Trial Outcomes & Findings for GeneXpert Performance Evaluation for Linkage to Tuberculosis Care (NCT NCT03044158)
NCT ID: NCT03044158
Last Updated: 2025-02-18
Results Overview
Effectiveness outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10644 participants
Primary outcome timeframe
Within 14 days after presentation to the health center for tuberculosis evaluation
Results posted on
2025-02-18
Participant Flow
Unit of analysis: Community Health Centers
Participant milestones
| Measure |
Control Group
Onsite ZN or LED fluorescence microscopy + hub-based GeneXpert testing per existing protocols
|
Intervention
Onsite molecular testing for TB with GeneXpert + process redesign to facilitate same-day TB diagnosis and treatment + performance feedback
GeneXpert: Onsite molecular testing with GeneXpert as a replacement for microscopy
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.
Performance Feedback: Feedback of TB diagnostic evaluation quality indicators to health center staff
|
|---|---|---|
|
Overall Study
STARTED
|
5098 10
|
5546 10
|
|
Overall Study
COMPLETED
|
5098 10
|
5546 10
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Excludes participants with unknown HIV status
Baseline characteristics by cohort
| Measure |
Control Group
n=5098 Participants
Onsite ZN or LED fluorescence microscopy + hub-based GeneXpert testing per existing protocols
|
Intervention
n=5546 Participants
Onsite molecular testing for TB with GeneXpert + process redesign to facilitate same-day TB diagnosis and treatment + performance feedback
GeneXpert: Onsite molecular testing with GeneXpert as a replacement for microscopy
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.
Performance Feedback: Feedback of TB diagnostic evaluation quality indicators to health center staff
|
Total
n=10644 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38 years
n=5098 Participants
|
40 years
n=5546 Participants
|
40 years
n=10644 Participants
|
|
Sex: Female, Male
Female
|
3112 Participants
n=5098 Participants
|
3289 Participants
n=5546 Participants
|
6401 Participants
n=10644 Participants
|
|
Sex: Female, Male
Male
|
1986 Participants
n=5098 Participants
|
2257 Participants
n=5546 Participants
|
4243 Participants
n=10644 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5098 Participants
|
0 Participants
n=5546 Participants
|
0 Participants
n=10644 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5098 Participants
n=5098 Participants
|
5546 Participants
n=5546 Participants
|
10644 Participants
n=10644 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5098 Participants
|
0 Participants
n=5546 Participants
|
0 Participants
n=10644 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5098 Participants
|
0 Participants
n=5546 Participants
|
0 Participants
n=10644 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5098 Participants
|
0 Participants
n=5546 Participants
|
0 Participants
n=10644 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5098 Participants
|
0 Participants
n=5546 Participants
|
0 Participants
n=10644 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5098 Participants
n=5098 Participants
|
5546 Participants
n=5546 Participants
|
10644 Participants
n=10644 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5098 Participants
|
0 Participants
n=5546 Participants
|
0 Participants
n=10644 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5098 Participants
|
0 Participants
n=5546 Participants
|
0 Participants
n=10644 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5098 Participants
|
0 Participants
n=5546 Participants
|
0 Participants
n=10644 Participants
|
|
Region of Enrollment
Uganda
|
5098 participants
n=5098 Participants
|
5546 participants
n=5546 Participants
|
10644 participants
n=10644 Participants
|
|
HIV infection
|
1905 Participants
n=4290 Participants • Excludes participants with unknown HIV status
|
2285 Participants
n=5273 Participants • Excludes participants with unknown HIV status
|
4190 Participants
n=9563 Participants • Excludes participants with unknown HIV status
|
PRIMARY outcome
Timeframe: Within 14 days after presentation to the health center for tuberculosis evaluationEffectiveness outcome.
Outcome measures
| Measure |
Control Group
n=5098 Participants
Onsite ZN or LED fluorescence microscopy + hub-based GeneXpert testing per existing protocols
|
Intervention
n=5546 Participants
Onsite molecular testing for TB with GeneXpert + process redesign to facilitate same-day TB diagnosis and treatment + performance feedback
GeneXpert: Onsite molecular testing with GeneXpert as a replacement for microscopy
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.
