Abstract
BackgroundLiving 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/designA 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.DiscussionCarrying 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 registrationCE 11.184 / NCT 01510340
Highlights
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
Challenges of an online randomized controlled trial Carrying out this online RCT poses various challenges, in terms of recruitment, ethics, and data collection, including participant follow-up over an extended period [92]
To attract and retain the online participation of persons living with HIV (PLHIV) interested in the study, the team sought the help of web design experts
Summary
Challenges of an online randomized controlled trial Carrying out this online RCT poses various challenges, in terms of recruitment, ethics, and data collection, including participant follow-up over an extended period [92]. To attract and retain the online participation of PLHIV interested in the study, the team sought the help of web design experts This help led to the development of a brand image (concept of branding) by an artistic director, who created a logo that would carry the image of the study and be recognizable by our target group. Schubart et al [102] and Bull et al [103] highlighted a number of elements that foster a high retention rate in online studies, including the availability of a health professional to provide feedback, the dynamic qualities of the study website, and the inclusion of a clinician coach, such as a nurse, in the intervention.
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