PrEP SMART Phase I Trial

Phase 1

Completed

• Conditions: At Risk for HIV

• Registration Number: NCT02895893
• Lead Sponsor: Duke University

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 Timeline

• Status Verified: 2016-07
• Study Start: 2016-07
• Study First Submitted: 2016-08-30
• Study First Submitted QC: 2016-09-06
• Study First Posted: 2016-09-12
• Primary Completion: 2017-05-04
• Study Completion: 2017-05-04
• Last Update Submitted: 2017-05-19
• Last Update Posted: 2017-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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
Feasibility as measured by the average number of times per day participants initiate an interaction with PrEP Smart	4 weeks

Secondary Outcome Measures

Name	Time	Method
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
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 following missed doses as measured by daily PrEP Smart assessment.	4 weeks

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States