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

Smear-positive TB Cases Clinical Trial

Official title:

Improving Community Based TB Care in Southern Ethiopia Cost and Cost Effectiveness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00913172
• Other study ID #: 000001
• Status: Completed
• Phase: Phase 4
• First received: May 28, 2009
• Last updated: May 14, 2010
• Start date: September 2006
• Est. completion date: April 2008

Study information

• Verified date: May 2009
• Source: University of Bergen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ethiopia: Ministry of Health
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 229
• Est. completion date: April 2008
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Pulmonary tuberculosis suspects of any age and sex

Exclusion Criteria:

• Healthy individuals or non tuberculosis patients

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Smear-positive TB Cases

Intervention

Other:
• Treatment
Directly observed treatment (DOT) by health extension workers (HEWs)

Locations

Country	Name	City	State
Ethiopia	YAHC	Yirgalem	Snnpr

Sponsors (1)

Lead Sponsor	Collaborator
University of Bergen

Country where clinical trial is conducted

Ethiopia, 

References & Publications (1)

Datiko DG, Lindtjørn 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cost per successfully treated smear-positive case		September 2006 to April 2008	Yes