Performance Feedback: Feedback of TB diagnostic evaluation quality indicators to health center staff
|
|---|---|---|
|
Number Treated for Microbiologically-confirmed TB Within 14 Days After Presentation to the Health Center for TB Evaluation
|
220 Participants
|
342 Participants
|
SECONDARY outcome
Timeframe: Within 14 days after presentation to the health center for tuberculosis evaluationEffectiveness outcome.
Outcome measures
| Measure |
Control Group
n=5098 Participants
Onsite ZN or LED fluorescence microscopy + hub-based GeneXpert testing per existing protocols
|
Intervention
n=5546 Participants
Onsite molecular testing for TB with GeneXpert + process redesign to facilitate same-day TB diagnosis and treatment + performance feedback
GeneXpert: Onsite molecular testing with GeneXpert as a replacement for microscopy
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.
Performance Feedback: Feedback of TB diagnostic evaluation quality indicators to health center staff
|
|---|---|---|
|
Number Diagnosed With Microbiologically-confirmed TB
|
299 Participants
|
389 Participants
|
SECONDARY outcome
Timeframe: Within 6 months of presentation to the health center for tuberculosis evaluationPopulation: All participants' data was analyzed to determine who had confirmed TB.
Effectiveness outcome. Time-to-diagnosis if microbiologically-confirmed TB.
Outcome measures
| Measure |
Control Group
n=311 Participants
Onsite ZN or LED fluorescence microscopy + hub-based GeneXpert testing per existing protocols
|
Intervention
n=391 Participants
Onsite molecular testing for TB with GeneXpert + process redesign to facilitate same-day TB diagnosis and treatment + performance feedback
GeneXpert: Onsite molecular testing with GeneXpert as a replacement for microscopy
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.
Performance Feedback: Feedback of TB diagnostic evaluation quality indicators to health center staff
|
|---|---|---|
|
Time to Microbiologically-confirmed TB
|
0 days
Interval 0.0 to 3.0
|
0 days
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Within 14 days of presentation to the health center for tuberculosis evaluationEffectiveness outcome.
Outcome measures
| Measure |
Control Group
n=5098 Participants
Onsite ZN or LED fluorescence microscopy + hub-based GeneXpert testing per existing protocols
|
Intervention
n=5546 Participants
Onsite molecular testing for TB with GeneXpert + process redesign to facilitate same-day TB diagnosis and treatment + performance feedback
GeneXpert: Onsite molecular testing with GeneXpert as a replacement for microscopy
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.
Performance Feedback: Feedback of TB diagnostic evaluation quality indicators to health center staff
|
|---|---|---|
|
Number Treated for TB
|
339 Participants
|
485 Participants
|
SECONDARY outcome
Timeframe: Days from initial health center visit to initiation of treatment if diagnosed, up to 6 months.Population: All participants' data was analyzed to determine who had confirmed TB and treatment initiated.
Effectiveness outcome. Time-to-treatment if microbiologically-confirmed TB and treated.
Outcome measures
| Measure |
Control Group
n=267 Participants
Onsite ZN or LED fluorescence microscopy + hub-based GeneXpert testing per existing protocols
|
Intervention
n=351 Participants
Onsite molecular testing for TB with GeneXpert + process redesign to facilitate same-day TB diagnosis and treatment + performance feedback
GeneXpert: Onsite molecular testing with GeneXpert as a replacement for microscopy
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.
Performance Feedback: Feedback of TB diagnostic evaluation quality indicators to health center staff
|
|---|---|---|
|
Time-to-treatment of Microbiologically-confirmed TB
|
1 days
Interval 0.0 to 8.0
|
0 days
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: Within 6 months of presentation to the health center for tuberculosis evaluationPopulation: Includes those with vital status follow-up at six months post-visit to health center
Effectiveness outcome.
Outcome measures
| Measure |
Control Group
n=3695 Participants
Onsite ZN or LED fluorescence microscopy + hub-based GeneXpert testing per existing protocols
|
Intervention
n=4421 Participants
Onsite molecular testing for TB with GeneXpert + process redesign to facilitate same-day TB diagnosis and treatment + performance feedback
GeneXpert: Onsite molecular testing with GeneXpert as a replacement for microscopy
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.
