Mailed HPV Self-Sampling Kits for Cervical Cancer Screening

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Baylor College of Medicine

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

Be currently enrolled in a healthcare coverage or financial assistance plan accepted by Harris Health System or have been enrolled in a Harris Health coverage plan in the past 12 months

No Pap test in the past 3.5 years or Pap/HPV co-test in the past 5.5 years

Patient of Harris Health System in Harris County (Houston), Texas

+3 more

Exclusion Criteria

No valid telephone contact information

Currently pregnant

I have had cervical dysplasia in the last 3.5 years.

+1 more

Participant Groups

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.

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