NCT04557423

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 797 (actual)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: Female
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	Community-Based Education	A previously evaluated educational intervention delivered in community settings. Includes culturally- and linguistically-appropriate materials.
BEHAVIORAL	Navigation to Screening	Community health educators provide navigation assistance to access clinic-based cervical cancer screening.
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.

Timeline

• Start date: 2021-04-08
• Primary completion: 2025-11-30
• Completion: 2025-11-30
• First posted: 2020-09-21
• Last updated: 2026-03-24

Locations

1 site across 1 country: United States