Clinical trial NCT03876626: Using Smart Phone Technology to Support HIV Medication Refill Adherence in Virginia
Official title: Using Smart Phone Technology to Support HIV Medication Refill Adherence in Virginia - Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hiv
Adherence, Medication
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: Virginia Department of Health
First posted: 2019-03-15
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Change in Patient Medication Refill Compliance
timeFrame: Assessed at baseline and 6-months
Secondary outcomes:
measure: App Usability
timeFrame: 30-days after enrollment
measure: Participant Check-In Engagement
timeFrame: Assessed at 6-months
measure: Participant Messaging Engagement
timeFrame: Assessed at 6-months
measure: Participant Community Engagement
timeFrame: Assessed at 6-months
measure: Participant Feature Engagement
timeFrame: Assessed at 6-months
measure: Change in Patient Refill Satisfaction
timeFrame: Assessed at baseline and 6-months
measure: Change in Provider Communication
timeFrame: Assessed at baseline and 6-months
measure: Program Alignment with Health Department Workflow
timeFrame: Assessed at 30-days and 6-months
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Henrico Health Department
state: Virginia
Study officials:
References: