- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00203762
Effect of Public Sector Antiretroviral Treatment Programme on Tuberculosis and Immunization Care
Effect of the South African Public Sector Antiretroviral Treatment Programme on the Performance of Tuberculosis and Immunization Programmes - A Cluster Controlled (Non-Randomized) Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: L R Fairall, MBChB
- Phone Number: 6919 +27 21 4066919
- Email: lfairall@uctgsh1.uct.ac.za
Study Contact Backup
- Name: G M Rembe, BSc(Hons)
- Phone Number: 6928 +27 21 4066928
- Email: grembe@uctgsh1.uct.ac.za
Study Locations
-
-
Western Cape
-
Cape Town, Western Cape, South Africa, 7937
- Recruiting
- University of Cape Town Lung Institute
-
Contact:
- L R Fairall, MBChB
- Phone Number: 6919 +27 21 4066919
- Email: lfairall@uctgsh1.uct.ac.za
-
Contact:
- G M Rembe, BSc(Hons)
- Phone Number: 6928 +27 21 4066928
- Email: grembe@uctgsh1.uct.ac.za
-
Principal Investigator:
- L R Fairall, MBChB
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
TB case detection
|
TB treatment completion
|
Measles immunization completed by 18 months
|
Secondary Outcome Measures
Outcome Measure |
---|
TB cure rate
|
TB mortality rate
|
TB treatment failure rate
|
TB treatment interruption rate
|
Proportion of TB cases that smear positive
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: L R Fairall, MBChB, University of Cape Town Lung Institute
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IDRC 102770-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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