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

NCT00939419 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 924

Last updated 2009-07-16

No results posted yet for this study

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.

Conditions

  • Tuberculosis, Pulmonary
  • Quality of Health Care
  • Community Health Care
  • Volunteer Health Workers
  • Tuberculosis Treatment Effectiveness

Interventions

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

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

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.

Sponsors & Collaborators

  • The Regional Government of Tigray,Ethiopia

    collaborator UNKNOWN
  • University of Nottingham

    collaborator OTHER
  • World Health Organization

    collaborator OTHER
  • University of Leeds

    lead OTHER

Principal Investigators

  • Mengiste M Melese, MD, MPH, PhD · Nuffield Centre for International Health and Development, Institute of Health Sciences, University of Leeds

  • Madley J Richard, MD · University of Nottingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2006-12-31
Completion
2007-02-28

Countries

  • Ethiopia

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00939419 on ClinicalTrials.gov