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

NCT05979714 | Active Not Recruiting

• 1 other identifier: 22-35957
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

HIV Infections

Keywords

Transwomen

Outcome Measures

Primary Outcomes (3)

• Feasibility of delivering CAB-RPV LA

  Assess the feasibility of delivering CAB-RPV LA to trans women living with HIV via a trans-tailored, integrated delivery model

  0, 9,18 Months

• Acceptability of delivering CAB-RPV LA

  Assess the acceptability of delivering CAB-RPV LA to trans women living with HIV via a trans-tailored, integrated delivery model

  0, 9,18 Months

• Client Satisfaction

  Assess client satisfaction with treatment when CAB-RPV LA is delivered through a trans-tailored integrated model

  0, 3, 6, 9 Months

Secondary Outcomes (4)

• Assess tolerability

  3, 6, 9 Months

• Assess adherence to injections

  3, 6, 9 Months

• Assess viral suppression

  3, 6, 9 Months

• Describe development of resistance mutations

  3, 6, 9 Months

Study Arms (1)

Cheeky Study Intervention

EXPERIMENTAL

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.

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

Interventions

Patient-centered injection site OTHER

CAB-RPV LA will be delivered in a trans-friendly injection clinic at Bridge HIV, which is centrally located in SF. The clinic is staffed by physicians, nurses, and peer navigators who are experienced working with the trans community and are experts in delivery of injectable formulations. For patients unable to attend follow-up clinic visits, arrangements will be made for a clinical provider and peer navigator to conduct a home visit for injection delivery. This implementation strategy will overcome structural barriers where it is difficult to get a visit appointment, and when appointments are missed, even harder to re-schedule. The central location in a quiet, safe and trans-affirming clinical site will make injections easy-to-access. Because the Bridge HIV clinic is not a primary care site, injections can be delivered with minimal wait times due to low patient load relative to clinical capacity.

Cheeky Study Intervention

Patient-centered adherence support BEHAVIORAL

A Trans peer navigator will support trans women living with HIV receiving long-acting injectable treatment through our delivery model. Peer navigators will reach out to trans women using our highly effective mobile SMS platform to provide additional support before and between visits. This platform provides automated weekly check-ins for streamlined support and bi-directional asynchronous texting with a peer navigator. Peer navigators will use this SMS platform to send appointment reminders, assess needs for re-scheduling, answer questions and triage concerns regarding CAB-RPV LA, and offer support for transportation or scheduling a home visit. This approach has demonstrated efficacy in improving ART adherence and viral suppression in people living with HIV as well as retention in care and adherence to PrEP.

Cheeky Study Intervention

Provider education OTHER

To support effective outreach to and education of providers on novel evidence-based practices, SFDPH has utilized public health detailing (brief educational visits via a nurse practitioner) to ensure providers are prepared to implement new interventions. This strategy has been effective in expanding the implementation of PrEP, RAPID ART initiation, and comprehensive STI screening across clinics in SF. For this study, we will develop educational materials on the CAB-RPV LA regimen, including a summary of results from Phase 3 trials (ATLAS20, FLAIR21), the FDA labeling indication, and details about SFDPH's implementation of CAB-RPV LA within our safety-net system and our new delivery model. These materials will include information on which patients will be eligible for this treatment modality and eligible for referral to our new delivery model, and how to make these referrals.

Cheeky Study Intervention

Improved clinic communication strategies BEHAVIORAL

For SFDPH clinics, Bridge HIV providers will communicate with primary care providers through EPIC, SFDPH's electronic health record (EHR), and one of the most common EHR systems used across clinic systems in the US. For this study, secure email and/or telephone encounters within EPIC will be used to facilitate efficient referrals of TGW living with HIV from their primary providers to the Bridge HIV injection clinic and ongoing secure communication between Bridge HIV clinicians and the primary care team. For non-SFDPH clinics, communication will be via secure email or other secure communication strategies.

Cheeky Study Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: transgender women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Public Health Foundation Enterprises, Inc.: lead
• ViiV Healthcare: collaborator
• San Francisco Department of Public Health: collaborator
• Lyon-Martin Community Health Services: collaborator

Study Sites (1)

Bridge HIV, San Francisco Department of Public Health

San Francisco, California, 94134, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Albert Liu, MD, MPH

  SFDPH Bridge HIV

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Director

Model Details: 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

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 7, 2023
• Study Start: May 31, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 5, 2024

Record last verified: 2024-08

Locations

US (1)