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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. (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
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care

Resource links provided by NLM:

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

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

Primary Outcome Measures:
  • 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.
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
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
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 
Study First Received: December 13, 2011
Last Updated: August 3, 2016
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on September 29, 2016