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Completed

NCT Number: NCT02378766

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 0A9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Website A

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

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.

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Collaborators

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

Registry information

Official study 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)

Acronym: LHIVEHEALTHY

Important dates

Study start
2015
Primary completion
2021
Study completion
2022
First posted
Mar 4, 2015
Registry last updated
Aug 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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