Cervical Cancer Self-Collection for Southeast Asian Immigrant and Refugee Women

NCT05286749 | Completed Results FDA Device

• 4 other identifiers: 2021-1525Protocol Version 8/8/2023UW21142A532050
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cervical Cancer Screening

Keywords

self-collection; community health workers

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Obtain or Self-Report Future Desire for Cervical Cancer Screening

  The results will be reported through summary statistics of the number of participants in each group subsequently engaging or seeking out cervical cancer screening either through services offered after workshop education or self-reported desire to follow up through their community health care provider.

  up to 1 day

Secondary Outcomes (2)

• Participant Satisfaction With Educational Workshops Survey Scores

  up to 1 day (pre workshop and post-workshop, up to 3 hours between surveys)

• Number of Participants Willing to Use HPV Self-collect Device for Their Cervical Cancer Screening

  up to 1 day

Study Arms (2)

Control

ACTIVE COMPARATOR

Participants take a workshop where they 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.

Procedure: Workshop plus Clinician-Collected Cervical Swab

Intervention

EXPERIMENTAL

Participants take a workshop where they 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.

Device: Workshop plus Participant-Collected Cervical Swab; Diagnostic Test: HPV testing on Participant-Collected Cervical Swab Samples

Interventions

Workshop plus Clinician-Collected Cervical Swab PROCEDURE

clinician-collection methods using speculum and cervical swabs

Control

Workshop plus Participant-Collected Cervical Swab DEVICE

Evalyn® Brush (Rovers® Medical Devices, Netherlands)

Intervention

HPV testing on Participant-Collected Cervical Swab Samples DIAGNOSTIC_TEST

Roche Cobas4800 HPV Test System (Roche Molecular Systems Inc., Rotkreuz, Switzerland)

Intervention

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fluent understanding in English, Hmong, Karen, Burmese, or Karenni

You may not qualify if:

• Prior hysterectomy
• Impaired decision-making capacity
• Pregnancy

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Milwaukee Consortium for Hmong Health (MCHH): collaborator

Study Sites (1)

MCHH's Community Center

Milwaukee, Wisconsin, 53205, United States

Location

Results Point of Contact

• Title: Tana Chongsuwat, MD, MPH
• Organization: UW School of Medicine and Public Health

tana.chongsuwat@fammed.wisc.edu

224-260-1666

Study Officials

• Jessica Dalby, MD

  UW School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be informed of random assignment into two groups. Participants will not be aware of which group they belong to. Participants in the control group are initially only provided educational materials about the standard of care for cervical cancer screening and offered clinician-collection for screening as the recommended method. Whereas the intervention group is provided additional materials about self-collection in the core educational material and is offered the Evalyn Device for self-collection as a screening option immediately at the end of the workshop. All participants will be made aware during a debrief session at the end of the study about what information could not be given at the time of consenting, and why they could not be told at that time.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Workshops are randomized to either a control or intervention group

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: March 18, 2022
• Study Start: August 13, 2022
• Primary Completion: February 10, 2024
• Study Completion: February 10, 2024
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)