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/NCT06004011</url>
    </required_header>
    <id_info>
      <org_study_id>Imp001</org_study_id>
      <nct_id>NCT06004011</nct_id>
    </id_info>
    <brief_title>AYAHIV Role-based Responsibilities for Oncology-focused Workforce (ARROW)</brief_title>
    <official_title>Integrated Delivery of Cancer Control Interventions for Adolescents and Young Adults Living With HIV in Zambia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Implenomics</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Population Council</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Society of Clinical and Radiation Oncologists of Zambia (ZASCRO)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>RTI International</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Implenomics</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Adolescents and young adults living with HIV experience higher premature mortality from&#xD;
        cancer than their uninfected peers. In Zambia, because of multilevel barriers, interventions&#xD;
        for early diagnosis and optimized treatment to reduce this cancer mortality are underutilized&#xD;
        for this disproportionally impacted cohort. In this study, we will test peer-to-peer&#xD;
        education and support strategies to increase use of early diagnosis services in HIV treatment&#xD;
        facilities and improve compliance with cancer treatment in the cancer center.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Zambia is a global epicenter for HIV with a large number of adolescents and young adults&#xD;
        living with HIV (AYAHIV). Compared with their uninfected peers, AYAHIV are at increased risk&#xD;
        of developing cancer, most frequently Kaposi sarcoma (KS), non-Hodgkin's lymphoma (NHL), and&#xD;
        cervical cancer (CC). To reduce this premature mortality, evidence-based strategies should be&#xD;
        implemented to both diagnose cancers at an earlier stage and help AYAHIV complete recommended&#xD;
        cancer treatment. We will use theory-informed multilevel strategies to create the AYAHIV&#xD;
        Role-based Responsibilities for Oncology-focused Workforce (ARROW) program to increase uptake&#xD;
        of services for early diagnosis and improve compliance with cancer treatment for KS, NHL, and&#xD;
        CC. Our overall approach is based on the evidence-based strategy of peer support for&#xD;
        engagement and learning. At the individual level, we will address barriers by embedding peer&#xD;
        counselors to support AYAHIV. At the provider level, we will create a peer-to-peer learning&#xD;
        network to build linkages between those specializing in pediatric and adult HIV treatment and&#xD;
        cancer care. At the health care system level, we will bring together health care&#xD;
        administrators and Zambian Ministry of Health policy makers to review barriers and to develop&#xD;
        and implement collaborative solutions. We will use implementation science methods to evaluate&#xD;
        effectiveness, implementation outcomes, and cost-effectiveness of the ARROW program compared&#xD;
        with a one-time education campaign by pursuing the following aims:&#xD;
  &#xD;
        Aim 1. Conduct randomized trials to compare the ARROW program with the one-time education&#xD;
        campaign in increasing services received by AYAHIV to facilitate early diagnosis (physical&#xD;
        exam for KS and NHL, CC screening, and timely diagnostic testing) and in improving adherence&#xD;
        to cancer treatment.&#xD;
  &#xD;
        Aim 2. Use mixed methods to assess implementation outcomes of the ARROW program compared with&#xD;
        one-time education based on acceptability, feasibility, appropriateness, fidelity, and&#xD;
        sustainability.&#xD;
  &#xD;
        Aim 3. Perform economic evaluations to assess cost-effectiveness and return-on-investment&#xD;
        scenarios.&#xD;
  &#xD;
        Successful completion of these aims will yield a set of data-driven strategies that can be&#xD;
        scaled up to reduce premature cancer mortality among AYAHIV. To support future implementation&#xD;
        efforts, we will generate incremental cost-effectiveness estimates, conduct policy&#xD;
        simulations, evaluate implementation outcomes, and assess challenges and facilitators to&#xD;
        optimize the ARROW program. The model tested in Zambia can serve as a blueprint for other&#xD;
        Sub-Saharan African countries to ensure AYAHIV receive optimal services to facilitate early&#xD;
        diagnosis and ensure completion of guideline-recommended treatments. The ARROW program will&#xD;
        also provide a framework for implementing expanded services, such as preventive services and&#xD;
        survivorship care, to further reduce the burden of cancer AYAHIV face.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 2023</start_date>
    <completion_date type="Anticipated">July 2027</completion_date>
    <primary_completion_date type="Anticipated">August 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Screening</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Proportion who complete screening/physical examination</measure>
      <time_frame>12 months after study enrollment</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Proportion who complete recommended cancer treatment modalities</measure>
      <time_frame>12 months after diagnosis</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Proportion who complete recommended follow-up supplemental diagnostic procedures</measure>
      <time_frame>3 months from receipt of follow-up referral</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion who initiate cancer treatment</measure>
      <time_frame>3 months from diagnosis</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion alive at 12 months</measure>
      <time_frame>12 months after diagnosis</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">4100</enrollment>
    <condition>Cervical Cancer</condition>
    <condition>Kaposi Sarcoma</condition>
    <condition>Non Hodgkin Lymphoma</condition>
    <arm_group>
      <arm_group_label>ARROW strategies</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The ARROW strategies which use peer-peer support at the patient level (through peer counselors), at the provider level (through peer lead education sessions) and at the health system level (through a health collaborative forum) to deliver high quality screenings and ensure cancer treatment completion.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>One-time education</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The comparator arm participants will receive one-time education and usual care services.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>ARROW strategies</intervention_name>
      <description>ARROW strategies are peer-to-peer support at the patient, provider and health system levels</description>
      <arm_group_label>ARROW strategies</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>One-time education</intervention_name>
      <description>The comparison group will receive a one-time education campaign that will provide informational brochures to adolescents and young adults living with HIV and HIV providers</description>
      <arm_group_label>One-time education</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  15 to 39 years of age at the time of study enrolment, on antiretroviral medication&#xD;
               (ART) for at least 6 months and with no pending plans to move from current residence&#xD;
               during the 3-year study duration&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  pregnant at study enrolment&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>15 Years</minimum_age>
      <maximum_age>39 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Sujha Subramanian</last_name>
      <phone>3022225034</phone>
      <email>sujha.subramanian@implenomics.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>cancer screening</keyword>
    <keyword>Implementation trial</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sarcoma, Kaposi</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/NCT06004011
  org study id: Imp001
  nct id: NCT06004011
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Adolescents and young adults living with HIV experience higher premature mortality from
        cancer than their uninfected peers. In Zambia, because of multilevel barriers, interventions
        for early diagnosis and optimized treatment to reduce this cancer mortality are underutilized
        for this disproportionally impacted cohort. In this study, we will test peer-to-peer
        education and support strategies to increase use of early diagnosis services in HIV treatment
        facilities and improve compliance with cancer treatment in the cancer center.
  Zambia is a global epicenter for HIV with a large number of adolescents and young adults
        living with HIV (AYAHIV). Compared with their uninfected peers, AYAHIV are at increased risk
        of developing cancer, most frequently Kaposi sarcoma (KS), non-Hodgkin's lymphoma (NHL), and
        cervical cancer (CC). To reduce this premature mortality, evidence-based strategies should be
        implemented to both diagnose cancers at an earlier stage and help AYAHIV complete recommended
        cancer treatment. We will use theory-informed multilevel strategies to create the AYAHIV
        Role-based Responsibilities for Oncology-focused Workforce (ARROW) program to increase uptake
        of services for early diagnosis and improve compliance with cancer treatment for KS, NHL, and
        CC. Our overall approach is based on the evidence-based strategy of peer support for
        engagement and learning. At the individual level, we will address barriers by embedding peer
        counselors to support AYAHIV. At the provider level, we will create a peer-to-peer learning
        network to build linkages between those specializing in pediatric and adult HIV treatment and
        cancer care. At the health care system level, we will bring together health care
        administrators and Zambian Ministry of Health policy makers to review barriers and to develop
        and implement collaborative solutions. We will use implementation science methods to evaluate
        effectiveness, implementation outcomes, and cost-effectiveness of the ARROW program compared
        with a one-time education campaign by pursuing the following aims:
  
