Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT06062979 |
| Other study ID # |
ViiV-219548 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2023 |
| Est. completion date |
June 30, 2025 |
Study information
| Verified date |
April 2024 |
| Source |
Whitman-Walker Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
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.
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.