Performance Feedback: Feedback of TB diagnostic evaluation quality indicators to health center staff
|
|---|---|---|
|
Number Who Died Within 6 Months
|
123 Participants
|
116 Participants
|
SECONDARY outcome
Timeframe: Presentation to the health center for tuberculosis evaluation during the 16-month study time framePopulation: All eligible were enrolled as there was a waiver of informed consent
Effectiveness outcome.
Outcome measures
| Measure |
Control Group
n=5098 Participants
Onsite ZN or LED fluorescence microscopy + hub-based GeneXpert testing per existing protocols
|
Intervention
n=5546 Participants
Onsite molecular testing for TB with GeneXpert + process redesign to facilitate same-day TB diagnosis and treatment + performance feedback
GeneXpert: Onsite molecular testing with GeneXpert as a replacement for microscopy
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.
Performance Feedback: Feedback of TB diagnostic evaluation quality indicators to health center staff
|
|---|---|---|
|
Number of Patients Enrolled
|
5098 Participants
|
5546 Participants
|
SECONDARY outcome
Timeframe: Within 6 months of presentation to the health center for tuberculosis evaluationEffectiveness outcome.
Outcome measures
| Measure |
Control Group
n=5098 Participants
Onsite ZN or LED fluorescence microscopy + hub-based GeneXpert testing per existing protocols
|
Intervention
n=5546 Participants
Onsite molecular testing for TB with GeneXpert + process redesign to facilitate same-day TB diagnosis and treatment + performance feedback
GeneXpert: Onsite molecular testing with GeneXpert as a replacement for microscopy
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.
Performance Feedback: Feedback of TB diagnostic evaluation quality indicators to health center staff
|
|---|---|---|
|
Number Tested for TB According to National Guidelines
|
2687 Participants
|
5108 Participants
|
SECONDARY outcome
Timeframe: Within 6 months of presentation to the health center for tuberculosis evaluationPopulation: The data analyzed included all adult patients in the target population. Those with rifampin-resistant tuberculosis, extrapulmonary tuberculosis and/or missing age data were excluded from the trial population. Therefore, the number of participants analyzed for this measure differs from other parts of the record.
Effectiveness outcome.
Outcome measures
| Measure |
Control Group
n=5201 Participants
Onsite ZN or LED fluorescence microscopy + hub-based GeneXpert testing per existing protocols
|
Intervention
n=5637 Participants
Onsite molecular testing for TB with GeneXpert + process redesign to facilitate same-day TB diagnosis and treatment + performance feedback
GeneXpert: Onsite molecular testing with GeneXpert as a replacement for microscopy
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.
Performance Feedback: Feedback of TB diagnostic evaluation quality indicators to health center staff
|
|---|---|---|
|
Number Suspected/Diagnosed With Rifampin-resistant TB
|
5 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: On the same-day of presentation to the health center for tuberculosis evaluationEffectiveness outcome.
Outcome measures
| Measure |
Control Group
n=5098 Participants
Onsite ZN or LED fluorescence microscopy + hub-based GeneXpert testing per existing protocols
|
Intervention
n=5546 Participants
Onsite molecular testing for TB with GeneXpert + process redesign to facilitate same-day TB diagnosis and treatment + performance feedback
GeneXpert: Onsite molecular testing with GeneXpert as a replacement for microscopy
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.
Performance Feedback: Feedback of TB diagnostic evaluation quality indicators to health center staff
|
|---|---|---|
|
Number Diagnosed and Treated for Microbiologically-confirmed TB
|
106 Participants
|
251 Participants
|
SECONDARY outcome
Timeframe: On the same-day of presentation to the health center for tuberculosis evaluationEffectiveness outcome.
Outcome measures
| Measure |
Control Group
n=5098 Participants
Onsite ZN or LED fluorescence microscopy + hub-based GeneXpert testing per existing protocols
|
Intervention
n=5546 Participants
Onsite molecular testing for TB with GeneXpert + process redesign to facilitate same-day TB diagnosis and treatment + performance feedback
GeneXpert: Onsite molecular testing with GeneXpert as a replacement for microscopy
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.
Performance Feedback: Feedback of TB diagnostic evaluation quality indicators to health center staff
|
|---|---|---|
|
Number Diagnosed AND Treated for TB
|
199 Participants
|
362 Participants
|
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 154 deaths
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 145 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place