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

Last updated: August 1, 2024
Sponsor: Public Health Foundation Enterprises, Inc.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Hiv Infections

Treatment

Improved clinic communication strategies

Patient-centered injection site

Provider education

Clinical Study ID

NCT05979714
22-35957
  • Ages > 18
  • Male

Study Summary

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

Eligibility Criteria

Inclusion

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 <50copies/ml)

  • Interested in initiating CAB-RPV LA for HIV treatment and willing to receiveinjections at Bridge HIV

  • Currently receiving HIV care by a care provider at one of the collaborating primarycare clinics.

  • Has a cell phone and active service

  • Able to understand, read, and speak English

Exclusion

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-RPVregimen

  • Rilpivirine: L100I; K101E; V106I and A; V108I; E138K and A, G, Q, R; V179F andI; 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 thejudgment of the investigator, would make participation in the study unsafe,complicate interpretation of study outcome data, or otherwise interfere withachieving the study objectives

Study Design

Total Participants: 50
Treatment Group(s): 4
Primary Treatment: Improved clinic communication strategies
Phase:
Study Start date:
May 31, 2023
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • Bridge HIV, San Francisco Department of Public Health

    San Francisco, California 94134
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.