HIVPhase 3HIVMediconlineNCT01510340
Evaluation of a Tailored Virtual Intervention to Empower Persons Living With HIV for Therapy Self-management
A Phase 3 study testing VIH-TAVIE in people with HIV, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- VIH-TAVIE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2012to Jun 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- have to be under ART for at least six months¸
- have internet access
Who cannot join
- be pregnant
- active IV drug user
- actual diagnosis of psychiatric health problem
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- HIV
- Being tested
- VIH-TAVIE
- Keywords
- adherence, HIV, antiretroviral therapy, tailored web intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIH-TAVIEBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Web sites | No intervention | Patients assigned to this arm are given a list of Web sites where they can collect information related to their condition at their leisure. |
| VIH-TAVIE | Experimental | Patients assigned to this arm must follow the four interactive computer sessions Receives: Behavioral: VIH-TAVIE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2019
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds de la Recherche en Santé du Québec
- Responsible party
- Sponsor
- Investigators
- José Côté, Ph.D., Principal investigator, CRCHUM, Université de MontréalGaston Godin, Ph.D., Study chair, Laval UniversityYann-Gael Guéhéneuc, Ph.D., Study chair, PolytechniqueCécile Tremblay, MD,Ph.D., Study chair, CRCHUMJoanne Otis, Ph.D., Study chair, Université du Québec a Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01510340
- Sponsor's protocol ID
- CE 11.184
- Acronym
- HIVMediconline
- Status last verified
- Aug 2021
- First submitted
- 13 Dec 2011
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cote J, Rouleau G, Ramirez-Garcia MP, Auger P, Thomas R, Leblanc J. Effectiveness of a Web-Based Intervention to Support Medication Adherence Among People Living With HIV: Web-Based Randomized Controlled Trial. JMIR Public Health Surveill. 2020 Apr 20;6(2):e17733. doi: 10.2196/17733.
PubMed 32310145Cote J, Godin G, Gueheneuc YG, Rouleau G, Ramirez-Garcia P, Otis J, Tremblay C, Fadel G. Evaluation of a real-time virtual intervention to empower persons living with HIV to use therapy self-management: study protocol for an online randomized controlled trial. Trials. 2012 Oct 5;13:187. doi: 10.1186/1745-6215-13-187.
PubMed 23039306
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Tailored Virtual Intervention to Empower Persons Living With HIV for Therapy Self-management
- ClinicalTrials.gov ID
- NCT01510340
- Acronym / sponsor ID
- HIVMediconline / CE 11.184
- Conditions
- HIV
- Keywords
- adherence, HIV, antiretroviral therapy, tailored web intervention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Fonds de la Recherche en Santé du Québec
- Study start
- Jan 2012
- Primary completion
- Dec 2019 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 16 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web sites | No intervention | –Patients assigned to this arm are given a list of Web sites where they can collect information related to their condition at their leisure. |
| VIH-TAVIE | Experimental | Behavioral: VIH-TAVIEPatients assigned to this arm must follow the four interactive computer sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- have to be under ART for at least six months¸
- have internet access
Key exclusion criteria (3 listed)
- be pregnant
- active IV drug user
- actual diagnosis of psychiatric health problem
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VIH-TAVIEThe 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. | Behavioural | VIH-TAVIE |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
- Results publication: PubMed 32310145Cote J, Rouleau G, Ramirez-Garcia MP, Auger P, Thomas R, Leblanc J. Effectiveness of a Web-Based Intervention to Support Medication Adherence Among People Living With HIV: Web-Based Randomized Controlled Trial. JMIR Public Health Surveill. 2020 Apr 20;6(2):e17733. doi: 10.2196/17733.
- Derived from this study: PubMed 23039306Cote J, Godin G, Gueheneuc YG, Rouleau G, Ramirez-Garcia P, Otis J, Tremblay C, Fadel G. Evaluation of a real-time virtual intervention to empower persons living with HIV to use therapy self-management: study protocol for an online randomized controlled trial. Trials. 2012 Oct 5;13:187. doi: 10.1186/1745-6215-13-187.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José Côté, Ph.D. principal investigator
CRCHUM, Université de Montréal
Gaston Godin, Ph.D. study chair
Laval University
Yann-Gael Guéhéneuc, Ph.D. study chair
Polytechnique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing VIH-TAVIE in people with HIV, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01510340, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2021.