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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03876626
Enrollment
26
Registered
2019-03-15
Start date
2019-03-21
Completion date
2020-09-21
Last updated
2025-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adherence, Medication, Hiv

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.

Interventions

OTHERPositiveLinks RX Mobile App

A mobile app designed with tools to facilitate patient self-monitoring, patient-provider communication, medication refills, and social support.

OTHERPositiveLinks RX Portal

An online portal that interacts with the mobile app to enable users to engage with participants though messaging and medication refill tracking.

Sponsors

Virginia Department of Health
CollaboratorOTHER_GOV
University of Virginia
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Patient Medication Refill ComplianceAssessed at baseline and 6-monthsPrimary 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

MeasureTime frameDescription
Participant Check-In EngagementAssessed at 6-monthsExamining participant app engagement through assessment of check-in response rates
Participant Messaging EngagementAssessed at 6-monthsExamining participant app engagement through assessment of messages sent and received
Participant Community EngagementAssessed at 6-monthsExamining participant app engagement through assessment of community posts
App Usability30-days after enrollmentAssessed through the system usability scale (SUS), a validated ten item scale. Additional usability factors will be assessed through qualitative methods.
Change in Patient Refill SatisfactionAssessed at baseline and 6-monthsAssessment of change in patient satisfaction with the refill process at their local health department. Utilizes a patient satisfaction with pharmaceutical services scale.
Change in Provider CommunicationAssessed at baseline and 6-monthsAssessment of change in patient perception of provider (local health department staff) communication. Utilizes the Consultation and Relational Empathy (CARE) scale.
Program Alignment with Health Department WorkflowAssessed at 30-days and 6-monthsAssessing alignment with health department workflow through provider end-of-study and usability interviews
Participant Feature EngagementAssessed at 6-monthsExamining participant app engagement through assessment of page views

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026