Using Smart Phone Technology to Support PrEP Uptake and Adherence

Overview

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.

Full Title of Study: “Using Smart Phone Technology to Support PrEP Uptake and Adherence in Virginia – Pilot Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 30, 2020

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.

Interventions

  • Behavioral: Use of smart phone technology to support medication adherence and uptake
    • Use of smart phone technology to support medication adherence and uptake

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Adherence
    • Time Frame: 6 months
    • Overall percentage of PrEP medication adherence

Secondary Measures

  • Usability
    • Time Frame: 6 months
    • How usable is the app to both patient participants and provider participants

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Virginia
  • Collaborator
    • Virginia Department of Health
  • Provider of Information About this Clinical Study
    • Principal Investigator: Karen Ingersoll, Clinical Psychologist – University of Virginia

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