Prospective Evaluation of Self-Testing to Increase Screening (PRESTIS)

• ClinicalTrials.gov Identifier: NCT03898167
• Recruitment Status: Enrolling by invitation
• First Posted: April 1, 2019
• Last Update Posted: August 15, 2022
• Sponsor: Baylor College of Medicine
• Collaborator: National Institute on Minority Health and Health Disparities (NIMHD)
• Information provided by (Responsible Party): Jane Montealegre, Baylor College of Medicine

Tracking Information

• First Submitted Date: March 29, 2019
• First Posted Date: April 1, 2019
• Last Update Posted Date: August 15, 2022
• Actual Study Start Date: February 13, 2020
• Estimated Primary Completion Date: February 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 29, 2019)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 29, 2019)

• 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

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: March 29, 2019)

• Detection of cervical precancer [ Time Frame: within 12 months of screening test result ]
  Histologically-confirmed cervical intraepithelial neoplasia grade II or greater (CIN2+)
• Treatment of cervical precancer [ 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

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Prospective Evaluation of Self-Testing to Increase Screening
• Official 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
• Brief Summary: 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.
• Detailed Description: 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Screening

Condition

• Cervical Cancer
• Human Papillomavirus Infection

Intervention

• Behavioral: Telephone Recall
  Participants receive a scripted telephone recall from a trained patient navigator.
• Behavioral: Mailed HPV Self-Sampling Kit
  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.
• Behavioral: Patient Navigation
  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.

Study Arms

• Active Comparator: Telephone Recall
  Participants receive a scripted telephone recall from a trained patient navigator on behalf of Harris Health System.
  Intervention: Behavioral: Telephone Recall
• Experimental: 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 pre-paid return envelope.
  Interventions:

  • Behavioral: Telephone Recall
  • Behavioral: Mailed HPV Self-Sampling Kit
• Experimental: Mailed HPV Self-Sampling Kit + 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.
  Interventions:

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

• Publications *: 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.

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Estimated Enrollment (submitted: March 29, 2019): 2268
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 2024
• Estimated Primary Completion Date: February 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes

• Ages: 30 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03898167
• Other Study ID Numbers: H-44944; R01MD013715 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Supporting Materials: Study Protocol

• Current Responsible Party: Jane Montealegre, Baylor College of Medicine
• Original Responsible Party: Same as current
• Current Study Sponsor: Baylor College of Medicine
• Original Study Sponsor: Same as current
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

• Principal Investigator: Jane R Montealegre, PhD; Baylor College of Medicine

• PRS Account: Baylor College of Medicine
• Verification Date: August 2022