Evaluation of Web-based Interventions to Support People Living With HIV in the Adoption of Health Behaviors

NCT ID: NCT02378766

Last Updated: 2022-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

750 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2022-04-30

Brief Summary

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The purpose of this study is to evaluate the efficacy of a web-based tailored intervention to support persons living with HIV (PLHIV) manage the demands inherent to their health condition, particularly as regards to the adoption of health behaviours such as being physically active, following a healthy diet and quitting smoking.

This randomized controlled trial is currently conducted entirely online at www.lhivehealthy.ca

Detailed Description

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This online randomized controlled trial with parallel-groups is conducted across Canada. Interested participants are invited to visit the study's Website at www.lhivehealthy.ca

The study's Website contains video clips explaining the study. After accepting the conditions and consenting, participants will enroll in the study by providing an email address and a pseudonym. Each participant will be validated through an email address check. After their enrolment, participants will receive a hyperlink via email to invite them to complete a baseline questionnaire.

After completing the baseline questionnaire, participants will be randomly assigned by the computer system either to an experimental group (TAVIE en santé) or to a control group (list of 5 websites).

Three and six months after the baseline questionnaire, participants will complete the online questionnaires again.

Conditions

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HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Website A

Patients assigned to this arm will be invited to complete a web-based tailored intervention called TAVIE en santé.

Group Type EXPERIMENTAL

Website A

Intervention Type BEHAVIORAL

Patients assigned to this arm will be invited to complete a web-based tailored intervention called TAVIE en santé (TAVIE : Traitement, Assistance Virtuelle Infirmière et Enseignement).

TAVIE en santé is a web-based tailored multicomponent intervention addressing smoking cessation, physical activity and healthy eating. Each component consists of seven interactive computer sessions lasting 5-10 minutes. The sessions, hosted by a virtual nurse, aims to develop and strengthen skills required for behavior change.

Website B

Patients assigned to this arm will be invited to consult a validated list of five predetermined websites.

Group Type OTHER

Website B

Intervention Type OTHER

Patients assigned to this arm will be invited to consult a validated list of five predetermined websites offering information about the health behavior they chose: being physically active, following a healthy diet or quitting smoking. These websites offers reliable information and their content were validated by experts.

Interventions

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Website A

Patients assigned to this arm will be invited to complete a web-based tailored intervention called TAVIE en santé (TAVIE : Traitement, Assistance Virtuelle Infirmière et Enseignement).

TAVIE en santé is a web-based tailored multicomponent intervention addressing smoking cessation, physical activity and healthy eating. Each component consists of seven interactive computer sessions lasting 5-10 minutes. The sessions, hosted by a virtual nurse, aims to develop and strengthen skills required for behavior change.

Intervention Type BEHAVIORAL

Website B

Patients assigned to this arm will be invited to consult a validated list of five predetermined websites offering information about the health behavior they chose: being physically active, following a healthy diet or quitting smoking. These websites offers reliable information and their content were validated by experts.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* to be living with HIV
* to be able to read and understand French or English
* to have access to the Internet
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

CIHR Canadian HIV Trials Network

NETWORK

Sponsor Role collaborator

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sylvie Cosette, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Institut de Cardiologie de Montréal

Cécile Tremblay, Md, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

CR-CHUM

Michal Abrahamowicz, Ph.D.

Role: STUDY_CHAIR

McGill University

François Boudreau, Ph.D.

Role: STUDY_CHAIR

Université du Québec à Trois-Rivièves

Jean-Louis Chiasson, Md

Role: STUDY_CHAIR

CR-CHUM

Alexandra De Pokomandy, Md

Role: STUDY_CHAIR

CUSM

Marie-Pierre Gagnon, Ph.D.

Role: STUDY_CHAIR

Laval University

Yann-Gaël Guéhéneuc, Ph.D.

Role: STUDY_CHAIR

École Polytechnique de Montréal

Joyal Miranda, Ph.D.

Role: STUDY_CHAIR

Toronto Metropolitan University

Pilar Ramirez-Garcia, Ph.D.

Role: STUDY_CHAIR

Université de Montréal

Catherine Worthington, Ph.D.

Role: STUDY_CHAIR

University of Victoria

José Côté, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

CR-CHUM, Université de Montréal

Locations

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Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Site Status

Countries

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Canada

References

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Cote J, Cossette S, Ramirez-Garcia P, De Pokomandy A, Worthington C, Gagnon MP, Auger P, Boudreau F, Miranda J, Gueheneuc YG, Tremblay C. Evaluation of a Web-based tailored intervention (TAVIE en sante) to support people living with HIV in the adoption of health promoting behaviours: an online randomized controlled trial protocol. BMC Public Health. 2015 Oct 12;15:1042. doi: 10.1186/s12889-015-2310-4.

Reference Type BACKGROUND
PMID: 26458508 (View on PubMed)

Other Identifiers

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CE 14.342

Identifier Type: -

Identifier Source: org_study_id

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