HIV InfectionsNCT04863261
Cabenuva Injection Tracking in CHORUS
A study testing Cabenuva Scheduling Alerts in the Retention & Huddle modules of the CHORUS App in people with HIV Infections, run by Epividian at 1 site in United States.
Trial summary
This is a cluster randomized trial in which clinics will be randomized to the intervention or the control arm. The purpose of this study is to assess if receiving alerts can help providers manage the scheduling of monthly cabotegravir + rilpivirine long-acting injections for the treatment of HIV. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV Infections
- What is being tested?
- Cabenuva Scheduling Alerts in the Retention & Huddle modules of the CHORUS App
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to 7 Jul 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- As per label, routine clinical care
- AIDS Healthcare Foundation (AHF) Clinic
- HIV primary care clinic
- Minimum of 100 people living with HIV in care with a viral load <50 copies/mL at the time of randomization (satellites will be included in the count of their parent clinic).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
AIDS Healthcare Foundation
Los Angeles, California, 90028
About this study
Official title: Facilitating the Management of CAB+RPV LA Patient Visits Through Daily Alerts and Morning Huddles
This is a cluster randomized trial in which clinics will be randomized to the intervention or the control arm. The purpose of this study is to assess if receiving alerts can help providers manage the scheduling of monthly cabotegravir + rilpivirine long-acting injections for the treatment of HIV.
Read the detailed description
A novel long-acting HIV antiretroviral therapy has recently been approved by the FDA: cabotegravir and rilpivirine delivered through intramuscular injection. These injections should be administered monthly, on the same day of the month as the initiation injections, up to 7 days before or after the date of the scheduled monthly injection visit.
This is a cluster randomized trial in which clinics will be randomized to the intervention or the control arm. Providers in the intervention group will receive alerts to remind them when patients are due for their injections, or if they missed their treatment window. Providers in the control group will not receive alerts and will manage injections as per their clinic's standard process. Surveys will be administered to understand the utility of the alerts for the management of these injections.
- Conditions
- HIV Infections
- Being tested
- Cabenuva Scheduling Alerts in the Retention & Huddle modules of the CHORUS App
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cabenuva Scheduling Alerts in the Retention & Huddle modules of the CHORUS AppOther
The CHORUS App has been developed as a tool for clinicians to easily visualize important patient information from their smart phones. Relevant information is electronically distributed and placed within the corresponding module in the CHORUS HCP mobile app for iOS and Android.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Clinics randomized to the intervention. A notification will be sent to the provider when a patient on CAB+RPV LA needs to be scheduled for their injections or when an appointment needs to be confirmed. Alerts are sent out to the provider when a patient is due or overdue for their injections. Receives: Other: Cabenuva Scheduling Alerts in the Retention & Huddle modules of the CHORUS App |
| Control | No intervention | Clinics randomized to the control group. No alerts or notification will be sent. The providers will manage their CAB+RPV LA patients using standard of care in their clinic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to treatment-window
Patient returns for their injections +/- 7 days from target date
Measured: 9 months
Acceptability and usefulness of the intervention
Survey to assess the implementation of the Cabenuva Scheduling Alerts in the Retention \& Huddle modules of the CHORUS App.
Measured: Month 1
Acceptability and usefulness of the intervention
Survey to assess the implementation of the Cabenuva Scheduling Alerts in the Retention \& Huddle modules of the CHORUS App.
Measured: Month 9
Secondary outcomes (2)
Number of CAB+RPV LA patients managed through the app
Reach
Measured: 9 months
Number of clinics that use the App for the management of CAB+RPV LA patients
Adoption
Measured: 9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start1 Oct 2021
- Primary completion7 Jul 2022
- Study completion7 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies 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
- Model description
- Cluster randomized trial. The clinics will be randomized to either start using the Cabenuva Scheduling Alerts in the Retention \& Huddle modules of the CHORUS App (Intervention Arm) or to standard of care (Control Arm).
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Epividian
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AIDS Healthcare Foundation, ViiV Healthcare
- Responsible party
- Sponsor
- Investigators
- Michael Wohlfeiler, MD, Principal investigator, AHF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04863261
- Sponsor's protocol ID
- Pro00050130
- Status last verified
- Oct 2021
- First submitted
- 23 Apr 2021
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wohlfeiler MB, Brunet L, Cochran Q, Fusco JS, Hsu RK, Fusco GP. Improving Adherence to the Target Window for Cabotegravir + Rilpivirine Long-Acting Injections Through the CHORUS App and Web Portal: A Cluster Randomized Trial. J Int Assoc Provid AIDS Care. 2024 Jan-Dec;23:23259582241245223. doi: 10.1177/23259582241245223.
