Tuberculosis, PulmonaryXPEL-TBNCT03044158
GeneXpert Performance Evaluation for Linkage to Tuberculosis Care
A study testing GeneXpert I, Process re-design and Performance Feedback in people with Tuberculosis, Pulmonary and Rifampicin Resistant Tuberculosis, run by University of California, San Francisco at 20 sites in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis, Pulmonary, Rifampicin Resistant Tuberculosis
- What is being tested?
- GeneXpert I, Process re-design and Performance Feedback
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,644 participants
- Where
- 20 sitesUganda
- Study dates
- 22 Oct 2018to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Uganda20 sites
St Francis Njeru Health Center III
Buikwe
Busana Health Center III
Busana
Busesa Health Center IV
Busesa
Buwama Health Center III
Buwama
Iganga TC
Iganga
Bukulula Health Center IV
Kalungu
Nazigo Health Center III
Kayunga
Kiganda Health Center IV
Kiganda
Kira Health Center III
Kira
Lugasa Health Center III
Lugala
Bishop Asili Health Center
Luwero
Kinoni Health Center III
Lwengo
Kityerera Health Center IV
Mayuge
Malongo Health Center III
Mayuge
Mayuge Health Center III
Mayuge
Wabulungu Health Center III
Mayuge
Malangala Health Center III
Mityana
Lwampanga Health Center III
Nakasongola
Namungalwe Health Center III
Namungalwe
Nankandulo Health Center IV
Nankandulo
About this study
Official title: 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.
Read the 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.
- Being tested
- GeneXpert I, Process re-design, Performance Feedback
- Keywords
- tuberculosis, implementation science, point-of-care, diagnostics, GeneXpert, Uganda
- Medical subject headings
- Tuberculosis, Pulmonary, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GeneXpert IDevice
Also called GeneXpert
Onsite molecular testing with GeneXpert I as a replacement for microscopy
Process re-designBehavioural
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.
Performance FeedbackOther
Feedback of TB diagnostic evaluation quality indicators to health center staff
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Onsite ZN or LED fluorescence microscopy + hub-based GeneXpert testing per existing protocols |
| Intervention | Experimental | Onsite molecular testing for TB with GeneXpert I + process redesign to facilitate same-day TB diagnosis and treatment + performance feedback Receives: Device: GeneXpert I; Behavioral: Process re-design; Other: Performance Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number Treated for Microbiologically-confirmed TB Within 14 Days After Presentation to the Health Center for TB Evaluation
Effectiveness outcome.
Measured: Within 14 days after presentation to the health center for tuberculosis evaluation
Secondary outcomes (10)
Number Diagnosed With Microbiologically-confirmed TB
Effectiveness outcome.
Measured: Within 14 days after presentation to the health center for tuberculosis evaluation
Time to Microbiologically-confirmed TB
Effectiveness outcome. Time-to-diagnosis if microbiologically-confirmed TB.
Measured: Within 6 months of presentation to the health center for tuberculosis evaluation
Number Treated for TB
Effectiveness outcome.
Measured: Within 14 days of presentation to the health center for tuberculosis evaluation
Time-to-treatment of Microbiologically-confirmed TB
Effectiveness outcome. Time-to-treatment if microbiologically-confirmed TB and treated.
Measured: Days from initial health center visit to initiation of treatment if diagnosed, up to 6 months.
Number Who Died Within 6 Months
Effectiveness outcome.
Measured: Within 6 months of presentation to the health center for tuberculosis evaluation
Number of Patients Enrolled
Effectiveness outcome.
Measured: Presentation to the health center for tuberculosis evaluation during the 16-month study time frame
Number Tested for TB According to National Guidelines
Effectiveness outcome.
Measured: Within 6 months of presentation to the health center for tuberculosis evaluation
Number Suspected/Diagnosed With Rifampin-resistant TB
Effectiveness outcome.
Measured: Within 6 months of presentation to the health center for tuberculosis evaluation
Number Diagnosed and Treated for Microbiologically-confirmed TB
Effectiveness outcome.
Measured: On the same-day of presentation to the health center for tuberculosis evaluation
Number Diagnosed AND Treated for TB
Effectiveness outcome.
Measured: On the same-day of presentation to the health center for tuberculosis evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2017 (estimated)
- Study start22 Oct 2018
- Primary completion31 Mar 2020
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (40)Papers the sponsor has linked to this study.
