Cervical Cancer Self-Collection for Southeast Asian Immigrant and Refugee Women
Condition: Cervical Cancer Screening
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      The primary purpose of this study is to determine whether educational workshops paired with
      self-collected high-risk human papillomaviruses (hrHPV) screening will increase participation
      in cervical cancer screening among Southeast Asian Immigrant and Refugee populations in
      Wisconsin compared with offering clinician collected screening (total sample size: 250
      participants). The investigators hypothesize that participation in cervical cancer screening
      will be higher among women in the intervention group as compared to the control group.
    

Detailed description: 
      The effectiveness of offering self-collection sampling options to Southeast Asian refugee and
      immigrant populations to improve cervical cancer screening participation has not been
      investigated. The Milwaukee Consortium for Hmong Health (MCHH), supported by the Well Woman
      Program, has had success increasing participation in breast cancer screening through outreach
      and education activities. However, it continues to have limited success engaging women in
      cervical cancer screening. The investigators have established a partnership with MCHH to
      develop innovative cervical cancer workshops that combine community health worker (CHW)-led
      engagement with self-collected hrHPV screening, with the primary objective of increasing
      participation, awareness, and engagement in cervical cancer screening and treatment
      activities among this population.

      Research Intervention: Control workshops are workshops where participants are provided
      education on standard-of-care for cervical cancer screening such as pap smear and HPV testing
      through clinician-collection methods using speculum and cervical swabs. Intervention
      workshops are workshops where participants are provided all the same education as control as
      well as additional education on self-collection for HPV-only testing using vaginal swab as an
      additional method. After each workshop, each group will be offered to participate in their
      assigned group's screening method (clinician-collected or self-collected).

        -  Primary Objective: To evaluate whether educational workshops paired with self-collected
           hrHPV screening will increase participation in cervical cancer screening among Southeast
           Asian refugee and immigrant populations in Wisconsin compared with offering
           clinician-collected screening.

        -  Secondary Objectives: To evaluate participant satisfaction with the educational
           workshops using satisfaction surveys.
    

Intervention name(s): Workshop plus Clinician-Collected Cervical Swab; Workshop plus Participant-Collected Cervical Swab; HPV testing on Participant-Collected Cervical Swab Samples
Intervention type(s): Procedure; Device; Diagnostic Test
Intervention description(s): clinician-collection methods using speculum and cervical swabs; Evalyn® Brush (Rovers® Medical Devices, Netherlands); Roche Cobas4800 HPV Test System (Roche Molecular Systems Inc., Rotkreuz, Switzerland)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Workshops are randomized to either a control or intervention group
Masking: Single (Participant)
Primary purpose: Screening
Keywords: self-collection; community health workers