Prospective Evaluation of Self-Testing to Increase Screening (PRESTIS) Asian/Asian American Women Supplement

Not Applicable

• Conditions: Human Papillomavirus Infection; Cervical Cancer
• Interventions: Behavioral: Telephone Recall; Behavioral: Mailed HPV Self-Sampling Kit; Behavioral: Patient Navigation

• Registration Number: NCT06577220
• Lead Sponsor: Baylor College of Medicine

Brief Summary

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.

Detailed Description

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. Using mailed self-sampling kits to test for high-risk human papillomavirus (HPV), the virus that causes cervical cancer, may overcome multiple barriers to clinic-based screening. The parent study (NCT03898167) is a randomized controlled trial to compare the effectiveness of three outreach interventions to increase primary screening participation and clinical follow-up among underscreened women a in a safety net health system. The three strategies that will be evaluated are: 1) telephone recall; 2) telephone recall with mailed self-sample HPV testing kits; and 3) telephone recall with mailed self-sample HPV testing kits and patient navigation. A supplemental accrual of Asian/Asian American persons (target n=240) was added to increase representation of this subpopulation in the parent trial.

Study Timeline

• Study Start: 2023-09-28
• Status Verified: 2024-08
• Study First Submitted: 2024-08-27
• Study First Submitted QC: 2024-08-27
• Last Update Submitted: 2024-08-27
• Study First Posted: 2024-08-29
• Last Update Posted: 2024-08-29
• Primary Completion: 2025-08-31
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 240

Inclusion Criteria

• Asian ethnicity reported in the electronic health record
• no history of hysterectomy or cervical cancer
• 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
• have at least 2 visits to ambulatory care within Harris Health System in the past 5 years
• 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

Exclusion Criteria

• no valid telephone contact information
• unable to communicate in English, Vietnamese or Spanish
• currently pregnant
• history of cervical dysplasia in the past 3.5 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mailed HPV Self-Sampling Kit	Telephone Recall	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
Mailed HPV Self-Sampling Kit + Patient Navigation	Telephone Recall	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.
Telephone Recall	Telephone Recall	Participants receive a scripted telephone recall from a trained patient navigator on behalf of Harris Health System
Mailed HPV Self-Sampling Kit + Patient Navigation	Mailed HPV Self-Sampling Kit	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.
Mailed HPV Self-Sampling Kit	Mailed HPV Self-Sampling Kit	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
Mailed HPV Self-Sampling Kit + Patient Navigation	Patient Navigation	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.

Primary Outcome Measures

Name	Time	Method
Primary screening participation	[Time Frame: within 6 months of randomization	completion and return of a mailed self-sample HPV testing kit that is adequate for testing (i.e., does not produce unsatisfactory results) or attendance for clinic-based screening

Secondary Outcome Measures

Name	Time	Method
Screening tests results	Time Frame: within 6 months of randomization	Results of HPV test using self-collected samples (positive, negative, or inadequate)
completion of clinical follow-up among women with an abnormal screening test result	Time Frame: within 12 months of screening test result	Electronic medical record (EMR)-confirmed attendance for colposcopy among participants who had a positive test by clinic-based screening; EMR- confirmed attendance for colposcopy or subsequent clinic-based screening among those who had a positive test by self-sampling

Trial Locations

Locations (1)

Harris Health System; 🇺🇸 Houston, Texas, United States