Abstract
BackgroundHIV 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.ObjectiveThe 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.MethodsThe 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.ResultsThis is an ongoing research project with initial results from the formative work expected in 2020 and those from the RCT in 2021.ConclusionsP3 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 RegistrationClinicalTrials.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
Highlights
BackgroundBetween 2002 and 2011, rates of new HIV infections declined by >30% overall in the United States but increased by 132% among young men who have sex with men (YMSM) aged 13-24 years [1]
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 meeting users’ needs in a familiar, stimulating way
pre-exposure prophylaxis (PrEP) adherence rates were lower among black YMSM and below the protective threshold at all time points measured [14]
Summary
BackgroundBetween 2002 and 2011, rates of new HIV infections declined by >30% overall in the United States but increased by 132% among young men who have sex with men (YMSM) aged 13-24 years [1]. There is overwhelming scientific evidence of the efficacy and safety of pre-exposure prophylaxis (PrEP) to prevent HIV infection in YMSM and young transgender women who have sex with men (YTWSM) [5,6,7]. In a recent study of PrEP use among 200 YMSM (mean age 20.2 years; 54.5% black, 26.5% Latino), at week 4, 56% had protective levels of intracellular tenofovir-diphosphate (TFV-DP) (ie, consistent with >4 pills per week). This decreased to 48% at week 24 and 34% at week 48. Given the widespread adoption of smartphones, mobile apps can be utilized to increase PrEP adherence for many YMSM and YTWSM
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