Smear-positive TB CasesNCT00913172
Cost and Cost-effectiveness of PTB+ Treatment in Southern Ethiopia
An observational study of Smear-positive TB Cases, run by University of Bergen at 1 site in Ethiopia.
Trial summary
Evidences for policy making and decision related to the cost of delivering tuberculosis (TB) control is lacking in Ethiopia. The investigators aimed to determine the cost and cost-effectiveness of involving health extension workers (HEWs) in TB treatment under the community-based initiative in Ethiopia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Smear-positive TB Cases
- What is being tested?
- Treatment
- How many people
- 229 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: This study was conducted along a CRT to find out if involving HEWs improves the treatment success rate of smear-positive patients. For both treatment alternatives, smear-positive patients who were diagnosed (from September 2006 to September 2007) and started treatment were prospectively enrolled until the end of treatment. The detail of the study are given elsewhere
Who may be able to join
- Pulmonary tuberculosis suspects of any age and sex
Who cannot join
- Healthy individuals or non tuberculosis patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Community Based TB Care in Southern Ethiopia Cost and Cost Effectiveness
Evidences for policy making and decision related to the cost of delivering tuberculosis (TB) control is lacking in Ethiopia. The investigators aimed to determine the cost and cost-effectiveness of involving health extension workers (HEWs) in TB treatment under the community-based initiative in Ethiopia.
Read the detailed description
Two treatment options were compared - health facility and community DOT. In 1995, Ethiopia adopted World Health Organization (WHO) recommended DOTS strategy for TB control. The treatment regimen for new smear-positive patients includes two months of ethambutol, rifampicin, isoniazid and pyrazinamide followed by six months of ethambutol and isoniazid. For children the continuation phase treatment was replaced by four months of rifampicin and isoniazid. Follow up sputum examinations were conducted at the end of 2, 5 and 7 months treatment.
- Conditions
- Smear-positive TB Cases
- Being tested
- Treatment
- Keywords
- TB, cost, HEWs, Cost-effectiveness, treatment success rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreatmentOther
Also called community based TB care
Directly observed treatment (DOT) by health extension workers (HEWs)
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Directly Observed Treatment under Health Extension Workers Receives: Other: Treatment | |
| Control group | Directly observed treatment under general health workers |
What is being measured
The primary outcome is the main question the study is designed to answer.
cost per successfully treated smear-positive case
Measured: September 2006 to April 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2009 (estimated)
- Study startSep 2006
- Primary completionMar 2007
- Study completionApr 2008
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 Smear-positive TB CasesStudies 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
- Time perspective
- Prospective
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Investigators
- Daniel G Datiko, MD, Principal investigator, UoB, RHBBernt Lindtjorn, MD, PhD, Study director, UoB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00913172
- Sponsor's protocol ID
- 000001
- Status last verified
- May 2009
- First submitted
- 28 May 2009
- Last updated
- 17 May 2010
- 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 20174642
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Community Based TB Care in Southern Ethiopia Cost and Cost Effectiveness
- ClinicalTrials.gov ID
- NCT00913172
- Acronym / sponsor ID
- 000001
- Conditions
- Smear-positive TB Cases
- Keywords
- TB, cost, HEWs, Cost-effectiveness, treatment success rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 4 Jun 2009 (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.
Evidences for policy making and decision related to the cost of delivering tuberculosis (TB) control is lacking in Ethiopia. The investigators aimed to determine the cost and cost-effectiveness of involving health extension workers (HEWs) in TB treatment under the community-based initiative in Ethiopia.
Detailed description
Two treatment options were compared - health facility and community DOT. In 1995, Ethiopia adopted World Health Organization (WHO) recommended DOTS strategy for TB control. The treatment regimen for new smear-positive patients includes two months of ethambutol, rifampicin, isoniazid and pyrazinamide followed by six months of ethambutol and isoniazid. For children the continuation phase treatment was replaced by four months of rifampicin and isoniazid. Follow up sputum examinations were conducted at the end of 2, 5 and 7 months treatment.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | – | Other: TreatmentDirectly Observed Treatment under Health Extension Workers |
| Control group | – | –Directly observed treatment under general health workers |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study was conducted along a CRT to find out if involving HEWs improves the treatment success rate of smear-positive patients. For both treatment alternatives, smear-positive patients who were diagnosed (from September 2006 to September 2007) and started treatment were prospectively enrolled until the end of treatment. The detail of the study are given elsewhere
Key inclusion criteria (1 listed)
- Pulmonary tuberculosis suspects of any age and sex
Key exclusion criteria (1 listed)
- Healthy individuals or non tuberculosis patients
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 |
|---|---|---|
| TreatmentAlso: community based TB careDirectly observed treatment (DOT) by health extension workers (HEWs) | Other | Intervention group |
Primary outcome
cost per successfully treated smear-positive case
Time frame: September 2006 to April 2008
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 17 May 2010.
- Results publication: 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.
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
UoB, RHB
Bernt Lindtjorn, MD, PhD study director
UoB
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 Smear-positive TB Cases, 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 17 May 2010. 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?
cost per successfully treated smear-positive case (time frame: September 2006 to April 2008). 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 NCT00913172, 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 17 May 2010.