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

Not Applicable

• Conditions: HIV Infections
• Interventions: Other: mHealth platform

• Registration Number: NCT02904733
• Lead Sponsor: Hospital Clinic of Barcelona

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-07-07
• Study First Submitted QC: 2016-09-13
• Study First Posted: 2016-09-19
• Study Start: 2017-04-07
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-14
• Last Update Posted: 2017-12-15
• Primary Completion: 2019-09
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3900

Inclusion Criteria

1. Documented HIV-1 infection
2. Aged at least 18 years old
3. Able to give informed consent
4. In possession of a smartphone, tablet, or similar technology supporting the mHealth platform
5. 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.
6. Clinically stable from an HIV perspective: Defined as without opportunistic infection or AIDS related cancers within the previous 12 months

Exclusion Criteria

1. Aged less than 18 years
2. Pregnant
3. Participating in a clinical trial or receiving an investigational medication
4. Unable to comprehend the patient information sheet
5. Unable to comprehend the instructions for using the mHealth platform
6. Considered for any other reason by their regular physician to be unsuitable for study participation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
mHealth platform	mHealth platform	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.

Primary Outcome Measures

Name	Time	Method
Changes in Patient Activation Measure (PAM-13) questionnaire from baseline	months 12 and 24

Secondary Outcome Measures

Name	Time	Method
Maintenance of virological suppression (HIV-1 RNA <50 c/ml)	months 12 and 24
Changes in adherence quantified by Morisky-Green questionnaire	months 12 and 24
Changes in Satisfaction System Usability Scale (SUS)	months 12 and 24
Change in CD4 count	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
Change in blood lipid profile	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

Trial Locations

Locations (5)

Centro Hospitalar de Lisboa Central; 🇵🇹 Lisboa, Portugal

Klinika za Infektivne Bolesti Dr. Fran Mihaljevic; 🇭🇷 Zagreb, Croatia

Hospital Clínic i Provincial; 🇪🇸 Barcelona, Spain

University of Brighton; 🇬🇧 Brighton, United Kingdom

Prins Leopold Instituut Voor Tropische Geneeskunde; 🇧🇪 Antwerp, Belgium