PrEP SMART Phase I Trial

NCT ID: NCT02895893

Last Updated: 2017-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2017-05-04

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.

Conditions

At Risk for HIV

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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".

Group Type: EXPERIMENTAL

PrEP Smart

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Intelligent Automation, Inc.

INDUSTRY

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Mitchell, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30201601 (View on PubMed)

Other Identifiers

Pro00071752

Identifier Type: -

Identifier Source: org_study_id