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

Not Applicable

Completed

• Conditions: Hiv; Adherence, Medication

• Registration Number: NCT03876626
• Lead Sponsor: University of Virginia

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.

Study Timeline

• Study First Submitted: 2019-02-25
• Study First Submitted QC: 2019-03-13
• Study First Posted: 2019-03-15
• Study Start: 2019-03-21
• Primary Completion: 2019-09-21
• Study Completion: 2020-09-21
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-10
• Last Update Posted: 2025-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Participant Community Engagement	Assessed at 6-months	Examining participant app engagement through assessment of community posts
Participant Feature Engagement	Assessed at 6-months	Examining participant app engagement through assessment of page views
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.
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
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.
Participant Check-In Engagement	Assessed at 6-months	Examining participant app engagement through assessment of check-in response rates
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.
Participant Messaging Engagement	Assessed at 6-months	Examining participant app engagement through assessment of messages sent and received

Trial Locations

Locations (1)

Henrico Health Department; 🇺🇸 Richmond, Virginia, United States