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Behavioral Intervention

Mailed HPV Self-Sampling Kits for Cervical Cancer Screening

N/A
Waitlist Available
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No history of hysterectomy or cervical cancer
Be older than 18 years old
Must not have
Unable to communicate in English, Vietnamese or Spanish
Timeline
Screening 3 weeks
Treatment Varies
Follow Up [time frame: within 6 months of diagnosis]
Awards & highlights

Summary

This trial aims to increase cervical cancer screening participation among Asian and Asian American women by sending them self-sampled kits for high-risk HPV testing through the mail. The study is being conducted in a safety-net

Who is the study for?
This trial is for Asian and Asian American women who find it difficult or unacceptable to attend regular Pap test screenings in a clinic. It aims to increase cervical cancer screening participation among underserved minority women within a safety-net health system.
What is being tested?
The PRESTIS trial is testing whether mailing self-sampling kits for HPV can effectively encourage more frequent screening for cervical cancer, compared to traditional methods like telephone recalls or patient navigation services.
What are the potential side effects?
Since the interventions involve non-invasive procedures such as receiving phone calls, navigating healthcare services, and using mailed self-sampling kits, there are no direct medical side effects associated with this study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have not had a hysterectomy or been diagnosed with cervical cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I can communicate in English, Vietnamese, or Spanish.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~[time frame: within 6 months of randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and [time frame: within 6 months of randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Primary screening participation
Secondary study objectives
Screening tests results
completion of clinical follow-up among women with an abnormal screening test result
Other study objectives
Detection of cervical precancer
Treatment of cervical precancer

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Mailed HPV Self-Sampling Kit + Patient NavigationExperimental Treatment3 Interventions
Participants receive a scripted telephone recall and mailed self-sampling kit with a pre-paid return envelope. Within 3-5 days of the kit's mail-out, participants will receive a telephone call from a patient navigator to provide one-on-one education.
Group II: Mailed HPV Self-Sampling KitExperimental Treatment2 Interventions
Participants receive a scripted telephone recall from a patient navigator on behalf of Harris Health System and receive a mailed HPV self-sampling kit with a prepaid return envelope
Group III: Telephone RecallActive Control1 Intervention
Participants receive a scripted telephone recall from a trained patient navigator on behalf of Harris Health System
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Patient Navigation
2017
Completed Phase 2
~38910

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
1,018 Previous Clinical Trials
6,031,189 Total Patients Enrolled
National Institute on Minority Health and Health Disparities (NIMHD)NIH
417 Previous Clinical Trials
1,370,609 Total Patients Enrolled
~115 spots leftby Aug 2025
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