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

Sponsor

Public Health Foundation Enterprises, Inc. (Other)

Overall Status

Recruiting

CT.gov ID

NCT05979714

Collaborator

ViiV Healthcare (Industry), San Francisco Department of Public Health (Other), Lyon-Martin Community Health Services (Other)

Enrollment

Location

Arm

18.1

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Other: Patient-centered injection site Behavioral: Patient-centered adherence support Other: Provider education Behavioral: Improved clinic communication strategies	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

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 otherThis 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

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Developing a Novel Delivery System for CAB-RPV LA in Transgender Women Living With HIV in Public Health Settings

Actual Study Start Date :

May 31, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cheeky Study Intervention	Other: Patient-centered injection site 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. Behavioral: Patient-centered adherence support 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. Other: Provider education 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. Behavioral: Improved clinic communication strategies 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.

Arm

Intervention/Treatment

Experimental: Cheeky Study Intervention

Other: Patient-centered injection site

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.

Behavioral: Patient-centered adherence support

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.

Other: Provider education

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.

Behavioral: Improved clinic communication strategies

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.

Outcome Measures

Primary Outcome Measures

Feasibility of delivering CAB-RPV LA [0, 9,18 Months]
Assess the feasibility of delivering CAB-RPV LA to trans women living with HIV via a trans-tailored, integrated delivery model
Acceptability of delivering CAB-RPV LA [0, 9,18 Months]
Assess the acceptability of delivering CAB-RPV LA to trans women living with HIV via a trans-tailored, integrated delivery model
Client Satisfaction [0, 3, 6, 9 Months]
Assess client satisfaction with treatment when CAB-RPV LA is delivered through a trans-tailored integrated model

Secondary Outcome Measures

Assess tolerability [3, 6, 9 Months]
Assess tolerability of CAB-RPV LA among trans women receiving CAB-LA injections
Assess adherence to injections [3, 6, 9 Months]
Assess adherence to monthly or bimonthly injections among trans women receiving CAB-RPV LA in this delivery model
Assess viral suppression [3, 6, 9 Months]
Assess viral suppression rates among trans women receiving CAB-RPV LA
Describe development of resistance mutations [3, 6, 9 Months]
Describe development of resistance mutations in cases of virologic failure among trans women receiving CAB-RPV LA

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts 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 rilvipirine
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bridge HIV, San Francisco Department of Public Health	San Francisco	California	United States	94134

Sponsors and Collaborators

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

Investigators

Principal Investigator: Albert Liu, MD, MPH, SFDPH Bridge HIV

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Albert Liu, Clinical Research Director, Public Health Foundation Enterprises, Inc.

ClinicalTrials.gov Identifier:

NCT05979714

Other Study ID Numbers:

22-35957

First Posted:

Aug 7, 2023

Last Update Posted:

Aug 7, 2023

Last Verified:

Jul 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Albert Liu, Clinical Research Director, Public Health Foundation Enterprises, Inc.

Transwomen

Additional relevant MeSH terms:

HIV Infections

Study Results

No Results Posted as of Aug 7, 2023