Back to resultsThe Cheeky Study: A Novel Delivery System for CAB-RPV LA
Primary Purpose
HIV Infections
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient-centered injection site
Patient-centered adherence support
Provider education
Improved clinic communication strategies
Sponsored by
About this trial
This is an interventional health services research trial for HIV Infections focused on measuring Transwomen
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 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
Sites / Locations
- Bridge HIV, San Francisco Department of Public HealthRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cheeky Study Intervention
Arm Description
Outcomes
Primary Outcome Measures
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
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
Client Satisfaction
Assess client satisfaction with treatment when CAB-RPV LA is delivered through a trans-tailored integrated model
Secondary Outcome Measures
Assess tolerability
Assess tolerability of CAB-RPV LA among trans women receiving CAB-LA injections
Assess adherence to injections
Assess adherence to monthly or bimonthly injections among trans women receiving CAB-RPV LA in this delivery model
Assess viral suppression
Assess viral suppression rates among trans women receiving CAB-RPV LA
Describe development of resistance mutations
Describe development of resistance mutations in cases of virologic failure among trans women receiving CAB-RPV LA
Full Information
NCT ID
NCT05979714
First Posted
July 31, 2023
Last Updated
July 31, 2023
Sponsor
Public Health Foundation Enterprises, Inc.
Collaborators
ViiV Healthcare, San Francisco Department of Public Health, Lyon-Martin Community Health Services
1. Study Identification
Unique Protocol Identification Number
NCT05979714
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Public Health Foundation Enterprises, Inc.
Collaborators
ViiV Healthcare, San Francisco Department of Public Health, Lyon-Martin Community Health Services
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Transwomen
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cheeky Study Intervention
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Patient-centered injection site
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Patient-centered adherence support
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Provider education
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Improved clinic communication strategies
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of delivering CAB-RPV LA
Description
Assess the feasibility of delivering CAB-RPV LA to trans women living with HIV via a trans-tailored, integrated delivery model
Time Frame
0, 9,18 Months
Title
Acceptability of delivering CAB-RPV LA
Description
Assess the acceptability of delivering CAB-RPV LA to trans women living with HIV via a trans-tailored, integrated delivery model
Time Frame
0, 9,18 Months
Title
Client Satisfaction
Description
Assess client satisfaction with treatment when CAB-RPV LA is delivered through a trans-tailored integrated model
Time Frame
0, 3, 6, 9 Months
Secondary Outcome Measure Information:
Title
Assess tolerability
Description
Assess tolerability of CAB-RPV LA among trans women receiving CAB-LA injections
Time Frame
3, 6, 9 Months
Title
Assess adherence to injections
Description
Assess adherence to monthly or bimonthly injections among trans women receiving CAB-RPV LA in this delivery model
Time Frame
3, 6, 9 Months
Title
Assess viral suppression
Description
Assess viral suppression rates among trans women receiving CAB-RPV LA
Time Frame
3, 6, 9 Months
Title
Describe development of resistance mutations
Description
Describe development of resistance mutations in cases of virologic failure among trans women receiving CAB-RPV LA
Time Frame
3, 6, 9 Months
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
transgender women
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Schaeffer
Phone
628-217-7456
Email
emily.schaeffer@sfdph.org
First Name & Middle Initial & Last Name or Official Title & Degree
Albert Liu, MD, MPH
Phone
415-437-7408
Email
albert.liu@sfdph.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert Liu, MD, MPH
Organizational Affiliation
SFDPH Bridge HIV
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bridge HIV, San Francisco Department of Public Health
City
San Francisco
State/Province
California
ZIP/Postal Code
94134
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Schaeffer
Phone
628-217-7456
Email
emily.schaeffer@sfdph.org
First Name & Middle Initial & Last Name & Degree
Schaeffer
First Name & Middle Initial & Last Name & Degree
Albert Liu, MD, MPH
First Name & Middle Initial & Last Name & Degree
Hyman Scott, MD, MPH
First Name & Middle Initial & Last Name & Degree
Susan Buchbinder, MD
First Name & Middle Initial & Last Name & Degree
Erin Wilson, PHD
12. IPD Sharing Statement
Learn more about this trial
The Cheeky Study: A Novel Delivery System for CAB-RPV LA
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