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Elimisha HPV (Human Papillomavirus)

Recruiting
18 years of age
Both
Phase N/A

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Overview

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.

Eligibility

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

Study details

Cervical Cancer, HPV, HIV, Stigma

NCT05736588

Duke University

30 April 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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