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Open Access Study protocol

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

José Côté12*, Gaston Godin3, Yann-Gaël Guéhéneuc4, Geneviève Rouleau1, Pilar Ramirez-Garcìa2, Joanne Otis5, Cécile Tremblay67 and Ghayas Fadel8

Author Affiliations

1 Research Chair in Innovative Nursing Practices, Research Centre of the Centre Hospitalier de l’Université de Montréal, Quebec, Canada

2 Université de Montréal, Quebec, Canada

3 Canada Research Chair on Behaviour and Health, Université Laval, Quebec, Canada

4 Canada Research Chair on Software Patterns and Patterns of Software, École Polytechnique Montreal, Quebec, Canada

5 Canada Research Chair in Health Education, Université du Québec à Montréal, Quebec, Canada

6 Université de Montréal, Quebec, Canada

7 Research Centre of the Centre Hospitalier de l’Université de Montréal, Quebec, Canada

8 Quebec Coalition Of Community-Based HIV/AIDS Organizations (COCQ-SIDA), Montreal, Quebec, Canada

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Trials 2012, 13:187  doi:10.1186/1745-6215-13-187

Published: 5 October 2012

Abstract

Background

Living with HIV makes considerable demands on a person in terms of self-management, especially as regards adherence to treatment and coping with adverse side-effects. The online HIV Treatment, Virtual Nursing Assistance and Education (Virus de I’immunodéficience Humaine–Traitement Assistance Virtuelle Infirmière et Enseignement; VIH-TAVIE™) intervention was developed to provide persons living with HIV (PLHIV) with personalized follow-up and real-time support in managing their medication intake on a daily basis. An online randomized controlled trial (RCT) will be conducted to evaluate the efficacy of this intervention primarily in optimizing adherence to combination anti-retroviral therapy (ART) among PLHIV.

Methods/design

A convenience sample of 232 PLHIV will be split evenly and randomly between an experimental group that will use the web application, and a control group that will be handed a list of websites of interest. Participants must be aged 18 years or older, have been on ART for at least 6 months, and have internet access. The intervention is composed of four interactive computer sessions of 20 to 30 minutes hosted by a virtual nurse who engages the PLHIV in a skills-learning process aimed at improving self-management of medication intake. Adherence constitutes the principal outcome, and is defined as the intake of at least 95% of the prescribed tablets. The following intermediary measures will be assessed: self-efficacy and attitude towards antiretroviral medication, symptom-related discomfort, and emotional support. There will be three measurement times: baseline (T0), after 3 months (T3) and 6 months (T6) of baseline measurement. The principal analyses will focus on comparing the two groups in terms of treatment adherence at the end of follow-up at T6. An intention-to-treat (ITT) analysis will be carried out to evaluate the true value of the intervention in a real context.

Discussion

Carrying out this online RCT poses various challenges in terms of recruitment, ethics, and data collection, including participant follow-up over an extended period. Collaboration between researchers from clinical disciplines (nursing, medicine), and experts in behavioral sciences information technology and media will be crucial to the development of innovative solutions to supplying and delivering health services.

Trial registration

CE 11.184 / NCT 01510340

Keywords:
Randomized controlled trial; Web-based study; People living with HIV; Self-management program; Adherence; Anti-retroviral therapy