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NCT Number: NCT03876626

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

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.

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Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Adherence, Medication Behavior Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Health Behavior Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Medication Adherence Patient Acceptance of Health Care Patient Compliance RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Treatment Adherence and Compliance Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henrico Health Department

Richmond, Virginia, 23228, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PositiveLinks RX Mobile App

Other

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

PositiveLinks RX Portal

Other

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

Primary outcomes

  1. Change in Patient Medication Refill Compliance

    Time frame: 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 outcomes

  1. App Usability

    Time frame: 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.

  2. Participant Check-In Engagement

    Time frame: Assessed at 6-months

    Examining participant app engagement through assessment of check-in response rates

  3. Participant Messaging Engagement

    Time frame: Assessed at 6-months

    Examining participant app engagement through assessment of messages sent and received

  4. Participant Community Engagement

    Time frame: Assessed at 6-months

    Examining participant app engagement through assessment of community posts

  5. Participant Feature Engagement

    Time frame: Assessed at 6-months

    Examining participant app engagement through assessment of page views

  6. Change in Patient Refill Satisfaction

    Time frame: 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.

  7. Change in Provider Communication

    Time frame: 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.

  8. Program Alignment with Health Department Workflow

    Time frame: Assessed at 30-days and 6-months

    Assessing alignment with health department workflow through provider end-of-study and usability interviews

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • Virginia Department of Health

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Mar 15, 2019
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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