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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 6 months of randomization

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 3Eligibility criteria met