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

NCT ID: NCT00203762

Last Updated: 2007-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2006-12-31

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.

Conditions

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Tuberculosis

Keywords

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Public sector antiretroviral treatment programmes

Intervention Type BEHAVIORAL

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Free State Department of Health

UNKNOWN

Sponsor Role collaborator

Medical Research Council, South Africa

OTHER

Sponsor Role collaborator

Knowledge Translation Programme, University of Toronto

OTHER

Sponsor Role collaborator

Institute for Clinical Evaluative Sciences

OTHER

Sponsor Role collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role collaborator

University of the Western Cape

OTHER

Sponsor Role collaborator

University of Cape Town

OTHER

Sponsor Role lead

Principal Investigators

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L R Fairall, MBChB

Role: PRINCIPAL_INVESTIGATOR

University of Cape Town Lung Institute

Locations

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University of Cape Town Lung Institute

Cape Town, Western Cape, South Africa

Site Status RECRUITING

Countries

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South Africa

Central Contacts

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L R Fairall, MBChB

Role: CONTACT

Phone: +27 21 4066919

Email: [email protected]

G M Rembe, BSc(Hons)

Role: CONTACT

Phone: +27 21 4066928

Email: [email protected]

Facility Contacts

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L R Fairall, MBChB

Role: primary

G M Rembe, BSc(Hons)

Role: backup

Other Identifiers

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IDRC 102770-001

Identifier Type: -

Identifier Source: org_study_id