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

NCT02378766 | Completed DMC

• 1 other identifier: CE 14.342
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 1

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

Conditions

HIV

Keywords

tailored web-based intervention; health behavior; hiv comorbidities; online trial

Outcome Measures

Primary Outcomes (3)

• Change in tobacco smoking

  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

  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

  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 Outcomes (3)

• Change in Intention regarding the adoption of the chosen health behaviour

  6 months

• Change in perceived control regarding the adoption of the chosen health behaviour

  6 months

• Change in attitude regarding the adoption of the chosen health behaviour

  6 months

Study Arms (2)

Website A

EXPERIMENTAL

Patients assigned to this arm will be invited to complete a web-based tailored intervention called TAVIE en santé.

Behavioral: Website A

Website B

OTHER

Patients assigned to this arm will be invited to consult a validated list of five predetermined websites.

Other: Website B

Interventions

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 A

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.

Website B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Canadian Institutes of Health Research (CIHR): collaborator
• CIHR Canadian HIV Trials Network: collaborator

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 0A9, Canada

Location

Related Publications (1)

• 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.

  PMID: 26458508 BACKGROUND

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Sylvie Cosette, Ph.D.

  Institut de Cardiologie de Montréal

  PRINCIPAL INVESTIGATOR

• Cécile Tremblay, Md, Ph.D.

  CR-CHUM

  PRINCIPAL INVESTIGATOR

• 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.

  Toronto Metropolitan University

  STUDY CHAIR

• Pilar Ramirez-Garcia, Ph.D.

  Université de Montréal

  STUDY CHAIR

• Catherine Worthington, Ph.D.

  University of Victoria

  STUDY CHAIR

• José Côté, Ph.D.

  CR-CHUM, Université de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2015
• First Posted: March 4, 2015
• Study Start: December 1, 2015
• Primary Completion: December 1, 2021
• Study Completion: April 1, 2022
• Last Updated: August 25, 2022

Record last verified: 2022-01

Locations

CA (1)