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

This study is currently recruiting participants.

Verified by University of Cape Town, March 2004

First Received: September 12, 2005 Last Updated: October 23, 2007 History of Changes

Sponsors and Collaborators:	University of Cape Town Free State Department of Health Medical Research Council, South Africa Knowledge Translation Programme, University of Toronto Institute for Clinical Evaluative Sciences, Toronto London School of Hygiene and Tropical Medicine University of the Western Cape
Information provided by:	University of Cape Town
ClinicalTrials.gov Identifier:	NCT00203762

Purpose

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.

Condition	Intervention
Tuberculosis	Behavioral: Public sector antiretroviral treatment programmes

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
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

Resource links provided by NLM:

MedlinePlus related topics: Childhood Immunization Tuberculosis

U.S. FDA Resources

Further study details as provided by University of Cape Town:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	39
Study Start Date:	May 2003
Estimated Study Completion Date:	December 2006

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

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00203762

Contacts

Contact: L R Fairall, MBChB	+27 21 4066919 ext 6919	lfairall@uctgsh1.uct.ac.za
Contact: G M Rembe, BSc(Hons)	+27 21 4066928 ext 6928	grembe@uctgsh1.uct.ac.za

Locations

South Africa, Western Cape
University of Cape Town Lung Institute	Recruiting
Cape Town, Western Cape, South Africa, 7937
Contact: L R Fairall, MBChB +27 21 4066919 ext 6919 lfairall@uctgsh1.uct.ac.za
Contact: G M Rembe, BSc(Hons) +27 21 4066928 ext 6928 grembe@uctgsh1.uct.ac.za
Principal Investigator: L R Fairall, MBChB

Sponsors and Collaborators

University of Cape Town

Free State Department of Health

Medical Research Council, South Africa

Knowledge Translation Programme, University of Toronto

Institute for Clinical Evaluative Sciences, Toronto

London School of Hygiene and Tropical Medicine

University of the Western Cape

Investigators

Principal Investigator:

L R Fairall, MBChB

University of Cape Town Lung Institute

More Information

No publications provided

Study ID Numbers:	IDRC 102770-001
Study First Received:	September 12, 2005
Last Updated:	October 23, 2007
ClinicalTrials.gov Identifier:	NCT00203762 History of Changes
Health Authority:	South Africa: Medicines Control Council

Keywords provided by University of Cape Town:

Pragmatic cluster non-randomized controlled trial
antiretroviral treatment
tuberculosis

childhood immunization
primary care
resource-restricted settings

Study placed in the following topic categories:

Bacterial Infections
Gram-Positive Bacterial Infections
Mycobacterium Infections
Tuberculosis

Additional relevant MeSH terms:

Bacterial Infections
Gram-Positive Bacterial Infections
Mycobacterium Infections
Tuberculosis
Actinomycetales Infections

ClinicalTrials.gov processed this record on September 11, 2009