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

NCT06062979 | Enrolling By Invitation FDA Drug

• 1 other identifier: ViiV-219548
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

• 4-month adherence rate

  % of patients initiated who received each injection in the +/- 7 day window period for 4 months

  4 months

Secondary Outcomes (4)

• 10-month adherence rate

  10 months

• Virologic suppression (200 copies/mL)

  1 through 12 months following first injection

• Virologic suppression (50 copies/mL)

  1 through 12 months following first injection

• Resistance associated viral mutations

  1 through 12 months following first injection

Other Outcomes (3)

• Implementation Feasibility (qualitative)

  6 months

• Implementation Acceptability (qualitative)

  6 months

• Adoption Rate

  12 months

Study Arms (2)

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

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

Interventions

rilpivirine/cabotegravir DRUG

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.

Enhanced (MORE) implementation (i.e., MORE group); Standard-of-care implementation (i.e., comparison group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• HIV-uninfected individuals

Sponsors & Collaborators

• Whitman-Walker Institute: lead
• ViiV Healthcare: collaborator

Study Sites (2)

Whitman-Walker 1525 Clinic

Washington D.C., District of Columbia, 20009, United States

Location

Whitman-Walker Max Robinson Center

Washington D.C., District of Columbia, 20032, United States

Location

MeSH Terms

Interventions

Rilpivirine; cabotegravir

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Megan Dieterich, PA

  Whitman-Walker Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: October 2, 2023
• Study Start: November 1, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: April 25, 2024

Record last verified: 2024-04

Locations

US (2)