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

Can Latent Tuberculosis Infection (LTBI) in Recent Migrants be Treated Effectively and Safely in Primary Care? A Cluster Randomised Controlled Trial.

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.

Study Overview

• Status: Completed
• Conditions: Latent Tuberculosis
• Intervention / Treatment: Other: Community/Primary Care; Other: 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.

• Study Type: Interventional
• Enrollment (Actual): 362
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, E7 8QP
    • Shrewsbury Road Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 35 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention; Participants with LTBI will be treated in the Community/Primary Care.	Other: Community/Primary Care; The treatment of Latent Tuberculosis Infection (LTBI) in the community by General Practitioners (Family Doctors) and Pharmacists
ACTIVE_COMPARATOR: Control; Participants with LTBI will be treated in the Hospital/TB Clinic	Other: Hospital/TB Clinic; The treatment of Latent Tuberculosis Infection (LTBI) in the Hospital TB Clinic by specialist doctors and nurses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete of Latent Tuberculosis Treatment	Based on patients taking at least 80 or 85 percent of doses during 3 months of treatment.	3 months
Adherence to Treatment	To describe the proportion of individuals in the two treatment arms who adhere to LTBI treatment based on the five-point MARS5 (Medication Adherence Report Scale) questionairre, collection of prescriptions and a point of care urine testing for metabolites of isoniazid (Iso-screen) performed at monthly intervals.	3 months
Acceptability of Treatment	To describe the proportion of individuals in the two treatment arms who accept LTBI treatment. This is defined as those initiating treatment and attending TB clinics and community pharmacies on at least one occasion.	3 months
Adverse Effects of Treatment	To assess the incidence of adverse effects of treatment for LTBI, including adverse liver function tests or any other effects leading to cessation of treatment. This will be assessed using liver function test results, and a monthly questionnaire.	3 months
Active Tuberculosis	The incidence of active TB occurring within 2 years after enrolment. TB incidence in the intervention and control group will be compared and there will be a sub-analysis of examining those who did or did not accept or complete treatment. This will be performed through matching the study population with the national Enhanced TB Surveillance System, where information on all reported TB cases nationally are recorded.	2 years
Patient Satisfaction	Assessed using a standardised non-validated questionnaire (Likert scale)	3 months
Cost-effectiveness of Treatment	Assessed using a health economic model that includes locally and nationally agreed tariffs for latent tuberculosis treatment.	2 years
Patient Knowledge	The impact of patients knowledge about Latent Tuberculosis on treatment acceptance and completion will be assessed at baseline using a standardised non-validated questionnaire.	3 months

Collaborators and Investigators

• Sponsor: Queen Mary University of London
• Collaborators: University College, London; Public Health England
• Investigators: Principal Investigator: Heinke Kunst, MD MSc, Queen Mary University of London

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2017
• Primary Completion (ACTUAL): September 1, 2019
• Study Completion (ACTUAL): March 1, 2020

Study Registration Dates

• First Submitted: August 5, 2016
• First Submitted That Met QC Criteria: February 27, 2017
• First Posted (ACTUAL): March 3, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 26, 2021
• Last Update Submitted That Met QC Criteria: November 24, 2021
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Latent Infection; Tuberculosis; Latent Tuberculosis
• Other Study ID Numbers: 4212301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No