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

Hiv Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03876626
• Other study ID #: 21185
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 21, 2019
• Est. completion date: September 2019

Study information

• Verified date: April 2019
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 26
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adherence, Medication
• Hiv

Intervention

Other:
• PositiveLinks RX Mobile App
A mobile app designed with tools to facilitate patient self-monitoring, patient-provider communication, medication refills, and social support.
• 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.

Locations

Country	Name	City	State
United States	Henrico Health Department	Richmond	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	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	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
Secondary	Participant Check-In Engagement	Examining participant app engagement through assessment of check-in response rates	Assessed at 6-months
Secondary	Participant Messaging Engagement	Examining participant app engagement through assessment of messages sent and received	Assessed at 6-months
Secondary	Participant Community Engagement	Examining participant app engagement through assessment of community posts	Assessed at 6-months
Secondary	Participant Feature Engagement	Examining participant app engagement through assessment of page views	Assessed at 6-months
Secondary	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
Secondary	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
Secondary	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