HIV InfectionsI-TRAINSNCT04973254
Improving Treatment and Retention Adherence in Nontraditional Settings
A study testing CAB-RPV LA and Standard treatment within an HIV clinic in people with HIV Infections, run by Boston Medical Center at 2 sites in United States.
Trial summary
This is a hybrid implementation-effectiveness study using both qualitative and quantitative methods. The research aims to examine whether providing a new, but approved, HIV once a month injection treatment [Cabotegravir-Rilpivirine Long Acting (CAB-RPV LA)] to individuals who are living with HIV outside of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- CAB-RPV LA and Standard treatment within an HIV clinic
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Feb 2022to 28 Mar 2023
- 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
- HIV-positive
- English or Spanish speaking
- Lab values that indicate the patient is a candidate for the medication and virally suppressed
- Willing to complete the locator form to receive appointment reminders prior to follow-up data collection
- HIV-positive
- English or Spanish speaking
Show all 13Show fewer
- Enrolled in care and receiving CAB-RPV LA injection at Boston Medical Center Infectious Disease Clinic (HIV clinic)
- Willing to complete the locator form to receive appointment reminders prior to follow-up data collection
- HIV-positive
- English or Spanish speaking
- Enrolled in care but NOT receiving CAB-RPV LA injection at Boston Medical Center Infectious Disease Clinic (HIV clinic)
- Willing to complete the locator form to receive appointment reminders prior to follow-up data collection
- Matched to participants demographically and in terms of other characteristics in Cohort 1 at a 2:1 ratio
Who cannot join
- Not virally suppressed prior to beginning CAB-RPV LA (does not apply to cohort 3)
- A history of adhering fully to their antiretroviral therapy (ART)
- Not willing to take CAB-RPV LA after detailed discussion of what the use of CAB-RPV LA will entail (does not apply to cohort 3)
- Unable to undergo clinical eligibility testing to confirm eligibility (does not apply to cohort 3)
- A history of integrase inhibitor mutations suggesting resistance to Cabotegravir or Cabenuva
- A history or evidence of resistance to either integrase strand transfer inhibitor (INSTI) or non-nucleoside reverse transcriptase inhibitors (NNRTI) HIV drugs
Show all 10Show fewer
- Currently pregnant or breastfeeding
- Currently has HIV 1 with an HIV 2 co-infection or an HIV 2 infection
- Taking any drugs that have known interactions with Cabenuva, including but not limited to carbamazepine, oxcarbazepine, phenobarbital, phenytoin, St Johns Wort, systemic Dexamethasone, rifabutin, rifampin and rifapentine
- Chronic Hepatitis B infection
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Boston Medical Center, Center for Infectious Disease
Boston, Massachusetts, 02118
Boston Medical Center, Project Trust
Boston, Massachusetts, 02118
About this study
Official title: Cabotegravir-Rilpivirine Long Acting (CAB-RPV LA) Implementation Strategies Among High-Risk Populations
This is a hybrid implementation-effectiveness study using both qualitative and quantitative methods. The research aims to examine whether providing a new, but approved, HIV once a month injection treatment [Cabotegravir-Rilpivirine Long Acting (CAB-RPV LA)] to individuals who are living with HIV outside of the standard doctors office or clinic increases adherence to treatment. This HIV monthly injections treatment which is already being delivered within the clinic setting, will be administered to participants in community partner spaces, reducing the barriers that having to present to a traditional clinic for treatment creates.
Individuals who will receive the injection need to have a history of being unable to take their HIV oral medication, as well as other barriers to care that make it difficult to engage in a traditional clinic setting. These barriers may include, but are not limited to, homelessness, substance use, mental illness, and stigma around their diagnosis.
Data will be collected on whether it was easier for the participants to receive care in a non-traditional setting, as well as whether the injection made it easier for them to remain adherent to their HIV medication in comparison to standard oral HIV medication.
