Cost and Cost-effectiveness of PTB+ Treatment in Southern... | NCT00913172

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

NCT00913172

Sponsor

University of Bergen

Status

Completed

Last Update Posted

May 17, 2010Estimated

Enrollment

229Actual

Phase

Not provided

Conditions

Smear-positive TB Cases

Interventions

Treatment

Countries

Ethiopia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Mar 2007Actual

Completion Date

Apr 2008Actual

First Submitted Date

May 28, 2009

First Submission Date that Met QC Criteria

Jun 3, 2009

First Posted Date

Jun 4, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 14, 2010

Last Update Posted Date

May 17, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

229Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention group		Directly Observed Treatment under Health Extension Workers	Other: Treatment
Control group		Directly observed treatment under general health workers

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Treatment	Other	Directly observed treatment (DOT) by health extension workers (HEWs)	Intervention group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pulmonary tuberculosis suspects of any age and sex

Exclusion Criteria:

Healthy individuals or non tuberculosis patients

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Daniel G Datiko, MD	UoB, RHB	Principal Investigator
Bernt Lindtjorn, MD, PhD	UoB	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
YAHC		Irgalem	Snnpr	72	Ethiopia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20174642	Result	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.