TuberculosisTBNCT03497195
Achieving Tuberculosis (TB) Control In Zambia
A study testing Screening at community level in people with Tuberculosis, run by University of Alabama at Birmingham at 1 site in Zambia.
Trial summary
To achieve TB control, innovative case finding interventions are needed that will reach the broader affected population including those that do not access the health facilities. Systematic community case finding with highly sensitive screening and diagnostic tools are needed. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Screening at community level
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18,194 participants
- Where
- 1 siteZambia
- Study dates
- 1 Jul 2017to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -
- Program Implementation:
- Any adult or child with TB symptoms (weight loss, chest pain, shortness of breath, fever, cough, hemoptysis, night sweats)
- Ability to produce sputum
- Verbal consent of parent or guardian if < 18 years old
- Operations Research:
Show all 12Show fewer
- Adults (18 years and older)
- TB symptoms (weight loss, chest pain, shortness of breath, fever, cough, hemoptysis, night sweats)
- Ability to provide a sputum sample
- Willing to provide written informed consent
- Willing to undergo full clinical evaluation
- Willing to undergo a CXR
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Zambia1 site
Center for Infectious Disease Research in Zambia (CIDRZ)
Lusaka, 10102
About this study
Official title: Achieving TB Control In Zambia Through Scale Up Of Innovative Tools And Proven Active TB Case Finding Interventions
To achieve TB control, innovative case finding interventions are needed that will reach the broader affected population including those that do not access the health facilities. Systematic community case finding with highly sensitive screening and diagnostic tools are needed. At the facility level, the index of suspicion for TB by health care workers needs to be raised to ensure that all those that need TB screening are appropriately screened.
Read the detailed description
The purpose of this study is to initiate sustained, active health facility and community-based case finding interventions to achieve improved TB case detection in high burden settings (Zambia) and contribute to TB control.
The interventions are expected to increase the impact of Xpert on TB case finding, thus increase TB case detection through scaling up of a combination of community level and facility level TB case finding interventions. The study will generate evidence on the added value of using Chest X-ray (CXR) screening at community level, whilst also comparing the performance of CXR with computer assisted diagnosis (CAD) and C-reactive protein (CRP) and symptoms as screening tools in terms sensitivity, specificity and cost effectiveness. Symptom screen alone has been shown to be suboptimal for screening as it misses a significant percentage of TB due to atypical presentation of TB in HIV-infected populations.
- Conditions
- Tuberculosis
- Being tested
- Screening at community level
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening at community levelDiagnostic test
comparison of chest x-ray and Xpert Ultra versus CRP and Xpert Ultra for active community based screening
| Study group | Role | What they receive |
|---|---|---|
| Community level screening; Arm 1 | Active comparator | use of chest X-ray plus Xpert Ultra for community level TB screening Receives: Diagnostic Test: Screening at community level |
| Community level screening: Arm 2 | Active comparator | use of C-reactive Protein and Xpert Ultra for community level TB screening Receives: Diagnostic Test: Screening at community level |
What is being measured
The primary outcome is the main question the study is designed to answer.
increase TB case detection
comparison of two diagnostic tools (Chest Xray with CAD versus CRP) and Xpert Ultra for active community based TB case detection
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start1 Jul 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18,194 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stewart Reid, University of Alabama at Birmingham
- Investigators
- Monde Muyoyeta, MD,PhD, Principal investigator, Center for Infectious Disease Research in Zambia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03497195
- Sponsor's protocol ID
- IRB-300001132
- Acronym
- TB
- Status last verified
- Sep 2019
- First submitted
- 6 Apr 2018
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zifodya JS, Kreniske JS, Schiller I, Kohli M, Dendukuri N, Schumacher SG, Ochodo EA, Haraka F, Zwerling AA, Pai M, Steingart KR, Horne DJ. Xpert Ultra versus Xpert MTB/RIF for pulmonary tuberculosis and rifampicin resistance in adults with presumptive pulmonary tuberculosis. Cochrane Database Syst Rev. 2021 Feb 22;2(2):CD009593. doi: 10.1002/14651858.CD009593.pub5.
PubMed 33616229
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Achieving TB Control In Zambia Through Scale Up Of Innovative Tools And Proven Active TB Case Finding Interventions
- ClinicalTrials.gov ID
- NCT03497195
- Acronym / sponsor ID
- TB / IRB-300001132
- Conditions
- Tuberculosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18,194 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 13 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To achieve TB control, innovative case finding interventions are needed that will reach the broader affected population including those that do not access the health facilities. Systematic community case finding with highly sensitive screening and diagnostic tools are needed. At the facility level, the index of suspicion for TB by health care workers needs to be raised to ensure that all those that need TB screening are appropriately screened.
Detailed description
The purpose of this study is to initiate sustained, active health facility and community-based case finding interventions to achieve improved TB case detection in high burden settings (Zambia) and contribute to TB control.
The interventions are expected to increase the impact of Xpert on TB case finding, thus increase TB case detection through scaling up of a combination of community level and facility level TB case finding interventions. The study will generate evidence on the added value of using Chest X-ray (CXR) screening at community level, whilst also comparing the performance of CXR with computer assisted diagnosis (CAD) and C-reactive protein (CRP) and symptoms as screening tools in terms sensitivity, specificity and cost effectiveness. Symptom screen alone has been shown to be suboptimal for screening as it misses a significant percentage of TB due to atypical presentation of TB in HIV-infected populations.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community level screening; Arm 1 | Active comparator | Diagnostic Test: Screening at community leveluse of chest X-ray plus Xpert Ultra for community level TB screening |
| Community level screening: Arm 2 | Active comparator | Diagnostic Test: Screening at community leveluse of C-reactive Protein and Xpert Ultra for community level TB screening |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- -
- Any adult or child with TB symptoms (weight loss, chest pain, shortness of breath, fever, cough, hemoptysis, night sweats)
- Ability to produce sputum
- Verbal consent of parent or guardian if < 18 years old
- Adults (18 years and older)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Screening at community levelcomparison of chest x-ray and Xpert Ultra versus CRP and Xpert Ultra for active community based screening | Diagnostic test | Community level screening: Arm 2, Community level screening; Arm 1 |
Primary outcome
increase TB case detection
Time frame: 6 months
comparison of two diagnostic tools (Chest Xray with CAD versus CRP) and Xpert Ultra for active community based TB case detection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Derived from this study: PubMed 33616229Zifodya JS, Kreniske JS, Schiller I, Kohli M, Dendukuri N, Schumacher SG, Ochodo EA, Haraka F, Zwerling AA, Pai M, Steingart KR, Horne DJ. Xpert Ultra versus Xpert MTB/RIF for pulmonary tuberculosis and rifampicin resistance in adults with presumptive pulmonary tuberculosis. Cochrane Database Syst Rev. 2021 Feb 22;2(2):CD009593. doi: 10.1002/14651858.CD009593.pub5.
- Individual participant dataSharing planned: No
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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.
Monde Muyoyeta, MD,PhD principal investigator
Center for Infectious Disease Research in Zambia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening at community level in people with Tuberculosis, run by University of Alabama at Birmingham at 1 site in Zambia.
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 12 inclusion and 0 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 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
increase TB case detection (time frame: 6 months). 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 NCT03497195, which also lists 1 linked publication.
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 25 Sep 2019.