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

NCT04557423 | Completed

• 1 other identifier: 19-1058
• Study Type: interventional
• Target: 797
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Uterine Cervical Neoplasms

Outcome Measures

Primary Outcomes (1)

• Participation in screening

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

  6 months

Secondary Outcomes (1)

• Program delivery cost

  6 months

Study Arms (2)

Evidence-Based Intervention

ACTIVE COMPARATOR

Culturally appropriate educational intervention focused on cervical cancer screening, with navigation assistance provided.

Behavioral: Community-Based Education; Behavioral: Navigation to Screening

HPV Self-Sampling

EXPERIMENTAL

Previously tested evidence-based intervention (i.e. culturally appropriate educational intervention focused on cervical cancer screening, with navigation assistance provided). Participants will also receive a self-sampling kit.

Behavioral: Community-Based Education; Behavioral: Navigation to Screening; Behavioral: HPV Self-Sampling

Interventions

Community-Based Education BEHAVIORAL

A previously evaluated educational intervention delivered in community settings. Includes culturally- and linguistically-appropriate materials.

Evidence-Based Intervention; HPV Self-Sampling

Navigation to Screening BEHAVIORAL

Community health educators provide navigation assistance to access clinic-based cervical cancer screening.

Evidence-Based Intervention; HPV Self-Sampling

HPV Self-Sampling BEHAVIORAL

An HPV self-sampling kit will be provided for home-based collection of cervical samples. Samples will be sent for analysis of HPV subtypes.

HPV Self-Sampling

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Fox Chase Cancer Center: lead
• Temple University: collaborator

Study Sites (1)

Temple University Lewis Katz School of Medicine

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Carolyn Y Fang, PhD

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: September 21, 2020
• Study Start: April 8, 2021
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

US (1)