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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 : Recruiting
First Posted : January 16, 2012
Last Update Posted : August 5, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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

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 2017
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

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

Arms and Interventions

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

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

Information from the National Library of Medicine

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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

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


Contacts
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

Locations
Canada, Quebec
José Côté Recruiting
Montréal, Quebec, Canada, H2X 0A9
Contact: Geneviève Rouleau, MSc    514-890-8000 ext 12744    genevieve.rouleau.chum@ssss.gouv.qc.ca   
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

Additional Information:
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: August 5, 2016
Last Verified: July 2016

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