Completion and Acceptability of Treatment Across Primary Care and the commUnity for Latent Tuberculosis

NCT ID: NCT03069807

Last Updated: 2021-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 362 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2020-03-31

Brief Summary

This study investigates whether recent migrants to the United Kingdom are more likely to complete treatment for Latent Tuberculosis Infection (LTBI) if they are treated in the community (by General Practitioners/Family Doctors and pharmacists) than in a hospital TB clinic.

Detailed Description

People with dormant/latent TB (LTBI) have TB bacteria in their bodies, but do not have any symptoms because the bacteria are not active. The investigators know that recent migrants with LTBI from countries where TB is very common (incidence greater than 150 per 100 000) are at risk of developing active TB (their dormant bacteria become active) after they arrive in the UK. Active TB can be both infectious and deadly. The treatment for LTBI is three-month course of antibiotics. This significantly reduces the risk of developing active TB. This treatment is currently arranged and supervised by hospital clinics, however, many migrants do not attend and numbers of people completing antibiotics is low. This leaves many at risk of developing active TB. This study investigates whether a community (primary care) based approach to the treatment of LTBI, coordinated by general practices and local pharmacists, will achieve higher rates of antibiotic completion. The London Borough of Newham, in the UK, has amongst the highest rates of active TB in Western Europe. As part of a strategy to tackle this disease burden, an innovative model of care has been implemented in the borough in which GPs and pharmacists screen and treat migrants with LTBI. Our trial will evaluate whether primary care based management of LTBI leads to higher rates of treatment completion amongst recent migrants when compared to hospital based care. This approach would save money (both for the health service and for patients in terms of travels costs) and reduce numbers of new cases of active TB.

The treatment for Latent Tuberculosis Infection will be 3 months of combined oral Rifampicin and Isoniazid with Pyridoxine. The dosage is weight dependent.

Conditions

Latent Tuberculosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention

Participants with LTBI will be treated in the Community/Primary Care.

Group Type: EXPERIMENTAL

Community/Primary Care

Intervention Type: OTHER

The treatment of Latent Tuberculosis Infection (LTBI) in the community by General Practitioners (Family Doctors) and Pharmacists

Control

Participants with LTBI will be treated in the Hospital/TB Clinic

Group Type: ACTIVE_COMPARATOR

Hospital/TB Clinic

Intervention Type: OTHER

The treatment of Latent Tuberculosis Infection (LTBI) in the Hospital TB Clinic by specialist doctors and nurses

Interventions

Community/Primary Care

The treatment of Latent Tuberculosis Infection (LTBI) in the community by General Practitioners (Family Doctors) and Pharmacists

Intervention Type: OTHER

Hospital/TB Clinic

The treatment of Latent Tuberculosis Infection (LTBI) in the Hospital TB Clinic by specialist doctors and nurses

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with LTBI aged 16-35 and who have entered the UK less than 5 years ago from a country with a TB incidence of greater than 150/100,000.
• Latent Tuberculosis is defined as a positive IGRA test without any symptoms or physical signs of active Tuberculosis and no evidence of active Tuberculosis on Chest X-ray.

Exclusion Criteria

1. Pregnant or breastfeeding women

2. Patients requiring medications that cannot be safely taken with Rifinah

3. HIV infection.

4. Individuals with known liver disease, or abnormal liver function tests (LFTs)

5. Diagnosis of cirrhosis (jaundice, haematemesis, ascites or previous episodes of liver encephalopathy)

6. Chronic or active hepatitis B or hepatitis C virus infection

7. Previous treatment for TB or LTBI.

8. Individuals who are unable to consent or who would usually be offered LTBI treatment under DOT because of their mental or social disabilities or those with drug or alcohol abuse

9. Evidence of active TB

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University College, London

OTHER

Sponsor Role: collaborator

Public Health England

OTHER_GOV

Sponsor Role: collaborator

Queen Mary University of London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heinke Kunst, MD MSc

Role: PRINCIPAL_INVESTIGATOR

Queen Mary University of London

Locations

Shrewsbury Road Health Centre

London, , United Kingdom

Countries

United Kingdom

References

Burman M, Zenner D, Copas AJ, Gosce L, Haghparast-Bidgoli H, White PJ, Hickson V, Greyson O, Trathen D, Ashcroft R, Martineau AR, Abubakar I, Griffiths CJ, Kunst H. Treatment of latent tuberculosis infection in migrants in primary care versus secondary care. Eur Respir J. 2024 Nov 7;64(5):2301733. doi: 10.1183/13993003.01733-2023. Print 2024 Nov.

Reference Type: DERIVED

PMID: 39174285 (View on PubMed)

Burman M, Copas A, Zenner D, Hickson V, Gosce L, Trathen D, Ashcroft R, Martineau AR, Abubakar I, Griffiths C, Kunst H. Protocol for a cluster randomised control trial evaluating the efficacy and safety of treatment for latent tuberculosis infection in recent migrants within primary care: the CATAPuLT trial. BMC Public Health. 2019 Nov 29;19(1):1598. doi: 10.1186/s12889-019-7983-7.

Reference Type: DERIVED

PMID: 31783742 (View on PubMed)

Other Identifiers

4212301

Identifier Type: -

Identifier Source: org_study_id