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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of the South African Public Sector Antiretroviral Treatment Programme on the Performance of Tuberculosis and Immunization Programmes - A Cluster Controlled (Non-Randomized) Trial

Conditions
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Tuberculosis

Intervention / Treatment
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* Behavioral: Public sector antiretroviral treatment programmes


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Public sector antiretroviral treatment programmes|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TB case detection |  |  | 
| TB treatment completion |  |  | 
| Measles immunization completed by 18 months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TB cure rate |  |  | 
| TB mortality rate |  |  | 
| TB treatment failure rate |  |  | 
| TB treatment interruption rate |  |  | 
| Proportion of TB cases that smear positive |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pragmatic cluster non-randomized controlled trial, antiretroviral treatment, tuberculosis, childhood immunization, primary care, resource-restricted settings