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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hiv, Adherence, Medication

Intervention / Treatment
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* Other: PositiveLinks RX Mobile App
* Other: PositiveLinks RX Portal


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Provider Participants<br>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<br>* An online portal that interacts with the mobile app to enable users to engage with participants though messaging and medication refill tracking.<br>|
| Other: Patient Participants<br>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<br>* A mobile app designed with tools to facilitate patient self-monitoring, patient-provider communication, medication refills, and social support.<br>|

What is the study measuring?
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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 |