Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02904733
Other study ID # EMERGE
Secondary ID
Status Recruiting
Phase N/A
First received July 7, 2016
Last updated December 14, 2017
Start date April 7, 2017
Est. completion date September 2019

Study information

Verified date December 2017
Source Hospital Clinic of Barcelona
Contact Jennifer Whetham, MD
Phone +44 1273 523081
Email Jennifer.Whetham@bsuh.nhs.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 3900
Est. completion date September 2019
Est. primary completion date September 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
mHealth platform
Use of a mHealth platform to inform and empower patient of hies/her own health

Locations

Country Name City State
Belgium Prins Leopold Instituut Voor Tropische Geneeskunde Antwerp
Croatia Klinika za Infektivne Bolesti Dr. Fran Mihaljevic Zagreb
Portugal Centro Hospitalar de Lisboa Central Lisboa
Spain Hospital Clínic i Provincial Barcelona
United Kingdom University of Brighton Brighton

Sponsors (12)

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

Countries where clinical trial is conducted

Belgium,  Croatia,  Portugal,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in Patient Activation Measure (PAM-13) questionnaire from baseline months 12 and 24
Secondary Changes in Satisfaction System Usability Scale (SUS) months 12 and 24
Secondary Maintenance of virological suppression (HIV-1 RNA <50 c/ml) months 12 and 24
Secondary Change in CD4 count months 12 and 24
Secondary Change in blood lipid profile months 12 and 24
Secondary Changes in Quality of life (EQ-5D-5L questionnaire) from baseline months 12 and 24
Secondary Changes in Quality of life (PROQOL-HIV questionnaire) from baseline months 12 and 24
Secondary Changes in adherence quantified by Morisky-Green questionnaire months 12 and 24
Secondary Percentage of patients with changes in ART from baseline months 12 and 24
Secondary Changes on self-reported economic questionnaire aspects from baseline months 12 and 24
See also
  Status Clinical Trial Phase
Completed NCT05454514 - Automated Medication Platform With Video Observation and Facial Recognition to Improve Adherence to Antiretroviral Therapy in Patients With HIV/AIDS N/A
Completed NCT03760458 - The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age Phase 1/Phase 2
Completed NCT03141918 - Effect of Supplementation of Bioactive Compounds on the Energy Metabolism of People Living With HIV / AIDS N/A
Completed NCT03067285 - A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study Phase 4
Recruiting NCT04579146 - Coronary Artery Disease (CAD) in Patients HIV-infected
Completed NCT06212531 - Papuan Indigenous Model of Male Circumcision N/A
Active, not recruiting NCT03256422 - Antiretroviral Treatment Taken 4 Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients Phase 3
Completed NCT03256435 - Retention in PrEP Care for African American MSM in Mississippi N/A
Completed NCT00517803 - Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies N/A
Active, not recruiting NCT03572335 - Systems Biology of Diffusion Impairment in Human Immunodeficiency Virus (HIV)
Completed NCT04165200 - Fecal Microbiota Transplantation as a Therapeutic Strategy for Patients Infected With HIV N/A
Recruiting NCT03854630 - Hepatitis B Virus Vaccination in HIV-positive Patients and Individuals at High Risk for HIV Infection Phase 4
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A
Completed NCT02234882 - Study on Pharmacokinetics Phase 1
Completed NCT01618305 - Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission Phase 4
Recruiting NCT05043129 - Safety and Immune Response of COVID-19 Vaccination in Patients With HIV Infection
Not yet recruiting NCT05536466 - The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine N/A
Recruiting NCT04985760 - Evaluation of Trimer 4571 Therapeutic Vaccination in Adults Living With HIV on Suppressive Antiretroviral Therapy Phase 1
Completed NCT05916989 - Stimulant Use and Methylation in HIV
Terminated NCT02116660 - Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284) Phase 2