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

Not Applicable

Active, not recruiting

• Conditions: Uterine Cervical Neoplasms
• Interventions: Behavioral: Community-Based Education; Behavioral: Navigation to Screening; Behavioral: HPV Self-Sampling

• Registration Number: NCT04557423
• Lead Sponsor: Fox Chase Cancer Center

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.

Study Timeline

• Study First Submitted: 2020-09-15
• Study First Submitted QC: 2020-09-15
• Study First Posted: 2020-09-21
• Study Start: 2021-04-08
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-21
• Primary Completion: 2025-11-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 797

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HPV Self-Sampling	Community-Based Education	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.
HPV Self-Sampling	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.
Evidence-Based Intervention	Community-Based Education	Culturally appropriate educational intervention focused on cervical cancer screening, with navigation assistance provided.
Evidence-Based Intervention	Navigation to Screening	Culturally appropriate educational intervention focused on cervical cancer screening, with navigation assistance provided.
HPV Self-Sampling	Navigation to Screening	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.

Primary Outcome Measures

Name	Time	Method
Participation in screening	6 months	The number of women who obtain clinic-based screening or return a self-collected sample

Secondary Outcome Measures

Name	Time	Method
Program delivery cost	6 months	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).

Trial Locations

Locations (1)

Temple University Lewis Katz School of Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States