TuberculosisNCT00203762
Effect of Public Sector Antiretroviral Treatment Programme on Tuberculosis and Immunization Care
A study testing Public sector antiretroviral treatment programmes in people with Tuberculosis, run by University of Cape Town at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Public sector antiretroviral treatment programmes
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 39 participants
- Where
- 1 siteSouth Africa
- Study dates
- May 2003to Dec 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Clinics:
- Clinics earmarked for the second year of the rollout of the antiretroviral treatment programme.
- Patients:
- None.
Trial locations and contacts
1 site in 1 country.
South Africa1 site, 1 recruiting
- Recruiting
University of Cape Town Lung Institute
Cape Town, Western Cape, 7937
L R Fairall, MBChB, +27 21 4066919 ext. 6919, lfairall@uctgsh1.uct.ac.za
G M Rembe, BSc(Hons), +27 21 4066928 ext. 6928, grembe@uctgsh1.uct.ac.za
About this 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
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.
Read the 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.
- Conditions
- Tuberculosis
- Being tested
- Public sector antiretroviral treatment programmes
- Keywords
- Pragmatic cluster non-randomized controlled trial, antiretroviral treatment, tuberculosis, childhood immunization, primary care, resource-restricted settings
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Public sector antiretroviral treatment programmesBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startMay 2003
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cape Town
- Sponsor type
- University, hospital or other
- Collaborators
- Free State Department of Health, Medical Research Council, South Africa, University of Toronto, Institute for Clinical Evaluative Sciences, London School of Hygiene and Tropical Medicine, University of the Western Cape
- Investigators
- L R Fairall, MBChB, Principal investigator, University of Cape Town Lung Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00203762
- Sponsor's protocol ID
- IDRC 102770-001
- Status last verified
- Mar 2004
- First submitted
- 12 Sep 2005
- Last updated
- 24 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00203762
- Acronym / sponsor ID
- IDRC 102770-001
- Conditions
- Tuberculosis
- Keywords
- Pragmatic cluster non-randomized controlled trial, antiretroviral treatment, tuberculosis, childhood immunization, primary care, resource-restricted settings
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- University of Cape TownUniversity, hospital or other
- Collaborators
- Free State Department of Health, Medical Research Council, South Africa, University of Toronto, Institute for Clinical Evaluative Sciences, London School of Hygiene and Tropical Medicine, University of the Western Cape
- Study start
- May 2003
- Study completion
- Dec 2006
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- 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.
Key exclusion criteria (4 listed)
- Clinics earmarked for the second year of the rollout of the antiretroviral treatment programme.
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Public sector antiretroviral treatment programmes | Behavioural | – |
Primary outcome
TB case detection
TB treatment completion
Measles immunization completed by 18 months
5 secondary outcomes
TB cure rate
TB mortality rate
TB treatment failure rate
TB treatment interruption rate
Proportion of TB cases that smear positive
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
L R Fairall, MBChB principal investigator
University of Cape Town Lung Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Public sector antiretroviral treatment programmes in people with Tuberculosis, run by University of Cape Town at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact L R Fairall, MBChB (+27 21 4066919 ext. 6919, lfairall@uctgsh1.uct.ac.za), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TB case detection. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2007.