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Elimisha HPV (Human Papillomavirus)

Primary Purpose

Cervical Cancer, HPV, HIV

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Elimisha HPV
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cervical Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Women attending government-supported health facilities (Aim 2) For Aim 2, activity 4, investigators will enroll approximately 804 randomly selected women, (67 per facility in each of 12 facilities). Inclusion criteria: *Has attended a study facility during the study period *Is eligible for cervical cancer screening per the Kenya Ministry of Health guidelines include: Women living with HIV (WLWH) will be between the age of 25 and 65. All other women will be between the age of 30 and 65 * All women should have an intact uterus and cervix Exclusion criteria: Does not understand the study purpose and details Is not willing to provide informed consent CHVs working at government-supported health facilities (Aim 2) Investigators will enroll approximately 36 Community Health Volunteers (CHVs) across 12 sites. CHVs will be identified by CHV supervisors and will be recruited into the study for training and participation in the stigma-responsive service delivery model at the time of randomization. Since study outcomes may appear to reflect their job performance, we will explain this as part of the informed consent and emphasize the voluntary nature of participation in the study. For both optimization of study activities and to avoid any coercion, CHVs will be able to decline participation without impact on their position in the facility. Inclusion criteria: Age 18 or older Must be a Community Health Volunteer (CHV) at government-supported facilities in Kisumu County Exclusion criteria: Does not understand the study purpose and details Is not willing to sign an informed consent HIV-peer navigators (Aim 2) Approximately 60 (10 per intervention health facility) HIV-peer navigator or a woman attending these facilities, including a woman living with HIV (WLWH). Inclusion criteria: Age 18 or older Must have complete HPV screening and treatment in the past Must be interested in getting trained as a peer navigator Exclusion criteria: Does not understand the study purpose and details Is not willing to sign an informed consent Aim 3 Participants Participants will be purposively recruited from each study arm to achieve a sample with heterogeneous demographic and clinical characteristics (e.g., age, HIV and HPV status). Women attending government-supported health facilities (Aim 3) Investigators will enroll approximately 24 women with the option to recruit more if new themes are emerging in the IDIs. Inclusion criteria: Will have completed an HPV screening test at one of the intervention or control facilities Agree to be audio recorded Exclusion criteria: Does not understand the study purpose and details Is not willing to provide informed consent Community Health Volunteers (CHVs) and Peer Navigators (Aims 3) Investigators will enroll approximately 10 CHVs and peer navigators with the option to recruit more if new themes are emerging in the IDIs. Inclusion criteria: Participated as a CHV or peer navigator at one of the facilities participating in the study Agree to be audio recorded Exclusion criteria: Does not understand the study purpose and details Is not willing to sign an informed consent Facility managers (Aim 3) Investigators will enroll approximately 12 facility managers. Inclusion criteria: Age 18 or older A manager at one of the facilities participating in the study Agree to be audio recorded Exclusion criteria: Does not understand the study purpose and details Is not willing to sign an informed consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Usual care

    Elimisha HPV

    Arm Description

    Elimisha HPV is a multi-level stigma-responsive cervical cancer prevention service delivery model that incorporates stigma-responsive education, peer navigation and a patient-centered delivery strategy, addressing drivers while mitigating harms from stigma.

    Outcomes

    Primary Outcome Measures

    Overall HPV testing rates
    Number of women screened/number of women attending clinic visits at least once during study period
    HPV testing rates among women living with HIV (WLWH) enrolled in care
    Number of WLWH enrolled in HIV care screening/number of WLWH attending clinic visits at least once during study period
    Follow-up rates for HPV treatment
    Number of women testing HPV+ seeking treatment/number of women testing HPV+
    Follow-up rates for treatment among WLWH
    Number of WLWH testing HPV+ seeking treatment/number of WLWH testing HPV+
    Proportion of WLWH enrolled in care attending at least one visit
    Overall level of stigma related to cervical cancer, HPV and HIV
    HPV-and Cervical Cancer Associated Stigma Scale will be used which is scored on a scale of 1-3 within each health domain, with 3 representing higher levels of stigma.
    Level of stigma related to cervical cancer
    HPV-and Cervical Cancer Associated Stigma Scale will be used which is scored on a scale of 1-3 within each health domain, with 3 representing higher levels of stigma.
    Level of stigma related to HPV
    HPV-and Cervical Cancer Associated Stigma Scale will be used which is scored on a scale of 1-3 within each health domain, with 3 representing higher levels of stigma.
    Level of stigma related to HIV
    HPV-and Cervical Cancer Associated Stigma Scale will be used which is scored on a scale of 1-3 within each health domain, with 3 representing higher levels of stigma.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 8, 2023
    Last Updated
    August 11, 2023
    Sponsor
    Duke University
    Collaborators
    Fogarty International Center of the National Institute of Health
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05736588
    Brief Title
    Elimisha HPV (Human Papillomavirus)
    Official Title
    A Stigma Responsive Service Delivery Model for HPV-based Screening Among Women Living With HIV
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    July 19, 2025 (Anticipated)
    Study Completion Date
    July 19, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Duke University
    Collaborators
    Fogarty International Center of the National Institute of Health

    4. Oversight

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

    5. Study Description

    Brief Summary
    This research study aims to develop a stigma-responsive educational intervention which includes simplified scripts that provide clear messages about HPV and video aimed at addressing fears and misperceptions from a peer perspective. These educational components will be incorporated into 'Elimisha' HPV a multi-level stigma-responsive cervical cancer prevention service delivery model.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cervical Cancer, HPV, HIV, Stigma

