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Effect of Public Sector Antiretroviral Treatment Programme on Tuberculosis and Immunization Care

Primary Purpose

Tuberculosis

Status
Unknown status
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Public sector antiretroviral treatment programmes
Sponsored by
University of Cape Town
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tuberculosis focused on measuring Pragmatic cluster non-randomized controlled trial, antiretroviral treatment, tuberculosis, childhood immunization, primary care, resource-restricted settings

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Clinics: Intervention: 15 primary care clinics participating in the first phases of the national antiretroviral treatment programme Control: 24 primary care clinics yet to be included in the national antiretroviral treatment programme randomly selected after stratification for health district and ranking of clinic size. Patients: All patients attending tuberculosis and childhood immunization programmes at the above 39 clinics one year before and one year after antiretroviral treatment services commenced in these facilities. Exclusion Criteria: Clinics: Clinics earmarked for the second year of the rollout of the antiretroviral treatment programme. Patients: None.

Sites / Locations

  • University of Cape Town Lung InstituteRecruiting

Outcomes

Primary Outcome Measures

TB case detection
TB treatment completion
Measles immunization completed by 18 months

Secondary Outcome Measures

TB cure rate
TB mortality rate
TB treatment failure rate
TB treatment interruption rate
Proportion of TB cases that smear positive

Full Information

First Posted
September 12, 2005
Last Updated
October 23, 2007
Sponsor
University of Cape Town
Collaborators
Free State Department of Health, Medical Research Council, South Africa, Knowledge Translation Programme, University of Toronto, Institute for Clinical Evaluative Sciences, London School of Hygiene and Tropical Medicine, University of the Western Cape
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1. Study Identification

Unique Protocol Identification Number
NCT00203762
Brief Title
Effect of Public Sector Antiretroviral Treatment Programme on Tuberculosis and Immunization Care
Official Title
Effect of the South African Public Sector Antiretroviral Treatment Programme on the Performance of Tuberculosis and Immunization Programmes - A Cluster Controlled (Non-Randomized) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2004
Overall Recruitment Status
Unknown status
Study Start Date
May 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Cape Town
Collaborators
Free State Department of Health, Medical Research Council, South Africa, Knowledge Translation Programme, University of Toronto, Institute for Clinical Evaluative Sciences, London School of Hygiene and Tropical Medicine, University of the Western Cape

4. Oversight

5. Study Description

Brief Summary
A scale-up of public sector antiretroviral treatment (ART) programmes may divert scarce resources from other priority primary care programmes like tuberculosis and childhood immunization. The purpose of this study is to compare the performance of tuberculosis (TB) and childhood immunization programmes in primary care facilities participating in the South African national antiretroviral treatment programme with those which have yet to be included in the ART programme.
Detailed Description
Large-scale public sector antiretroviral treatment programmes, like those planned for sub-Saharan Africa, will compete for scarce resources, in particular scarce human resources, with other priority primary care programmes like tuberculosis and childhood immunization. This could lead to impaired performance in other priority programmes like childhood immunization while health workers are distracted by the demands of establishing and maintaining ART programmes. On the other hand, ART provisions may have positive spin-offs for related programmes like improved case detection of tuberculosis among HIV-positive patients seeking ART. The impact of the ART programme on primary healthcare more generally must be weighed against the benefits of providing antiretroviral treatment to those with AIDS. Comparison: Primary care clinics in the Free State province, South Africa. 15 clinics participating in the first phases of the national ART programme will be compared with 24 clinics which have yet to be included in the national treatment programme. The unit of analysis will be the clinic although the outcome data will be collected from individual patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis
Keywords
Pragmatic cluster non-randomized controlled trial, antiretroviral treatment, tuberculosis, childhood immunization, primary care, resource-restricted settings

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
39 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Public sector antiretroviral treatment programmes
Primary Outcome Measure Information:
Title
TB case detection
Title
TB treatment completion
Title
Measles immunization completed by 18 months
Secondary Outcome Measure Information:
Title
TB cure rate
Title
TB mortality rate
Title
TB treatment failure rate
Title
TB treatment interruption rate
Title
Proportion of TB cases that smear positive

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinics: Intervention: 15 primary care clinics participating in the first phases of the national antiretroviral treatment programme Control: 24 primary care clinics yet to be included in the national antiretroviral treatment programme randomly selected after stratification for health district and ranking of clinic size. Patients: All patients attending tuberculosis and childhood immunization programmes at the above 39 clinics one year before and one year after antiretroviral treatment services commenced in these facilities. Exclusion Criteria: Clinics: Clinics earmarked for the second year of the rollout of the antiretroviral treatment programme. Patients: None.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
L R Fairall, MBChB
Phone
+27 21 4066919
Ext
6919
Email
lfairall@uctgsh1.uct.ac.za
First Name & Middle Initial & Last Name or Official Title & Degree
G M Rembe, BSc(Hons)
Phone
+27 21 4066928
Ext
6928
Email
grembe@uctgsh1.uct.ac.za
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
L R Fairall, MBChB
Organizational Affiliation
University of Cape Town Lung Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cape Town Lung Institute
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7937
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
L R Fairall, MBChB
Phone
+27 21 4066919
Ext
6919
Email
lfairall@uctgsh1.uct.ac.za
First Name & Middle Initial & Last Name & Degree
G M Rembe, BSc(Hons)
Phone
+27 21 4066928
Ext
6928
Email
grembe@uctgsh1.uct.ac.za
First Name & Middle Initial & Last Name & Degree
L R Fairall, MBChB

12. IPD Sharing Statement

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Effect of Public Sector Antiretroviral Treatment Programme on Tuberculosis and Immunization Care

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