Read the detailed description
The proposed implementation research is designed to evaluate a novel approach to engage individuals with HIV who are at the highest risk for not accessing care or adhering to treatment. The investigators are not testing CAB-RPV LA; this is an approved drug. The investigators are also not studying the drug nor studying it for a new population, new dosage or new route of administration. Rather, the investigators are conducting an implementation three-arm cohort study that uses quantitative methods and propose to test implementation of CAB-RPV LA in community-based settings. The three cohorts/groups will be:
- cohort 1- individuals who receive CAB-RPV LA at an alternative community-based site
- cohort 2- individuals who receive CAB-RPV LA in the HIV clinic
- cohort 3- individuals who share characteristics of cohort 1 and are engaged in standard of care
The research is designed to answer the following implementation and clinical questions.
- Implementation Questions
- Will community-based delivery of CAB-RPV LA be an acceptable and feasible delivery method to high-risk people living with HIV (PLWH) from the patient, provider and community organization perspectives? (acceptability/feasibility)
- Can a community-based delivery strategy lead to initiation and completion of injections for six months for at least 80% of individuals who are enrolled into cohort 1 for an initial visit in an outreach setting? (reach) See Section 11 for information on the details of the sample size calculations and Section 7.2 for how study staff will stay in contact with participants to maximize potential for longer term engagement.
- What are the characteristics of patients who are most likely to have an initial injection and do these characteristics differ for individuals who receive CAB-RPV LA in and outside of the HIV clinic? (equity)
- Are patients who are seen for CAB-RPV LA in community-based settings satisfied with their HIV care? (patient-centeredness)
- Will consistent delivery of CAB-RPV LA be possible in community-based (non-HIV clinic) settings? (feasibility)
- Will the providers at a drop-in center or community-based organization be willing to implement CAB-RPV LA within their non-traditional setting? (adoption)
- Clinical Questions
- Can individuals targeted for intervention at community-based delivery site achieve viral suppression and receive initial injection?
- Can a community-based delivery strategy ensure engagement in services and receipt of CAB-RPV LA visits among high-risk populations? (effectiveness)
- Is a community-based delivery strategy using CAB-RPV LA superior to the current standard of care in ensuring treatment adherence for individuals at highest risk? (effectiveness) Can high-risk individuals who receive community-based CAB-RPV LA be adherent to care, defined as undetectable viral load, for six months?
- Conditions
- HIV Infections
- Being tested
- CAB-RPV LA, Standard treatment within an HIV clinic
- Keywords
- HIV injectable medication, Cabotegravir-Rilpivirine Long Acting (CAB-RPV LA), Treatment adherence, Community-based delivery strategy, Patient-centeredness, Acceptability, Feasibility
- Medical subject headings
- HIV Infections, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAB-RPV LAOther
Also called Cabotegravir-Rilpivirine Long Acting
Monthly administration of injectable HIV medication
Standard treatment within an HIV clinicOther
Standard of care for HIV positive patients will be provided in the HIV clinic that may include HIV medication or may include oral medications.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1- HIV injection at a community-based site | Experimental | CAB-RPV LA administered to patients in an alternative community-based site Receives: Other: CAB-RPV LA |
| Cohort 2- HIV injection at a HIV clinic | Active comparator | CAB-RPV LA administered to patients in the HIV clinic Receives: Other: CAB-RPV LA |
| Cohort 3- Standard of care for HIV | Active comparator | Individuals who share characteristics of cohort 1 and are engaged in standard of care Receives: Other: Standard treatment within an HIV clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to Cabenuva Injections
The number of participants who received CAB-RPV LA injections within the treatment window.
Measured: 3 months, 6 months
Adherence to Primary Care Appointments
The number participants who had a primary care appointment in the previous 3 months.
Measured: 3 months, 6 months
Adherence to Mental Health/Behavioral Appointments
The number participants who had a mental health/behavioral appointment in the previous 3 months.
Measured: 3 months, 6 months
Adherence to Substance Abuse Appointments in Cohorts 1 and 2
The number participants who had a substance abuse appointment in the previous 3 months.