- Other trials for Tuberculosis, PulmonaryStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10,644 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- 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)
- Responsible party
- Sponsor
- Investigators
- Adithya Cattamanchi, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03044158
- Sponsor's protocol ID
- R01HL130192
- Other IDs
- PACTR201610001763265, R01HL130192
- Acronym
- XPEL-TB
- Status last verified
- Jan 2025
- First submitted
- 23 Jan 2017
- Last updated
- 18 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
MacPherson P, Houben RM, Glynn JR, Corbett EL, Kranzer K. Pre-treatment loss to follow-up in tuberculosis patients in low- and lower-middle-income countries and high-burden countries: a systematic review and meta-analysis. Bull World Health Organ. 2014 Feb 1;92(2):126-38. doi: 10.2471/BLT.13.124800. Epub 2013 Nov 22.
PubMed 24623906Cattamanchi A, Dowdy DW, Davis JL, Worodria W, Yoo S, Joloba M, Matovu J, Hopewell PC, Huang L. Sensitivity of direct versus concentrated sputum smear microscopy in HIV-infected patients suspected of having pulmonary tuberculosis. BMC Infect Dis. 2009 May 6;9:53. doi: 10.1186/1471-2334-9-53.
PubMed 19419537Chihota VN, Ginindza S, McCarthy K, Grant AD, Churchyard G, Fielding K. Missed Opportunities for TB Investigation in Primary Care Clinics in South Africa: Experience from the XTEND Trial. PLoS One. 2015 Sep 18;10(9):e0138149. doi: 10.1371/journal.pone.0138149. eCollection 2015.
PubMed 26383102Davis J, Katamba A, Vasquez J, Crawford E, Sserwanga A, Kakeeto S, Kizito F, Dorsey G, den Boon S, Vittinghoff E, Huang L, Adatu F, Kamya MR, Hopewell PC, Cattamanchi A. Evaluating tuberculosis case detection via real-time monitoring of tuberculosis diagnostic services. Am J Respir Crit Care Med. 2011 Aug 1;184(3):362-7. doi: 10.1164/rccm.201012-1984OC. Epub 2011 Mar 11.
PubMed 21471088Aspler A, Menzies D, Oxlade O, Banda J, Mwenge L, Godfrey-Faussett P, Ayles H. Cost of tuberculosis diagnosis and treatment from the patient perspective in Lusaka, Zambia. Int J Tuberc Lung Dis. 2008 Aug;12(8):928-35.
PubMed 18647453Kemp JR, Mann G, Simwaka BN, Salaniponi FM, Squire SB. Can Malawi's poor afford free tuberculosis services? Patient and household costs associated with a tuberculosis diagnosis in Lilongwe. Bull World Health Organ. 2007 Aug;85(8):580-5. doi: 10.2471/blt.06.033167.
PubMed 17768515Simwaka BN, Bello G, Banda H, Chimzizi R, Squire BS, Theobald SJ. The Malawi National Tuberculosis Programme: an equity analysis. Int J Equity Health. 2007 Dec 31;6:24. doi: 10.1186/1475-9276-6-24.
PubMed 18163918Botha E, den Boon S, Lawrence KA, Reuter H, Verver S, Lombard CJ, Dye C, Enarson DA, Beyers N. From suspect to patient: tuberculosis diagnosis and treatment initiation in health facilities in South Africa. Int J Tuberc Lung Dis. 2008 Aug;12(8):936-41.
PubMed 18647454Ouyang H, Chepote F, Gilman RH, Moore DA. Failure to complete the TB diagnostic algorithm in urban Peru: a study of contributing factors. Trop Doct. 2005 Apr;35(2):120-1. doi: 10.1258/0049475054037002. No abstract available.
PubMed 15970047Steingart KR, Schiller I, Horne DJ, Pai M, Boehme CC, Dendukuri N. Xpert(R) MTB/RIF assay for pulmonary tuberculosis and rifampicin resistance in adults. Cochrane Database Syst Rev. 2014 Jan 21;2014(1):CD009593. doi: 10.1002/14651858.CD009593.pub3.
PubMed 24448973Dowdy DW, Cattamanchi A, Steingart KR, Pai M. Is scale-up worth it? Challenges in economic analysis of diagnostic tests for tuberculosis. PLoS Med. 2011 Jul;8(7):e1001063. doi: 10.1371/journal.pmed.1001063. Epub 2011 Jul 26.
