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

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ClinicalTrials.gov Identifier: NCT02378766
Recruitment Status : Recruiting
First Posted : March 4, 2015
Last Update Posted : January 27, 2020
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
CIHR Canadian HIV Trials Network
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

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


Condition or disease Intervention/treatment Phase
HIV Behavioral: Website A Other: Website B Not Applicable

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.

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Study Type : Interventional
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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 Start Date : December 2015
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adoption HIV/AIDS

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.


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.




Primary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02378766


Contacts
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Contact: José Côté, Ph.D. 514-890-8000 ext 15536 jose.cote@umontreal.ca
Contact: Patricia Auger, M.Sc. 514-890-8000 ext 17931 patricia.auger.chum@ssss.gouv.qc.ca

Locations
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Canada, Quebec
Centre Hospitalier de l'Université de Montréal Recruiting
Montréal, Quebec, Canada, H2X 0A9
Contact: Patricia Auger, M.Sc.    514-890-8000 ext 17931    patricia.auger.chum@ssss.gouv.qc.ca   
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Canadian Institutes of Health Research (CIHR)
CIHR Canadian HIV Trials Network
Investigators
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Principal Investigator: Sylvie Cosette, Ph.D. Institut de Cardiologie de Montréal
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
Additional Information:
Publications:
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Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT02378766    
Other Study ID Numbers: CE 14.342
First Posted: March 4, 2015    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
tailored web-based intervention
health behavior
hiv comorbidities
online trial