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

NCT06577220 | Active Not Recruiting DMC

• 1 other identifier: H-44944 S1
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer; Human Papillomavirus Infection

Keywords

Screening; Human Papillomavirus Infection; Self-Testing

Outcome Measures

Primary Outcomes (1)

• Primary screening participation

  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

  [Time Frame: within 6 months of randomization

Secondary Outcomes (2)

• Screening tests results

  Time Frame: within 6 months of randomization

• completion of clinical follow-up among women with an abnormal screening test result

  Time Frame: within 12 months of screening test result

Other Outcomes (2)

• Detection of cervical precancer

  [Time Frame: within 12 months of screening test result]

• Treatment of cervical precancer

  [Time Frame: within 6 months of diagnosis]

Study Arms (3)

Telephone Recall

ACTIVE COMPARATOR

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

Behavioral: Telephone Recall

Mailed HPV Self-Sampling Kit

EXPERIMENTAL

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

Behavioral: Telephone Recall; Behavioral: Mailed HPV Self-Sampling Kit

Mailed HPV Self-Sampling Kit + Patient Navigation

EXPERIMENTAL

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.

Behavioral: Telephone Recall; Behavioral: Mailed HPV Self-Sampling Kit; Behavioral: Patient Navigation

Interventions

Telephone Recall BEHAVIORAL

Participants receive a scripted telephone recall from a trained patient navigator.

Mailed HPV Self-Sampling Kit; Mailed HPV Self-Sampling Kit + Patient Navigation; Telephone Recall

Mailed HPV Self-Sampling Kit BEHAVIORAL

Participants receive a mailed kit that allows them to self-collect a cervical sample in their home and return it to a laboratory for human papillomavirus (HPV) testing.

Mailed HPV Self-Sampling Kit; Mailed HPV Self-Sampling Kit + Patient Navigation

Patient Navigation BEHAVIORAL

Participant receives telephone call from patient navigator within 3-5 days of receipt of self-collection kit. Patient navigator provides one-on-one education on cervical cancer screening and self-collection of cervical sample.

Mailed HPV Self-Sampling Kit + Patient Navigation

Eligibility Criteria

• Age: 30 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Harris Health System

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Montealegre JR, Anderson ML, Hilsenbeck SG, Chiao EY, Cantor SB, Parker SL, Daheri M, Bulsara S, Escobar B, Deshmukh AA, Jibaja-Weiss ML, Zare M, Scheurer ME. Mailed self-sample HPV testing kits to improve cervical cancer screening in a safety net health system: protocol for a hybrid effectiveness-implementation randomized controlled trial. Trials. 2020 Oct 21;21(1):872. doi: 10.1186/s13063-020-04790-5.

  PMID: 33087164 BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Papillomavirus Infections

Interventions

Patient Navigation

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: August 29, 2024
• Study Start: September 28, 2023
• Primary Completion: January 24, 2025
• Study Completion: January 24, 2026
• Last Updated: October 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Within one year of study completion.
• Access Criteria: Available upon request to Principal Investigator.

Locations

US (1)