GeneXpert Performance Evaluation for Linkage to Tuberculosis Care (XPEL-TB)

January 30, 2025 updated by: University of California, San Francisco

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10644

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uganda
      • Buikwe, Uganda
        • St Francis Njeru Health Center III
      • Busana, Uganda
        • Busana Health Center III
      • Busesa, Uganda
        • Busesa Health Center IV
      • Buwama, Uganda
        • Buwama Health Center III
      • Iganga, Uganda
        • Iganga TC
      • Kalungu, Uganda
        • Bukulula Health Center IV
      • Kayunga, Uganda
        • Nazigo Health Center III
      • Kiganda, Uganda
        • Kiganda Health Center IV
      • Kira, Uganda
        • Kira Health Center III
      • Lugala, Uganda
        • Lugasa Health Center III
      • Luwero, Uganda
        • Bishop Asili Health Center
      • Lwengo, Uganda
        • Kinoni Health Center III
      • Mayuge, Uganda
        • Kityerera Health Center IV
      • Mayuge, Uganda
        • Malongo Health Center III
      • Mayuge, Uganda
        • Mayuge Health Center III
      • Mayuge, Uganda
        • Wabulungu Health Center III
      • Mityana, Uganda
        • Malangala Health Center III
      • Nakasongola, Uganda
        • Lwampanga Health Center III
      • Namungalwe, Uganda
        • Namungalwe Health Center III
      • Nankandulo, Uganda
        • Nankandulo Health Center IV

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 96 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number Treated for Microbiologically-confirmed TB Within 14 Days After Presentation to the Health Center for TB Evaluation
Time Frame: Within 14 days after presentation to the health center for tuberculosis evaluation
Effectiveness outcome.
Within 14 days after presentation to the health center for tuberculosis evaluation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number Diagnosed With Microbiologically-confirmed TB
Time Frame: Within 14 days after presentation to the health center for tuberculosis evaluation
Effectiveness outcome.
Within 14 days after presentation to the health center for tuberculosis evaluation
Time to Microbiologically-confirmed TB
Time Frame: Within 6 months of presentation to the health center for tuberculosis evaluation
Effectiveness outcome. Time-to-diagnosis if microbiologically-confirmed TB.
Within 6 months of presentation to the health center for tuberculosis evaluation
Number Treated for TB
Time Frame: Within 14 days of presentation to the health center for tuberculosis evaluation
Effectiveness outcome.
Within 14 days of presentation to the health center for tuberculosis evaluation
Time-to-treatment of Microbiologically-confirmed TB
Time Frame: Days from initial health center visit to initiation of treatment if diagnosed, up to 6 months.
Effectiveness outcome. Time-to-treatment if microbiologically-confirmed TB and treated.
Days from initial health center visit to initiation of treatment if diagnosed, up to 6 months.
Number Who Died Within 6 Months
Time Frame: Within 6 months of presentation to the health center for tuberculosis evaluation
Effectiveness outcome.
Within 6 months of presentation to the health center for tuberculosis evaluation
Number of Patients Enrolled
Time Frame: Presentation to the health center for tuberculosis evaluation during the 16-month study time frame
Effectiveness outcome.
Presentation to the health center for tuberculosis evaluation during the 16-month study time frame
Number Tested for TB According to National Guidelines
Time Frame: Within 6 months of presentation to the health center for tuberculosis evaluation
Effectiveness outcome.
Within 6 months of presentation to the health center for tuberculosis evaluation
Number Suspected/Diagnosed With Rifampin-resistant TB
Time Frame: Within 6 months of presentation to the health center for tuberculosis evaluation
Effectiveness outcome.
Within 6 months of presentation to the health center for tuberculosis evaluation
Number Diagnosed and Treated for Microbiologically-confirmed TB
Time Frame: On the same-day of presentation to the health center for tuberculosis evaluation
Effectiveness outcome.
On the same-day of presentation to the health center for tuberculosis evaluation
Number Diagnosed AND Treated for TB
Time Frame: On the same-day of presentation to the health center for tuberculosis evaluation
Effectiveness outcome.
On the same-day of presentation to the health center for tuberculosis evaluation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

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

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2018

Primary Completion (Actual)

March 31, 2020

Study Completion (Actual)

July 31, 2022

Study Registration Dates

First Submitted

January 23, 2017

First Submitted That Met QC Criteria

February 2, 2017

First Posted (Estimated)

February 6, 2017

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 30, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01HL130192 (U.S. NIH Grant/Contract)
  • PACTR201610001763265 (Registry Identifier: Pan African Clinical Trials Registry)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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