Improving Community Based Tuberculosis Care in Ethiopia (community)

• ClinicalTrials.gov Identifier: NCT00803322
• Recruitment Status: Completed
• First Posted: December 5, 2008
• Last Update Posted: December 5, 2008
• Sponsor: University of Bergen
• Collaborator: Centre for International Health, SNNP Regional health Bureau
• Information provided by: University of Bergen

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 Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified 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, 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.

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

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
• Current Responsible Party: Daniel Gemechu Datiko, Centre for International Health, SNNP Regional health Bureau
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Bergen
• Original Study Sponsor: Same as current
• 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