2 weeks of initial sputum submission]

      Effectiveness outcome.

    8. 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.

    9. Number diagnosed AND completing treatment [Days from initial health center visit to treatment outcome, up to 2 years.]

      Effectiveness outcome.

    10. Number who died within 6 months [Days from initial health center visit to treatment outcome, up to 6 months.]

      Effectiveness outcome.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • 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

    Exclusion Criteria:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St Francis Njeru Health Center III Buikwe Uganda
    2 Busana Health Center III Busana Uganda
    3 Busesa Health Center IV Busesa Uganda
    4 Buwama Health Center III Buwama Uganda
    5 Iganga TC Iganga Uganda
    6 Bukulula Health Center IV Kalungu Uganda
    7 Nazigo Health Center III Kayunga Uganda
    8 Kiganda Health Center IV Kiganda Uganda
    9 Kira Health Center III Kira Uganda
    10 Lugasa Health Center III Lugala Uganda
    11 Bishop Asili Health Center Luwero Uganda
    12 Kinoni Health Center III Lwengo Uganda
    13 Kityerera Health Center IV Mayuge Uganda
    14 Malongo Health Center III Mayuge Uganda
    15 Mayuge Health Center III Mayuge Uganda
    16 Wabulungu Health Center III Mayuge Uganda
    17 Malangala Health Center III Mityana Uganda
    18 Lwampanga Health Center III Nakasongola Uganda
    19 Namungalwe Health Center III Namungalwe Uganda
    20 Nankandulo Health Center IV Nankandulo Uganda

    Sponsors and Collaborators

    • University of California, San Francisco
    • Makerere University
    • Johns Hopkins Bloomberg School of Public Health
    • London School of Hygiene and Tropical Medicine
    • Yale University
    • National Heart, Lung, and Blood Institute (NHLBI)

    Investigators

    • Principal Investigator: Adithya Cattamanchi, MD, University of California, San Francisco

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of California, San Francisco
    ClinicalTrials.gov Identifier:
    NCT03044158
    Other Study ID Numbers:
    • R01HL130192
    • PACTR201610001763265
    • R01HL130192
    First Posted:
    Feb 6, 2017
    Last Update Posted:
    Jul 22, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of California, San Francisco
    tuberculosis
    implementation science
    point-of-care
    diagnostics
    GeneXpert
    Uganda
    Additional relevant MeSH terms:
    Tuberculosis
    Tuberculosis, Pulmonary

    Study Results

    No Results Posted as of Jul 22, 2022