Clinical Effectiveness-Implementation Hybrid Type 2 Study on Home-Delivered Cabenuva for People Living With HIV Who Are Not Retained in Care (CREATE)

April 23, 2024 updated by: Whitman-Walker Institute
The purpose of this study is to assess adherence to home-delivered long-acting injectable rilpivirine/cabotegravir (Cabenuva) among people living with HIV enrolled in the Mobile Outreach Retention and Engagement (MORE) program at Whitman-Walker Health due to significant barriers to being retained in care; the MORE program provides supportive services including dedicated care navigation, transportation assistance, and mobile/home-delivered care. The investigators will examine the equivalence of treatment outcomes among patients receiving injectable treatment within the MORE program as compared to those of patients receiving Cabenuva in standard care at Whitman-Walker Health.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Advances in HIV treatment could promote better health and racial equity to address the gaps seen across the HIV care continuum nationally and locally. In Washington DC, HIV viral load suppression among People Living With HIV (PLWH) lies at 66%. Whitman-Walker Clinic, Inc., d/b/a Whitman-Walker Health (WWH), is a Federally Qualified Health Center ("FQHC") affiliated with Whitman-Walker Institute, Inc. ("Institute"). Institute is uniquely capable of addressing gaps with Cabenuva through WWH's existing MORE program, which includes supportive navigation and wrap-around services paired with home-based HIV care. However, there are many implementation knowledge gaps to identify with implementing Cabenuva injection protocols for PLWH who face significant barriers to retention in care and who may significantly benefit from integrating Cabenuva within the context of the MORE program.

The investigators propose a home-delivered Cabenuva HIV care program in Washington, D.C. to address the local HIV care continuum gaps. The investigative team has over five years of experience and lessons learned from our Mobile Outreach, Retention and Engagement (MORE) home-based HIV care program and plan to integrate Cabenuva therapy. MORE utilizes NP/PA providers and an HIV care navigator to deliver care to over 130 HIV-infected clients, who have a history of having fallen out of care, in their homes. The investigators envision that the inclusion of injectable treatment can expand the current program by geographic reach and the number of PWLH served by coupling Cabenuva with our ability to deliver patient-centered care outside of the traditional clinic. This proposal is critical to gathering early insights in Cabenuva implementation in Washington, D.C. and other EHE territories in FQHC clinic and affiliated non-clinic settings. Moreover, the data collected will demonstrate the extent to which a population experiencing significant barriers to retention in care-for whom Cabenuva would otherwise likely be counterindicated-can be supported via the MORE program to achieve comparable adherence and outcomes to typical patients receiving standard of care Cabenuva.

WWH is currently providing Cabenuva treatment as a treatment option for eligible patients. The purpose of the proposed study is to further investigate the delivery of Cabenuva among two subpopulations of WWH patients.

Cabenuva within standard clinical care at WWH: The majority of WWH patients receiving HIV treatment are offered and receive Cabenuva within the standard clinical setting. Among these patients, the proposed study will gather EMR-based data to characterize retention and HIV outcomes and to compare these and other relevant implementation factors with the MORE group. Medical providers identify eligible patients for Cabenvua based on a WWH protocol devised by medical leadership and a Cabenuva workgroup. Eligibility is viral load < 100,000 copies, no medication contraindications, no co-existing Hepatitis B infection, and no RAMs for rilpivirine or cabotegravir. Medical providers explain the risk and benefits and if the patient desires Cabeuva, the prescription is sent to the WWH onsite pharmacy at WWH sites MRC or 1525. The patient's case is sent via the EHR to the Cabenuva injection clinic admin lead at WWH. Patient appointment reminders and medication attainment are coordinated through SMS and phone call communication with patients.

Cabenuva within MORE-based clinical care at WWH: To address the unique structural and psychosocial factors that create significant barriers to engagement and retention in care for a subset of patients with a history of non-retention, the MORE program was developed. MORE's primary features include home-based care delivery, dedicated care navigation, transportation support, and wrap-around supportive services. WWH is currently expanding the MORE program to provide injectable Cabenuva to these patients for whom, without the intensive support of the MORE program, treatment with Cabenuva would likely be counterindicated. More follows a stepped-care approach to support that includes a customized combination of its services to each patient based on need and preferences.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20009
        • Whitman-Walker 1525 Clinic
      • Washington, District of Columbia, United States, 20032
        • Whitman-Walker Max Robinson Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

This study will be conducted among people living with HIV who are 18 years or older receiving HIV treatment at Whitman-Walker Health

Description

Inclusion Criteria:

  • HIV-infected individuals, aged 18 years or older, who are eligible to receive Cabenuva as standard of care at Whitman-Walker Health
  • For those participants who will be prospectively enrolled via informed consent and offered survey and qualitative interviews, participants will be those receiving HIV-related treatment via the MORE program

Exclusion Criteria:

  • HIV-uninfected individuals

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Enhanced (MORE) implementation (i.e., MORE group)
Study participants in this condition will be those engaged in clinical care as part of the MORE program, receiving supportive, wrap-around, and home-based HIV care services; all participants will be offered injectable Cabenuva and studied with regard to uptake and outcomes. Participants in this group will receive quantitative health survey assessments as per standard of care at Whitman-Walker Health. Participants will be offered quantitative and qualitative assessments regarding their experiences related to Cabenuva.
Drug: rilpivirine/cabotegravir
WWH is currently providing Cabenuva treatment as a treatment option for eligible patients. The purpose of the proposed study is to use an observational, prospective cohort design to further investigate the delivery of Cabenuva among two subpopulations of WWH patients.
Standard-of-care implementation (i.e., comparison group)
Study participants in this comparison condition will be those engaged in clinical care receiving Cabenuva per standard of care at Whitman-Walker Health. Participants in this group will contribute ongoing electronic health record data under the auspices of an IRB-granted waiver of informed consent and waiver of HIPAA authorization.
Drug: rilpivirine/cabotegravir
WWH is currently providing Cabenuva treatment as a treatment option for eligible patients. The purpose of the proposed study is to use an observational, prospective cohort design to further investigate the delivery of Cabenuva among two subpopulations of WWH patients.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
4-month adherence rate
Time Frame: 4 months
% of patients initiated who received each injection in the +/- 7 day window period for 4 months
4 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
10-month adherence rate
Time Frame: 10 months
% of patients who received each injection in the +/- 7 day window period for 10 months
10 months
Virologic suppression (200 copies/mL)
Time Frame: 1 through 12 months following first injection
% of patients with virologic suppression (measured twice within 4 weeks and both values <200 copies/mL)
1 through 12 months following first injection
Virologic suppression (50 copies/mL)
Time Frame: 1 through 12 months following first injection
% of patients with virologic suppression (measured twice within 4 weeks and both values <50 copies/mL)
1 through 12 months following first injection
Resistance associated viral mutations
Time Frame: 1 through 12 months following first injection
% of patients with detection of resistance associated mutations
1 through 12 months following first injection

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adoption Rate
Time Frame: 12 months
# of providers who referred their patients to receive home-delivered Cabenuva among total number of providers
12 months
Implementation Feasibility (qualitative)
Time Frame: 6 months
Participants will be asked, "How easy was it to receive Cabenuva injections at home?"
6 months
Implementation Acceptability (qualitative)
Time Frame: 6 months
Participants will be asked, "How do you like receiving an injection at home?"
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Whitman-Walker Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
ViiV Healthcare

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Megan Dieterich, PA, Whitman-Walker Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 25, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ViiV-219548

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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