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

This study has been completed.
Sponsor:
Collaborators:
The Regional Government of Tigray,Ethiopia
University of Nottingham
World Health Organization
Information provided by:
University of Leeds
ClinicalTrials.gov Identifier:
NCT00939419
First received: July 14, 2009
Last updated: July 15, 2009
Last verified: July 2009
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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.

Resource links provided by NLM:


Further study details as provided by University of Leeds:

Primary Outcome Measures:
  • Cured and successful completion of treatment of smear positive and smear negative pulmonary tuberculosis cases. [ Time Frame: August 2005 to January 2007 ] [ Designated as safety issue: No ]

Enrollment: 924
Study Start Date: January 2005
Study Completion Date: February 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00939419

Locations
Ethiopia
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
Investigators
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

Additional Information:
Publications:
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
Study First Received: July 14, 2009
Last Updated: July 15, 2009
Health Authority: Ethiopia: Ethical Review Committee

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

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

ClinicalTrials.gov processed this record on November 20, 2014