PrEP SMART PHASE I TRIAL

Brief Summary

Detailed Description

The goal of this Phase I study is to conduct a proof-of-concept trial of a contingency management (CM) targeting adherence to oral HIV antiretroviral pre-exposure prophylaxis (PrEP) administered via a smartphone-based medication adherence platform (PrEP SMART, "the app"). PrEP provides a strong preventative benefit to individuals at-risk for HIV. While oral PrEP adherence is highly correlated with its efficacy in clinical trials, adherence rates are variable and range from 29-80%. In real-world practice settings, PrEP adherence may even be lower. As such, interventions are needed to improve and sustain adherence to oral PrEP, thereby maximizing preventative benefits in at-risk populations. CM is a behavioral intervention that involves the systematic use of reinforcement dependent on the occurrence of a predefined behavior. CM improves adherence to antiretroviral therapy and post-exposure prophylaxis, but CM has yet to be applied to PrEP adherence. The investigative team recently developed a smartphone-based platform for medication adherence that can integrate CM. Given that mobile technologies such as smartphones are increasingly ubiquitous, a CM-based program administered via smartphone may be a practical intervention that augments PrEP adherence. In the proposed research, PrEP SMART will provide medication reminders; monetary incentives for daily, verified adherence to PrEP; education about oral PrEP; and assess potential adherence barriers. This will be a 4-week open-label, stage I trial in a community sample of young men who have sex with men (YMSM, n = 12) already prescribed and taking oral PrEP (ages 18-30). YMSM were selected because they are the only high risk group experiencing an increase in HIV incidence in the U.S. The investigative team is particularly well-positioned as we have expertise in the development of mobile apps to improve medication adherence, including in the context of HIV care; oral PrEP efficacy trials; and are conducting research using the "parent version" of PrEP SMART (mSMART; Mobile App based Personalized Solutions and Tools for Medication Adherence of Rx Pill) platform in another clinical context. The primary aim of this study is to conduct a proof-of-concept trial of PrEP SMART. * Aim 1a: User interaction with the app will allow for evaluation of feasibility (e.g., the number of app uses/day) * Aim 1b: Acceptability will be assessed via self-report ratings and qualitative interviewing * Aim 1c: Medication adherence will be evaluated via daily smartphone camera-based medication event assessments to establish preliminary data on the impact of mSMART for future efficacy trials. * Aim 1d: Adherence barriers will be evaluated by mSMART following missed doses.

Primary Outcomes

Secondary Outcomes

• Barriers to adherence will be measured by the number of times it was taken outside of a 1 hour window(4 weeks)
• Barriers to adherence will be measured by self-report via the PrEP Smart application.(4 weeks)
• Acceptability as measured by questionnaire that includes questions about satisfaction and likelihood of recommending to others on a Likert scale of 1 to 4.(4 weeks)
• Acceptability as measured by an interview that will be conducted by the Principal Investigator.(4 weeks)
• Barriers to adherence following missed doses as measured by daily PrEP Smart assessment.(4 weeks)