NCT03876626

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable hiv

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 15, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

March 21, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2020

Completed
Last Updated

July 14, 2025

Status Verified

July 1, 2025

Enrollment Period

6 months

First QC Date

February 25, 2019

Last Update Submit

July 10, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • App Usability

    30-days after enrollment

  • Participant Check-In Engagement

    Assessed at 6-months

  • Participant Messaging Engagement

    Assessed at 6-months

  • Participant Community Engagement

    Assessed at 6-months

  • Participant Feature Engagement

    Assessed at 6-months

  • +3 more secondary outcomes

Study Arms (2)

Provider Participants

OTHER

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

Patient Participants

OTHER

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

Interventions

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

Patient Participants

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

Provider Participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Current Henrico Health Department employee working with the ADAP pharmacy; Able to read in English; Able to speak English; Able to sign informed consent

You may not qualify if:

  • Severe cognitive impairment that interferes with a subjects ability to consent; non-English speaking; Prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henrico Health Department

Richmond, Virginia, 23228, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeMedication Adherence

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2019

First Posted

March 15, 2019

Study Start

March 21, 2019

Primary Completion

September 21, 2019

Study Completion

September 21, 2020

Last Updated

July 14, 2025

Record last verified: 2025-07

Locations