Clinical trial NCT02895893: PrEP SMART Phase I Trial
Official title: PrEP SMART PHASE I TRIAL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: At Risk for HIV
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Intelligent Automation, Inc.
First posted: 2016-09-12
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility as measured by the average number of times per day participants initiate an interaction with PrEP Smart
timeFrame: 4 weeks
measure: 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.
timeFrame: 4 weeks
Secondary outcomes:
measure: Barriers to adherence following missed doses as measured by daily PrEP Smart assessment.
timeFrame: 4 weeks
measure: Acceptability as measured by questionnaire that includes questions about satisfaction and likelihood of recommending to others on a Likert scale of 1 to 4.
timeFrame: 4 weeks
measure: Acceptability as measured by an interview that will be conducted by the Principal Investigator.
timeFrame: 4 weeks
measure: Barriers to adherence will be measured by the number of times it was taken outside of a 1 hour window
timeFrame: 4 weeks
measure: Barriers to adherence will be measured by self-report via the PrEP Smart application.
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: John Mitchell, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.