PubMed 38613372
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating the Management of CAB+RPV LA Patient Visits Through Daily Alerts and Morning Huddles
- ClinicalTrials.gov ID
- NCT04863261
- Acronym / sponsor ID
- Pro00050130
- Conditions
- HIV Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- EpividianIndustry (pharma, biotech, devices)
- Collaborators
- AIDS Healthcare Foundation, ViiV Healthcare
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 7 Jul 2022 (actual)
- Study completion
- 7 Jul 2022 (actual)
- First posted
- 28 Apr 2021 (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.
This is a cluster randomized trial in which clinics will be randomized to the intervention or the control arm. The purpose of this study is to assess if receiving alerts can help providers manage the scheduling of monthly cabotegravir + rilpivirine long-acting injections for the treatment of HIV.
Detailed description
A novel long-acting HIV antiretroviral therapy has recently been approved by the FDA: cabotegravir and rilpivirine delivered through intramuscular injection. These injections should be administered monthly, on the same day of the month as the initiation injections, up to 7 days before or after the date of the scheduled monthly injection visit.
This is a cluster randomized trial in which clinics will be randomized to the intervention or the control arm. Providers in the intervention group will receive alerts to remind them when patients are due for their injections, or if they missed their treatment window. Providers in the control group will not receive alerts and will manage injections as per their clinic's standard process. Surveys will be administered to understand the utility of the alerts for the management of these injections.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomized trial. The clinics will be randomized to either start using the Cabenuva Scheduling Alerts in the Retention \& Huddle modules of the CHORUS App (Intervention Arm) or to standard of care (Control Arm).
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Other: Cabenuva Scheduling Alerts in the Retention & Huddle modules of the CHORUS AppClinics randomized to the intervention. A notification will be sent to the provider when a patient on CAB+RPV LA needs to be scheduled for their injections or when an appointment needs to be confirmed. Alerts are sent out to the provider when a patient is due or overdue for their injections. |
| Control | No intervention | –Clinics randomized to the control group. No alerts or notification will be sent. The providers will manage their CAB+RPV LA patients using standard of care in their clinic. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- As per label, routine clinical care
- AIDS Healthcare Foundation (AHF) Clinic
- HIV primary care clinic
- Minimum of 100 people living with HIV in care with a viral load <50 copies/mL at the time of randomization (satellites will be included in the count of their parent clinic).
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Cabenuva Scheduling Alerts in the Retention & Huddle modules of the CHORUS AppThe CHORUS App has been developed as a tool for clinicians to easily visualize important patient information from their smart phones. Relevant information is electronically distributed and placed within the corresponding module in the CHORUS HCP mobile app for iOS and Android. | Other | Intervention |
Primary outcome
Adherence to treatment-window
Time frame: 9 months
Patient returns for their injections +/- 7 days from target date
Acceptability and usefulness of the intervention
Time frame: Month 1
Survey to assess the implementation of the Cabenuva Scheduling Alerts in the Retention \& Huddle modules of the CHORUS App.
Acceptability and usefulness of the intervention
Time frame: Month 9
Survey to assess the implementation of the Cabenuva Scheduling Alerts in the Retention \& Huddle modules of the CHORUS App.
2 secondary outcomes
Number of CAB+RPV LA patients managed through the app
Time frame: 9 months
Number of clinics that use the App for the management of CAB+RPV LA patients
Time frame: 9 month
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 25 Feb 2025.
- Derived from this study: PubMed 38613372Wohlfeiler MB, Brunet L, Cochran Q, Fusco JS, Hsu RK, Fusco GP. Improving Adherence to the Target Window for Cabotegravir + Rilpivirine Long-Acting Injections Through the CHORUS App and Web Portal: A Cluster Randomized Trial. J Int Assoc Provid AIDS Care. 2024 Jan-Dec;23:23259582241245223. doi: 10.1177/23259582241245223.
- Individual participant dataSharing planned: No
Related trials for HIV Infections
Not yet recruiting
Evaluating the Healthy Families PrEP Program for Women at Risk for HIV
HIV, Pregnancy
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Not yet recruiting
Supporting Health and Empowerment Through Contingency Management and Affect Regulation
HIV Risk
RecruitingPhase 1
HEME-25 Open-Label Feasibility Study of Elranatamab Utilized as Consolidation in Newly Diagnosed Plasmablastic Lymphoma With or Without HIV
Plasmablastic Lymphoma, HIV
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Michael Wohlfeiler, MD principal investigator
AHF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cabenuva Scheduling Alerts in the Retention & Huddle modules of the CHORUS App in people with HIV Infections, run by Epividian 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 4 inclusion and 0 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 25 Feb 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?
Adherence to treatment-window (time frame: 9 months). 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?
On the ClinicalTrials.gov record for NCT04863261, which also lists 1 linked publication.
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 25 Feb 2025.