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HPV Self-Testing for Cervical Cancer (PRESTIS Trial)

N/A
Waitlist Available
Led By Jane R Montealegre, PhD
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
have at least 2 visits to ambulatory care within Harris Health System in the past 5 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 6 months of randomization
Awards & highlights

PRESTIS Trial Summary

This trial found that mailing self-sampled kits for high-risk HPV to women was a cost-effective way to increase screening participation among underserved minority women.

Who is the study for?
This trial is for women who are patients at Harris Health System in Houston, Texas. They should have had at least two visits there in the past five years, no cervical cancer or hysterectomy history, and not had a Pap test in 3.5 years or a Pap/HPV co-test in 5.5 years. Participants must be enrolled in an accepted healthcare plan and not currently pregnant, without recent cervical dysplasia, and able to communicate in English or Spanish.Check my eligibility
What is being tested?
The study is testing if mailing HPV self-sampling kits to underserved minority women increases screening rates compared to traditional clinic-based Pap tests. It also evaluates telephone recall and patient navigation as methods to improve participation among those who might find clinic visits challenging.See study design
What are the potential side effects?
There may be minimal side effects associated with this trial since it involves non-invasive self-sampling for HPV testing rather than medication or invasive procedures. However, participants could experience anxiety or discomfort related to the self-testing process.

PRESTIS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have not had a hysterectomy or cervical cancer.
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I have visited a Harris Health System clinic at least twice in the last 5 years.
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I have not had a hysterectomy or cervical cancer.
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I have visited a Harris Health System clinic at least twice in the last 5 years.

PRESTIS Trial Timeline

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

Treatment Details

Study Objectives

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

PRESTIS 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 pre-paid 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
997 Previous Clinical Trials
5,999,751 Total Patients Enrolled
National Institute on Minority Health and Health Disparities (NIMHD)NIH
374 Previous Clinical Trials
1,212,204 Total Patients Enrolled
Jane R Montealegre, PhDPrincipal InvestigatorBaylor College of Medicine

Media Library

Mailed HPV Self-Sampling Kit Clinical Trial Eligibility Overview. Trial Name: NCT03898167 — N/A
Human Papillomavirus Research Study Groups: Telephone Recall, Mailed HPV Self-Sampling Kit, Mailed HPV Self-Sampling Kit + Patient Navigation
Human Papillomavirus Clinical Trial 2023: Mailed HPV Self-Sampling Kit Highlights & Side Effects. Trial Name: NCT03898167 — N/A
Mailed HPV Self-Sampling Kit 2023 Treatment Timeline for Medical Study. Trial Name: NCT03898167 — N/A

Frequently Asked Questions

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

Would I be eligible to participate in this medical experiment?

"This medical trial seeks 2268 men and women between the ages of 30 to 65 with active human papillomavirus infections. Additionally, participants must not have had a hysterectomy or cervical cancer in their history, no Pap test/HPV co-test within 3.5/5.5 years respectively, be registered at Harris Health System located in Houston Texas for at least 2 visits over 5 years , currently enrolled on a healthcare coverage plan accepted by Harris Health or having been so in the past 12 months ."

Answered by AI

Are participants currently enrolling in this experiment?

"The information hosted on clinicaltrials.gov clarifies that this research endeavour, which was initially posted in February of 2020 and last modified in August 2022 is not presently recruiting volunteers. Nevertheless, there are 455 other experiments currently searching for test subjects."

Answered by AI

Are participants over 20 years of age eligible for this clinical investigation?

"This trial only accepts applicants between the ages of 30 and 65. Conversely, there are a total of 413 trials designed to cater for patients outside this demographic range (30 specifically targeting those under 18 years old and 383 tailored towards seniors)."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Harris Health System
What portion of applicants met pre-screening criteria?
Met criteria
~446 spots leftby Mar 2025