NCT00803322

Brief Summary

The purpose of this study is to see if involving community health workers improves tuberculosis case finding and treatment outcome.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
318

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 5, 2008

Completed
Last Updated

December 5, 2008

Status Verified

December 1, 2008

Enrollment Period

1 year

First QC Date

December 3, 2008

Last Update Submit

December 4, 2008

Conditions

Keywords

TBcommunitycommunity health workersEthiopiaidentify suspects of pulmonary tuberculosiscollect sputum specimen for examinationtreat smear positive cases in the community

Outcome Measures

Primary Outcomes (1)

  • smear positive tuberculosis case notification rate

    september 2006 - setmeber 2007

Secondary Outcomes (1)

  • smear positive treatment success rate

    september 2006 - April 2007

Study Arms (2)

1

communities where tuberculosis patients followed the conventional health facility based tuberculosis case finding and treatment

2

community where suspects of pulmonary tuberculosis were identified by community health workers and received treatment in the community

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

suspects of pulmonary tuberculosis in the study are. In group two suspects were identified and treated bo community health workers while in group on used the conventional health facility based tuberculosis diagnosis and treatment

You may qualify if:

  • suspects of pulmonary tuberculosis

You may not qualify if:

  • not in the study area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dale and Wonsho districts Sidama zone, Southern Ethiopia

Irgalem, Snnpr, 149, Ethiopia

Location

Related Publications (2)

  • 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.

  • Datiko DG, Lindtjorn B. Health extension workers improve tuberculosis case detection and treatment success in southern Ethiopia: a community randomized trial. PLoS One. 2009;4(5):e5443. doi: 10.1371/journal.pone.0005443. Epub 2009 May 8.

MeSH Terms

Conditions

Tuberculosis, Pulmonary

Condition Hierarchy (Ancestors)

TuberculosisMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Daniel G Datiko, MD

    CIH of Bergen University and RHB of SNNPRS Ethiopia

    PRINCIPAL INVESTIGATOR
  • Bernt Lindtjorn

    CIH UIB

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 3, 2008

First Posted

December 5, 2008

Study Start

September 1, 2006

Primary Completion

September 1, 2007

Study Completion

April 1, 2008

Last Updated

December 5, 2008

Record last verified: 2008-12

Locations