PrEP SMART Phase I Trial
PrepSmart
PrEP SMART PHASE I TRIAL
1 other identifier
interventional
12
1 country
1
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").
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jul 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 30, 2016
CompletedFirst Posted
Study publicly available on registry
September 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 4, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 4, 2017
CompletedMay 22, 2017
July 1, 2016
10 months
August 30, 2016
May 19, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Feasibility as measured by the average number of times per day participants initiate an interaction with PrEP Smart
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.
4 weeks
Secondary Outcomes (5)
Barriers to adherence following missed doses as measured by daily PrEP Smart assessment.
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.
4 weeks
Acceptability as measured by an interview that will be conducted by the Principal Investigator.
4 weeks
Barriers to adherence will be measured by the number of times it was taken outside of a 1 hour window
4 weeks
Barriers to adherence will be measured by self-report via the PrEP Smart application.
4 weeks
Study Arms (1)
Smartphone app condition
EXPERIMENTALMen 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".
Interventions
Men who have sex with men and already prescribed and taking oral PrEP will use an application on their smart phone for 4 weeks.
Eligibility Criteria
You may qualify if:
- Male
- 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
You may not qualify if:
- History of chronic/significant medical or psychiatric condition that will interfere with study participation
- Unable to attend sessions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- Intelligent Automation, Inc.collaborator
Study Sites (1)
Duke University Medical Center
Durham, North Carolina, 27705, United States
Related Publications (1)
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.
PMID: 30201601DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
John Mitchell, Ph.D.
Duke University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2016
First Posted
September 12, 2016
Study Start
July 1, 2016
Primary Completion
May 4, 2017
Study Completion
May 4, 2017
Last Updated
May 22, 2017
Record last verified: 2016-07