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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00203762
Enrollment
39
Registered
2005-09-20
Start date
2003-05-31
Completion date
2006-12-31
Last updated
2007-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis

Keywords

Pragmatic cluster non-randomized controlled trial, antiretroviral treatment, tuberculosis, childhood immunization, primary care, resource-restricted settings

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.

Interventions

BEHAVIORALPublic sector antiretroviral treatment programmes

Sponsors

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

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

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

Secondary

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

Countries

South Africa

Contacts

Primary ContactL R Fairall, MBChB
lfairall@uctgsh1.uct.ac.za+27 21 4066919
Backup ContactG M Rembe, BSc(Hons)
grembe@uctgsh1.uct.ac.za+27 21 4066928

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026