Evidence-Based Approach to Empower Asian American Women in Cervical Cancer Screening

  • STATUS
    Recruiting
  • End date
    Apr 30, 2026
  • participants needed
    800
  • sponsor
    Fox Chase Cancer Center
Updated on 11 October 2022
cancer screening
cervical cancer screening
human papilloma virus vaccine
Accepts healthy volunteers

Summary

This is a randomized trial to evaluate the effects of a community-based intervention on increasing cervical cancer screening rates in underserved Korean and Vietnamese American women. All women will receive an educational program and navigation assistance. Women in the intervention condition will also receive a self-sampling kit for self-collection of a cervical sample for HPV testing. The investigators will evaluate whether the inclusion of a self-sampling kit increases the proportion of Asian American women who participate in cervical cancer screening.

Description

Aim 1: Compare rates of providing a self-collected sample vs. obtaining clinic-based screening among 800 Asian American women. It is hypothesized that the proportion of women in the HPV self-sampling program who provide a self-collected sample will be higher than the proportion of women in the clinic-based program who obtain clinic-based screening.

Aim 2: Examine mediators of participation. The investigators will examine both individualand social/environmental-level factors associated with participation across both programs. It is hypothesized that higher levels of perceived self-efficacy, lower levels of embarrassment, and fewer barriers will be associated with higher rates of participation in both conditions. Further, it is hypothesized that women in the HPV self-sampling program will report greater self-efficacy, less embarrassment, and fewer barriers compared to women in the clinic-based program.

Aim 3: Assess the relative cost-effectiveness of HPV self-sampling vs. clinic-based screening. The investigators will conduct an incremental cost-effectiveness analysis from a societal perspective incorporating trial-based direct medical and participant-borne costs associated with HPV self-sampling vs. clinic-based screening. It is hypothesized that the self-sampling program will be less costly to implement and achieve a higher participation rate.

Details
Condition Uterine Cervical Neoplasms
Treatment HPV self-sampling, Community-Based Education, Navigation to Screening
Clinical Study IdentifierNCT04557423
SponsorFox Chase Cancer Center
Last Modified on11 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Women who are of Asian race and self-identify as Korean or Vietnamese
are 30-65 years of age
are overdue for cervical cancer screening (e.g., no cytology-based screening within the past 3 years; no hrHPV testing either alone or in combination with cytology in the past 5 years)

Exclusion Criteria

have a prior diagnosis of cervical cancer or cervical abnormality (e.g., dysplasia)
had a hysterectomy with removal of the cervix
have a compromised immune system (e.g., known HIV)
unable to provide informed consent
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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