Clinical Trials Logo

Clinical Trial 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").


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT02895893
Study type Interventional
Source Duke University
Contact
Status Completed
Phase Phase 1
Start date July 2016
Completion date May 4, 2017

See also
  Status Clinical Trial Phase
Recruiting NCT03592719 - Motivational Interviewing to Increase PrEP Uptake (MI-PrEP) N/A
Recruiting NCT03080597 - PrEP for HBCUs (Study 2) N/A
Completed NCT01347164 - Evaluation of a New HIV Prevention Intervention for Black Bisexually-active Men Phase 2