Clinical trial NCT03069807: Completion and Acceptability of Treatment Across Primary Care and the commUnity for Latent Tuberculosis
Official title: Can Latent Tuberculosis Infection (LTBI) in Recent Migrants be Treated Effectively and Safely in Primary Care? A Cluster Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Latent Tuberculosis
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
Collaborators: name: University College, London
name: Public Health England
First posted: 2017-03-03
Enrollment: 362
Sex: ALL
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Completion of Latent Tuberculosis Treatment
timeFrame: 3 months
Secondary outcomes:
measure: Complete of Latent Tuberculosis Treatment
timeFrame: 3 months
measure: Adherence to Treatment
timeFrame: 3 months
measure: Acceptability of Treatment
timeFrame: 3 months
measure: Adverse Effects of Treatment
timeFrame: 3 months
measure: Active Tuberculosis
timeFrame: 2 years
measure: Patient Satisfaction
timeFrame: 3 months
measure: Cost-effectiveness of Treatment
timeFrame: 2 years
measure: Patient Knowledge
timeFrame: 3 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Shrewsbury Road Health Centre
Study officials:
affiliation: Queen Mary University of London
name: Heinke Kunst, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.