Protocol of the randomized control trial: the WiseApp trial for improving health outcomes in PLWH (WiseApp)

BACKGROUND: Poor adherence to antiretroviral therapy (ART) is one of the primary barriers to viral load suppression. mHealth technology can help overcome challenges with ART adherence. This paper outlines the protocol for the WiseApp randomized control trial. The WiseApp contains real-time medication monitoring linking an electronic pill bottle and fitness tracker to the app, helping persons living with HIV (PLWH) self-manage their medication adherence and improve their overall quality of life. The primary objective of the trial is to test the effect of the WiseApp's medication adherence features on antiretroviral adherence in underserved PLWH in New York City. METHODS: This ongoing study is a two-arm randomized control trial. Participants are randomized 1:1 to the WiseApp intervention arm or the control arm at baseline and followed for 6 months. Eligibility criteria include: 18 years of age, have a diagnosis of HIV, speak and understand English or Spanish, live in the United States, own a smartphone, currently taking ART medications, and report the past 30 days adherence of 80% or less as measured using the Visual Analogue Scale (VAS), or have a viral load of over 400 copies/mL. The sample size for the trial is 200 people. All study participants receive the WiseApp, a CleverCap electronic pill bottle, and a fitness tracker. The intervention group also receives videos and health surveys centered on medication adherence and managing living with HIV as well as medication reminders. In contrast, the control group receives walk step reminders, videos, and surveys focused on overall wellness. DISCUSSION: The WiseApp Trial has the potential to improve HIV self-management applications, being one of the few randomized controlled trials of a mHealth medication adherence and HIV self-management application in the United States. The trial could also bring new opportunities for advancement in reaching economically disenfranchised and underserved populations in the United States. The real-time monitoring of the WiseApp has the potential to help providers initiate interventions to help patients resume treatment before drug resistance begins. TRIAL REGISTRATION: This trial was registered with ClinicalTrials.gov (NCT03205982) on July 2, 2017.