xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05979714</url>
    </required_header>
    <id_info>
      <org_study_id>22-35957</org_study_id>
      <nct_id>NCT05979714</nct_id>
    </id_info>
    <brief_title>The Cheeky Study: A Novel Delivery System for CAB-RPV LA</brief_title>
    <official_title>Developing a Novel Delivery System for CAB-RPV LA in Transgender Women Living With HIV in Public Health Settings</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Public Health Foundation Enterprises, Inc.</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>ViiV Healthcare</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
      <collaborator>
        <agency>San Francisco Department of Public Health</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Lyon-Martin Community Health Services</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Public Health Foundation Enterprises, Inc.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a single-arm implementation study of a novel integrated delivery model of CAB-RPV LA&#xD;
        for transwomen living with HIV.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        CAB-RPV LA as a monthly injectable could address disparities in viral suppression among trans&#xD;
        women living with HIV. This study is designed to enroll a diverse population of trans women&#xD;
        living with HIV who receive HIV care within collaborating primary care clinics. This study&#xD;
        proposes using mixed methods to tailor and evaluate implementation and client outcomes when&#xD;
        CAB-RPV LA is delivered through this integrated delivery model.&#xD;
  &#xD;
        This will be a 9-month pilot study among 40 participants who will be provided CAB-RPV LA&#xD;
        through an integrated trans-friendly delivery model using 4 implementation strategies to&#xD;
        improve the adoption and integration of CAB-RPV LA delivery to trans women. These strategies&#xD;
        are aimed at all levels of implementation - system, clinic, provider, and patient to maximize&#xD;
        impact. The 4 strategies are a patient-centered injection site (Bridge HIV, SFDPH),&#xD;
        patient-centered adherence support (peer health navigation and SMS platform with reminders&#xD;
        and communication with staff), provider education, and improved clinic communication&#xD;
        strategies.. CAB-RPV LA is being provided as standard of care and is not paid for by the&#xD;
        study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 31, 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <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.&#xD;
  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</intervention_model_description>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Feasibility of delivering CAB-RPV LA</measure>
      <time_frame>0, 9,18 Months</time_frame>
      <description>Assess the feasibility of delivering CAB-RPV LA to trans women living with HIV via a trans-tailored, integrated delivery model</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acceptability of delivering CAB-RPV LA</measure>
      <time_frame>0, 9,18 Months</time_frame>
      <description>Assess the acceptability of delivering CAB-RPV LA to trans women living with HIV via a trans-tailored, integrated delivery model</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Client Satisfaction</measure>
      <time_frame>0, 3, 6, 9 Months</time_frame>
      <description>Assess client satisfaction with treatment when CAB-RPV LA is delivered through a trans-tailored integrated model</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Assess tolerability</measure>
      <time_frame>3, 6, 9 Months</time_frame>
      <description>Assess tolerability of CAB-RPV LA among trans women receiving CAB-LA injections</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Assess adherence to injections</measure>
      <time_frame>3, 6, 9 Months</time_frame>
      <description>Assess adherence to monthly or bimonthly injections among trans women receiving CAB-RPV LA in this delivery model</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Assess viral suppression</measure>
      <time_frame>3, 6, 9 Months</time_frame>
      <description>Assess viral suppression rates among trans women receiving CAB-RPV LA</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Describe development of resistance mutations</measure>
      <time_frame>3, 6, 9 Months</time_frame>
      <description>Describe development of resistance mutations in cases of virologic failure among trans women receiving CAB-RPV LA</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>HIV Infections</condition>
    <arm_group>
      <arm_group_label>Cheeky Study Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Patient-centered injection site</intervention_name>
      <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.</description>
      <arm_group_label>Cheeky Study Intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Patient-centered adherence support</intervention_name>
      <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.</description>
      <arm_group_label>Cheeky Study Intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Provider education</intervention_name>
      <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.</description>
      <arm_group_label>Cheeky Study Intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Improved clinic communication strategies</intervention_name>
      <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.</description>
      <arm_group_label>Cheeky Study Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 18 years or older&#xD;
  &#xD;
            -  Male sex at birth and gender identity other than male&#xD;
  &#xD;
            -  Willing and able to provide written informed consent&#xD;
  &#xD;
            -  HIV-infected, confirmed by laboratory testing (can be via medical record)&#xD;
  &#xD;
            -  Eligible to receive CAB-RPV LA per FDA-approved label&#xD;
  &#xD;
            -  Virologically suppressed at the last visit within the last 6 months (HIV RNA &lt;50&#xD;
               copies/ml)&#xD;
  &#xD;
            -  Interested in initiating CAB-RPV LA for HIV treatment and willing to receive&#xD;
               injections at Bridge HIV&#xD;
  &#xD;
            -  Currently receiving HIV care by a care provider at one of the collaborating primary&#xD;
               care clinics.&#xD;
  &#xD;
            -  Has a cell phone and active service&#xD;
  &#xD;
