PrEP SMART Phase I Trial (PrepSmart)
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|ClinicalTrials.gov Identifier: NCT02895893|
Recruitment Status : Completed
First Posted : September 12, 2016
Last Update Posted : May 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|At Risk for HIV||Behavioral: PrEP Smart||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PrEP SMART PHASE I TRIAL|
|Study Start Date :||July 2016|
|Actual Primary Completion Date :||May 4, 2017|
|Actual Study Completion Date :||May 4, 2017|
Experimental: Smartphone app condition
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
Men who have sex with men and already prescribed and taking oral PrEP will use an application on their smart phone for 4 weeks.
- Feasibility as measured by the average number of times per day participants initiate an interaction with PrEP Smart [ Time Frame: 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. [ Time Frame: 4 weeks ]
- Barriers to adherence following missed doses as measured by daily PrEP Smart assessment. [ Time Frame: 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. [ Time Frame: 4 weeks ]
- Acceptability as measured by an interview that will be conducted by the Principal Investigator. [ Time Frame: 4 weeks ]
- Barriers to adherence will be measured by the number of times it was taken outside of a 1 hour window [ Time Frame: 4 weeks ]
- Barriers to adherence will be measured by self-report via the PrEP Smart application. [ Time Frame: 4 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02895893
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||John Mitchell, Ph.D.||Duke University|