HIV Infections
Conditions
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.
Interventions
OTHERmHealth platform
Use of a mHealth platform to inform and empower patient of hies/her own health
Sponsors
Brighton and Sussex University Hospitals NHS Trust
Instituut Voor Tropische Geneeskunde (ITM), Antwerp, Belgium.
Klinika za infektivne bolesti (KIB), Zagreb, Croatia
Centro Hospitalar de Lisboa Central
Fundacion Clinic per a la Recerca Biomédica
University of Brighton
Podmedics, ( POD), Northwood, United Kingdom
Universidad Politecnica de Madrid
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
Hospital Clinic of Barcelona
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Patient Activation Measure (PAM-13) questionnaire from baseline | months 12 and 24 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Changes in Satisfaction System Usability Scale (SUS) | months 12 and 24 |
| Changes in Quality of life (PROQOL-HIV questionnaire) from baseline | 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 |
| Maintenance of virological suppression (HIV-1 RNA <50 c/ml) | months 12 and 24 |
Countries
Belgium, Croatia, Portugal, Spain, United Kingdom
Contacts
Primary ContactJennifer Whetham, MD
Backup ContactAgathe León, MD
Outcome results
None listed