PrEP SMART Phase I Trial (PrepSmart)

PrEP SMART PHASE I TRIAL

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").

Study Overview

• Status: Completed
• Conditions: At Risk for HIV
• Intervention / Treatment: Behavioral: PrEP Smart

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: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Intelligent Automation, Inc.
• Investigators: Principal Investigator: John Mitchell, Ph.D., Duke University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): May 4, 2017
• Study Completion (Actual): May 4, 2017

Study Registration Dates

• First Submitted: August 30, 2016
• First Submitted That Met QC Criteria: September 6, 2016
• First Posted (Estimate): September 12, 2016

Study Record Updates

• Last Update Posted (Actual): May 22, 2017
• Last Update Submitted That Met QC Criteria: May 19, 2017
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: Pro00071752

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided