HivNCT03876626
Using Smart Phone Technology to Support HIV Medication Refill Adherence in Virginia
A study testing PositiveLinks RX Mobile App and PositiveLinks RX Portal in people with Hiv and Adherence, Medication, run by University of Virginia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hiv, Adherence, Medication
- What is being tested?
- PositiveLinks RX Mobile App and PositiveLinks RX Portal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2019to 21 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Severe cognitive impairment that interferes with a subjects ability to consent; non-English speaking; Prisoners
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Smart Phone Technology to Support HIV Medication Refill Adherence in Virginia - Pilot Study
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.
Read the 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.
- Conditions
- Hiv, Adherence, Medication
- Being tested
- PositiveLinks RX Mobile App, PositiveLinks RX Portal
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PositiveLinks RX Mobile AppOther
A mobile app designed with tools to facilitate patient self-monitoring, patient-provider communication, medication refills, and social support.
PositiveLinks RX PortalOther
An online portal that interacts with the mobile app to enable users to engage with participants though messaging and medication refill tracking.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: PositiveLinks RX Mobile App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed at baseline and 6-months
Secondary outcomes (8)
App Usability
Assessed through the system usability scale (SUS), a validated ten item scale. Additional usability factors will be assessed through qualitative methods.
Measured: 30-days after enrollment
Participant Check-In Engagement
Examining participant app engagement through assessment of check-in response rates
Measured: Assessed at 6-months
Participant Messaging Engagement
Examining participant app engagement through assessment of messages sent and received
Measured: Assessed at 6-months
Participant Community Engagement
Examining participant app engagement through assessment of community posts
Measured: Assessed at 6-months
Participant Feature Engagement
Examining participant app engagement through assessment of page views
Measured: Assessed at 6-months
Change in Patient Refill Satisfaction
Assessment of change in patient satisfaction with the refill process at their local health department. Utilizes a patient satisfaction with pharmaceutical services scale.
Measured: Assessed at baseline and 6-months
Change in Provider Communication
Assessment of change in patient perception of provider (local health department staff) communication. Utilizes the Consultation and Relational Empathy (CARE) scale.
Measured: Assessed at baseline and 6-months
Program Alignment with Health Department Workflow
Assessing alignment with health department workflow through provider end-of-study and usability interviews
Measured: Assessed at 30-days and 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start21 Mar 2019
- Primary completion21 Sep 2019
- Study completion21 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HivStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Department of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03876626
- Sponsor's protocol ID
- 21185
- Status last verified
- Jul 2025
- First submitted
- 25 Feb 2019
- Last updated
- 14 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Smart Phone Technology to Support HIV Medication Refill Adherence in Virginia - Pilot Study
- ClinicalTrials.gov ID
- NCT03876626
- Acronym / sponsor ID
- 21185
- Conditions
- Hiv, Adherence, Medication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Virginia Department of Health
- Study start
- 21 Mar 2019 (actual)
- Primary completion
- 21 Sep 2019 (actual)
- Study completion
- 21 Sep 2020 (actual)
- First posted
- 15 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Provider Participants | Other | Other: PositiveLinks RX PortalEmployees 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. |
| Patient Participants | Other | Other: PositiveLinks RX Mobile AppClients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Severe cognitive impairment that interferes with a subjects ability to consent; non-English speaking; Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PositiveLinks RX Mobile AppA mobile app designed with tools to facilitate patient self-monitoring, patient-provider communication, medication refills, and social support. | Other | Patient Participants |
| PositiveLinks RX PortalAn online portal that interacts with the mobile app to enable users to engage with participants though messaging and medication refill tracking. | Other | Provider Participants |
Primary outcome
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.
8 secondary outcomes
App Usability
Time frame: 30-days after enrollment
Participant Check-In Engagement
Time frame: Assessed at 6-months
Participant Messaging Engagement
Time frame: Assessed at 6-months
Participant Community Engagement
Time frame: Assessed at 6-months
Participant Feature Engagement
Time frame: Assessed at 6-months
Change in Patient Refill Satisfaction
Time frame: Assessed at baseline and 6-months
Change in Provider Communication
Time frame: Assessed at baseline and 6-months
Program Alignment with Health Department Workflow
Time frame: Assessed at 30-days and 6-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
Related trials for Hiv
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Not yet recruiting
Adapting the ESTEEM Intervention to Improve Mental Health and PrEP Uptake Among Men at Risk of HIV
PrEP Use
RecruitingPhase 2
Evaluating the Safety and Immunogenicity of MTBVAC
HIV I Infection, Tuberculosis
Active, not recruiting
Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men
HIV Infections, STI
Not yet recruiting
PNF RCT to Decrease Alcohol Use and Increase HIV Prevention
HIV (Human Immunodeficiency Virus), Alcohol Misuse
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PositiveLinks RX Mobile App and PositiveLinks RX Portal in people with Hiv and Adherence, Medication, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient Medication Refill Compliance (time frame: Assessed at baseline and 6-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.