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Behavioral Intervention
Mailed HPV Self-Sampling Kit + Patient Navigation for Cervical Cancer
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
* Asian ethnicity reported in the electronic health record
* no history of hysterectomy or cervical cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up [time frame: within 6 months of diagnosis]
Awards & highlights
Summary
Regularly attending for Pap test cervical cancer screening in a clinic is often unfeasible and/or unacceptable to many women and persons with a cervix. This study is a supplement to increase representation of Asian and Asian American women in a pragmatic clinical trial that evaluates if mailing and testing self-sampled kits for high-risk human papillomavirus (HPV) can cost-effectively increase screening participation among underserved minority women in a safety-net health system.
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 belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time frame: within 6 months of randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time frame: within 6 months of randomization
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
1,008 Previous Clinical Trials
6,003,368 Total Patients Enrolled
National Institute on Minority Health and Health Disparities (NIMHD)NIH
397 Previous Clinical Trials
1,344,151 Total Patients Enrolled
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