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

This study has been completed.
Sponsor:
Information provided by:
University of Bergen
ClinicalTrials.gov Identifier:
NCT00913172
First received: May 28, 2009
Last updated: May 14, 2010
Last verified: May 2009
  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 ] [ Designated as safety issue: Yes ]

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

Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: May 28, 2009
Last Updated: May 14, 2010
Health Authority: Ethiopia: Ministry of Health

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

ClinicalTrials.gov processed this record on August 28, 2014