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

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

Study Overview

• Status: Recruiting
• Conditions: Uterine Cervical Neoplasms
• Intervention / Treatment: Behavioral: Community-Based Education; Behavioral: Navigation to Screening; Behavioral: HPV Self-Sampling

Detailed Description

Aim 1: Compare rates of providing a self-collected sample vs. obtaining clinic-based screening among 800 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 Type: Interventional
• Enrollment (Estimated): 800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ellen Kim; Phone Number: 215-707-7706; Email: ellen.kim@temple.edu
• Study Contact Backup: Name: Phuong Do; Email: phuong.do@temple.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Recruiting
      • Temple University Lewis Katz School of Medicine
      • Contact: Phuong Do; Email: phuong.do@temple.edu
      • Contact: Ellen Kim; Email: ellen.kim@temple.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Women who are of Asian race and self-identify as Korean or Vietnamese
• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Evidence-Based Intervention; Culturally appropriate educational intervention focused on cervical cancer screening, with navigation assistance provided.	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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participation in screening	The number of women who obtain clinic-based screening or return a self-collected sample	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	6 months

Collaborators and Investigators

• Sponsor: Fox Chase Cancer Center
• Collaborators: Temple University
• Investigators: Principal Investigator: Carolyn Y Fang, PhD, Fox Chase Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2021
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: September 15, 2020
• First Submitted That Met QC Criteria: September 15, 2020
• First Posted (Actual): September 21, 2020

Study Record Updates

• Last Update Posted (Actual): January 25, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Uterine Cervical Neoplasms
• Other Study ID Numbers: 19-1058

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: De-identified data and associated documentation can be made available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. All procedures will be compliant with NIH regulations on the distribution of unique research resources.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No