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

May 14, 2010 updated by: University of Bergen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

229

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ethiopia
    • Snnpr
      • Yirgalem, Snnpr, Ethiopia, 72
        • YAHC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

Inclusion Criteria:

  • Pulmonary tuberculosis suspects of any age and sex

Exclusion Criteria:

  • Healthy individuals or non tuberculosis patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intervention group
Directly Observed Treatment under Health Extension Workers
Other: Treatment
Directly observed treatment (DOT) by health extension workers (HEWs)
Other Names:
  • community based TB care
Control group
Directly observed treatment under general health workers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
cost per successfully treated smear-positive case
Time Frame: September 2006 to April 2008
September 2006 to April 2008

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bergen

Investigators

  • Principal Investigator: Daniel G Datiko, MD, UoB, RHB
  • Study Director: Bernt Lindtjorn, MD, PhD, UoB

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

May 28, 2009

First Submitted That Met QC Criteria

June 3, 2009

First Posted (Estimate)

June 4, 2009

Study Record Updates

Last Update Posted (Estimate)

May 17, 2010

Last Update Submitted That Met QC Criteria

May 14, 2010

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 000001 (Other Grant/Funding Number: New York City Mayors Office Community Mental Health)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Smear-positive TB Cases

Clinical Trials on Treatment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe