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| Name | Class |
|---|---|
| Intelligent Automation, Inc. | INDUSTRY |
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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").
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smartphone app condition | Experimental | 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". |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PrEP Smart | Behavioral | Men who have sex with men and already prescribed and taking oral PrEP will use an application on their smart phone for 4 weeks. |
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Mitchell, Ph.D. | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30201601 | Derived | Mitchell JT, LeGrand S, Hightow-Weidman LB, McKellar MS, Kashuba AD, Cottrell M, McLaurin T, Satapathy G, McClernon FJ. Smartphone-Based Contingency Management Intervention to Improve Pre-Exposure Prophylaxis Adherence: Pilot Trial. JMIR Mhealth Uhealth. 2018 Sep 10;6(9):e10456. doi: 10.2196/10456. |
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| 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 |