Clinical trial NCT02378766: Evaluation of Web-based Interventions to Support People Living With HIV in the Adoption of Health Behaviors
Official title: Evaluation of a Tailored Virtual Intervention as an Instrument of Prevention and Support to Improve the Health of PLHIV and Reduce Comorbidity Associated With HIV (MP-02-2015-5853)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: tailored web-based intervention
health behavior
hiv comorbidities
online trial
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: CIHR Canadian HIV Trials Network
First posted: 2015-03-04
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Change in tobacco smoking
timeFrame: 6 months
measure: Change in level of physical activity
timeFrame: 6 months
measure: Change in diet quality
timeFrame: 6 months
Secondary outcomes:
measure: Change in Intention regarding the adoption of the chosen health behaviour
timeFrame: 6 months
measure: Change in perceived control regarding the adoption of the chosen health behaviour
timeFrame: 6 months
measure: Change in attitude regarding the adoption of the chosen health behaviour
timeFrame: 6 months
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal
state: Quebec
Study officials:
affiliation: Institut de Cardiologie de Montréal
name: Sylvie Cosette, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: CR-CHUM
name: Cécile Tremblay, Md, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill University
name: Michal Abrahamowicz, Ph.D.
role: STUDY_CHAIR
affiliation: Université du Québec à Trois-Rivièves
name: François Boudreau, Ph.D.
role: STUDY_CHAIR
affiliation: CR-CHUM
name: Jean-Louis Chiasson, Md
role: STUDY_CHAIR
affiliation: CUSM
name: Alexandra De Pokomandy, Md
role: STUDY_CHAIR
affiliation: Laval University
name: Marie-Pierre Gagnon, Ph.D.
role: STUDY_CHAIR
affiliation: École Polytechnique de Montréal
name: Yann-Gaël Guéhéneuc, Ph.D.
role: STUDY_CHAIR
affiliation: Toronto Metropolitan University
name: Joyal Miranda, Ph.D.
role: STUDY_CHAIR
affiliation: Université de Montréal
name: Pilar Ramirez-Garcia, Ph.D.
role: STUDY_CHAIR
affiliation: University of Victoria
name: Catherine Worthington, Ph.D.
role: STUDY_CHAIR
affiliation: CR-CHUM, Université de Montréal
name: José Côté, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.