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

August 24, 2022 updated by: Centre hospitalier de l'Université de Montréal (CHUM)

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

750

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H2X 0A9
        • Centre hospitalier de l'Université de Montréal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Website A
Patients assigned to this arm will be invited to complete a web-based tailored intervention called TAVIE en santé.
Behavioral: 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.
Other: Website B
Patients assigned to this arm will be invited to consult a validated list of five predetermined websites.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in tobacco smoking
Time Frame: 6 months
Measured with a single question: "In the past 7 days, have you had a smoke or even just a single puff? (0=no/1=yes)". Compared to biochemical verification (urinary cotinine test), this self-report measure has a sensitivity of 96.9% and a specificity of 93.4% (Noonan, Jiang et al. 2013) and it correlates well with biochemical validation (Velicer, Prochaska et al. 1992).
6 months
Change in level of physical activity
Time Frame: 6 months
The level of physical activity will be measured through the adaptation of a procedure elaborated and validated by Godin and al. (1985, 1986). Participants will indicate, during a typical week and for each level of intensity (high, moderate, low), the frequency and the mean duration of physical activity practice.
6 months
Change in diet quality
Time Frame: 6 months
Measured with the brief tool Starting The Conversation an 8-item simplified food frequency instrument (Paxton, Strycker et al. 2011) derived from a validated 54-item instrument (Jilcott, Keyserling et al. 2007). Item scores are tallied for an overall score (range of 0-16). STC is stable over time and sensitive to treatment/intervention.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Intention regarding the adoption of the chosen health behaviour
Time Frame: 6 months
Intention is assessed by three items: 1) "I intend to (a: stop smoking, b: do more physical activity, c: make better choices regarding fat in my diet)" rated on a scale from 1 = strongly disagree to 5 = strongly agree; 2) "I will (a, b or c)" rated on a scale from 1 = very unlikely to 5 = very likely; 3) "the chances that I will (a, b or c) are…" rated on a scale from 1 = very low to 5 = very high. Intention item scores are tallied for an overall score (range of 3-15).
6 months
Change in perceived control regarding the adoption of the chosen health behaviour
Time Frame: 6 months
Perceived control is assessed by three items : 1) "I feel that I will be able to (a: stop smoking, b: do more physical activity, c: make better choices regarding fat in my diet)" rated on a scale from 1 = strongly disagree to 5 = strongly agree; 2) "I am confident that I will succeed in (a, b or c)" rated on a scale from 1 = strongly disagree to 5 = strongly agree; 3) "how much control do you have over (a, b or c)?" rated on a scale from 1 = strongly uncontrollable to 5 = strongly controllable. Perceived control item scores are tallied for an overall score (range of 3-15).
6 months
Change in attitude regarding the adoption of the chosen health behaviour
Time Frame: 6 months
Attitude is measured by asking participants to respond-using five 5-point adjective pairs (unpleasant/pleasant, useless/useful, bad/good, unsatisfying/satisfying, boring/interesting) to the statement linked to their chosen behavior, "Smoking cessation would be for me…" or "Doing more physical activity would be for me…" or "Making better choices regarding fat in my diet would be for me…". Attitude item scores are tallied for an overall score (range of 5-25).
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborators

Canadian Institutes of Health Research (CIHR)
CIHR Canadian HIV Trials Network

Investigators

  • Principal Investigator: Sylvie Cosette, Ph.D., Institut de Cardiologie de Montreal
  • Principal Investigator: Cécile Tremblay, Md, Ph.D., CR-CHUM
  • Study Chair: Michal Abrahamowicz, Ph.D., McGIll University
  • Study Chair: François Boudreau, Ph.D., Université du Québec à Trois-Rivièves
  • Study Chair: Jean-Louis Chiasson, Md, CR-CHUM
  • Study Chair: Alexandra De Pokomandy, Md, CUSM
  • Study Chair: Marie-Pierre Gagnon, Ph.D., Laval University
  • Study Chair: Yann-Gaël Guéhéneuc, Ph.D., École Polytechnique de Montréal
  • Study Chair: Joyal Miranda, Ph.D., Ryerson University
  • Study Chair: Pilar Ramirez-Garcia, Ph.D., Université de Montréal
  • Study Chair: Catherine Worthington, Ph.D., University of Victoria
  • Principal Investigator: José Côté, Ph.D., CR-CHUM, Université de Montréal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Actual)

December 1, 2021

Study Completion (Actual)

April 1, 2022

Study Registration Dates

First Submitted

February 17, 2015

First Submitted That Met QC Criteria

February 27, 2015

First Posted (Estimate)

March 4, 2015

Study Record Updates

Last Update Posted (Actual)

August 25, 2022

Last Update Submitted That Met QC Criteria

August 24, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CE 14.342

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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