HIVNCT02001064
Care4Today v2.0 Application for Improving Adherence to HIV Medications
A study testing Care4Today v2.0 mobile application + electronic monitoring of adherence in people with HIV and AIDS, run by University of California, San Diego at 1 site in United States.
Trial summary
Although poor antiretroviral (ART) adherence in HIV does not mean a complete lack of therapeutic results, the benefit of ART increases as adherence improves. Consequences of suboptimal ART adherence are viral rebound, development of drug-resistant HIV strains, and more rapid progression to AIDS. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Care4Today v2.0 mobile application + electronic monitoring of adherence
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Oct 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Ability to provide informed consent
- 18 years or older at the time of enrollment
- HIV-infected
- Taking at least one medication to treat HIV illness
- Indication of medication nonadherence, or having a condition (e.g., active substance use, depression) that puts the individual at risk for medication non adherence
- Willingness to use electronic monitoring caps to track ART medication
- Willingness to respond to application alert messages
Who cannot join
- Axis I psychiatric diagnosis of psychotic disorder or mood disorder with psychotic features
- Presence of a neurological condition (beyond HIV infection) known to impact cognitive functioning (e.g., Huntington's Disease, Stroke)
- Unwillingness or inability to use electronic medication monitoring technology
- Unwillingness or inability to use daily alert messages
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of Care4Today v.2.0 Application for Improving Adherence to HIV Medications
Although poor antiretroviral (ART) adherence in HIV does not mean a complete lack of therapeutic results, the benefit of ART increases as adherence improves. Consequences of suboptimal ART adherence are viral rebound, development of drug-resistant HIV strains, and more rapid progression to AIDS. Moreover, HIV-infected persons tend to have numerous co-occurring conditions and therefore take many medications making adherence to multiple drug regimens more difficult. A mobile application capable of improving medication adherence among HIV-infected persons would be highly useful.
The investigators propose an intervention study designed to address these potential mechanisms of nonadherence by utilizing the Care4Today v2.0 smartphone application (app). The current study is a small pilot Randomized Controlled Trial (RCT) comparing the smart phone application titled "Care4Today v2.0" versus standard of care to improve medication adherence to ART over a 4-week period with 60 HIV-infected participants.
Read more
The pilot RCT consists of 60 HIV-infected persons who are at risk for ART medication nonadherence. Using random assignment, 30 HIV-infected participants will be assigned to medication adherence improvement via "Care4Today" app as compared to 30 HIV-infected participants assigned standard of care.
The investigators will assess the effectiveness and acceptability of the app in improving objectively measured ART adherence (i.e., via medication event monitoring system caps) over a 4-week period via a pilot RCT with 30 HIV-infected persons assigned to the Care4Today intervention and 30 HIV-infected persons assigned to standard of care.
- Being tested
- Care4Today v2.0 mobile application + electronic monitoring of adherence
- Keywords
- interventions, technology, adherence, ARV
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care4Today v2.0 mobile application + electronic monitoring of adherenceBehavioural
Care4Today mobile application will send automated medication alert messages to HIV-infected persons. The alert messages are customizable and automated, and real-time results are viewable within the application. The Care4Today intervention is designed to improve adherence to ART medications among HIV-infected persons who experience adherence difficulties over standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Care4Today v2.0 mobile application + electronic monitoring of adherence | Experimental | Care4Today v2.0 mobile application
Participants in the experimental application arm will use the Care4Today v2.0 mobile application for antiretroviral medication adherence support. Alert messages generated via the app will be targeted to the specific schedule and needs of the individual.
Electronic monitoring of adherence:
Participants' adherence to antiretroviral therapy medication is measured via Medication Event Monitoring System (MEMS) cap. Receives: Behavioral: Care4Today v2.0 mobile application + electronic monitoring of adherence |
| Electronic monitoring of adherence | No intervention | Participants' adherence to antiretroviral therapy medication is measured via Medication Event Monitoring System (MEMS) cap. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants ≥90% Adherent to Antiretroviral Medication Based on MEMS Cap Openings
Adherence will be measured using Medication Event Monitoring Systems (MEMS). Adherence defined as % MEMS adherence (doses taken/doses prescribed) within 2 hours of the indicated dose time. Adherence was dichotomized into 2 groups: <90% and ≥90% using MEMS caps.
