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| Sponsors and Collaborators: |
University of Leeds The Regional Government of Tigray,Ethiopia University of Nottingham, Division of Epidemiology and Public health. The World Health Organisation, Ethiopia |
|---|---|
| Information provided by: | University of Leeds |
| ClinicalTrials.gov Identifier: | NCT00939419 |
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 IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Investigator), Parallel Assignment, Efficacy Study |
| Official Title: | A Randomised Control Trial on the Effectiveness of Three Modalities of Tuberculosis Treatment Supervision Under DOTS Strategy in Ethiopia. |
| 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
|
| 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.
|
| 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.
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Show Detailed Description Eligibility| Ages Eligible for Study: | 15 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Ethiopia, Tigray | |
| Tigray Regional Health Bureau, Department for Diseases Prevention and Control | |
| Mekelle, Tigray, Ethiopia, 7 | |
| 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 Medical School, Division of Epidemiology and Public health. |
More Information
| Responsible Party: | Nuffield Centre for International Health and Development, Leeds Institute of Health Sciences. ( Mengiste Mesfin Melese ) |
| Study ID Numbers: | 3140-ET |
| Study First Received: | July 14, 2009 |
| Last Updated: | July 15, 2009 |
| ClinicalTrials.gov Identifier: | NCT00939419 History of Changes |
| Health Authority: | Ethiopia: Ethical Review Committee |
|
Tuberculosis care community tuberculosis care Health facility based tuberculosis care |
|
Bacterial Infections Gram-Positive Bacterial Infections Respiratory Tract Infections Respiratory Tract Diseases |
Lung Diseases Tuberculosis, Pulmonary Mycobacterium Infections Tuberculosis |
|
Bacterial Infections Gram-Positive Bacterial Infections Respiratory Tract Infections Respiratory Tract Diseases Lung Diseases |
Tuberculosis, Pulmonary Mycobacterium Infections Tuberculosis Actinomycetales Infections |
