Testing the Efficacy of a Social Networking Gamification App to Improve Pre-Exposure Prophylaxis Adherence (P3: Prepared, Protected, emPowered): Protocol for a Randomized Controlled Trial.
No Thumbnail Available
Date
0000-00-00
Journal Title
Journal ISSN
Volume Title
Publisher
Abstract
BACKGROUND HIV prevalence is high among young men who have sex with men YMSM and young transgender women who have sex with men YTWSM particularly among minorities Despite its proven efficacy and safety the uptake of and adherence to pre exposure prophylaxis PrEP among YMSM and YTWSM is currently limited To date evidence based interventions to promote and sustain PrEP adherence have been limited and not shown to be highly efficacious Given the widespread adoption of smartphones mobile apps can be utilized to increase PrEP adherence for many YMSM and YTWSM OBJECTIVE The study consists of a formative research phase to develop an app based intervention P3 Prepared Protected emPowered to increase PrEP adherence and a randomized controlled trial RCT to test its efficacy P3 is a mobile app built on an established health platform which includes social networking and game based components to encourage PrEP adherence among YMSM and YTWSM P3 includes all P3 features plus adherence counseling delivered via two way text messaging short message service SMS through the app METHODS The formative research phase includes usability testing to assess users comprehension of P3 s educational content understanding and use of intervention features and overall impressions of app functionality followed by app refinements A subsequent field trial will identify and resolve any remaining technical challenges A three arm RCT P3 P3 and standard of care will then be conducted at 6 iTech subject recruitment venues to assess intervention efficacy and to conduct a comparison of costs to deliver the 2 intervention arms RESULTS This is an ongoing research project with initial results from the formative work expected in 2020 and those from the RCT in 2021 CONCLUSIONS P3 aims to provide an engaging interactive experience that is highly appealing for the target population leveraging technology already heavily integrated into the lives of young people and thus meeting users needs in a familiar stimulating way If efficacious P3 could be a sustainable easily disseminated lower cost PrEP intervention for YMSM and YTWSM Further the research aims to determine the processes that are essential to developing and implementing future health related gamification interventions TRIAL REGISTRATION ClinicalTrials gov NCT03320512 https clinicaltrials gov ct2 show NCT03320512 Archived by WebCite at http www webcitation org 74OVZkICl INTERNATIONAL REGISTERED REPORT IDENTIFIER IRRID DERR1 10 2196 10448