prep smart phase i trial

Conditions: At Risk for HIV

Summary: 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").

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.

Eligibility criteria:
inclusion criteria: * male * 18-30 years of age * self-report having sex with men in the past 6 months * currently prescribed prep (truvada) for hiv prevention * english-speaking * participant has an android or ios smartphone exclusion criteria: * history of chronic/significant medical or psychiatric condition that will interfere with study participation * unable to attend sessions