Using Smart Phone Technology to Support PrEP Uptake and Adherence

Not Applicable

Completed

• Conditions: Adherence, Medication; HIV Prevention; PrEP

• Registration Number: NCT04868383
• Lead Sponsor: University of Virginia

Brief Summary

This is a single arm pilot study of a new smartphone app to support adherence to PrEP medication for HIV prevention in public clinics in Virginia.

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 Timeline

• Study Start: 2019-01-01
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-30
• Status Verified: 2021-04
• Study First Submitted: 2021-04-29
• Study First Submitted QC: 2021-04-29
• Last Update Submitted: 2021-04-29
• Study First Posted: 2021-04-30
• Last Update Posted: 2021-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Adherence	6 months	Overall percentage of PrEP medication adherence

Secondary Outcome Measures

Name	Time	Method
Usability	6 months	How usable is the app to both patient participants and provider participants

Trial Locations

Locations (1)

Virginia Department of Health; 🇺🇸 Charlottesville, Virginia, United States