HIV Infections Clinical Trial
Official title:
Validation Study of mHealth Technology in HIV to Improve Empowerment and Healthcare Utilisation: Research and Innovation to Generate Evidence for Personalised Care (EmERGE)
A large (3900 patients) cohort study, undertaken in five European sites to validate in a
mHealth platform to enable self-management of HIV in patients with stable disease using a
tailored HTA process, Model for Assessment of Telemedicine Applications (MAST), specifically
developed for the assessment of mHealth solutions.
As site recruitment will be sequential and the recruitment period will last 18 months, a
maximum follow-up of 35 Months will be undertaken. Study visits will take place at baseline
defined as the time of mHealth introduction, months 6, 12, 18, 24 and 30.
Number of Study Centres: 5 Duration of Study: 35 Months Criteria for Evaluation: Usability of
the mHealth platform, patient self-management and empowerment, clinical safety (virological
suppression maintenance, CD4 count, laboratory parameters, adverse events and adherence),
quality of life and self-economy will be assessed by questionnaires and laboratory
parameters.
Routine data on patient demographics, treatment and investigations which will include viral
load, CD4, haematology, biochemistry and urine sample. Patient Activation Measure, Quality of
life, adherence questionnaire and economic questionnaires will be performed at baseline and
at months 12 and 24. Satisfaction System Usability Scale will be evaluated at month 12 and
24.
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