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Usual Care for Cervical Cancer (STEP Trial)

N/A
Waitlist Available
Led By Diana SM Buist, PhD, MPH
Research Sponsored by Kaiser Permanente
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-5 years (projected)
Awards & highlights

STEP Trial Summary

This trial will compare how well different outreach approaches work in getting women to do home-based HPV tests for cervical cancer screening, and whether these approaches are cost-effective.

Eligible Conditions
  • Cervical Cancer
  • Uterine Diseases
  • Cervical Carcinoma
  • HPV-Related Malignancy
  • Cervical Diseases
  • Tumors
  • Urogenital Neoplasms
  • Uterine Cancer
  • Genital Warts
  • Cervical Dysplasia
  • Human Papillomavirus

STEP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-5 years (projected)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-5 years (projected) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Screening Completion by Outreach Approach and Prior Screening Behavior
Secondary outcome measures
Completion of Recommended Follow-up After a Positive Kit Result
Health System Costs to Implementing Home Testing by Outreach Approach and Prior Screening Behavior
Incremental Cost-effectiveness Ratio by Outreach Approach and Prior Screening Behavior
+4 more

STEP Trial Design

4Treatment groups
Active Control
Group I: Usual CareActive Control1 Intervention
Group II: EducationActive Control1 Intervention
Group III: Direct MailActive Control1 Intervention
Group IV: Opt-inActive Control1 Intervention

Find a Location

Who is running the clinical trial?

University of WashingtonOTHER
1,738 Previous Clinical Trials
1,811,580 Total Patients Enrolled
University of Texas Southwestern Medical CenterOTHER
1,047 Previous Clinical Trials
1,021,028 Total Patients Enrolled
Kaiser PermanenteLead Sponsor
538 Previous Clinical Trials
24,081,057 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial available to individuals over the age of 45?

"As per the criteria for enrollment, individuals aged 30-64 are eligible to partake in this medical trial. 342 other trials target those under 18 and 2633 focus on senior citizens over 65."

Answered by AI

Who is an eligible candidate for this medical experiment?

"The recruitment phase of this trial is accepting 32623 participants aged between 30 and 64 with uterine cervical diseases. Qualifying individuals must also be women in the noted age bracket."

Answered by AI

Is there currently an enrollment period for this experiment?

"At present, this clinical trial is not actively recruiting. Originally posted on November 20th 2020 and last updated on August 16th 2021, it has been determined that the study does not require additional participants. Fortunately, there are still 2,905 other medical trials searching for volunteers at the moment."

Answered by AI

What is the ultimate goal of this research endeavor?

"The primary intent of this trial, which will take around 6 months to monitor, is to measure the incremental cost-effectiveness ratio through outreach and pre-screening behavior. Secondary goals include determining the proportion of patients in the intervention group who return their home kits or receive an in clinic screening with regards to current medical guidelines; calculating how many participants do not screen at all based on outreach methodology and prior screenings; and timing from randomization to when participants initiate/have access to screenings by both outreach approach and previous screenings."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Kaiser Permanente Washington Health Research Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I have had hpv since I was a lot younger , I was told by the doctor that I have abnormal cells and need more invasive treatment, that was two years ago, I never went back to the doctor. I have medical records to provide, I would like to be a part of this study if not to save my life but at least have the opportunity to save others life . Thank you for your time and consideration.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

Will the travel be at my cost or theirs ? Also will I be staying up there through the crucial parts of the study ??
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Self-Testing Options in the Era of Primary HPV Screening for Cervical Cancer Trial
2020. "Self-Testing Options in the Era of Primary HPV Screening for Cervical Cancer Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04679675.
~7420 spots leftby Apr 2025
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