Using Smart Phone Technology to Support PrEP Uptake and Adherence (prep'd)
Using Smart Phone Technology to Support PrEP Uptake and Adherence in Virginia - Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Testing the impact of a smart phone application's impact on PrEP uptake and adherence.
The app features daily medication reminders, daily mood and stress evaluations, a community message board for social support, and patient-provider secure, HIPAA compliant private messaging between patients and clinic providers. Participants will be recruited from VDH clinics. We will evaluate the adherence and uptake rates of PrEP among study participants. Usage data will be collected from the application, and from participant surveys at 30 day, 3 month, and 6 month study timepoints. Surveys will include questionnaires on medication adherence, empathy of providers, experiences with the app, stigma and disclosure attitudes, and social support, along with mental health screening. The study will be analyzed as a prospective one arm study by comparing baseline to 3M and 6M surveys, along with examining and characterizing app usage across time.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Virginia
-
Charlottesville, Virginia, United States, 22908
- Virginia Department of Health
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 years of age or older
- one or considering being on PrEP for HIV prevention
- Patient at a VDH or VDH funded clinic
- ability to read at a 5th grade reading level
Exclusion Criteria:
- HIV positive individuals
- Persons under the age of 18
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Single pilot arm
In this single arm pilot study, all participants will receive access to a novel smartphone app designed to support PrEP uptake and adherence for a 6 month period.
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Use of smart phone technology to support medication adherence and uptake
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adherence
Time Frame: 6 months
|
Overall percentage of PrEP medication adherence
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Usability
Time Frame: 6 months
|
How usable is the app to both patient participants and provider participants
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 20478
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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