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

NCT00939419 | Completed Phase 4 DMC

• 1 other identifier: 3140-ET
• Study Type: interventional
• Target: 924
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Tuberculosis care; community tuberculosis care; Health facility based tuberculosis care

Outcome Measures

Primary Outcomes (1)

• Cured and successful completion of treatment of smear positive and smear negative pulmonary tuberculosis cases.

  August 2005 to January 2007

Study Arms (3)

Health worker TB care group

OTHER

Other: Health workers TB care group

Community health worker TB care group

OTHER

Other: Community health workers TB care group

Self-administered treatment group

OTHER

Other: Self-administered treatment group

Interventions

Health workers TB care group OTHER

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

Also known as: Health facility-based tuberculosis care

Health worker TB care group

Community health workers TB care group OTHER

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.

Also known as: Community based TB care

Community health worker TB care group

Self-administered treatment group OTHER

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.

Also known as: Patient-administered treatment, Self-care

Self-administered treatment group

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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-)

You may not qualify if:

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

Sponsors & Collaborators

• University of Leeds: lead
• The Regional Government of Tigray,Ethiopia: collaborator
• University of Nottingham: collaborator
• World Health Organization: collaborator

Study Sites (1)

Tigray Regional Health Bureau, Department for Diseases Prevention and Control

Mek'ele, Tigray, 7, Ethiopia

Location

Related Publications (2)

• Mesfin MM, Newell JN, Walley JD, Gessessew A, Madeley RJ. Delayed consultation among pulmonary tuberculosis patients: a cross sectional study of 10 DOTS districts of Ethiopia. BMC Public Health. 2009 Feb 9;9:53. doi: 10.1186/1471-2458-9-53.

  PMID: 19203378 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Tuberculosis, Pulmonary

Interventions

Self Care

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Mengiste M Melese, MD, MPH, PhD

  Nuffield Centre for International Health and Development, Institute of Health Sciences, University of Leeds

  PRINCIPAL INVESTIGATOR

• Madley J Richard, MD

  University of Nottingham

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 14, 2009
• First Posted: July 15, 2009
• Study Start: January 1, 2005
• Primary Completion: December 1, 2006
• Study Completion: February 1, 2007
• Last Updated: July 16, 2009

Record last verified: 2009-07

Locations

ET (1)