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Usual care
    Arm Type
    No Intervention
    Arm Title
    Elimisha HPV
    Arm Type
    Experimental
    Arm Description
    Elimisha HPV is a multi-level stigma-responsive cervical cancer prevention service delivery model that incorporates stigma-responsive education, peer navigation and a patient-centered delivery strategy, addressing drivers while mitigating harms from stigma.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Elimisha HPV
    Intervention Description
    Elimisha HPV is a multi-level stigma-responsive cervical cancer prevention service delivery model that incorporates stigma-responsive education, peer navigation and a patient-centered delivery strategy, addressing drivers while mitigating harms from stigma.
    Primary Outcome Measure Information:
    Title
    Overall HPV testing rates
    Description
    Number of women screened/number of women attending clinic visits at least once during study period
    Time Frame
    Approximately 18 months
    Title
    HPV testing rates among women living with HIV (WLWH) enrolled in care
    Description
    Number of WLWH enrolled in HIV care screening/number of WLWH attending clinic visits at least once during study period
    Time Frame
    Approximately 18 months
    Title
    Follow-up rates for HPV treatment
    Description
    Number of women testing HPV+ seeking treatment/number of women testing HPV+
    Time Frame
    Approximately 18 months
    Title
    Follow-up rates for treatment among WLWH
    Description
    Number of WLWH testing HPV+ seeking treatment/number of WLWH testing HPV+
    Time Frame
    Approximately 18 months
    Title
    Proportion of WLWH enrolled in care attending at least one visit
    Time Frame
    Approximately 18 months
    Title
    Overall level of stigma related to cervical cancer, HPV and HIV
    Description
    HPV-and Cervical Cancer Associated Stigma Scale will be used which is scored on a scale of 1-3 within each health domain, with 3 representing higher levels of stigma.
    Time Frame
    Approximately 18 months
    Title
    Level of stigma related to cervical cancer
    Description
    HPV-and Cervical Cancer Associated Stigma Scale will be used which is scored on a scale of 1-3 within each health domain, with 3 representing higher levels of stigma.
    Time Frame
    Approximately 18 months
    Title
    Level of stigma related to HPV
    Description
    HPV-and Cervical Cancer Associated Stigma Scale will be used which is scored on a scale of 1-3 within each health domain, with 3 representing higher levels of stigma.
    Time Frame
    Approximately 18 months
    Title
    Level of stigma related to HIV
    Description
    HPV-and Cervical Cancer Associated Stigma Scale will be used which is scored on a scale of 1-3 within each health domain, with 3 representing higher levels of stigma.
    Time Frame
    Approximately 18 months
    Other Pre-specified Outcome Measures:
    Title
    Factors related to the success of the delivery model
    Description
    Factors at the patient, community health volunteer and peer navigator level; factors at the health facility level; and factors at the County Health Management Team level.
    Time Frame
    Approximately 18 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Women attending government-supported health facilities (Aim 2) For Aim 2, activity 4, investigators will enroll approximately 804 randomly selected women, (67 per facility in each of 12 facilities). Inclusion criteria: *Has attended a study facility during the study period *Is eligible for cervical cancer screening per the Kenya Ministry of Health guidelines include: Women living with HIV (WLWH) will be between the age of 25 and 65. All other women will be between the age of 30 and 65 * All women should have an intact uterus and cervix Exclusion criteria: Does not understand the study purpose and details Is not willing to provide informed consent CHVs working at government-supported health facilities (Aim 2) Investigators will enroll approximately 36 Community Health Volunteers (CHVs) across 12 sites. CHVs will be identified by CHV supervisors and will be recruited into the study for training and participation in the stigma-responsive service delivery model at the time of randomization. Since study outcomes may appear to reflect their job performance, we will explain this as part of the informed consent and emphasize the voluntary nature of participation in the study. For both optimization of study activities and to avoid any coercion, CHVs will be able to decline participation without impact on their position in the facility. Inclusion criteria: Age 18 or older Must be a Community Health Volunteer (CHV) at government-supported facilities in Kisumu County Exclusion criteria: Does not understand the study purpose and details Is not willing to sign an informed consent HIV-peer navigators (Aim 2) Approximately 60 (10 per intervention health facility) HIV-peer navigator or a woman attending these facilities, including a woman living with HIV (WLWH). Inclusion criteria: Age 18 or older Must have complete HPV screening and treatment in the past Must be interested in getting trained as a peer navigator Exclusion criteria: Does not understand the study purpose and details Is not willing to sign an informed consent Aim 3 Participants Participants will be purposively recruited from each study arm to achieve a sample with heterogeneous demographic and clinical characteristics (e.g., age, HIV and HPV status). Women attending government-supported health facilities (Aim 3) Investigators will enroll approximately 24 women with the option to recruit more if new themes are emerging in the IDIs. Inclusion criteria: Will have completed an HPV screening test at one of the intervention or control facilities Agree to be audio recorded Exclusion criteria: Does not understand the study purpose and details Is not willing to provide informed consent Community Health Volunteers (CHVs) and Peer Navigators (Aims 3) Investigators will enroll approximately 10 CHVs and peer navigators with the option to recruit more if new themes are emerging in the IDIs. Inclusion criteria: Participated as a CHV or peer navigator at one of the facilities participating in the study Agree to be audio recorded Exclusion criteria: Does not understand the study purpose and details Is not willing to sign an informed consent Facility managers (Aim 3) Investigators will enroll approximately 12 facility managers. Inclusion criteria: Age 18 or older A manager at one of the facilities participating in the study Agree to be audio recorded Exclusion criteria: Does not understand the study purpose and details Is not willing to sign an informed consent
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Megan Huchko, MD, MPH
    Phone
    919 613 5062
    Email
    megan.huchko@duke.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

    Elimisha HPV (Human Papillomavirus)

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