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

Tuberculosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00203762
• Other study ID #: IDRC 102770-001
• Status: Recruiting
• Phase: N/A
• First received: September 12, 2005
• Last updated: October 23, 2007
• Start date: May 2003
• Est. completion date: December 2006

Study information

• Verified date: March 2004
• Source: University of Cape Town
• Contact: L R Fairall, MBChB
• Phone: +27 21 4066919
• Email: lfairall[@]uctgsh1.uct.ac.za
• Is FDA regulated: No
• Health authority: South Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 39
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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:

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tuberculosis

Intervention

Behavioral:
• Public sector antiretroviral treatment programmes

Locations

Country	Name	City	State
South Africa	University of Cape Town Lung Institute	Cape Town	Western Cape

Sponsors (7)

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

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TB case detection
Primary	TB treatment completion
Primary	Measles immunization completed by 18 months
Secondary	TB cure rate
Secondary	TB mortality rate
Secondary	TB treatment failure rate
Secondary	TB treatment interruption rate
Secondary	Proportion of TB cases that smear positive