PRecision biomArker-Guided MAnagement of TuberculosIs Contacts: a Discrete Choice Experiment (PRAGMATIC-DCE)

University College London (UCL)

Status: Enrolling

Conditions: Tuberculosis (TB)

Study type: Observational

Funder types: Other

Identifiers

NCT07024836

175542

Details and patient eligibility

About

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).

Full 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).

Enrollment: 430 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• Unable to provide informed consent.

Trial design

430 participants in 3 patient groups

Patient participants for qualitative stage (stage 1)

Description:

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)

Description:

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)

Description:

200 healthcare workers will also undertake a quantitative discrete choice experiment to evaluate preferences and trade-offs that influence recommendation of preventive TB treatment.