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OpenTrials
Completed

NCT Number: NCT04557423

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 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.

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Key information

Age range

30 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Temple University Lewis Katz School of Medicine

Philadelphia, Pennsylvania, 19140, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Community-Based Education

Behavioral

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

Navigation to Screening

Behavioral

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

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.

Primary outcomes

  1. Participation in screening

    Time frame: 6 months

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

Secondary outcomes

  1. Program delivery cost

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Fox Chase Cancer Center

Other

Collaborators

  • Temple University

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Sep 21, 2020
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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