Measured: Completion of 30-day intervention
Average Minutes From Antiretroviral Medication Dose Time Based on MEMS Cap Openings
The absolute value (in minutes) from the time a participant was scheduled to take an antiretroviral medication dose to when the participant opened the MEMS cap
Measured: Completion of 30-day intervention
Percentage of Doses Taken in Dose Time Window
Measured: Completion of 30-day intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIVStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Research & Development, LLC
- Responsible party
- Principal investigator, David J. Moore, Ph.D., University of California, San Diego
- Investigators
- David J. Moore, Ph.D., Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02001064
- Sponsor's protocol ID
- Care4Today-13
- Status last verified
- Jul 2021
- First submitted
- 27 Nov 2013
- Last updated
- 29 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Care4Today v.2.0 Application for Improving Adherence to HIV Medications
- ClinicalTrials.gov ID
- NCT02001064
- Acronym / sponsor ID
- Care4Today-13
- Keywords
- interventions, technology, adherence, ARV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Janssen Research & Development, LLC
- Study start
- Oct 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 4 Dec 2013 (estimated)
- Results
- Posted 29 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although poor antiretroviral (ART) adherence in HIV does not mean a complete lack of therapeutic results, the benefit of ART increases as adherence improves. Consequences of suboptimal ART adherence are viral rebound, development of drug-resistant HIV strains, and more rapid progression to AIDS. Moreover, HIV-infected persons tend to have numerous co-occurring conditions and therefore take many medications making adherence to multiple drug regimens more difficult. A mobile application capable of improving medication adherence among HIV-infected persons would be highly useful.
The investigators propose an intervention study designed to address these potential mechanisms of nonadherence by utilizing the Care4Today v2.0 smartphone application (app). The current study is a small pilot Randomized Controlled Trial (RCT) comparing the smart phone application titled "Care4Today v2.0" versus standard of care to improve medication adherence to ART over a 4-week period with 60 HIV-infected participants.
The pilot RCT consists of 60 HIV-infected persons who are at risk for ART medication nonadherence. Using random assignment, 30 HIV-infected participants will be assigned to medication adherence improvement via "Care4Today" app as compared to 30 HIV-infected participants assigned standard of care.
The investigators will assess the effectiveness and acceptability of the app in improving objectively measured ART adherence (i.e., via medication event monitoring system caps) over a 4-week period via a pilot RCT with 30 HIV-infected persons assigned to the Care4Today intervention and 30 HIV-infected persons assigned to standard of care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Care4Today v2.0 mobile application + electronic monitoring of adherence | Experimental | Behavioral: Care4Today v2.0 mobile application + electronic monitoring of adherenceCare4Today v2.0 mobile application Participants in the experimental application arm will use the Care4Today v2.0 mobile application for antiretroviral medication adherence support. Alert messages generated via the app will be targeted to the specific schedule and needs of the individual. Electronic monitoring of adherence: Participants' adherence to antiretroviral therapy medication is measured via Medication Event Monitoring System (MEMS) cap. |
| Electronic monitoring of adherence | No intervention | –Participants' adherence to antiretroviral therapy medication is measured via Medication Event Monitoring System (MEMS) cap. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Ability to provide informed consent
- 18 years or older at the time of enrollment
- HIV-infected
- Taking at least one medication to treat HIV illness
- Indication of medication nonadherence, or having a condition (e.g., active substance use, depression) that puts the individual at risk for medication non adherence
Key exclusion criteria (4 listed)
- Axis I psychiatric diagnosis of psychotic disorder or mood disorder with psychotic features
- Presence of a neurological condition (beyond HIV infection) known to impact cognitive functioning (e.g., Huntington's Disease, Stroke)
- Unwillingness or inability to use electronic medication monitoring technology
- Unwillingness or inability to use daily alert messages
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 |
|---|---|---|
| Care4Today v2.0 mobile application + electronic monitoring of adherenceCare4Today mobile application will send automated medication alert messages to HIV-infected persons. The alert messages are customizable and automated, and real-time results are viewable within the application. The Care4Today intervention is designed to improve adherence to ART medications among HIV-infected persons who experience adherence difficulties over standard of care. | Behavioural | Care4Today v2.0 mobile application + electronic monitoring of adherence |
Primary outcome
Number of Participants ≥90% Adherent to Antiretroviral Medication Based on MEMS Cap Openings
Time frame: Completion of 30-day intervention
Adherence will be measured using Medication Event Monitoring Systems (MEMS). Adherence defined as % MEMS adherence (doses taken/doses prescribed) within 2 hours of the indicated dose time. Adherence was dichotomized into 2 groups: <90% and ≥90% using MEMS caps.
Average Minutes From Antiretroviral Medication Dose Time Based on MEMS Cap Openings
Time frame: Completion of 30-day intervention
The absolute value (in minutes) from the time a participant was scheduled to take an antiretroviral medication dose to when the participant opened the MEMS cap
Percentage of Doses Taken in Dose Time Window
Time frame: Completion of 30-day intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
David J. Moore, Ph.D. principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care4Today v2.0 mobile application + electronic monitoring of adherence in people with HIV and AIDS, run by University of California, San Diego 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 7 inclusion and 4 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 29 Jul 2021. 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?
Yes. Results are posted in the registry (first posted 29 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants ≥90% Adherent to Antiretroviral Medication Based on MEMS Cap Openings (time frame: Completion of 30-day intervention). The study lists 3 primary outcomes in all. 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 29 Jul 2021.