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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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.

Current Primary Outcome: Completion of Latent Tuberculosis Treatment [ Time Frame: 3 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Complete of Latent Tuberculosis Treatment [ Time Frame: 3 months ]
  Based on patients taking at least 80 or 85 percent of doses during 3 months of treatment.
• Adherence to Treatment [ Time Frame: 3 months ]
  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.
• Acceptability of Treatment [ Time Frame: 3 months ]
  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.
• Adverse Effects of Treatment [ Time Frame: 3 months ]
  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.
• Active Tuberculosis [ Time Frame: 2 years ]
  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.
• Patient Satisfaction [ Time Frame: 3 months ]
  Assessed using a standardised non-validated questionnaire (Likert scale)
• Cost-effectiveness of Treatment [ Time Frame: 2 years ]
  Assessed using a health economic model that includes locally and nationally agreed tariffs for latent tuberculosis treatment.
• Patient Knowledge [ Time Frame: 3 months ]
  The impact of patients knowledge about Latent Tuberculosis on treatment acceptance and completion will be assessed at baseline using a standardised non-validated questionnaire.

Original Secondary Outcome: Same as current

Information By: Queen Mary University of London

Dates:
Date Received: August 5, 2016
Date Started: September 2016
Date Completion: April 2018
Last Updated: February 27, 2017
Last Verified: August 2016