Clinical trial NCT00203762: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Tuberculosis
Keywords: Pragmatic cluster non-randomized controlled trial
antiretroviral treatment
tuberculosis
childhood immunization
primary care
resource-restricted settings
Lead sponsor: University of Cape Town
Sponsor class: OTHER
Collaborators: name: Free State Department of Health
name: Medical Research Council, South Africa
name: Knowledge Translation Programme, University of Toronto
name: Institute for Clinical Evaluative Sciences
name: London School of Hygiene and Tropical Medicine
name: University of the Western Cape
First posted: 2005-09-20
Enrollment: 39
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: TB case detection
measure: TB treatment completion
measure: Measles immunization completed by 18 months
Secondary outcomes:
measure: TB cure rate
measure: TB mortality rate
measure: TB treatment failure rate
measure: TB treatment interruption rate
measure: Proportion of TB cases that smear positive
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: University of Cape Town Lung Institute
state: Western Cape
Study officials:
affiliation: University of Cape Town Lung Institute
name: L R Fairall, MBChB
role: PRINCIPAL_INVESTIGATOR
References: