EmERGE validation study V3.0

  • Research type

    Research Study

  • Full title

    Validation study of mHealth technology in HIV to improve Empowerment and healthcare utilisation: Research and innovation to Generate Evidence for personalised care

  • IRAS ID

    211169

  • Contact name

    Jennifer Whetham

  • Contact email

    Jennifer.Whetham@bsuh.nhs.uk

  • Sponsor organisation

    Fundació Clínic per la recerca biomédica

  • Duration of Study in the UK

    2 years, 11 months, 30 days

  • Research summary

    The EmERGE validation study will take place in five European sites to evaluate a redesigned clinical pathway for the care of patients living with stable HIV infection which includes the use of a mobile phone application or ‘app’.
    Patients who are living with stable HIV infection at the five clinical sites (Brighton, Antwerp, Barcelona, Lisbon and Zagreb) will be invited to take part in the study. Patients who agree to take part in the study will be seen by their clinician once a year (rather than twice a year) with results from interim visits checked by a clinician and sent to them via an ‘app’ on their own mobile phone.
    If a person becomes unwell or if the results are abnormal, patients will be reviewed in the clinic in the usual way. Some patients living with stable HIV attending the Brighton clinic are already seen once a year with interim results emailed to patients.
    The 'app' or mobile Health (mHealth) platform is being developed as part of the wider EmERGE project, and its use will be evaluated by this validation study. The whole project is running over a period of five years – with patients being followed up within the validation study for between 12 and 35 months.
    Patients taking part will be asked to complete questionnaires on empowerment, quality of life, adherence to medication, cost and patient experience at the beginning of the study and then annually. Additionally data will be collected on clinical outcomes and attendances to the clinic.
    The total recruitment target is 3808 for all sites.
    This project has received funding from the European Union’s Horizon 2020 research and innovation programme under Grant Agreement No. 643736.

  • REC name

    London - Brighton & Sussex Research Ethics Committee

  • REC reference

    16/LO/2122

  • Date of REC Opinion

    10 Jan 2017

  • REC opinion

    Further Information Favourable Opinion