Epic Allies, a Gamified Mobile Phone App to Improve Engagement in Care, Antiretroviral Uptake, and Adherence Among Young Men Who Have Sex With Men and Young Transgender Women Who Have Sex With Men: Protocol...
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BACKGROUND In the United States young men who have sex with men YMSM and transgender women who have sex with men YTWSM bear a disproportionate burden of prevalent and incident HIV infections Once diagnosed many YMSM and YTWSM struggle to engage in HIV care adhere to antiretroviral therapy ART and achieve viral suppression Computer based interventions including those focused on behavior change are recognized as effective tools for engaging youth OBJECTIVE The purpose of the study described in this protocol is to evaluate the efficacy of Epic Allies a theory based mobile phone app that utilizes game mechanics and social networking features to improve engagement in HIV care ART uptake ART adherence and viral suppression among HIV positive YMSM and YTWSM The study also qualitatively assesses intervention acceptability perceived impact and sustainability METHODS This is a two group active control randomized controlled trial of the Epic Allies app YMSM and YTWSM aged 16 to 24 inclusive with detectable HIV viral load are randomized 1 1 within strata of new to care newly entered HIV medical care 12 months of baseline visit or ART nonadherent first entered HIV medical care 12 months before baseline visit to intervention or control conditions The intervention condition addresses ART adherence barriers through medication reminders and adherence monitoring tracking of select adherence related behaviors eg alcohol and marijuana use an interactive dashboard that displays the participant s adherence related behaviors and provides tailored feedback encouragement messages from other users daily HIV ART educational articles and gamification features eg mini games points badges to increase motivation for behavior change and app engagement The control condition features weekly phone based notifications to encourage participants to view educational information in the control app Follow up assessments are administered at 13 26 and 39 weeks for each arm The primary outcome measure is viral suppression Secondary outcome measures include engagement in care ART uptake ART adherence and psychosocial barriers to engagement in care and ART adherence including psychological distress stigma and social support RESULTS Baseline enrollment began in September 2015 and was completed in September 2016 n 146 and assessment of intervention outcomes continued through August 2017 Results for primary and secondary outcome measures are expected to be reported in ClinicalTrials gov by April 30 2018 CONCLUSIONS If successful Epic Allies will represent a novel adherence intervention for a group disproportionately impacted by HIV in the United States Adherent patients would require less frequent clinic visits and experience fewer HIV related secondary infections thereby reducing health care costs and HIV transmission Epic Allies could easily be expanded and adopted for use among larger populations of YMSM and YTWSM other HIV positive populations and for those diagnosed with other chronic diseases such as diabetes and hypertension TRIAL REGISTRATION ClinicalTrials gov NCT02782130 https clinicaltrials gov ct2 show NCT02782130 Archived by Webcite at http www webcitation org 6yGODyerk