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The Effectiveness of Health Facility-based and Community-based Care for Tuberculosis

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ClinicalTrials.gov Identifier: NCT00939419
Recruitment Status : Completed
First Posted : July 15, 2009
Last Update Posted : July 16, 2009
Information provided by:

Study Description
Brief Summary:
The purpose of the study is whether the provision of tuberculosis care using volunteer community health workers or self-administered treatment for 7 months is equally effective with the existing 8 months of TB care in public health facilities by health workers. Patient care by volunteer community health workers and 7 months of self-administered treatment are more patient-convenient delivery options than the ongoing TB care in health facility.

Condition or disease Intervention/treatment Phase
Tuberculosis, Pulmonary Quality of Health Care Community Health Care Volunteer Health Workers Tuberculosis Treatment Effectiveness Other: Health workers TB care group Other: Community health workers TB care group Other: Self-administered treatment group Phase 4

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 924 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Randomised Control Trial on the Effectiveness of Three Modalities of Tuberculosis Treatment Supervision Under DOTS Strategy in Ethiopia.
Study Start Date : January 2005
Primary Completion Date : December 2006
Study Completion Date : February 2007

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Arms and Interventions

Arm Intervention/treatment
Health worker TB care group Other: Health workers TB care group
Patients received daily tuberculosis care in public health facilities by trained health worker during the first 8 weeks followed by self-treatment for the remaining 6 months. Patients were expected to visit public health facility every month for follow up. Supervisory support was given to TB focal persons by the respective district TB coordinators on a monthly basis. Anti-TB drugs were delivered to health institutions on a quarterly basis by district TB coordinators during supervision
Other Name: Health facility-based tuberculosis care
Community health worker TB care group Other: Community health workers TB care group
Patients had daily TB care including observation of treatment by the CHWs in their villages for the second month. Thereafter, treatment was self-administered with a monthly follow up visit to a CHW home for the remaining 6 months. Technical support and anti-TB drugs were given to CHWs by the respective public health facility TB health worker every fortnight.
Other Name: Community based TB care
Self-administered treatment group Other: Self-administered treatment group
Patients took their medication at home for seven months after one month of daily care in public health facilities by TB health workers. They were taught by the TB health worker to collect their anti-TB drugs fortnightly and report missed daily doses. Follow up assessment and continued support was made by TB health worker on a monthly basis in their nearby health facility.
Other Names:
  • Patient-administered treatment
  • Self-care

Outcome Measures

Primary Outcome Measures :
  1. Cured and successful completion of treatment of smear positive and smear negative pulmonary tuberculosis cases. [ Time Frame: August 2005 to January 2007 ]

Eligibility Criteria

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • age 15 years or above
  • no previous tuberculosis treatment
  • sputum exam positive for tuberculosis (PTB+); or negative sputum results but with consistent clinical and chest x-ray features (PTB-)

Exclusion Criteria:

  • age less than 15 years
  • previously treated with anti-TB drugs
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00939419

Tigray Regional Health Bureau, Department for Diseases Prevention and Control
Mekelle, Tigray, Ethiopia, 7
Sponsors and Collaborators
University of Leeds
The Regional Government of Tigray,Ethiopia
University of Nottingham
World Health Organization
Principal Investigator: Mengiste M Melese, MD, MPH, PhD Nuffield Centre for International Health and Development, Institute of Health Sciences, University of Leeds
Study Director: Madley J Richard, MD University of Nottingham
More Information

Mengiste M Mesfin et al. Community-based tuberculosis control interventions in pilot districts of Tigray, Ethiopia: baseline studies Ethiop. J. Health Dev. 2005; 19 (Special Issue): 1-37.

Responsible Party: Mengiste Mesfin Melese, Nuffield Centre for International Health and Development, Leeds Institute of Health Sciences.
ClinicalTrials.gov Identifier: NCT00939419     History of Changes
Other Study ID Numbers: 3140-ET
First Posted: July 15, 2009    Key Record Dates
Last Update Posted: July 16, 2009
Last Verified: July 2009

Keywords provided by University of Leeds:
Tuberculosis care
community tuberculosis care
Health facility based tuberculosis care

Additional relevant MeSH terms:
Tuberculosis, Pulmonary
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections