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

Sponsor
University of Virginia (Other)
Overall Status
Unknown status
CT.gov ID
NCT03876626
Collaborator
Virginia Department of Health (Other)
26
1
2
5.4
4.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: PositiveLinks RX Mobile App
  • Other: PositiveLinks RX Portal
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
26 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Using Smart Phone Technology to Support HIV Medication Refill Adherence in Virginia - Pilot Study
Actual Study Start Date :
Mar 21, 2019
Anticipated Primary Completion Date :
Sep 1, 2019
Anticipated Study Completion Date :
Sep 1, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in Patient Medication Refill Compliance [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 Outcome Measures

  1. App Usability [30-days after enrollment]

    Assessed through the system usability scale (SUS), a validated ten item scale. Additional usability factors will be assessed through qualitative methods.

  2. Participant Check-In Engagement [Assessed at 6-months]

    Examining participant app engagement through assessment of check-in response rates

  3. Participant Messaging Engagement [Assessed at 6-months]

    Examining participant app engagement through assessment of messages sent and received

  4. Participant Community Engagement [Assessed at 6-months]

    Examining participant app engagement through assessment of community posts

  5. Participant Feature Engagement [Assessed at 6-months]

    Examining participant app engagement through assessment of page views

  6. Change in Patient Refill Satisfaction [Assessed at baseline and 6-months]

    Assessment of change in patient satisfaction with the refill process at their local health department. Utilizes a patient satisfaction with pharmaceutical services scale.

  7. Change in Provider Communication [Assessed at baseline and 6-months]

    Assessment of change in patient perception of provider (local health department staff) communication. Utilizes the Consultation and Relational Empathy (CARE) scale.

  8. Program Alignment with Health Department Workflow [Assessed at 30-days and 6-months]

    Assessing alignment with health department workflow through provider end-of-study and usability interviews

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Henrico Health Department Richmond Virginia United States 23228

Sponsors and Collaborators

  • University of Virginia
  • Virginia Department of Health

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rebecca Dillingham, MD/MPH, Harrison Distinguished Teaching Associate Professor of Medicine, University of Virginia
ClinicalTrials.gov Identifier:
NCT03876626
Other Study ID Numbers:
  • 21185
First Posted:
Mar 15, 2019
Last Update Posted:
Apr 17, 2019
Last Verified:
Apr 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 17, 2019