The Effectiveness of Health Facility-based and Community-based Care for Tuberculosis
This study has been completed.
Sponsor:
University of Leeds
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
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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:
|
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
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 Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections |
Bacterial Infections Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections |
ClinicalTrials.gov processed this record on June 17, 2013