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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02895893
Other study ID # Pro00071752
Secondary ID
Status Completed
Phase Phase 1
First received August 30, 2016
Last updated May 19, 2017
Start date July 2016
Est. completion date May 4, 2017

Study information

Verified date July 2016
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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").


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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date May 4, 2017
Est. primary completion date May 4, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 30 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Behavioral:
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.

Locations

Country Name City State
United States Duke University Medical Center Durham North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Duke University Intelligent Automation, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility as measured by the average number of times per day participants initiate an interaction with PrEP Smart 4 weeks
Primary 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
Secondary Barriers to adherence following missed doses as measured by daily PrEP Smart assessment. 4 weeks
Secondary 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
Secondary Acceptability as measured by an interview that will be conducted by the Principal Investigator. 4 weeks
Secondary Barriers to adherence will be measured by the number of times it was taken outside of a 1 hour window 4 weeks
Secondary Barriers to adherence will be measured by self-report via the PrEP Smart application. 4 weeks
See also
  Status Clinical Trial Phase
Completed NCT03080597 - PrEP for HBCUs (Study 2) N/A
Completed NCT01347164 - Evaluation of a New HIV Prevention Intervention for Black Bisexually-active Men Phase 2