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Clinical Trials/NCT02378766
NCT02378766
Completed
N/A

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)

Centre hospitalier de l'Université de Montréal (CHUM)1 site in 1 country750 target enrollmentDecember 2015
ConditionsHIV

Overview

Phase
N/A
Intervention
Not specified
Conditions
HIV
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Enrollment
750
Locations
1
Primary Endpoint
Change in tobacco smoking
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2015
End Date
April 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Responsible Party
Sponsor

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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).

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.

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 Outcomes

  • Change in perceived control regarding the adoption of the chosen health behaviour(6 months)
  • Change in Intention regarding the adoption of the chosen health behaviour(6 months)
  • Change in attitude regarding the adoption of the chosen health behaviour(6 months)

Study Sites (1)

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