STOP study - Screening for Tuberculosis in Pregnancy study

  • Research type

    Research Study

  • Full title

    Uptake, effectiveness and acceptability of routine screening of pregnant migrants for latent tuberculosis infection in antenatal care: a feasibility study

  • IRAS ID

    247388

  • Contact name

    Heinke Kunst

  • Contact email

    h.kunst@qmul.ac.uk

  • Sponsor organisation

    Queen Mary University of London

  • Clinicaltrials.gov Identifier

    NCT04098341

  • Duration of Study in the UK

    1 years, 9 months, 0 days

  • Research summary

    The UK has the second highest tuberculosis (TB) incidence in Western Europe. Most active cases occur in migrants due to reactivation of latent TB infection (LTBI) acquired abroad. Screening migrants for LTBI was recently introduced by Public Health England (PHE) to reduce TB rates and transmission of infectious cases. Newham, which has one of the highest TB rates in London introduced the first large-scale LTBI screening programme for migrants, but it is poorly accessed by pregnant women and screening uptake is low. The issue of how best to screen for TB during
    pregnancy is important because pregnant and postpartum women are at particularly high risk of developing TB, and migrants from countries with high TB rates may only interact with healthcare services during pregnancy. Effective strategies are urgently needed to improve screening uptake for LTBI in pregnant migrants. The Antenatal clinic is an attractive location to screen for LTBI because uptake and acceptability of opt-out screening for other infectious diseases (HIV) is high. We will evaluate the uptake, effectiveness and acceptability of routine screening for LTBI in antenatal clinics. Eligible patients are pregnant women, aged 16-35 who have entered the UK within 5 years from a country with TB rates of >150/100,000. Screening will involve a blood test, taken with other routine antenatal blood tests. We expect that in this setting, screening will be acceptable and uptake will be high. Our main outcome will be to assess the uptake of screening in at least 200 women. Acceptability of screening and understanding barriers of healthcare professionals to test for LTBI are secondary aims. The study will provide important information about a new setting in which to screen pregnant migrants for LTBI and barriers to starting treatment postpartum,which will inform the definitive trial to guide national policy on LTBI screening in antenatal care.

  • REC name

    London - City & East Research Ethics Committee

  • REC reference

    19/LO/0557

  • Date of REC Opinion

    12 Apr 2019

  • REC opinion

    Favourable Opinion