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Trial record 1 of 70 for:    PrEP SMART
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PrEP SMART Phase I Trial (PrepSmart)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02895893
Recruitment Status : Completed
First Posted : September 12, 2016
Last Update Posted : May 22, 2017
Sponsor:
Collaborator:
Intelligent Automation, Inc.
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE August 30, 2016
First Posted Date  ICMJE September 12, 2016
Last Update Posted Date May 22, 2017
Study Start Date  ICMJE July 2016
Actual Primary Completion Date May 4, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2016)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2016)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PrEP SMART Phase I Trial
Official Title  ICMJE PrEP SMART PHASE I TRIAL
Brief 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").
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE At Risk for HIV
Intervention  ICMJE 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.
Study Arms  ICMJE 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".
Intervention: Behavioral: PrEP Smart
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 19, 2017)
12
Original Estimated Enrollment  ICMJE
 (submitted: September 6, 2016)
20
Actual Study Completion Date  ICMJE May 4, 2017
Actual Primary Completion Date May 4, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02895893
Other Study ID Numbers  ICMJE Pro00071752
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Intelligent Automation, Inc.
Investigators  ICMJE
Principal Investigator: John Mitchell, Ph.D. Duke University
PRS Account Duke University
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP