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Clinical Trials/NCT03876626
NCT03876626
Completed
N/A

Using Smart Phone Technology to Support HIV Medication Refill Adherence in Virginia - Pilot Study

University of Virginia1 site in 1 country26 target enrollmentMarch 21, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hiv
Sponsor
University of Virginia
Enrollment
26
Locations
1
Primary Endpoint
Change in Patient Medication Refill Compliance
Status
Completed
Last Updated
9 months ago

Overview

Brief Summary

The purpose of this study is to pilot a mobile health intervention, originally designed for HIV retention in care, for use in aiding patients with medication refills. The study will implement the PositiveLinks Rx app with the Henrico Health department. The study will assess user engagement and satisfaction with the app as well as preliminary impact on patient refill compliance.

Detailed Description

The study will enrolled provider and patient participants at the Henrico Health Department in Virginia who either receive or provide medication refills through the AIDS Drug Assistance Program (ADAP). Patient participants will be provided access to a mobile app that allows them to track their mood, stress, and medication adherence, access an anonymous online community, securely message providers, and receive medication refill alerts. Provider participants will be able to view the information entered by enrolled clients, securely message clients, and track medication refill processes. Study participants will be asked to provide feedback on usability, utility, impact, and effectiveness of the program. Additional assessments will evaluate for impact on medication refill adherence and patient-provider communication.

Registry
clinicaltrials.gov
Start Date
March 21, 2019
End Date
September 21, 2020
Last Updated
9 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Currently picking up of receiving medications through ADAP from the Henrico Health Department; Able to read in English; Able to speak English; Able to sign informed consent
  • Provider Inclusion Criteria:
  • Current Henrico Health Department employee working with the ADAP pharmacy; Able to read in English; Able to speak English; Able to sign informed consent

Exclusion Criteria

  • Severe cognitive impairment that interferes with a subjects ability to consent; non-English speaking; Prisoners

Outcomes

Primary Outcomes

Change in Patient Medication Refill Compliance

Time Frame: Assessed at baseline and 6-months

Primary variable analysis will include examination of patient medication refill compliance at baseline and at the 6-month follow-up to assess for any change in refill compliance.

Secondary Outcomes

  • Participant Community Engagement(Assessed at 6-months)
  • Participant Feature Engagement(Assessed at 6-months)
  • Change in Patient Refill Satisfaction(Assessed at baseline and 6-months)
  • Program Alignment with Health Department Workflow(Assessed at 30-days and 6-months)
  • App Usability(30-days after enrollment)
  • Participant Check-In Engagement(Assessed at 6-months)
  • Change in Provider Communication(Assessed at baseline and 6-months)
  • Participant Messaging Engagement(Assessed at 6-months)

Study Sites (1)

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