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Cervical Cancer Screening Program for Asian American Women

N/A

Recruiting

Led By Carolyn Y Fang, PhD

Research Sponsored by Fox Chase Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Are 30-65 years of age

Be older than 18 years old

Must not have

Have a prior diagnosis of cervical cancer or cervical abnormality (e.g., dysplasia)

Unable to provide informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will evaluate whether providing a self-sampling kit along with an educational program and navigation assistance increases cervical cancer screening rates in underserved Korean and Vietnamese American women.

Who is the study for?

This trial is for Korean or Vietnamese American women aged 30-65 who are overdue for cervical cancer screening and have not had a recent cytology-based screen or HPV test. It's not open to those with previous cervical abnormalities, those who've had their cervix removed, anyone with compromised immunity like HIV, or if they can't consent.

What is being tested?

The study tests whether adding a self-sampling kit for HPV testing to an educational program and navigation assistance increases cervical cancer screening rates in the target group compared to just education and assistance.

What are the potential side effects?

Since this trial involves non-invasive interventions such as education, navigation assistance, and self-sampling kits for HPV testing, there are minimal expected side effects. However, discomfort or emotional distress from the self-collection process cannot be ruled out.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 30 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with cervical cancer or a cervical abnormality before.

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I am unable to understand and give consent for treatment.

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I have had my uterus and cervix removed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Participation in screening

Secondary study objectives

Program delivery cost

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: HPV Self-SamplingExperimental Treatment3 Interventions

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.

Group II: Evidence-Based InterventionActive Control2 Interventions

Culturally appropriate educational intervention focused on cervical cancer screening, with navigation assistance provided.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

HPV Self-Sampling

2023

N/A

~110

0 / 4Eligibility criteria met