Effectiveness of a Web-Based Intervention to Support Medication Adherence Among People Living With HIV: Web-Based Randomized Controlled Trial

Abstract

Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet #Preprint #PeerReviewMe: Warning: This is a unreviewed preprint. Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn. Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period. Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author). Background: Taking antiretroviral therapy (ART) is part of the daily life of people living with HIV (PLHIV). Different eHealth initiatives adjunctive to usual care have been proposed to support optimal medication adherence. VIH-TAVIE, an online virtual intervention, was developed to empower PLHIV to manage their ART and symptoms optimally. Objective: A randomized controlled trial (RCT) was conducted to evaluate the effectiveness of VIH-TAVIE. Methods: The RCT was carried out entirely online: recruitment, consent granting, questionnaire completion, and intervention exposure: either consultation of VIH-TAVIETM (experimental group, EG) or websites (control group, CG). To be eligible for the study, PLHIV had to: be 18 years old or over, be on ART for at least six months, have internet access and internet literacy. Participants were randomly assigned either to an experimental group (n=45) or to a control group (n=43). The primary outcome was ART-adherence. Secondary outcomes included self-efficacy regarding medication intake, symptom-related discomfort, skills and strategies, social support. All outcomes were measured with a self-administered online questionnaire at three time points: baseline, and three and six months later. A generalized linear mixed model was built to assess the evolution of ART-adherence over time in both groups. Results: The sample was composed of 88 participants of whom 83.0% were men. The median age of the sample was 41.5 years. Participants had been diagnosed with HIV a median of 7.0 years earlier (IQR: 3.0–17.0) and had been on ART a median of 5.0 years (IQR: 2.0–12.0). The proportion of treatment-adherent patients at baseline was high in both groups (EG=82.9%, CG= 76.9%). Participants also reported high treatment adherence, high self-efficacy, and high skills, perceived good social support, and experienced low discomfort from symptoms. Analyses revealed no inter-group difference on ART adherence (OR: 1.9, 95%CI: 0.6–6.4). Conclusions: The study highlights challenges and lessons learned of conducting entirely online RCT among PLHIV. The challenges were related to PLHIV’s engagement on three levels: starting the online study (recruitment), completing the virtual intervention, and continuing the study (retention). These results contributes to the existing body of knowledge regarding how to conduct online evaluation studies of eHealth interventions aimed at developing and strengthening personal skills and abilities. Clinical Trial: Clinical Trials.gov NCT 01510340