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TuberculosisNCT00214708

Can Screening People Registering With Primary Care Improve the Detection of Tuberculosis?

An observational study of Tuberculosis, run by Barts & The London NHS Trust at 1 site in United Kingdom.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This randomised controlled trial tests whether screening people registering with general practices cost-effectively increases the detection of tuberculosis. The study objectives are to: 1. Read more about this study

Who is it for?
Ages Up to 105 years
Conditions the study is for
Tuberculosis
What is being tested?
Screening for Tuberculosis
Type of treatment
Surgery or procedure
How many people
0 participants
Where
1 siteUnited Kingdom
Study dates
Jan 2002to Sep 2002
Phase
Observational
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 Up to 105 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • The intervention is screening for TB in general practices which were randomised to control or intervention

Who cannot join

  • Practices that refused to participate could not be included. We excluded the general practice where the pilot study was undertaken

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • City and Hackney

    London, E9

Other trials in United Kingdom

About this study

Official title: Can Screening People Registering With Primary Care Improve the Detection of Tuberculosis? A Cluster Randomised Controlled Trial in an East London Primary Care Trust

This randomised controlled trial tests whether screening people registering with general practices cost-effectively increases the detection of tuberculosis. The study objectives are to:

  1. recruit, and randomise with stratification, forty Hackney general practices to usual activity or screening for TB primarily during registration health checks (by practice nurses and GPs) and transfer-in visits for children (by health visitors)
  2. implement a screening programme comprising education, resources and clinical support for intervention practices using proven behaviour change strategies
  3. gather outcomes and costs
  4. build research capacity within an ELENoR Primary Care Research Team and across a Primary Care Trust.

The primary outcome is the proportion of TB cases identified in primary care. The study is powered to detect a 20% increase (from 55% to 75%) in the detection of new cases of TB in primary care with 80% power at the 5% significance level. Secondary outcomes are rates of prophylaxis for latent TB infection (LTBI), BCG immunisation, smear negative (early) TB and costs. Analyses will be by intention to treat.

Read the detailed description

To date, studies of screening for tuberculosis have used relatively weak designs. A randomised trial would give stronger evidence as to whether screening is worthwhile and therefore would be welcome. We have tested the feasibility of screening in two general practices in Hackney; our results suggest that it is simple and straightforward, that the people screened were comfortable taking part, and that screening does indeed identify people with tuberculosis.

How (or indeed whether) to screen for tuberculosis constitutes a major policy issue for inner city public health care. Our work will go some way toward answering this important question and will have local, national and international relevance. There are important benefits for those taking part. First, the project is part of a local health development scheme which encourages GPs to register refugees and asylum seekers. This means that a group of people who find it difficult to get health care will be more likely to be able to find a GP. Second, people registering with general practices who are screening will all have a brief discussion about tuberculosis when they attend a health check at the surgery. This will make people more informed about tuberculosis and help to remove the stigma that attends tuberculosis. Third, screening is likely to identify people with tuberculosis, or who need BCG vaccination to prevent tuberculosis. These people will benefit from early treatment or immunisation.

We will invite all general practices in Hackney to take part. Practices that agree will then be randomly allocated (by a computer programme) into two groups: practices who will screen and those who will carry on as usual without screening. The project researcher responsible for data collection will not know to which group the practices have been assigned. Practices allocated to the screening group will be offered a programme designed to encourage screening as part of the new patient registration checks (by practice nurses and GPs) and during children's transfer-in visits (by health visitors). The programme is founded on proven ways of helping people change how they work and includes the following: an education programme run by the primary care research team, with a local chest consultant as opinion leader; Heaf guns, Heaf heads, and tuberculin (to test for presence of TB); TB screening guidelines; regular support and advice from the local TB specialist nurse; incorporation of a TB screening template into the practice computer consulting system; and an incentive fee paid to the practices for carrying out the Heaf tests. TB identication rates for both groups will be ascertained after 25 months of screening. The cost of implementing the screening process will also be measured.

Patients / public involvment (subjects and partners):

People attending for new registration checks and children seen at transfer-in visits are the study participants. They will be informed about the study (using information sheets in various languages); they can decline to take part if they like. Public involvement in the design and execution of the study comes in three forms. First, the East London Refuge and Asylum seeker worker has contributed to the study design and will be involved throught the study. Second, the work is part of an East London Health Improvement Plan, which itself has public support. Third, the study has approval from the East London and Esssex Network of Researchers' Research Advisory Committee, which has two consumer representatives

Conditions
Tuberculosis
Being tested
Screening for Tuberculosis
Keywords
Tuberculosis, Screening, Heaf, BCG
Medical subject headings
Tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Screening for TuberculosisProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary outcome is the proportion of TB cases identified in primary care. The study is powered to detect a 20% increase (from 55% to 75%) in the detection of new cases of TB in primary care with 80% power at the 5% significance level.

Secondary outcomes (1)
  1. Secondary outcomes are rates of prophylaxis for latent TB infection (LTBI), BCG immunisation, smear negative (early) TB and costs. Analyses will be by intention to treat.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2005 (estimated)
  2. Study startJan 2002 (estimated)
  3. Primary completionSep 2002 (estimated)
  4. Study completionSep 2002 (estimated)

Why it stopped: Study withdrawn

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00214708
Sponsor's protocol ID
TB-02-04-CG
Status last verified
Feb 2025
First submitted
16 Sep 2005
Last updated
6 Feb 2025
Results posted
No

Publications

  • Griffiths C, Sturdy P, Brewin P, Bothamley G, Eldridge S, Martineau A, MacDonald M, Ramsay J, Tibrewal S, Levi S, Zumla A, Feder G. Educational outreach to promote screening for tuberculosis in primary care: a cluster randomised controlled trial. Lancet. 2007 May 5;369(9572):1528-1534. doi: 10.1016/S0140-6736(07)60707-7.

    PubMed 17482983

Questions about this trial

What is this clinical trial studying?

An observational study of Tuberculosis, run by Barts & The London NHS Trust at 1 site in United Kingdom.

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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 6 Feb 2025. 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 United Kingdom. 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?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary outcome is the proportion of TB cases identified in primary care. The study is powered to detect a 20% increase (from 55% to 75%) in the detection of new cases of TB in primary care with 80% power at the 5% significance level.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00214708, which also lists 1 linked publication.

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 6 Feb 2025.

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