NCT02904733

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,900

participants targeted

Target at P75+ for not_applicable hiv-infections

Timeline
Completed

Started Apr 2017

Geographic Reach
5 countries

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 19, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

April 7, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

December 15, 2017

Status Verified

December 1, 2017

Enrollment Period

2.4 years

First QC Date

July 7, 2016

Last Update Submit

December 14, 2017

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

  • Changes in Patient Activation Measure (PAM-13) questionnaire from baseline

    months 12 and 24

Secondary Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (1)

mHealth platform

EXPERIMENTAL

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

Interventions

mHealth platformOTHER

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

mHealth platform

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Prins Leopold Instituut Voor Tropische Geneeskunde

Antwerp, 2000, Belgium

RECRUITING

Klinika za Infektivne Bolesti Dr. Fran Mihaljevic

Zagreb, 10000, Croatia

RECRUITING

Centro Hospitalar de Lisboa Central

Lisbon, 1169 097, Portugal

RECRUITING

Hospital Clínic i Provincial

Barcelona, 08036, Spain

RECRUITING

University of Brighton

Brighton, BN2 4AT, United Kingdom

RECRUITING

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Central Study Contacts

Jennifer Whetham, MD

CONTACT

+44 1273 523081Jennifer.Whetham@bsuh.nhs.uk

Agathe León, MD

CONTACT

+34932275400aleon@clinic.ub.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

July 7, 2016

First Posted

September 19, 2016

Study Start

April 7, 2017

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

December 15, 2017

Record last verified: 2017-12

Locations

BE(1)CR(1)PT(1)GB(1)ES(1)