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

NCT03069807 | Completed

• 1 other identifier: 4212301
• Study Type: interventional
• Target: 362
• Locations: 1 country
• Sites: 1

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.

Conditions

Latent Tuberculosis

Outcome Measures

Primary Outcomes (1)

• Completion of Latent Tuberculosis Treatment

  Based on patients taking at least 90 percent of doses of Rifinah during 3 months of treatment.

  3 months

Secondary Outcomes (8)

• Complete of Latent Tuberculosis Treatment

  3 months

• Adherence to Treatment

  3 months

• Acceptability of Treatment

  3 months

• Adverse Effects of Treatment

  3 months

• Active Tuberculosis

  2 years

Study Arms (2)

Intervention

EXPERIMENTAL

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

Other: Community/Primary Care

Control

ACTIVE COMPARATOR

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

Other: Hospital/TB Clinic

Interventions

Community/Primary Care OTHER

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

Intervention

Hospital/TB Clinic OTHER

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

Control

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant or breastfeeding women
• Patients requiring medications that cannot be safely taken with Rifinah
• HIV infection.
• Individuals with known liver disease, or abnormal liver function tests (LFTs)
• Diagnosis of cirrhosis (jaundice, haematemesis, ascites or previous episodes of liver encephalopathy)
• Chronic or active hepatitis B or hepatitis C virus infection
• Previous treatment for TB or LTBI.
• 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
• Evidence of active TB

Sponsors & Collaborators

• Queen Mary University of London: lead
• University College, London: collaborator
• Public Health England: collaborator

Study Sites (1)

Shrewsbury Road Health Centre

London, E7 8QP, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 39174285 DERIVED

• 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.

  PMID: 31783742 DERIVED

MeSH Terms

Conditions

Latent Tuberculosis

Interventions

Residence Characteristics; Primary Health Care

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics; Epidemiologic Measurements; Public Health; Environment and Public Health; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Heinke Kunst, MD MSc

  Queen Mary University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster-randomised trial evaluating treatment completion (the primary outcome), uptake, acceptability, safety and cost-effectiveness of treating latent tuberculosis infection (LTBI) in migrants in primary care, compared with secondary care.

Study Record Dates

• First Submitted: August 5, 2016
• First Posted: March 3, 2017
• Study Start: January 1, 2017
• Primary Completion: September 1, 2019
• Study Completion: March 1, 2020
• Last Updated: November 26, 2021

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)