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OpenTrials
Completed

NCT Number: NCT04868383

Using Smart Phone Technology to Support PrEP Uptake and Adherence

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.

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Key information

Conditions

HIV Prevention Adherence, Medication Behavior Health Behavior Medication Adherence Patient Acceptance of Health Care Patient Compliance PreP Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Department of Health

Charlottesville, Virginia, 22908, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Use of smart phone technology to support medication adherence and uptake

Behavioral

Use of smart phone technology to support medication adherence and uptake

Primary outcomes

  1. Adherence

    Time frame: 6 months

    Overall percentage of PrEP medication adherence

Secondary outcomes

  1. Usability

    Time frame: 6 months

    How usable is the app to both patient participants and provider participants

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • Virginia Department of Health

Registry information

Official study title

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

Acronym: prep'd

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 30, 2021
Registry last updated
Apr 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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