HIV InfectionsNCT05979714
The Cheeky Study: A Novel Delivery System for CAB-RPV LA
A study testing Patient-centered injection site, Patient-centered adherence support and Provider education in people with HIV Infections, run by Public Health Foundation Enterprises, Inc. at 1 site in United States.
Trial summary
This is a single-arm implementation study of a novel integrated delivery model of CAB-RPV LA for transwomen living with HIV. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- HIV Infections
- What is being tested?
- Patient-centered injection site, Patient-centered adherence support and Provider education
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Bridge HIV, San Francisco Department of Public Health
San Francisco, California, 94134
About this study
Official title: Developing a Novel Delivery System for CAB-RPV LA in Transgender Women Living With HIV in Public Health Settings
This is a single-arm implementation study of a novel integrated delivery model of CAB-RPV LA for transwomen living with HIV.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- Patient-centered injection site, Patient-centered adherence support, Provider education, Improved clinic communication strategies
- Keywords
- Transwomen
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-centered injection siteOther
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.
Patient-centered adherence supportBehavioural
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.
Provider educationOther
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.
Improved clinic communication strategiesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Patient-centered injection site; Behavioral: Patient-centered adherence support; Other: Provider education; Behavioral: Improved clinic communication strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 0, 9,18 Months
Client Satisfaction
Assess client satisfaction with treatment when CAB-RPV LA is delivered through a trans-tailored integrated model
Measured: 0, 3, 6, 9 Months
Secondary outcomes (4)
Assess tolerability
Assess tolerability of CAB-RPV LA among trans women receiving CAB-LA injections
Measured: 3, 6, 9 Months
Assess adherence to injections
Assess adherence to monthly or bimonthly injections among trans women receiving CAB-RPV LA in this delivery model
Measured: 3, 6, 9 Months
Assess viral suppression
Assess viral suppression rates among trans women receiving CAB-RPV LA
Measured: 3, 6, 9 Months
Describe development of resistance mutations
Describe development of resistance mutations in cases of virologic failure among trans women receiving CAB-RPV LA
Measured: 3, 6, 9 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start31 May 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Public Health Foundation Enterprises, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- ViiV Healthcare, San Francisco Department of Public Health, Lyon-Martin Community Health Services
- Responsible party
- Principal investigator, Albert Liu, Public Health Foundation Enterprises, Inc.
- Investigators
- Albert Liu, MD, MPH, Principal investigator, SFDPH Bridge HIV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05979714
- Sponsor's protocol ID
- 22-35957
- Status last verified
- Aug 2024
- First submitted
- 31 Jul 2023
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Novel Delivery System for CAB-RPV LA in Transgender Women Living With HIV in Public Health Settings
- ClinicalTrials.gov ID
- NCT05979714
- Acronym / sponsor ID
- 22-35957
- Conditions
- HIV Infections
- Keywords
- Transwomen
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Public Health Foundation Enterprises, Inc.University, hospital or other
- Collaborators
- ViiV Healthcare, San Francisco Department of Public Health, Lyon-Martin Community Health Services
- Study start
- 31 May 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 7 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Cheeky Study Intervention | Experimental | Other: Patient-centered injection site, Behavioral: Patient-centered adherence support, Other: Provider education, Behavioral: Improved clinic communication strategiesThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (12 listed)
- 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
- Prior hypersensitivity to cabotegravir or rilpivirine
- Current or expected use of any of the following medications:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient-centered injection siteCAB-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. | Other | Cheeky Study Intervention |
| Patient-centered adherence supportA 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. | Behavioural | Cheeky Study Intervention |
| Provider educationTo 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. | Other | Cheeky Study Intervention |
| Improved clinic communication strategiesFor 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. | Behavioural | Cheeky Study Intervention |
Primary outcome
Feasibility of delivering CAB-RPV LA
Time frame: 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
Time frame: 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
Time frame: 0, 3, 6, 9 Months
Assess client satisfaction with treatment when CAB-RPV LA is delivered through a trans-tailored integrated model
4 secondary outcomes
Assess tolerability
Time frame: 3, 6, 9 Months
Assess adherence to injections
Time frame: 3, 6, 9 Months
Assess viral suppression
Time frame: 3, 6, 9 Months
Describe development of resistance mutations
Time frame: 3, 6, 9 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Albert Liu, MD, MPH principal investigator
SFDPH Bridge HIV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient-centered injection site, Patient-centered adherence support and Provider education in people with HIV Infections, run by Public Health Foundation Enterprises, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of delivering CAB-RPV LA (time frame: 0, 9,18 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2024.