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

NCT ID: NCT00913172

Last Updated: 2010-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

229 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-09-30

Study Completion Date

2008-04-30

Brief Summary

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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

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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

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Smear-positive TB Cases

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Intervention group

Directly Observed Treatment under Health Extension Workers

Treatment

Intervention Type OTHER

Directly observed treatment (DOT) by health extension workers (HEWs)

Control group

Directly observed treatment under general health workers

No interventions assigned to this group

Interventions

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Treatment

Directly observed treatment (DOT) by health extension workers (HEWs)

Intervention Type OTHER

Other Intervention Names

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community based TB care

Eligibility Criteria

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Inclusion Criteria

* Pulmonary tuberculosis suspects of any age and sex

Exclusion Criteria

* Healthy individuals or non tuberculosis patients
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Bergen

OTHER

Sponsor Role lead

Responsible Party

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University of Bergen

Principal Investigators

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Daniel G Datiko, MD

Role: PRINCIPAL_INVESTIGATOR

UoB, RHB

Bernt Lindtjorn, MD, PhD

Role: STUDY_DIRECTOR

UoB

Locations

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YAHC

Irgalem, Snnpr, Ethiopia

Site Status

Countries

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Ethiopia

References

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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.

Reference Type RESULT
PMID: 20174642 (View on PubMed)

Other Identifiers

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000001

Identifier Type: -

Identifier Source: org_study_id

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