PrEP SMART Phase I Trial (PrepSmart)
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About
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").
Full 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.
Enrollment
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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
Trial design
Primary purpose
Allocation
Interventional model
Masking
12 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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