Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT04557423
Study type Interventional
Source Fox Chase Cancer Center
Contact Ellen Kim
Phone 215-707-7706
Email ellen.kim@temple.edu
Status Recruiting
Phase N/A
Start date April 8, 2021
Completion date April 30, 2026

See also
  Status Clinical Trial Phase
Not yet recruiting NCT03225443 - Observation and Evaluation of Short-term Curative Effect of Local Advanced Cervical Cancer Treated With Particle Radiotherapy Versus Neoadjuvant Chemotherapy N/A
Recruiting NCT01373723 - Economic Evaluation of Three Populational Screening Strategies for Cervical Cancer N/A
Terminated NCT01194609 - A Pilot Study of Radiation-Immune Cell Combination Therapy in Cervical Cancer Phase 1/Phase 2
Completed NCT02808832 - An HPV Vaccine Provider Intervention in Safety Net Clinics N/A
Terminated NCT01234480 - Intended Use Study of the BD SurePath Plus™ Pap
Completed NCT01014026 - Self-sampling and Human Papillomavirus (HPV)-Testing for Unscreened Women in Cervical Cancer Prevention Phase 3
Terminated NCT01075412 - FLT PET Imaging for Cervical Cancer Phase 2
Completed NCT02865889 - Cost-Effectiveness and Patients Satisfaction of Conventional vs Robotic-Assisted Laparoscopy in Gynecologic Oncologic Indications N/A
Completed NCT00377845 - Cervix Cytological Screening - Comparison of Tampon Self-Test and the Routine Smear. Phase 0
Recruiting NCT05531981 - Detection of Minimal Residual Disease Based on HPV ctDNA in Cervical Cancer
Recruiting NCT05393440 - First-in-human (FIH) Phase I Trial of BS-006 in Cervical Cancer Phase 1
Recruiting NCT05007106 - MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005) Phase 2
Completed NCT02866006 - Safety and Tolerability Evaluation Study of BVAC-C in Patients With HPV Type 16 or 18 Positive Cervical Cancer Phase 1/Phase 2
Completed NCT03270995 - Cognitive-Existential Group Therapy to Reduce Fear of Cancer Recurrence: A RCT Study N/A
Completed NCT02320578 - 2D Versus 3D Radical Laparoscopic Hysterectomy for Cervical Cancer: a Prospective Randomized Trial N/A
Terminated NCT02900248 - CureOne Registry: Advanced Malignancy or Myelodysplasia, Tested by Standard Sequencing and Treated by Physician Choice
Not yet recruiting NCT05065853 - Urinary and Vaginal HPV Testing in Cervical Cancer Screening
Completed NCT01231945 - Low-Cost Molecular Cervical Cancer Screening Study N/A
Completed NCT01717391 - [F-18] Fluorothymidine PET/CT Imaging for Pelvic Cancers Phase 2
Active, not recruiting NCT04947605 - Epidemiological Landscape of Cervical Cancer in Latin America