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NCT Number: NCT06577220

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

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.

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This study is active but is not currently recruiting participants.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telephone Recall

Behavioral

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

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.

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.

Primary outcomes

  1. Primary screening participation

    Time frame: [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 outcomes

  1. Screening tests results

    Time frame: Time Frame: within 6 months of randomization

    Results of HPV test using self-collected samples (positive, negative, or inadequate)

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

    Time frame: 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

Other outcomes

  1. Detection of cervical precancer

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

    Histologically-confirmed cervical intraepithelial neoplasia grade II or greater (CIN2+)

  2. Treatment of cervical precancer

    Time frame: [Time Frame: within 6 months of diagnosis]

    Treatment of histologically-confirmed cervical intraepithelial neoplasia grade II or greater (CIN2+) per American Society for Colposcopy and Cervical Pathology guidelines

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

A Randomized Controlled Trial of Mailed Self-Sample HPV Testing to Increase Cervical Cancer Screening Participation Among Minority/Underserved Women in an Integrated Safety Net Healthcare System Asian/Asian American Women

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Aug 29, 2024
Registry last updated
Oct 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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