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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
Must not have
unable to communicate in English or Spanish
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 6 months of randomization
Awards & highlights

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.
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.
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.

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.

Exclusion Criteria

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

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

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 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
1,018 Previous Clinical Trials
6,029,161 Total Patients Enrolled
National Institute on Minority Health and Health Disparities (NIMHD)NIH
417 Previous Clinical Trials
1,368,581 Total Patients Enrolled
Jane R Montealegre, PhDPrincipal InvestigatorM.D. Anderson Cancer Center

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
~406 spots leftby Sep 2025
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