Pulmonary TuberculosiscommunityNCT00803322
Improving Community Based Tuberculosis Care in Ethiopia
An observational study of Pulmonary Tuberculosis, run by University of Bergen at 1 site in Ethiopia.
Trial summary
The purpose of this study is to see if involving community health workers improves tuberculosis case finding and treatment outcome. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Tuberculosis
- How many people
- 318 participants
- Where
- 1 siteEthiopia
- Study dates
- Sep 2006to Apr 2008
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: suspects of pulmonary tuberculosis in the study are. In group two suspects were identified and treated bo community health workers while in group on used the conventional health facility based tuberculosis diagnosis and treatment
Who may be able to join
- suspects of pulmonary tuberculosis
Who cannot join
- not in the study area
Trial locations and contacts
1 site in 1 country.
Ethiopia1 site
Dale and Wonsho districts Sidama zone, Southern Ethiopia
Irgalem, Snnpr, 149
About this study
Official title: Community Health Workers Improve Tuberculosis Case Notification and Treatment Success in Southern Ethiopia
The purpose of this study is to see if involving community health workers improves tuberculosis case finding and treatment outcome.
Read the detailed description
Tuberculosis suspects in the study area
Outcome smear positive tuberculosis cases identified smear positive tuberculosis cases treated
- Conditions
- Pulmonary Tuberculosis
- Keywords
- TB, community, community health workers, Ethiopia, identify suspects of pulmonary tuberculosis, collect sputum specimen for examination, treat smear positive cases in the community
- Medical subject headings
- Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | communities where tuberculosis patients followed the conventional health facility based tuberculosis case finding and treatment | |
| 2 | community where suspects of pulmonary tuberculosis were identified by community health workers and received treatment in the community |
What is being measured
The primary outcome is the main question the study is designed to answer.
smear positive tuberculosis case notification rate
Measured: september 2006 - setmeber 2007
Secondary outcomes (1)
smear positive treatment success rate
Measured: september 2006 - April 2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2008 (estimated)
- Study startSep 2006
- Primary completionSep 2007
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary TuberculosisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- Centre For International Health
- Investigators
- Daniel G Datiko, MD, Principal investigator, CIH of Bergen University and RHB of SNNPRS EthiopiaBernt Lindtjorn, Study director, CIH UIB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00803322
- Sponsor's protocol ID
- 0001
- Other IDs
- 001
- Acronym
- community
- Status last verified
- Dec 2008
- First submitted
- 3 Dec 2008
- Last updated
- 5 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Datiko DG, Lindtjorn B. Cost and cost-effectiveness of smear-positive tuberculosis treatment by Health Extension Workers in Southern Ethiopia: a community randomized trial. PLoS One. 2010 Feb 17;5(2):e9158. doi: 10.1371/journal.pone.0009158.
PubMed 20174642Datiko DG, Lindtjorn B. Health extension workers improve tuberculosis case detection and treatment success in southern Ethiopia: a community randomized trial. PLoS One. 2009;4(5):e5443. doi: 10.1371/journal.pone.0005443. Epub 2009 May 8.
PubMed 19424460
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Health Workers Improve Tuberculosis Case Notification and Treatment Success in Southern Ethiopia
- ClinicalTrials.gov ID
- NCT00803322
- Acronym / sponsor ID
- community / 0001
- Conditions
- Pulmonary Tuberculosis
- Keywords
- TB, community, community health workers, Ethiopia, identify suspects of pulmonary tuberculosis, collect sputum specimen for examination, treat smear positive cases in the community
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- Centre For International Health
- Study start
- Sep 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 5 Dec 2008 (estimated)
- 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.
The purpose of this study is to see if involving community health workers improves tuberculosis case finding and treatment outcome.
Detailed description
Tuberculosis suspects in the study area
Outcome smear positive tuberculosis cases identified smear positive tuberculosis cases treated
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –communities where tuberculosis patients followed the conventional health facility based tuberculosis case finding and treatment |
| 2 | – | –community where suspects of pulmonary tuberculosis were identified by community health workers and received treatment in the community |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- suspects of pulmonary tuberculosis in the study are. In group two suspects were identified and treated bo community health workers while in group on used the conventional health facility based tuberculosis diagnosis and treatment
Key inclusion criteria (1 listed)
- suspects of pulmonary tuberculosis
Key exclusion criteria (1 listed)
- not in the study area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
smear positive tuberculosis case notification rate
Time frame: september 2006 - setmeber 2007
1 secondary outcome
smear positive treatment success rate
Time frame: september 2006 - April 2007
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 5 Dec 2008.
- Derived from this study: PubMed 20174642Datiko DG, Lindtjorn B. Cost and cost-effectiveness of smear-positive tuberculosis treatment by Health Extension Workers in Southern Ethiopia: a community randomized trial. PLoS One. 2010 Feb 17;5(2):e9158. doi: 10.1371/journal.pone.0009158.
- Derived from this study: PubMed 19424460Datiko DG, Lindtjorn B. Health extension workers improve tuberculosis case detection and treatment success in southern Ethiopia: a community randomized trial. PLoS One. 2009;4(5):e5443. doi: 10.1371/journal.pone.0005443. Epub 2009 May 8.
Related trials for Pulmonary Tuberculosis
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
Active, not recruitingObservational study
Mycobacterial and Opportunistic Infections in HIV-Negative Thai and Taiwanese Patients Associated With Autoantibodies to Interferon-gamma
Nontuberculous Mycobacteria, Mycobacterium 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.
Daniel G Datiko, MD principal investigator
CIH of Bergen University and RHB of SNNPRS Ethiopia
Bernt Lindtjorn study director
CIH UIB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Tuberculosis, run by University of Bergen at 1 site in Ethiopia.
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 1 inclusion and 1 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 5 Dec 2008. 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 Ethiopia. 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?
smear positive tuberculosis case notification rate (time frame: september 2006 - setmeber 2007). 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 NCT00803322, which also lists 2 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 5 Dec 2008.