Validation Study of mHealth Technology in HIV to Improve Empowerment and Healthcare Utilisation: Research and Innovation to Generate Evidence for Personalised Care (EmERGE)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Validation Study of mHealth Technology in HIV to Improve Empowerment and Healthcare Utilisation: Research and Innovation to Generate Evidence for Personalised Care (EmERGE)

Conditions
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HIV Infections

Intervention / Treatment
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* Other: mHealth platform


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Documented HIV-1 infection Aged at least 18 years old Able to give informed consent In possession of a smartphone, tablet, or similar technology supporting the mHealth platform Stable on ART: Defined as ART should be unchanged for at least 3 months and viral load undetectable (<50 copies/ml) for at least 6 months. Clinically stable from an HIV perspective: Defined as without opportunistic infection or AIDS related cancers within the previous 12 months Exclusion Criteria: Aged less than 18 years Pregnant Participating in a clinical trial or receiving an investigational medication Unable to comprehend the patient information sheet Unable to comprehend the instructions for using the mHealth platform Considered for any other reason by their regular physician to be unsuitable for study participation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mHealth platform<br>Stable HIV-1 infected subjects will be followed-up using an mHealth platform. The platform will provide users with web based and mobile device applications which interface securely with relevant medical data and facilitate remote access to healthcare providers. The minimum length of follow-up will be 12 months and the maximum 35 months. | Other: mHealth platform<br>* Use of a mHealth platform to inform and empower patient of hies/her own health<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Patient Activation Measure (PAM-13) questionnaire from baseline |  | months 12 and 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Satisfaction System Usability Scale (SUS) |  | months 12 and 24 | 
| Maintenance of virological suppression (HIV-1 RNA <50 c/ml) |  | months 12 and 24 | 
| Change in CD4 count |  | months 12 and 24 | 
| Change in blood lipid profile |  | months 12 and 24 | 
| Changes in Quality of life (EQ-5D-5L questionnaire) from baseline |  | months 12 and 24 | 
| Changes in Quality of life (PROQOL-HIV questionnaire) from baseline |  | months 12 and 24 | 
| Changes in adherence quantified by Morisky-Green questionnaire |  | months 12 and 24 | 
| Percentage of patients with changes in ART from baseline |  | months 12 and 24 | 
| Changes on self-reported economic questionnaire aspects from baseline |  | months 12 and 24 |