The Cheeky Study: A Novel Delivery System for CAB-RPV LA

Public Health Foundation Enterprises, Inc.

Status: Active, not recruiting

Conditions: HIV Infections

Treatments: Behavioral: Improved clinic communication strategies; Behavioral: Patient-centered adherence support; Other: Patient-centered injection site; Other: Provider education

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05979714

22-35957

Details and patient eligibility

About

This is a single-arm implementation study of a novel integrated delivery model of CAB-RPV LA for transwomen living with HIV.

Full description

CAB-RPV LA as a monthly injectable could address disparities in viral suppression among trans women living with HIV. This study is designed to enroll a diverse population of trans women living with HIV who receive HIV care within collaborating primary care clinics. This study proposes using mixed methods to tailor and evaluate implementation and client outcomes when CAB-RPV LA is delivered through this integrated delivery model.

This will be a 9-month pilot study among 40 participants who will be provided CAB-RPV LA through an integrated trans-friendly delivery model using 4 implementation strategies to improve the adoption and integration of CAB-RPV LA delivery to trans women. These strategies are aimed at all levels of implementation - system, clinic, provider, and patient to maximize impact. The 4 strategies are a patient-centered injection site (Bridge HIV, SFDPH), patient-centered adherence support (peer health navigation and SMS platform with reminders and communication with staff), provider education, and improved clinic communication strategies.. CAB-RPV LA is being provided as standard of care and is not paid for by the study.

Enrollment: 50 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 years or older
• Male sex at birth and gender identity other than male
• Willing and able to provide written informed consent
• HIV-infected, confirmed by laboratory testing (can be via medical record)
• Eligible to receive CAB-RPV LA per FDA-approved label
• Virologically suppressed at the last visit within the last 6 months (HIV RNA <50 copies/ml)
• Interested in initiating CAB-RPV LA for HIV treatment and willing to receive injections at Bridge HIV
• Currently receiving HIV care by a care provider at one of the collaborating primary care clinics.
• Has a cell phone and active service
• Able to understand, read, and speak English

Exclusion criteria

• Unable to receive gluteal injections

• Plans to move away from the site area within the next 9 months.

• History of known or suspected drug resistance that would compromise the CAB-RPV regimen

  • Rilpivirine: L100I; K101E; V106I and A; V108I; E138K and A, G, Q, R; V179F and I; Y181C and I; V189I; G190E; H221Y and H/L; F227C; and M230I and L; K103N+K238T, K103N+E138G+K238T; Y188L
  • Cabotegravir: Q146L; S153Y; I162M; T124A; Q148H, K; C56S; V72I; L74M; V75A; T122N; E138K; G140S; G149A; M154I; and N155H

• Prior hypersensitivity to cabotegravir or rilpivirine

• Current or expected use of any of the following medications:

  • Anticonvulsants: carbamazepine, oxcarbazepine, phenobarbital, phenytoin
  • Antimycobacterials: rifabutin, rifampin, rifapentine
  • Systemic glucocorticoids: more than a single dose of dexamethasone
  • Herbal: St John's Wort

• Any medical, psychiatric, or social condition or other responsibilities that, in the judgment of the investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Cheeky Study Intervention

Experimental group

Description:

This study represents a hybrid design type 3 focusing primarily on implementation outcomes and secondarily on clinical effectiveness among trans women living with HIV receiving care within primary care clinics in San Francisco. A type 3 design was chosen, as the clinical efficacy of CAB- RPV LA has been established in clinical trials, and the focus of this study is on initial implementation of CAB-RPV LA within these clinics.

Treatment:

Other: Provider education

Behavioral: Patient-centered adherence support

Other: Patient-centered injection site

Behavioral: Improved clinic communication strategies