Acceptability, Effect and Cost of Mobile-Health on Art Adherence and Assessment of Covid-19 Knowledge Among Youths: A Mixed Methods Sequential Study in Kiryandongo. A Study Protocol Youth Trial

Abstract Background: AIDS is the leading cause of death among young people in sub-Saharan Africa. Adherence to antiretroviral therapy is the principal determinant for achieving and sustaining viral suppression, which decreases progression to AIDS and reduces risk of mortality. Few studies have evaluated mHealth adherence tools among youths in resource-limited settings.We aim to evaluate whethermHealth tool improves ART adherence outcomes among youth receiving ART at a rural district in Western Uganda. The Corona virus disease outbreak was announced a Public Health Emergency of International concern on Jan 2020; and declared a global pandemic by World Health Organization on Mar, 2020.In rural areas, there is little data on knowledge and myths on COVID among youths.General objective:To assessacceptability, effect and cost of themHealth tool on ART adherence, knowledge and myths on COVID-19among youth initiating and on ART at KiryandongoDistrict.Methods: This is a mixed methodsequential exploratory study, with the qualitative study conducted first followed by a randomized control trial and healthcare cost evaluation.The qualitative study will assess barriers, enablers of adherence and acceptability of mHealth among youths receiving care at three health facilities inKiryandongo District.The randomized control trial of 206 youth initiatingARTto either Standard of Care or mHealth tool plus Standard of care to assesseffect of mHealth tool on ART adherence and retention in care. Through a basic cell phone, participants in the intervention arm will receive pill reminders, clinic appointment reminders, health voice messages and self-reported symptoms in addition to standard of care. Collection of data on knowledge and myths on COVID-19, HIV and sexual behavior. The health care evaluationnested within randomized trial, will assess the cost of interventionin comparison to Standard of care.Discussion: This project will determine acceptability, effectiveness of mHealth, knowledge & myths on COVID-19and cost of delivering pill and clinic appointment reminders, and voice messages to a population with suboptimal ART adherence in a resource-limited setting.Trial registration: Fully registered under clinicaltrials.gov by 20th Jan 2021. The study is ongoing. Recruitment started Aug 2020.Clinical Trial registration: NCT 04718974