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AYAHIV Role-based Responsibilities for Oncology-focused Workforce (ARROW)

Primary Purpose

Cervical Cancer, Kaposi Sarcoma, Non Hodgkin Lymphoma

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ARROW strategies
One-time education
Sponsored by
Implenomics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cervical Cancer focused on measuring cancer screening, Implementation trial

Eligibility Criteria

15 Years - 39 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 15 to 39 years of age at the time of study enrolment, on antiretroviral medication (ART) for at least 6 months and with no pending plans to move from current residence during the 3-year study duration Exclusion Criteria: pregnant at study enrolment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    ARROW strategies

    One-time education

    Arm 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.

    The comparator arm participants will receive one-time education and usual care services.

    Outcomes

    Primary Outcome Measures

    Proportion who complete screening/physical examination
    Proportion who complete recommended cancer treatment modalities

    Secondary Outcome Measures

    Proportion who complete recommended follow-up supplemental diagnostic procedures
    Proportion who initiate cancer treatment
    Proportion alive at 12 months

    Full Information

    First Posted
    August 15, 2023
    Last Updated
    August 15, 2023
    Sponsor
    Implenomics
    Collaborators
    Population Council, Society of Clinical and Radiation Oncologists of Zambia (ZASCRO), RTI International
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06004011
    Brief Title
    AYAHIV Role-based Responsibilities for Oncology-focused Workforce (ARROW)
    Official Title
    Integrated Delivery of Cancer Control Interventions for Adolescents and Young Adults Living With HIV in Zambia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    August 2026 (Anticipated)
    Study Completion Date
    July 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Implenomics
    Collaborators
    Population Council, Society of Clinical and Radiation Oncologists of Zambia (ZASCRO), RTI International

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cervical Cancer, Kaposi Sarcoma, Non Hodgkin Lymphoma
    Keywords
    cancer screening, Implementation trial

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    4100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ARROW strategies
    Arm Type
    Experimental
    Arm 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 Title
    One-time education
    Arm Type
    Active Comparator
    Arm Description
    The comparator arm participants will receive one-time education and usual care services.
    Intervention Type
    Other
    Intervention Name(s)
    ARROW strategies
    Intervention Description
    ARROW strategies are peer-to-peer support at the patient, provider and health system levels
    Intervention Type
    Other
    Intervention Name(s)
    One-time education
    Intervention 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
    Primary Outcome Measure Information:
    Title
    Proportion who complete screening/physical examination
    Time Frame
    12 months after study enrollment
    Title
    Proportion who complete recommended cancer treatment modalities
    Time Frame
    12 months after diagnosis
    Secondary Outcome Measure Information:
    Title
    Proportion who complete recommended follow-up supplemental diagnostic procedures
    Time Frame
    3 months from receipt of follow-up referral
    Title
    Proportion who initiate cancer treatment
    Time Frame
    3 months from diagnosis
    Title
    Proportion alive at 12 months
    Time Frame
    12 months after diagnosis

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    39 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 15 to 39 years of age at the time of study enrolment, on antiretroviral medication (ART) for at least 6 months and with no pending plans to move from current residence during the 3-year study duration Exclusion Criteria: pregnant at study enrolment
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sujha Subramanian
    Phone
    3022225034
    Email
    sujha.subramanian@implenomics.com

    12. IPD Sharing Statement

    Learn more about this trial

    AYAHIV Role-based Responsibilities for Oncology-focused Workforce (ARROW)

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