PubMed 21814496Keeler E, Perkins MD, Small P, Hanson C, Reed S, Cunningham J, Aledort JE, Hillborne L, Rafael ME, Girosi F, Dye C. Reducing the global burden of tuberculosis: the contribution of improved diagnostics. Nature. 2006 Nov 23;444 Suppl 1:49-57. doi: 10.1038/nature05446. No abstract available.
PubMed 17159894Theron G, Zijenah L, Chanda D, Clowes P, Rachow A, Lesosky M, Bara W, Mungofa S, Pai M, Hoelscher M, Dowdy D, Pym A, Mwaba P, Mason P, Peter J, Dheda K; TB-NEAT team. Feasibility, accuracy, and clinical effect of point-of-care Xpert MTB/RIF testing for tuberculosis in primary-care settings in Africa: a multicentre, randomised, controlled trial. Lancet. 2014 Feb 1;383(9915):424-35. doi: 10.1016/S0140-6736(13)62073-5. Epub 2013 Oct 28.
PubMed 24176144Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999 Sep;89(9):1322-7. doi: 10.2105/ajph.89.9.1322.
PubMed 10474547Godin G, Belanger-Gravel A, Eccles M, Grimshaw J. Healthcare professionals' intentions and behaviours: a systematic review of studies based on social cognitive theories. Implement Sci. 2008 Jul 16;3:36. doi: 10.1186/1748-5908-3-36.
PubMed 18631386
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GeneXpert Performance Evaluation for Linkage to Tuberculosis Care: The XPEL-TB Trial
- ClinicalTrials.gov ID
- NCT03044158
- Acronym / sponsor ID
- XPEL-TB / R01HL130192
- Keywords
- tuberculosis, implementation science, point-of-care, diagnostics, GeneXpert, Uganda
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,644 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- 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)
- Study start
- 22 Oct 2018 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 6 Feb 2017 (estimated)
- Results
- Posted 18 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Onsite ZN or LED fluorescence microscopy + hub-based GeneXpert testing per existing protocols |
| Intervention | Experimental | Device: GeneXpert I, Behavioral: Process re-design, Other: Performance FeedbackOnsite molecular testing for TB with GeneXpert I + process redesign to facilitate same-day TB diagnosis and treatment + performance feedback |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GeneXpert IAlso: GeneXpertOnsite molecular testing with GeneXpert I as a replacement for microscopy | Device | Intervention |
| Process re-designResearch 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. | Behavioural | Intervention |
| Performance FeedbackFeedback of TB diagnostic evaluation quality indicators to health center staff | Other | Intervention |
Primary outcome
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.
10 secondary outcomes
Number Diagnosed With Microbiologically-confirmed TB
Time frame: 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
Number Treated for TB
Time frame: 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.
Number Who Died Within 6 Months
Time frame: 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
Number Tested for TB According to National Guidelines
Time frame: 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
Number Diagnosed and Treated for Microbiologically-confirmed TB
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24623906MacPherson P, Houben RM, Glynn JR, Corbett EL, Kranzer K. Pre-treatment loss to follow-up in tuberculosis patients in low- and lower-middle-income countries and high-burden countries: a systematic review and meta-analysis. Bull World Health Organ. 2014 Feb 1;92(2):126-38. doi: 10.2471/BLT.13.124800. Epub 2013 Nov 22.
- Background: PubMed 19419537Cattamanchi A, Dowdy DW, Davis JL, Worodria W, Yoo S, Joloba M, Matovu J, Hopewell PC, Huang L. Sensitivity of direct versus concentrated sputum smear microscopy in HIV-infected patients suspected of having pulmonary tuberculosis. BMC Infect Dis. 2009 May 6;9:53. doi: 10.1186/1471-2334-9-53.
- Background: PubMed 26383102Chihota VN, Ginindza S, McCarthy K, Grant AD, Churchyard G, Fielding K. Missed Opportunities for TB Investigation in Primary Care Clinics in South Africa: Experience from the XTEND Trial. PLoS One. 2015 Sep 18;10(9):e0138149. doi: 10.1371/journal.pone.0138149. eCollection 2015.
