Uterine Cervical Neoplasms Clinical Trial
Official title:
Evidence-Based Approach to Empower Asian American Women in Cervical Cancer Screening
NCT number | NCT04557423 |
Other study ID # | 19-1058 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 8, 2021 |
Est. completion date | April 30, 2026 |
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.
Status | Recruiting |
Enrollment | 800 |
Est. completion date | April 30, 2026 |
Est. primary completion date | April 30, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 30 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Temple University Lewis Katz School of Medicine | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Fox Chase Cancer Center | Temple University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Participation in screening | The number of women who obtain clinic-based screening or return a self-collected sample | 6 months | |
Secondary | 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 |
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