Tuberculosis (TB)PRAGMATIC-DCENCT07024836
PRecision biomArker-Guided MAnagement of TuberculosIs Contacts: a Discrete Choice Experiment
An observational study of Tuberculosis (TB), run by University College, London at 1 site in United Kingdom.
Trial summary
This study is part of a broader programme of work to develop and pilot a randomised-controlled trial of new tests to identify people who will benefit most from preventive treatment for tuberculosis (TB). The aim of the current study is to explore factors affecting patient decisions to start preventive treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis (TB)
- How many people
- 430 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 May 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. Adults tested, or eligible for testing, for latent tuberculosis infection in routine clinical services. 2. Nurses, doctors or allied health professionals who have any experience of testing or treatment for TB or latent TB infection in UK services.
Who may be able to join
- Adults (aged ≥18 years) who have been tested for latent TB infection in routine clinical services, or are eligible for testing. Eligible people for testing include migrants from countries with high TB incidence (entered UK within 5 years), people with recent contact with a person with TB disease, and people eligible for LTBI screening prior to starting immunosuppression or through occupational health testing.
Who cannot join
- Unable to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Whittington Hospital
London
Rubin Rose-Key, 07771472837, r.rose-key@ucl.ac.uk
Mahdad Noursadeghi
About this study
This study is part of a broader programme of work to develop and pilot a randomised-controlled trial of new tests to identify people who will benefit most from preventive treatment for tuberculosis (TB). The aim of the current study is to explore factors affecting patient decisions to start preventive treatment. The specific objectives are to understand how patients make decisions about preventive treatment initiation for TB (stage 1); and to design and conduct a "discrete choice experiment" survey to further evaluate preferences (stage 2).
Read the detailed description
We will perform up to 30 semi-structured interviews among people undergoing testing for latent TB infection, as part of routine clinical screening programmes (stage 1). Adults (aged ≥18 years) who have been or are being tested for LTBI in routine clinical services will be eligible for inclusion through purposive sampling. The findings from the qualitative study will then be used to inform the a discrete choice experiment (DCE). The DCE will be conducted to quantify the trade-off between future TB risk and preventive treatment acceptance, from patient and healthcare provided perspectives (stage 2).
- Conditions
- Tuberculosis (TB)
- Keywords
- preference, discrete choice experiment, qualitative, latent tuberculosis infection
- Medical subject headings
- Tuberculosis, Latent Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patient participants for qualitative stage (stage 1) | Semi-structured interviews will first be conducted among 20-30 people undergoing testing for latent tuberculosis infection, as part of routine clinical screening programmes (Stage 1). | |
| Patient participants for discrete choice experiment (stage 2) | 200 patients will then undertake a quantitative discrete choice experiment to evaluate preferences and trade-offs that influence acceptance of preventive TB treatment. | |
| Healthcare worker participants for discrete choice experiment (stage 2) | 200 healthcare workers will also undertake a quantitative discrete choice experiment to evaluate preferences and trade-offs that influence recommendation of preventive TB treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preventive treatment acceptance
Discrete choice experiment data will be analysed to evaluate the primary outcome of preventive TB treatment acceptance in the survey.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start22 May 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis (TB)Studies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 430 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aberdeen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07024836
- Sponsor's protocol ID
- 175542
- Acronym
- PRAGMATIC-DCE
- Status last verified
- Jun 2025
- First submitted
- 16 May 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised data from the discrete choice experiment will be made publicly available at the time of peer-reviewed publication.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRecision biomArker-Guided MAnagement of TuberculosIs Contacts: a Discrete Choice Experiment
- ClinicalTrials.gov ID
- NCT07024836
- Acronym / sponsor ID
- PRAGMATIC-DCE / 175542
- Conditions
- Tuberculosis (TB)
- Keywords
- preference, discrete choice experiment, qualitative, latent tuberculosis infection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 430 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- University of Aberdeen
- Study start
- 22 May 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Jun 2025 (actual)
- 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.
This study is part of a broader programme of work to develop and pilot a randomised-controlled trial of new tests to identify people who will benefit most from preventive treatment for tuberculosis (TB). The aim of the current study is to explore factors affecting patient decisions to start preventive treatment. The specific objectives are to understand how patients make decisions about preventive treatment initiation for TB (stage 1); and to design and conduct a "discrete choice experiment" survey to further evaluate preferences (stage 2).
Detailed description
We will perform up to 30 semi-structured interviews among people undergoing testing for latent TB infection, as part of routine clinical screening programmes (stage 1). Adults (aged ≥18 years) who have been or are being tested for LTBI in routine clinical services will be eligible for inclusion through purposive sampling. The findings from the qualitative study will then be used to inform the a discrete choice experiment (DCE). The DCE will be conducted to quantify the trade-off between future TB risk and preventive treatment acceptance, from patient and healthcare provided perspectives (stage 2).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patient participants for qualitative stage (stage 1) | – | –Semi-structured interviews will first be conducted among 20-30 people undergoing testing for latent tuberculosis infection, as part of routine clinical screening programmes (Stage 1). |
| Patient participants for discrete choice experiment (stage 2) | – | –200 patients will then undertake a quantitative discrete choice experiment to evaluate preferences and trade-offs that influence acceptance of preventive TB treatment. |
| Healthcare worker participants for discrete choice experiment (stage 2) | – | –200 healthcare workers will also undertake a quantitative discrete choice experiment to evaluate preferences and trade-offs that influence recommendation of preventive TB treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Adults tested, or eligible for testing, for latent tuberculosis infection in routine clinical services. 2. Nurses, doctors or allied health professionals who have any experience of testing or treatment for TB or latent TB infection in UK services.
Key inclusion criteria (1 listed)
- Adults (aged ≥18 years) who have been tested for latent TB infection in routine clinical services, or are eligible for testing. Eligible people for testing include migrants from countries with high TB incidence (entered UK within 5 years), people with recent contact with a person with TB disease, and people eligible for LTBI screening prior to starting immunosuppression or through occupational health testing.
Key exclusion criteria (1 listed)
- Unable to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Preventive treatment acceptance
Time frame: Baseline
Discrete choice experiment data will be analysed to evaluate the primary outcome of preventive TB treatment acceptance in the survey.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Individual participant dataSharing planned: Yes. Anonymised data from the discrete choice experiment will be made publicly available at the time of peer-reviewed publication.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis (TB), run by University College, London 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: looking for participants now, as of the sponsor's last update on 17 Jun 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rishi K Gupta, PhD (020 3549 5979, r.gupta@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preventive treatment acceptance (time frame: Baseline). 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 17 Jun 2025.