- Background: PubMed 21471088Davis J, Katamba A, Vasquez J, Crawford E, Sserwanga A, Kakeeto S, Kizito F, Dorsey G, den Boon S, Vittinghoff E, Huang L, Adatu F, Kamya MR, Hopewell PC, Cattamanchi A. Evaluating tuberculosis case detection via real-time monitoring of tuberculosis diagnostic services. Am J Respir Crit Care Med. 2011 Aug 1;184(3):362-7. doi: 10.1164/rccm.201012-1984OC. Epub 2011 Mar 11.
- Background: PubMed 18647453Aspler A, Menzies D, Oxlade O, Banda J, Mwenge L, Godfrey-Faussett P, Ayles H. Cost of tuberculosis diagnosis and treatment from the patient perspective in Lusaka, Zambia. Int J Tuberc Lung Dis. 2008 Aug;12(8):928-35.
- Background: PubMed 17768515Kemp JR, Mann G, Simwaka BN, Salaniponi FM, Squire SB. Can Malawi's poor afford free tuberculosis services? Patient and household costs associated with a tuberculosis diagnosis in Lilongwe. Bull World Health Organ. 2007 Aug;85(8):580-5. doi: 10.2471/blt.06.033167.
- Background: PubMed 18163918Simwaka BN, Bello G, Banda H, Chimzizi R, Squire BS, Theobald SJ. The Malawi National Tuberculosis Programme: an equity analysis. Int J Equity Health. 2007 Dec 31;6:24. doi: 10.1186/1475-9276-6-24.
- Background: PubMed 18647454Botha E, den Boon S, Lawrence KA, Reuter H, Verver S, Lombard CJ, Dye C, Enarson DA, Beyers N. From suspect to patient: tuberculosis diagnosis and treatment initiation in health facilities in South Africa. Int J Tuberc Lung Dis. 2008 Aug;12(8):936-41.
- Background: PubMed 15970047Ouyang H, Chepote F, Gilman RH, Moore DA. Failure to complete the TB diagnostic algorithm in urban Peru: a study of contributing factors. Trop Doct. 2005 Apr;35(2):120-1. doi: 10.1258/0049475054037002. No abstract available.
- Background: PubMed 24448973Steingart KR, Schiller I, Horne DJ, Pai M, Boehme CC, Dendukuri N. Xpert(R) MTB/RIF assay for pulmonary tuberculosis and rifampicin resistance in adults. Cochrane Database Syst Rev. 2014 Jan 21;2014(1):CD009593. doi: 10.1002/14651858.CD009593.pub3.
- Background: PubMed 21814496Dowdy DW, Cattamanchi A, Steingart KR, Pai M. Is scale-up worth it? Challenges in economic analysis of diagnostic tests for tuberculosis. PLoS Med. 2011 Jul;8(7):e1001063. doi: 10.1371/journal.pmed.1001063. Epub 2011 Jul 26.
- Background: PubMed 17159894Keeler E, Perkins MD, Small P, Hanson C, Reed S, Cunningham J, Aledort JE, Hillborne L, Rafael ME, Girosi F, Dye C. Reducing the global burden of tuberculosis: the contribution of improved diagnostics. Nature. 2006 Nov 23;444 Suppl 1:49-57. doi: 10.1038/nature05446. No abstract available.
- Individual participant dataSharing planned: No
Related trials for Tuberculosis, Pulmonary
RecruitingPhase 3
A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberculosis
Rifampicin-Resistant Pulmonary Tuberculosis, Multidrug-Resistant Pulmonary Tuberculosis
RecruitingPhase 2
BRIGHT-Child TB: Short-Course Treatment for Non-Severe Pulmonary Tuberculosis in Children
Tuberculosis
Recruiting
Channa Striata and Curcuma Domestica Supplementation in Patients With Active Pulmonary Tuberculosis
Pulmonary Tuberculosis
RecruitingPhase 2
Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis
Pulmonary Tuberculosis
RecruitingPhase 2
Platform Assessing Regimens and Durations In a Global Multisite Consortium for TB
Pulmonary Tuberculosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adithya Cattamanchi, MD principal investigator
University of California, San Francisco
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GeneXpert I, Process re-design and Performance Feedback in people with Tuberculosis, Pulmonary and Rifampicin Resistant Tuberculosis, run by University of California, San Francisco at 20 sites in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03044158, which also lists 40 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025; AzTrials last refreshed its copy on 29 Oct 2026.