Measured: 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start23 Feb 2022
- Primary completion17 Mar 2023
- Study completion28 Mar 2023
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 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Three-arm cohort study comparing adherence to HIV treatment of monthly injections delivered outside of standard clinical settings to treatment adherence in the HIV clinic setting and to HIV standard care delivered in the HIV clinic
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ViiV Healthcare
- Responsible party
- Sponsor
- Investigators
- Mari-Lynn Drainoni, PhD, Principal investigator, BU School of Medicine, Infectious Diseases and Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04973254
- Sponsor's protocol ID
- H-41724
- Other IDs
- 4300844001
- Acronym
- I-TRAINS
- Status last verified
- Dec 2024
- First submitted
- 13 Jul 2021
- Last updated
- 15 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cabotegravir-Rilpivirine Long Acting (CAB-RPV LA) Implementation Strategies Among High-Risk Populations
- ClinicalTrials.gov ID
- NCT04973254
- Acronym / sponsor ID
- I-TRAINS / H-41724
- Conditions
- HIV Infections
- Keywords
- HIV injectable medication, Cabotegravir-Rilpivirine Long Acting (CAB-RPV LA), Treatment adherence, Community-based delivery strategy, Patient-centeredness, Acceptability, Feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- ViiV Healthcare
- Study start
- 23 Feb 2022 (actual)
- Primary completion
- 17 Mar 2023 (actual)
- Study completion
- 28 Mar 2023 (actual)
- First posted
- 22 Jul 2021 (actual)
- Results
- Posted 15 Jan 2025
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 hybrid implementation-effectiveness study using both qualitative and quantitative methods. The research aims to examine whether providing a new, but approved, HIV once a month injection treatment [Cabotegravir-Rilpivirine Long Acting (CAB-RPV LA)] to individuals who are living with HIV outside of the standard doctors office or clinic increases adherence to treatment. This HIV monthly injections treatment which is already being delivered within the clinic setting, will be administered to participants in community partner spaces, reducing the barriers that having to present to a traditional clinic for treatment creates.
Individuals who will receive the injection need to have a history of being unable to take their HIV oral medication, as well as other barriers to care that make it difficult to engage in a traditional clinic setting. These barriers may include, but are not limited to, homelessness, substance use, mental illness, and stigma around their diagnosis.
Data will be collected on whether it was easier for the participants to receive care in a non-traditional setting, as well as whether the injection made it easier for them to remain adherent to their HIV medication in comparison to standard oral HIV medication.
Detailed description
The proposed implementation research is designed to evaluate a novel approach to engage individuals with HIV who are at the highest risk for not accessing care or adhering to treatment. The investigators are not testing CAB-RPV LA; this is an approved drug. The investigators are also not studying the drug nor studying it for a new population, new dosage or new route of administration. Rather, the investigators are conducting an implementation three-arm cohort study that uses quantitative methods and propose to test implementation of CAB-RPV LA in community-based settings. The three cohorts/groups will be:
- cohort 1- individuals who receive CAB-RPV LA at an alternative community-based site
- cohort 2- individuals who receive CAB-RPV LA in the HIV clinic
- cohort 3- individuals who share characteristics of cohort 1 and are engaged in standard of care
The research is designed to answer the following implementation and clinical questions.
- Implementation Questions
- Will community-based delivery of CAB-RPV LA be an acceptable and feasible delivery method to high-risk people living with HIV (PLWH) from the patient, provider and community organization perspectives? (acceptability/feasibility)
- Can a community-based delivery strategy lead to initiation and completion of injections for six months for at least 80% of individuals who are enrolled into cohort 1 for an initial visit in an outreach setting? (reach) See Section 11 for information on the details of the sample size calculations and Section 7.2 for how study staff will stay in contact with participants to maximize potential for longer term engagement.
