Completion and Acceptability of Treatment Across Primary Care and the commUnity for Latent Tuberculosis
Condition: Latent Tuberculosis
MeSH terms: Tuberculosis; Latent Tuberculosis
Study type: Interventional

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.
    

Intervention name(s): Community/Primary Care; Hospital/TB Clinic
Intervention type(s): Other; Other
Intervention description(s): The treatment of Latent Tuberculosis Infection (LTBI) in the community by General Practitioners (Family Doctors) and Pharmacists; The treatment of Latent Tuberculosis Infection (LTBI) in the Hospital TB Clinic by specialist doctors and nurses
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: None (Open Label)
Primary purpose: Health Services Research