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

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

Barriers and facilitators of interventions for improving antiretroviral therapy adherence: a systematic review of global qualitative evidence

“…Our findings are consistent with these reviews: that participating in these interventions empowered PLHIV, gave them greater motivation to sustain better adherence [15] and provided them with more courage to seek medical advice from health providers and support from community members [35,39]. This finding is consistent with other interventions that formally incorporated empowerment of PLHIV into their intervention design and secondary outcomes [63–65]. This suggests that empowerment of PLHIV may be useful when designing and implementing ART adherence interventions.…”

The Effect of Education Based on Health Promotion Model (HPM) on Adherence to Antiretroviral Therapy (ART) in HIV- Infected Patients

“…In this study, education on the improvement of feelings about treatment led to an increase in adherence to therapy. In several studies, the positive effect of education on beliefs about the use of medication and adherence to therapy has been reported (9,11,19). In a study by Cote (2012), it was pointed out that computer training could improve the feelings and affects about therapy and increase adherence almost by 20% (11).…”

“…Several studies have been conducted on adherence to ART, but not on the behavioral change model (8)(9)(10), and only few studies have focused on constructs (11,12). Therefore, many studies should be conducted using models and theories of behavior change to investigate the efficiency of such models in adherence to therapy.…”

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“…Current studies mostly highlight the passive role that PLHIV play in their own medical journey rather than their multidimensional needs which inform patient-centred care [39,40]. However, respondents reported the need to be heard, represented and involved in shared decision-making processes to feel validated, 'nothing about me without me' [41].…”