Improving Community Based Tuberculosis Care in Ethiopia (community)

Tracking Information
First Submitted Date	December 3, 2008
First Posted Date	December 5, 2008
Last Update Posted Date	December 5, 2008
Study Start Date	September 2006
Actual Primary Completion Date	September 2007 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: December 4, 2008)	smear positive tuberculosis case notification rate [ Time Frame: september 2006 - setmeber 2007 ]
Original Primary Outcome Measures	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures; (submitted: December 4, 2008)	smear positive treatment success rate [ Time Frame: september 2006 - April 2007 ]
Original Secondary Outcome Measures	Same as current
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Improving Community Based Tuberculosis Care in Ethiopia
Official Title	Community Health Workers Improve Tuberculosis Case Notification and Treatment Success in Southern Ethiopia
Brief Summary	The purpose of this study is to see if involving community health workers improves tuberculosis case finding and treatment outcome.
Detailed Description	Tuberculosis suspects in the study area Outcome smear positive tuberculosis cases identified smear positive tuberculosis cases treated
Study Type	Observational
Study Design	Observational Model: Cohort; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Probability 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
Condition	Pulmonary Tuberculosis
Intervention	Not Provided
Study Groups/Cohorts	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
Publications *	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.; Datiko DG, Lindtjørn 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: December 4, 2008)	318
Original Actual Enrollment	Same as current
Actual Study Completion Date	April 2008
Actual Primary Completion Date	September 2007 (Final data collection date for primary outcome measure)
Eligibility Criteria	Inclusion Criteria: suspects of pulmonary tuberculosis Exclusion Criteria: not in the study area
Sex/Gender	Sexes Eligible for Study: All
Ages	Child, Adult, Older Adult
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Ethiopia
Removed Location Countries
Administrative Information
NCT Number	NCT00803322
Other Study ID Numbers	0001; 001
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Daniel Gemechu Datiko, Centre for International Health, SNNP Regional health Bureau
Study Sponsor	University of Bergen
Collaborators	Centre for International Health, SNNP Regional health Bureau
Investigators	Principal Investigator: Daniel G Datiko, MD CIH of Bergen University and RHB of SNNPRS Ethiopia Study Director: Bernt Lindtjorn CIH UIB
PRS Account	University of Bergen
Verification Date	December 2008