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

NCT04557423CompletedNAINTERVENTIONAL

Summary

This is a randomized trial to evaluate the effects of a community-based intervention on increasing cervical cancer screening rates in underserved Asian American (Korean, Vietnamese, and Chinese) 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.

Key Facts

Lead Sponsor

Fox Chase Cancer Center

Enrollment

797

Start Date

2021-04-08

Completion Date

2025-11-30

Study Type

INTERVENTIONAL

Official Title

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

Interventions

Community-Based EducationNavigation to ScreeningHPV Self-Sampling

Conditions

Uterine Cervical Neoplasms

Eligibility

Age Range

30 Years – 65 Years

Sex

FEMALE

Inclusion Criteria:

* Women who are of Asian race and self-identify as Korean, Vietnamese, or Chinese
* 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

Outcome Measures

Primary Outcomes

Participation in screening

The number of women who obtain clinic-based screening or return a self-collected sample

Time frame: 6 months

Secondary Outcomes

Program delivery cost

The costs associated with delivering each program. This will include: (1) Participant costs (time spent participating in educational sessions and time required to complete screening; transportation costs, if incurred); (2) Screening costs (cost of clinic-based screening, or cost of the HPV self-sampling kit); (3) Program delivery costs (community health educator time for conducting the educational programs, time will be valued at wage rates including benefits; costs of educational materials \[flyers, booklets\] and reminder letters); (4) Navigation costs (time and labor involved in navigating women to the clinic for screening will be documented using a log of CHE time and expenses incurred).

Time frame: 6 months

Locations

Temple University Lewis Katz School of Medicine, Philadelphia, United States

Linked Diseases

Uterine Cervical Neoplasms

Uterine Cervical Neoplasms — a type of gynecological cancer.