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

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.
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Experimental: VIH-TAVIE
Patients assigned to this arm must follow the four interactive computer sessions
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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.
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- 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.

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

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
Canada, Quebec | |
José Côté | |
Montréal, Quebec, Canada, H2X 0A9 |
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 |
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: | 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 |