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

This study is currently recruiting participants.
Verified July 2016 by Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01510340
First Posted: January 16, 2012
Last Update Posted: August 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Fonds de la Recherche en Santé du Québec
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)
  Purpose
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 Intervention Phase
HIV Behavioral: VIH-TAVIE Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care

Resource links provided by NLM:


Further study details as provided by Centre hospitalier de l'Université de Montréal (CHUM):

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 234
Study Start Date: January 2012
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Submitted: December 13, 2011
First Posted: January 16, 2012
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