Grant: Travel Awards - Institute Community Support

Context: About 36.7 million people are infected with HIV worldwide. Despite the high efficacy of Antiretroviral treatment (ART), adherence to ART is a major challenge for HIV care. The I-Score study aims to implement a platform trial (PT) approach for the development of an electronic patient reported outcome (e-PRO) that helps identifying barriers to ART adherence. We conducted a systematic review to inform the design and planning of the PT, summarizing various aspects relevant for the feasibility of an e-PRO development in a large western HIV patient cohort. Objective: This study seeks to provide a comprehensive review of the clinical trials using adaptive randomizations, platform trials and multi arm multi stage designs. The systematic review summarizes what has been learned about the context, ethics, biases, sample size requirements and risk of inflated type I errors associated with these advanced trial designs. The review aims to confirm feasibility and acceptability of platform trials for e-PRO development and other e-Health applications. Study Design: Following PRISMA guidelines a systematic review was conducted using four databases (Medline, Pub med, Embase, Scopus) and grey literature based on pre-defined search strategies. Two researchers applied pre- defined eligibility criteria and conducted quality appraisal and data extraction. Studies published between 1947-2018 were eligible for inclusion, as were any published empirical studies (qualitative, quantitative, clinical trials) describing PT. All non-clinical trials, not focused on adaptive randomization, published in languages other than English were excluded. Results: Our results lay the empirical foundation for the implementation of a platform trial approach for the development of an e-PRO application for HIV patients. Conclusions: Platform trials are innovative and cost-effective study designs with potential utility in the evaluation of multiple treatments and interventions like e-health applications.