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

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ClinicalTrials.gov Identifier: NCT01510340
Recruitment Status : Suspended (Changes & upgrades in informatic infrastructure of the web-based intervention.)
First Posted : January 16, 2012
Last Update Posted : January 25, 2018
Sponsor:
Collaborator:
Fonds de la Recherche en Santé du Québec
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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).

Condition or disease Intervention/treatment Phase
HIV Behavioral: VIH-TAVIE Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 234 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Study Start Date : January 2012
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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
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.


Outcome Measures
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Primary Outcome Measures :
  1. Adherence [ Time Frame: 6 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01510340


Locations
Canada, Quebec
José Côté
Montréal, Quebec, Canada, H2X 0A9
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Fonds de la Recherche en Santé du Québec
Investigators
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
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT01510340     History of Changes
Other Study ID Numbers: CE 11.184
First Posted: January 16, 2012    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
adherence
HIV
antiretroviral therapy
tailored web intervention