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CompletedNCT01510340HIVMediconlineUpdated Aug 6, 2021

Evaluation of a Tailored Virtual Intervention to Empower Persons Living With HIV for Therapy Self-management

A Phase 3 interventional study of VIH-TAVIE in HIV, sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-06.

Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Phase 3, Interventional, and Supportive care

Phase
Phase 3
Study type
Interventional
Enrollment
217
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate the efficacy of an online virtual intervention in optimizing adherence to antiretroviral medication intake among Persons Living with HIV (PLHIV).

02

Conditions studied

  • HIV

Keywords

  • adherence
  • HIV
  • antiretroviral therapy
  • tailored web intervention
03

In context

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM) is the lead sponsor of 370 studies on the registry; 110 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • have to be under ART for at least six months¸
  • have internet access

Exclusion criteria

Exclusion Criteria:

  • be pregnant
  • active IV drug user
  • actual diagnosis of psychiatric health problem
05

Study design

Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
217 participants (actual)

Study arms

  • No intervention
    Web sites

    Patients assigned to this arm are given a list of Web sites where they can collect information related to their condition at their leisure.

  • Experimental
    VIH-TAVIE

    Patients assigned to this arm must follow the four interactive computer sessions

    Behavioral: VIH-TAVIE

Interventions

  • BehavioralVIH-TAVIE

    The tailored virtual intervention is composed of four interactive computer sessions hosted by a virtual nurse who engages the PLHIV in a medication-intake self-management skills-learning process.

06

What researchers measure

Primary outcomes

  1. Adherence

    Adherence will be evaluated through a self-administered questionnaire that was developed for and validated on the targeted population (Godin, Gagné, \& Naccache, 2003). The questionnaire comprises seven items that serve to determine how many times a person forgets to take his or her medication. The questionnaire's validity was demonstrated (sensitivity: 71 %; specificity: 72%; correct classification: 72%; odds ratio: 6.15) using immunologic (CD4 count) and virologic (viral load) parameters as validation criteria. Adherence is defined as the intake of at least 95% of prescribed tablets.

    Time frame: 6 months

07

Study locations

1 site
  • José Côté
    Montréal, Quebec H2X 0A9, Canada
08

References and documents

Publications

  • Cote J, Rouleau G, Ramirez-Garcia MP, Auger P, Thomas R, Leblanc J. Effectiveness of a Web-Based Intervention to Support Medication Adherence Among People Living With HIV: Web-Based Randomized Controlled Trial. JMIR Public Health Surveill. 2020 Apr 20;6(2):e17733. doi: 10.2196/17733. PubMed 32310145 ↗
  • Cote J, Godin G, Gueheneuc YG, Rouleau G, Ramirez-Garcia P, Otis J, Tremblay C, Fadel G. Evaluation of a real-time virtual intervention to empower persons living with HIV to use therapy self-management: study protocol for an online randomized controlled trial. Trials. 2012 Oct 5;13:187. doi: 10.1186/1745-6215-13-187. PubMed 23039306 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01510340
Lead sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Fonds de la Recherche en Santé du Québec
Responsible party
Sponsor
First posted
Jan 16, 2012
Start date
Jan 2012
Primary completion
Dec 2019
Completion
Jun 2020
Last update
Aug 6, 2021

Study contacts

José Côté, Ph.D.
principal investigator · CRCHUM, Université de Montréal
Gaston Godin, Ph.D.
study chair · Laval University
Yann-Gael Guéhéneuc, Ph.D.
study chair · Polytechnique
Cécile Tremblay, MD,Ph.D.
study chair · CRCHUM
Joanne Otis, Ph.D.
study chair · Université du Québec a Montréal

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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