PrEP SMART Phase I Trial | Clinical Trial

Key information

Conditions

At Risk for HIV

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Duke University Medical Center

Durham, North Carolina, 27705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

Intelligent Automation, Inc.

Registry information

Acronym: PrepSmart

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Sep 12, 2016
Registry last updated: May 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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