        Aim 1. Conduct randomized trials to compare the ARROW program with the one-time education
        campaign in increasing services received by AYAHIV to facilitate early diagnosis (physical
        exam for KS and NHL, CC screening, and timely diagnostic testing) and in improving adherence
        to cancer treatment.
  
        Aim 2. Use mixed methods to assess implementation outcomes of the ARROW program compared with
        one-time education based on acceptability, feasibility, appropriateness, fidelity, and
        sustainability.
  
        Aim 3. Perform economic evaluations to assess cost-effectiveness and return-on-investment
        scenarios.
  
        Successful completion of these aims will yield a set of data-driven strategies that can be
        scaled up to reduce premature cancer mortality among AYAHIV. To support future implementation
        efforts, we will generate incremental cost-effectiveness estimates, conduct policy
        simulations, evaluate implementation outcomes, and assess challenges and facilitators to
        optimize the ARROW program. The model tested in Zambia can serve as a blueprint for other
        Sub-Saharan African countries to ensure AYAHIV receive optimal services to facilitate early
        diagnosis and ensure completion of guideline-recommended treatments. The ARROW program will
        also provide a framework for implementing expanded services, such as preventive services and
        survivorship care, to further reduce the burden of cancer AYAHIV face.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Screening
  masking: None (Open Label)
  measure: Proportion who complete screening/physical examination
  time frame: 12 months after study enrollment
  measure: Proportion who complete recommended cancer treatment modalities
  time frame: 12 months after diagnosis
  measure: Proportion who complete recommended follow-up supplemental diagnostic procedures
  time frame: 3 months from receipt of follow-up referral
  measure: Proportion who initiate cancer treatment
  time frame: 3 months from diagnosis
  measure: Proportion alive at 12 months
  time frame: 12 months after diagnosis
  arm group label: ARROW strategies
  arm group type: Experimental
  description: The ARROW strategies which use peer-peer support at the patient level (through peer counselors), at the provider level (through peer lead education sessions) and at the health system level (through a health collaborative forum) to deliver high quality screenings and ensure cancer treatment completion.
  arm group label: One-time education
  arm group type: Active Comparator
  description: The comparator arm participants will receive one-time education and usual care services.
  intervention type: Other
  intervention name: ARROW strategies
  description: ARROW strategies are peer-to-peer support at the patient, provider and health system levels
  arm group label: ARROW strategies
  intervention type: Other
  intervention name: One-time education
  description: The comparison group will receive a one-time education campaign that will provide informational brochures to adolescents and young adults living with HIV and HIV providers
  arm group label: One-time education
  criteria: 
  gender: All
  minimum age: 15 Years
  maximum age: 39 Years
  healthy volunteers: No
  last name: Sujha Subramanian
  phone: 3022225034
  email: sujha.subramanian@implenomics.com
  responsible party type: Sponsor
  mesh term: Sarcoma, Kaposi