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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor:
Collaborator:
Fonds de la Recherche en Santé du Québec
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT01510340
First received: December 13, 2011
Last updated: August 3, 2016
Last verified: July 2016

December 13, 2011
August 3, 2016
January 2012
December 2017   (final data collection date for primary outcome measure)
Adherence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01510340 on ClinicalTrials.gov Archive Site
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Evaluation of a Tailored Virtual Intervention to Empower Persons Living With HIV for Therapy Self-management
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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).
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Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
HIV
Behavioral: VIH-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.
  • 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
    Intervention: Behavioral: VIH-TAVIE
Côté J, Godin G, Guéhéneuc YG, Rouleau G, Ramirez-Garcìa 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
234
April 2018
December 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • be pregnant
  • active IV drug user
  • actual diagnosis of psychiatric health problem
Both
18 Years and older   (Adult, Senior)
No
Contact: José Côté, Ph.D. (514) 890-8000 ext 15536 jose.cote@umontreal.ca
Contact: Geneviève Rouleau, M.Sc. (514) 890-8000 ext 12744 genevieve.rouleau.chum@ssss.gouv.qc.ca
Canada
 
NCT01510340
CE 11.184
Yes
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Centre hospitalier de l'Université de Montréal (CHUM)
Centre hospitalier de l'Université de Montréal (CHUM)
Fonds de la Recherche en Santé du Québec
Principal Investigator: José Côté, Ph.D. CRCHUM, Université de Montréal
Study Chair: Gaston Godin, Ph.D. Laval University
Study Chair: Yann-Gael Guéhéneuc, Ph.D. Polytechnique
Study Chair: Cécile Tremblay, MD,Ph.D. CRCHUM
Study Chair: Joanne Otis, Ph.D. Universite du Quebec a Montreal
Centre hospitalier de l'Université de Montréal (CHUM)
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP