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

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

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.

Study Overview

• Status: Unknown
• Conditions: Hiv; Adherence, Medication
• Intervention / Treatment: Other: PositiveLinks RX Portal; Other: PositiveLinks RX Mobile App

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.

• Study Type: Interventional
• Enrollment (Anticipated): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23228
      • Henrico Health Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Patient 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Provider Participants; Employees who work with medication refills through the AIDS Drug Assistance Program at the Henrico Health Department will be invited to participate in the study as providers. Provider participants will receive access to a web based system that allows them to view information for their enrolled clients, securely message clients, and track medication refills. Providers will be asked to participate in a 30-day usability interview and a end-of-study assessment.	Other: PositiveLinks RX Portal; An online portal that interacts with the mobile app to enable users to engage with participants though messaging and medication refill tracking.
Other: Patient Participants; Clients who receive medication refills through the AIDS Drug Assistance Program at the Henrico Health Department will be invited to participate in the study as patients. 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	Other: PositiveLinks RX Mobile App; A mobile app designed with tools to facilitate patient self-monitoring, patient-provider communication, medication refills, and social support.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Patient Medication Refill Compliance	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.	Assessed at baseline and 6-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
App Usability	Assessed through the system usability scale (SUS), a validated ten item scale. Additional usability factors will be assessed through qualitative methods.	30-days after enrollment
Participant Check-In Engagement	Examining participant app engagement through assessment of check-in response rates	Assessed at 6-months
Participant Messaging Engagement	Examining participant app engagement through assessment of messages sent and received	Assessed at 6-months
Participant Community Engagement	Examining participant app engagement through assessment of community posts	Assessed at 6-months
Participant Feature Engagement	Examining participant app engagement through assessment of page views	Assessed at 6-months
Change in Patient Refill Satisfaction	Assessment of change in patient satisfaction with the refill process at their local health department. Utilizes a patient satisfaction with pharmaceutical services scale.	Assessed at baseline and 6-months
Change in Provider Communication	Assessment of change in patient perception of provider (local health department staff) communication. Utilizes the Consultation and Relational Empathy (CARE) scale.	Assessed at baseline and 6-months
Program Alignment with Health Department Workflow	Assessing alignment with health department workflow through provider end-of-study and usability interviews	Assessed at 30-days and 6-months

Collaborators and Investigators

• Sponsor: University of Virginia
• Collaborators: Virginia Department of Health

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2019
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): September 1, 2019

Study Registration Dates

• First Submitted: February 25, 2019
• First Submitted That Met QC Criteria: March 13, 2019
• First Posted (Actual): March 15, 2019

Study Record Updates

• Last Update Posted (Actual): April 17, 2019
• Last Update Submitted That Met QC Criteria: April 15, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 21185

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No