            -  Able to understand, read, and speak English&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Unable to receive gluteal injections&#xD;
  &#xD;
            -  Plans to move away from the site area within the next 9 months.&#xD;
  &#xD;
            -  History of known or suspected drug resistance that would compromise the CAB-RPV&#xD;
               regimen&#xD;
  &#xD;
                 -  Rilpivirine: L100I; K101E; V106I and A; V108I; E138K and A, G, Q, R; V179F and I;&#xD;
                    Y181C and I; V189I; G190E; H221Y and H/L; F227C; and M230I and L; K103N+K238T,&#xD;
                    K103N+E138G+K238T; Y188L&#xD;
  &#xD;
                 -  Cabotegravir: Q146L; S153Y; I162M; T124A; Q148H, K; C56S; V72I; L74M; V75A;&#xD;
                    T122N; E138K; G140S; G149A; M154I; and N155H&#xD;
  &#xD;
            -  Prior hypersensitivity to cabotegravir or rilvipirine&#xD;
  &#xD;
            -  Current or expected use of any of the following medications:&#xD;
  &#xD;
                 -  Anticonvulsants: carbamazepine, oxcarbazepine, phenobarbital, phenytoin&#xD;
  &#xD;
                 -  Antimycobacterials: rifabutin, rifampin, rifapentine&#xD;
  &#xD;
                 -  Systemic glucocorticoids: more than a single dose of dexamethasone&#xD;
  &#xD;
                 -  Herbal: St John's Wort&#xD;
  &#xD;
            -  Any medical, psychiatric, or social condition or other responsibilities that, in the&#xD;
               judgment of the investigator, would make participation in the study unsafe, complicate&#xD;
               interpretation of study outcome data, or otherwise interfere with achieving the study&#xD;
               objectives&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <gender_based>Yes</gender_based>
      <gender_description>transgender women</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Albert Liu, MD, MPH</last_name>
      <role>Principal Investigator</role>
      <affiliation>SFDPH Bridge HIV</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Emily Schaeffer</last_name>
      <phone>628-217-7456</phone>
      <email>emily.schaeffer@sfdph.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Albert Liu, MD, MPH</last_name>
      <phone>415-437-7408</phone>
      <email>albert.liu@sfdph.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Bridge HIV, San Francisco Department of Public Health</name>
        <address>
          <city>San Francisco</city>
          <state>California</state>
          <zip>94134</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Emily Schaeffer</last_name>
        <phone>628-217-7456</phone>
        <email>emily.schaeffer@sfdph.org</email>
      </contact>
      <contact_backup>
        <last_name>Schaeffer</last_name>
      </contact_backup>
      <investigator>
        <last_name>Albert Liu, MD, MPH</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Hyman Scott, MD, MPH</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Susan Buchbinder, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Erin Wilson, PHD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Public Health Foundation Enterprises, Inc.</investigator_affiliation>
      <investigator_full_name>Albert Liu</investigator_full_name>
      <investigator_title>Clinical Research Director</investigator_title>
    </responsible_party>
    <keyword>Transwomen</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>HIV Infections</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05979714
  org study id: 22-35957
  nct id: NCT05979714
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: Yes
  This is a single-arm implementation study of a novel integrated delivery model of CAB-RPV LA
        for transwomen living with HIV.
  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.
  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 other
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Feasibility of delivering CAB-RPV LA
  time frame: 0, 9,18 Months
  description: Assess the feasibility of delivering CAB-RPV LA to trans women living with HIV via a trans-tailored, integrated delivery model
  measure: Acceptability of delivering CAB-RPV LA
  time frame: 0, 9,18 Months
  description: Assess the acceptability of delivering CAB-RPV LA to trans women living with HIV via a trans-tailored, integrated delivery model
  measure: Client Satisfaction
  time frame: 0, 3, 6, 9 Months
  description: Assess client satisfaction with treatment when CAB-RPV LA is delivered through a trans-tailored integrated model
  measure: Assess tolerability
  time frame: 3, 6, 9 Months
  description: Assess tolerability of CAB-RPV LA among trans women receiving CAB-LA injections
  measure: Assess adherence to injections
  time frame: 3, 6, 9 Months
  description: Assess adherence to monthly or bimonthly injections among trans women receiving CAB-RPV LA in this delivery model
  measure: Assess viral suppression
  time frame: 3, 6, 9 Months
  description: Assess viral suppression rates among trans women receiving CAB-RPV LA
  measure: Describe development of resistance mutations
  time frame: 3, 6, 9 Months
  description: Describe development of resistance mutations in cases of virologic failure among trans women receiving CAB-RPV LA
  arm group label: Cheeky Study Intervention
  arm group type: Experimental
  intervention type: Other
  intervention name: Patient-centered injection site
  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.
  arm group label: Cheeky Study Intervention
  intervention type: Behavioral
  intervention name: Patient-centered adherence support
  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.
  arm group label: Cheeky Study Intervention
  intervention type: Other
  intervention name: Provider education
  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.
  arm group label: Cheeky Study Intervention
  intervention type: Behavioral
  intervention name: Improved clinic communication strategies
  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.
  arm group label: Cheeky Study Intervention
  criteria: 
  gender: Male
  gender based: Yes
  gender description: transgender women
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Albert Liu, MD, MPH
  role: Principal Investigator
  affiliation: SFDPH Bridge HIV
  last name: Emily Schaeffer
  phone: 628-217-7456
  email: emily.schaeffer@sfdph.org
  last name: Albert Liu, MD, MPH
  phone: 415-437-7408
  email: albert.liu@sfdph.org
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Public Health Foundation Enterprises, Inc.
  investigator full name: Albert Liu
  investigator title: Clinical Research Director
  mesh term: HIV Infections