NCT07024836

Brief 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. 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).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
430

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress63%
May 2025Dec 2026

First Submitted

Initial submission to the registry

May 16, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

May 22, 2025

Completed
26 days until next milestone

First Posted

Study publicly available on registry

June 17, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

June 17, 2025

Status Verified

June 1, 2025

Enrollment Period

1.5 years

First QC Date

May 16, 2025

Last Update Submit

June 9, 2025

Conditions

Keywords

preferencediscrete choice experimentqualitativelatent tuberculosis infection

Outcome Measures

Primary Outcomes (1)

  • Preventive treatment acceptance

    Discrete choice experiment data will be analysed to evaluate the primary outcome of preventive TB treatment acceptance in the survey.

    Baseline

Study Arms (3)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • Unable to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Whittington Hospital

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

TuberculosisLatent Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsLatent Infection

Central Study Contacts

Rishi K Gupta, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2025

First Posted

June 17, 2025

Study Start

May 22, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

June 17, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

Anonymised data from the discrete choice experiment will be made publicly available at the time of peer-reviewed publication.

Time Frame
Indefinitely from the time of peer-reviewed publication.
Access Criteria
The anonymised discrete choice experiment data will be publicly available

Locations