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NCT04868383 Clinical Trial

Using Smart Phone Technology to Support PrEP Uptake and Adherence

HIV Prevention Clinical Trial

— prep'd  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04868383
Other study ID # 20478
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2019
Est. completion date December 30, 2020

Study information
Verified date April 2021
Source University of Virginia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 62
Est. completion date December 30, 2020
Est. primary completion date December 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Virginia Department of Health Charlottesville Virginia

Sponsors (2)
Lead Sponsor Collaborator
University of Virginia Virginia Department of Health

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adherence Overall percentage of PrEP medication adherence 6 months
Secondary Usability How usable is the app to both patient participants and provider participants 6 months
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