HPV Self-Testing for Cervical Cancer

(PRESTIS Trial)

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Disqualifiers: Pregnancy, Cervical dysplasia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

2268 Participants Needed

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. This study 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.

Research Team

Jane Montealegre

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

You have not had a Pap test in the past 3.

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

I have not had a hysterectomy or cervical cancer.

Exclusion Criteria

no valid telephone contact information

currently pregnant

I have had cervical dysplasia within the last 3.5 years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive one of three outreach interventions: telephone recall, telephone recall with mailed self-sample HPV testing kits, or telephone recall with mailed self-sample HPV testing kits and patient navigation

6 months

Remote interactions

Follow-up

Participants are monitored for clinical follow-up and treatment of cervical precancer if necessary

12 months

Treatment Details

Interventions

• Mailed HPV Self-Sampling Kit
• Patient Navigation
• Telephone Recall

Trial Overview 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.

Participant Groups

Group I: Mailed HPV Self-Sampling Kit + Patient Navigation Experimental Treatment 3 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 Kit Experimental Treatment 2 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 Recall Active Control 1 Intervention

Participants receive a scripted telephone recall from a trained patient navigator on behalf of Harris Health System.

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+