Self-Collected Pap Smear for Cervical Cancer Screening (Pap Trial)

N/A

Recruiting

Led By John B Waits, MD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

Total hysterectomy (removal of uterus and cervix)

Prior history of cervical cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether a self-administered Pap smear is as accurate as one administered by a healthcare provider.

Who is the study for?

This trial is for women aged 21-65 in rural Alabama who are due for routine cervical cancer screening. It's not open to those with a history of cervical cancer, a positive Pap smear result, those who've had their uterus and cervix removed, or anyone in another cancer prevention study.

What is being tested?

The study is comparing the effectiveness of self-administered Pap smears (Self-PAP) versus traditional Pap smears done by healthcare providers to see if they're equally accurate for cervical cancer screening.

What are the potential side effects?

There are generally no side effects associated with either method of Pap smear testing. However, some individuals may experience mild discomfort or spotting after the procedure.

Eligibility Criteria

Exclusion Criteria

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

Select...

I have had my uterus and cervix removed.

Select...

I have had cervical cancer in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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

Group I: Traditional PapExperimental Treatment1 Intervention

Each patient will participate in both arms of the study on the day of the clinical examination. This arm includes the traditional, healthcare provider obtained Papanicolaou (Pap) smear specimen. They will be compared to each other for congruence and accuracy.

Group II: Self-PAPExperimental Treatment1 Intervention

Each patient will participate in both arms of the study on the day of the clinical examination. This arm includes the self-administered Papanicolaou (Pap) smear. They will be compared to each other for congruence and accuracy.

0 / 2Eligibility criteria met