PrEP SMART Phase I Trial

Phase 1

Completed

• Conditions: At Risk for HIV
• Interventions: Behavioral: PrEP Smart

• 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

Arm && Interventions

Group	Intervention	Description
Smartphone app condition	PrEP Smart	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".

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