Evaluation of a Tailored Virtual Intervention to Empower Persons Living With HIV for Therapy Self-management (HIVMediconline)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Centre hospitalier de l'Université de Montréal (CHUM).
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
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: January 11, 2012
Last verified: July 2011
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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 Endpoint Classification: Efficacy Study 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 ] [ 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: | December 2012 |
| Estimated Primary Completion Date: | June 2012 (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 |
| 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
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@umontreal.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:
No publications provided by Centre hospitalier de l'Université de Montréal (CHUM)
Additional 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: | January 11, 2012 |
| 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 March 01, 2015