NCT00203762

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

October 24, 2007

Status Verified

March 1, 2004

First QC Date

September 12, 2005

Last Update Submit

October 23, 2007

Conditions

Keywords

Pragmatic cluster non-randomized controlled trialantiretroviral treatmenttuberculosischildhood immunizationprimary careresource-restricted settings

Outcome Measures

Primary Outcomes (3)

  • TB case detection

  • TB treatment completion

  • Measles immunization completed by 18 months

Secondary Outcomes (5)

  • TB cure rate

  • TB mortality rate

  • TB treatment failure rate

  • TB treatment interruption rate

  • Proportion of TB cases that smear positive

Interventions

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Clinics:
  • Clinics earmarked for the second year of the rollout of the antiretroviral treatment programme.
  • Patients:
  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cape Town Lung Institute

Cape Town, Western Cape, 7937, South Africa

RECRUITING

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • L R Fairall, MBChB

    University of Cape Town Lung Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

G M Rembe, BSc(Hons)

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

May 1, 2003

Study Completion

December 1, 2006

Last Updated

October 24, 2007

Record last verified: 2004-03

Locations