Evaluation of a Tailored Virtual Intervention to Empower Persons Living With HIV for Therapy Self-management

NCT01510340 | Completed Phase 3 DMC

• 1 other identifier: CE 11.184
• Study Type: interventional
• Target: 217
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy of an online virtual intervention in optimizing adherence to antiretroviral medication intake among Persons Living with HIV (PLHIV).

Conditions

HIV

Keywords

adherence; HIV; antiretroviral therapy; tailored web intervention

Outcome Measures

Primary Outcomes (1)

• Adherence

  Adherence will be evaluated through a self-administered questionnaire that was developed for and validated on the targeted population (Godin, Gagné, \& Naccache, 2003). The questionnaire comprises seven items that serve to determine how many times a person forgets to take his or her medication. The questionnaire's validity was demonstrated (sensitivity: 71 %; specificity: 72%; correct classification: 72%; odds ratio: 6.15) using immunologic (CD4 count) and virologic (viral load) parameters as validation criteria. Adherence is defined as the intake of at least 95% of prescribed tablets.

  6 months

Study Arms (2)

Web sites

NO INTERVENTION

Patients assigned to this arm are given a list of Web sites where they can collect information related to their condition at their leisure.

VIH-TAVIE

EXPERIMENTAL

Patients assigned to this arm must follow the four interactive computer sessions

Behavioral: VIH-TAVIE

Interventions

VIH-TAVIE BEHAVIORAL

The tailored virtual intervention is composed of four interactive computer sessions hosted by a virtual nurse who engages the PLHIV in a medication-intake self-management skills-learning process.

VIH-TAVIE

Eligibility Criteria

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

You may qualify if:

• have to be under ART for at least six months¸
• have internet access

You may not qualify if:

• be pregnant
• active IV drug user
• actual diagnosis of psychiatric health problem

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Fonds de la Recherche en Santé du Québec: collaborator

Study Sites (1)

José Côté

Montreal, Quebec, H2X 0A9, Canada

Location

Related Publications (2)

• Cote J, Rouleau G, Ramirez-Garcia MP, Auger P, Thomas R, Leblanc J. Effectiveness of a Web-Based Intervention to Support Medication Adherence Among People Living With HIV: Web-Based Randomized Controlled Trial. JMIR Public Health Surveill. 2020 Apr 20;6(2):e17733. doi: 10.2196/17733.

  PMID: 32310145 RESULT

• Cote J, Godin G, Gueheneuc YG, Rouleau G, Ramirez-Garcia P, Otis J, Tremblay C, Fadel G. Evaluation of a real-time virtual intervention to empower persons living with HIV to use therapy self-management: study protocol for an online randomized controlled trial. Trials. 2012 Oct 5;13:187. doi: 10.1186/1745-6215-13-187.

  PMID: 23039306 DERIVED

Related Links

• Related Info

Study Officials

• José Côté, Ph.D.

  CRCHUM, Université de Montréal

  PRINCIPAL INVESTIGATOR

• Gaston Godin, Ph.D.

  Laval University

  STUDY CHAIR

• Yann-Gael Guéhéneuc, Ph.D.

  Polytechnique

  STUDY CHAIR

• Cécile Tremblay, MD,Ph.D.

  CRCHUM

  STUDY CHAIR

• Joanne Otis, Ph.D.

  Université du Québec a Montréal

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2011
• First Posted: January 16, 2012
• Study Start: January 1, 2012
• Primary Completion: December 1, 2019
• Study Completion: June 1, 2020
• Last Updated: August 6, 2021

Record last verified: 2021-08

Locations

CA (1)