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

NCT ID: NCT04557423

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 797 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-08
• Study Completion Date: 2025-11-30

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.

Detailed Description

Aim 1: Compare rates of providing a self-collected sample vs. obtaining clinic-based screening among 1100 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 individual- and 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.

Conditions

Uterine Cervical Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Evidence-Based Intervention

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

Group Type: ACTIVE_COMPARATOR

Community-Based Education

Intervention Type: BEHAVIORAL

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

Navigation to Screening

Intervention Type: BEHAVIORAL

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

HPV Self-Sampling

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.

Group Type: EXPERIMENTAL

Community-Based Education

Intervention Type: BEHAVIORAL

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

Navigation to Screening

Intervention Type: BEHAVIORAL

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

HPV Self-Sampling

Intervention Type: 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.

Interventions

Community-Based Education

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

Intervention Type: BEHAVIORAL

Navigation to Screening

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

Intervention Type: BEHAVIORAL

HPV Self-Sampling

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Temple University

OTHER

Sponsor Role: collaborator

Fox Chase Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Carolyn Fang, PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carolyn Y Fang, PhD

Role: PRINCIPAL_INVESTIGATOR

Fox Chase Cancer Center

Locations

Temple University Lewis Katz School of Medicine

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

19-1058

Identifier Type: -

Identifier Source: org_study_id