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Cost and Cost-effectiveness of PTB+ Treatment in Southern Ethiopia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00913172
First Posted: June 4, 2009
Last Update Posted: May 17, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Bergen
  Purpose
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.

Condition Intervention Phase
Smear-positive TB Cases Other: Treatment Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Improving Community Based TB Care in Southern Ethiopia Cost and Cost Effectiveness

Further study details as provided by University of Bergen:

Primary Outcome Measures:
  • cost per successfully treated smear-positive case [ Time Frame: September 2006 to April 2008 ]

Enrollment: 229
Study Start Date: September 2006
Study Completion Date: April 2008
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Intervention group
Directly Observed Treatment under Health Extension Workers
Other: Treatment
Directly observed treatment (DOT) by health extension workers (HEWs)
Other Name: community based TB care
Control group
Directly observed treatment under general health workers

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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
Criteria

Inclusion Criteria:

  • Pulmonary tuberculosis suspects of any age and sex

Exclusion Criteria:

  • Healthy individuals or non tuberculosis patients
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00913172


Locations
Ethiopia
YAHC
Yirgalem, Snnpr, Ethiopia, 72
Sponsors and Collaborators
University of Bergen
Investigators
Principal Investigator: Daniel G Datiko, MD UoB, RHB
Study Director: Bernt Lindtjorn, MD, PhD UoB
  More Information

Publications:
Responsible Party: Bernt Lindtjørn, Professor, University of Bergen
ClinicalTrials.gov Identifier: NCT00913172     History of Changes
Other Study ID Numbers: 000001
First Submitted: May 28, 2009
First Posted: June 4, 2009
Last Update Posted: May 17, 2010
Last Verified: May 2009

Keywords provided by University of Bergen:
TB
cost
HEWs
Cost-effectiveness
treatment success rate