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

Study Overview

• Status: Unknown
• Conditions: HIV Infections
• Intervention / Treatment: Other: mHealth platform

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 Type: Interventional
• Enrollment (Anticipated): 3900
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer Whetham, MD; Phone Number: +44 1273 523081; Email: Jennifer.Whetham@bsuh.nhs.uk
• Study Contact Backup: Name: Agathe León, MD; Phone Number: 2447 +34932275400; Email: aleon@clinic.ub.es

Study Locations

• Belgium
  • Antwerp, Belgium, 2000
    • Recruiting
    • Prins Leopold Instituut Voor Tropische Geneeskunde
    • Contact: Ludgiw Aspers, MD
• Croatia
  • Zagreb, Croatia, 10000
    • Recruiting
    • Klinika za Infektivne Bolesti Dr. Fran Mihaljevic
    • Contact: Josip Begovac, MD
• Portugal
  • Lisboa, Portugal, 1169 097
    • Recruiting
    • Centro Hospitalar de Lisboa Central
    • Contact: Eugenio Teofilo, MD
• Spain
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clinic i Provincial
    • Contact: Agathe Leon, MD; Phone Number: 34.93.227.54.00
    • Contact: Eva González, MD; Phone Number: 34.93.227.54.00
• United Kingdom
  • Brighton, United Kingdom, BN2 4AT
    • Recruiting
    • University of Brighton
    • Contact: Jennifer Whetham, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: mHealth platform; Use of a mHealth platform to inform and empower patient of hies/her own health

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona
• Collaborators: Fundacion Clinic per a la Recerca Biomédica; Brighton and Sussex University Hospitals NHS Trust; Universidad Politecnica de Madrid; University of Brighton; Centro Hospitalar de Lisboa Central; Instituut Voor Tropische Geneeskunde (ITM), Antwerp, Belgium.; Klinika za infektivne bolesti (KIB), Zagreb, Croatia; Podmedics, ( POD), Northwood, United Kingdom; National Prospective Monitoring System HIV Health-economics Collaboration, (NPMS), Richmond, United Kingdom; European Aids Treatment Group (EATG), Brussels, Belgium; mHealth Futures LTD, Brighton, United Kingdom

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2017
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): September 1, 2019

Study Registration Dates

• First Submitted: July 7, 2016
• First Submitted That Met QC Criteria: September 13, 2016
• First Posted (Estimate): September 19, 2016

Study Record Updates

• Last Update Posted (Actual): December 15, 2017
• Last Update Submitted That Met QC Criteria: December 14, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: EMERGE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No