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OpenTrials
Completed

NCT Number: NCT03898167

Prospective Evaluation of Self-Testing to Increase Screening

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.

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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. 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. This study 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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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 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: within 6 months of randomization

    cervical cancer screening participation within 6 months, defined as return of a mailed HPV self-collection kit or attendance for clinic-based screening.

Secondary outcomes

  1. Screening Tests Results

    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: Attendance to clinical follow up was assessed within 12 months of screening test result, up to 18 months post randomization.

    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

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

Acronym: PRESTIS

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Apr 1, 2019
Registry last updated
Sep 4, 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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