- What are the characteristics of patients who are most likely to have an initial injection and do these characteristics differ for individuals who receive CAB-RPV LA in and outside of the HIV clinic? (equity)
- Are patients who are seen for CAB-RPV LA in community-based settings satisfied with their HIV care? (patient-centeredness)
- Will consistent delivery of CAB-RPV LA be possible in community-based (non-HIV clinic) settings? (feasibility)
- Will the providers at a drop-in center or community-based organization be willing to implement CAB-RPV LA within their non-traditional setting? (adoption)
- Clinical Questions
- Can individuals targeted for intervention at community-based delivery site achieve viral suppression and receive initial injection?
- Can a community-based delivery strategy ensure engagement in services and receipt of CAB-RPV LA visits among high-risk populations? (effectiveness)
- Is a community-based delivery strategy using CAB-RPV LA superior to the current standard of care in ensuring treatment adherence for individuals at highest risk? (effectiveness) Can high-risk individuals who receive community-based CAB-RPV LA be adherent to care, defined as undetectable viral load, for six months?
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three-arm cohort study comparing adherence to HIV treatment of monthly injections delivered outside of standard clinical settings to treatment adherence in the HIV clinic setting and to HIV standard care delivered in the HIV clinic
| Arm | Type | Receives |
|---|---|---|
| Cohort 1- HIV injection at a community-based site | Experimental | Other: CAB-RPV LACAB-RPV LA administered to patients in an alternative community-based site |
| Cohort 2- HIV injection at a HIV clinic | Active comparator | Other: CAB-RPV LACAB-RPV LA administered to patients in the HIV clinic |
| Cohort 3- Standard of care for HIV | Active comparator | Other: Standard treatment within an HIV clinicIndividuals who share characteristics of cohort 1 and are engaged in standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- HIV-positive
- English or Spanish speaking
- Lab values that indicate the patient is a candidate for the medication and virally suppressed
- Willing to complete the locator form to receive appointment reminders prior to follow-up data collection
- HIV-positive
Key exclusion criteria (10 listed)
- Not virally suppressed prior to beginning CAB-RPV LA (does not apply to cohort 3)
- A history of adhering fully to their antiretroviral therapy (ART)
- Not willing to take CAB-RPV LA after detailed discussion of what the use of CAB-RPV LA will entail (does not apply to cohort 3)
- Unable to undergo clinical eligibility testing to confirm eligibility (does not apply to cohort 3)
- A history of integrase inhibitor mutations suggesting resistance to Cabotegravir or Cabenuva
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 |
|---|---|---|
| CAB-RPV LAAlso: Cabotegravir-Rilpivirine Long ActingMonthly administration of injectable HIV medication | Other | Cohort 1- HIV injection at a community-based site, Cohort 2- HIV injection at a HIV clinic |
| Standard treatment within an HIV clinicStandard of care for HIV positive patients will be provided in the HIV clinic that may include HIV medication or may include oral medications. | Other | Cohort 3- Standard of care for HIV |
Primary outcome
Adherence to Cabenuva Injections
Time frame: 3 months, 6 months
The number of participants who received CAB-RPV LA injections within the treatment window.
Adherence to Primary Care Appointments
Time frame: 3 months, 6 months
The number participants who had a primary care appointment in the previous 3 months.
Adherence to Mental Health/Behavioral Appointments
Time frame: 3 months, 6 months
The number participants who had a mental health/behavioral appointment in the previous 3 months.
Adherence to Substance Abuse Appointments in Cohorts 1 and 2
Time frame: 3 months, 6 months
The number participants who had a substance abuse appointment in the previous 3 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Mari-Lynn Drainoni, PhD principal investigator
BU School of Medicine, Infectious Diseases and Boston Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAB-RPV LA and Standard treatment within an HIV clinic in people with HIV Infections, run by Boston Medical Center at 2 sites 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 13 inclusion and 10 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 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 15 Jan 2025). 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?
Adherence to Cabenuva Injections (time frame: 3 months, 6 months). The study lists 4 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 15 Jan 2025.