Clinical trial NCT05979714: The Cheeky Study: A Novel Delivery System for CAB-RPV LA
Official title: Developing a Novel Delivery System for CAB-RPV LA in Transgender Women Living With HIV in Public Health Settings
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: HIV Infections
Keywords: Transwomen
Lead sponsor: Public Health Foundation Enterprises, Inc.
Sponsor class: OTHER
Collaborators: name: ViiV Healthcare
name: San Francisco Department of Public Health
name: Lyon-Martin Community Health Services
First posted: 2023-08-07
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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. Our approach will be guided by a rigorous implementation science approach using the Proctor Model to evaluate our implementation strategies.

The Proctor Model posits that improvements in outcomes are dependent on the evidence-based intervention selected for implementation and on the strategies used to deliver the intervention. The model distinguishes between the intervention (CAB-RPV LA), different types of implementation strategies, and different levels of outcomes that are expected to build on each other
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of delivering CAB-RPV LA
timeFrame: 0, 9,18 Months
measure: Acceptability of delivering CAB-RPV LA
timeFrame: 0, 9,18 Months
measure: Client Satisfaction
timeFrame: 0, 3, 6, 9 Months
Secondary outcomes:
measure: Assess tolerability
timeFrame: 3, 6, 9 Months
measure: Assess adherence to injections
timeFrame: 3, 6, 9 Months
measure: Assess viral suppression
timeFrame: 3, 6, 9 Months
measure: Describe development of resistance mutations
timeFrame: 3, 6, 9 Months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Bridge HIV, San Francisco Department of Public Health
state: California
Study officials:
affiliation: SFDPH Bridge HIV
name: Albert Liu, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: