Abstract
BackgroundPre-exposure prophylaxis (PrEP) provides a strong preventative benefit to individuals at risk for HIV. While PrEP adherence is highly correlated with its efficacy, adherence rates are variable both across and within persons.ObjectiveThe objective of this study was to develop and pilot-test a smartphone-based intervention, known as mSMART, that targets PrEP adherence. mSMART provides contingency management in the form of monetary incentives for daily PrEP adherence based on a real-time adherence assessment using a camera-based medication event-monitoring tool as well as medication reminders, PrEP education, individualized behavioral strategies to address PrEP adherence barriers, and medication adherence feedback.MethodsThis was a 4-week open-label, phase I trial in a community sample of young men who have sex with men already on PrEP (N=10).ResultsAlthough adherence composite scores corresponding to PrEP biomarkers indicated that 90% (9/10) of the sample already had an acceptable baseline adherence in the protective range, by the end of the 4-week period, the scores improved for 30% (3/10) of the sample—adherence did not worsen for any participants. Participants reported mean PrEP adherence rates of 91% via daily entries in mSMART. At the end of the 4-week period, participants indicated acceptable ratings of satisfaction, usability, and willingness to recommend mSMART to others. There were no technical difficulties associated with smartphone compatibility, user misunderstandings about mSMART features that interfered with daily use, or study attrition.ConclusionsThis study is the first to apply contingency management to PrEP adherence. Findings indicated that mSMART is feasible and acceptable. Such an adherence intervention administered via a user-friendly smartphone app can allow for widespread dissemination. Future efficacy trials are needed.Trial RegistrationClinicalTrials.gov NCT02895893; https://clinicaltrials.gov/ct2/show/NCT02895893 (Accessed by Webcite at http://www.webcitation.org/72JskjDJq)
Highlights
Pre-exposure prophylaxis (PrEP) in the form of tenofovir disoproxil fumarate and emtricitabine is a highly effective tool to prevent HIV infection [1,2,3,4,5,6,7,8,9]
Findings indicated that mSMART is feasible and acceptable
Adherence rates to this once daily medication are highly variable in clinical trials, ranging from 12% to 82% [4,10,11,12,13,14,15]. This is significant for HIV prevention because the effectiveness of oral PrEP is strongly associated with sustained adherence [3,4,16]
Summary
Pre-exposure prophylaxis (PrEP) in the form of tenofovir disoproxil fumarate and emtricitabine is a highly effective tool to prevent HIV infection [1,2,3,4,5,6,7,8,9]. Adherence rates to this once daily medication are highly variable in clinical trials, ranging from 12% to 82% [4,10,11,12,13,14,15] This is significant for HIV prevention because the effectiveness of oral PrEP is strongly associated with sustained adherence [3,4,16]. Among those receiving PrEP in a 72-week open-label extension trial, HIV incidence significantly dropped from 4.7 infections per 100 person-years if the drug was not detected in blood to 2.3, 0.6, and 0.0 infections per year if blood levels correlated with participants’ taking less than 2 tablets per week, 2-3 tablets per week, and ≥4 tablets per week, respectively [3]. While PrEP adherence is highly correlated with its efficacy, adherence rates are variable both across and within persons
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