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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:
Centre hospitalier de l'Université de Montréal (CHUM)
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
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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: 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| 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
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
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:
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 |
Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
|
adherence HIV antiretroviral therapy tailored web intervention |
ClinicalTrials.gov processed this record on July 19, 2017