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Clinical Trials/NCT04868383
NCT04868383
Completed
Not Applicable

Using Smart Phone Technology to Support PrEP Uptake and Adherence in Virginia - Pilot Study

University of Virginia1 site in 1 country62 target enrollmentJanuary 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV Prevention
Sponsor
University of Virginia
Enrollment
62
Locations
1
Primary Endpoint
Adherence
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2019
End Date
December 30, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Karen Ingersoll

Clinical Psychologist

University of Virginia

Eligibility Criteria

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

Outcomes

Primary Outcomes

Adherence

Time Frame: 6 months

Overall percentage of PrEP medication adherence

Secondary Outcomes

  • Usability(6 months)

Study Sites (1)

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