PrEP SMART Phase I Trial

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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PrEP SMART PHASE I TRIAL

Conditions
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At Risk for HIV

Intervention / Treatment
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* Behavioral: PrEP Smart


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smartphone app condition<br>Men who are at risk for HIV and already prescribed and taking Truvada will be asked to use an application on their smart phones called PrEP Smart. | Behavioral: PrEP Smart<br>* Men who have sex with men and already prescribed and taking oral PrEP will use an application on their smart phone for 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility as measured by the average number of times per day participants initiate an interaction with PrEP Smart |  | 4 weeks | 
| Feasibility as measured by the average number of times per day subjects respond to a prompt from PrEP Smart over the course of the four week period. |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barriers to adherence following missed doses as measured by daily PrEP Smart assessment. |  | 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 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 |