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

NCT05286749 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2024-09-19

Study results available
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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

Interventions

PROCEDURE

Workshop plus Clinician-Collected Cervical Swab

clinician-collection methods using speculum and cervical swabs

DEVICE

Workshop plus Participant-Collected Cervical Swab

Evalyn® Brush (Rovers® Medical Devices, Netherlands)

DIAGNOSTIC_TEST

HPV testing on Participant-Collected Cervical Swab Samples

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

Sponsors & Collaborators

  • Milwaukee Consortium for Hmong Health (MCHH)

    collaborator OTHER

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Jessica Dalby, MD · UW School of Medicine and Public Health

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-13
Primary Completion
2024-02-10
Completion
2024-02-10
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05286749 on ClinicalTrials.gov