Prospective Evaluation of Self-Testing to Increase Screening

NCT03898167 | Completed Results DMC

• 3 other identifiers: H-44944R01MD013715R01MD013715-04S2
• Study Type: interventional
• Target: 2,474
• 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. 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.

Conditions

Cervical Cancer; Human Papillomavirus Infection

Keywords

Screening; Human Papillomavirus Infection; Self-Testing

Outcome Measures

Primary Outcomes (1)

• Primary Screening Participation

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

  within 6 months of randomization

Secondary Outcomes (2)

• Screening Tests Results

  within 6 months of randomization

• Completion of Clinical Follow-up Among Women With an Abnormal Screening Test Result

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

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 pre-paid 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:

• 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 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 (5)

• 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

• Amboree TL, Parker SL, Bulsara S, Anderson ML, Schmeler KM, Chiao EY, Montealegre JR. Cervical cancer screening among English- and Spanish-speaking Hispanic women in an urban safety net health system, 2015-2020. BMC Womens Health. 2023 Jun 15;23(1):309. doi: 10.1186/s12905-023-02448-3.

  PMID: 37316815 BACKGROUND

• Parker S, Deshmukh AA, Chen B, Lairson DR, Daheri M, Vernon SW, Montealegre JR. Perceived barriers to cervical cancer screening and motivators for at-home human papillomavirus self-sampling during the COVID-19 pandemic: Results from a telephone survey. Elife. 2023 May 26;12:e84664. doi: 10.7554/eLife.84664.

  PMID: 37232493 RESULT

• Parker SL, Amboree TL, Bulsara S, Daheri M, Anderson ML, Hilsenbeck SG, Jibaja-Weiss ML, Zare M, Schmeler KM, Deshmukh AA, Chiao EY, Scheurer ME, Montealegre JR. Self-Sampling for Human Papillomavirus Testing: Acceptability in a U.S. Safety Net Health System. Am J Prev Med. 2024 Mar;66(3):540-547. doi: 10.1016/j.amepre.2023.10.020. Epub 2023 Nov 5.

  PMID: 37935320 RESULT

• Montealegre JR, Hilsenbeck SG, Bulsara S, Parker SL, Amboree TL, Anderson ML, Daheri M, Jibaja-Weiss ML, Schmeler KM, Deshmukh AA, Chiao EY, Scheurer ME. Self-Collection for Cervical Cancer Screening in a Safety-Net Setting: The PRESTIS Randomized Clinical Trial. JAMA Intern Med. 2025 Sep 1;185(9):1119-1127. doi: 10.1001/jamainternmed.2025.2971.

  PMID: 40478588 DERIVED

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

Limitations and Caveats

Participants knew self-collection was part of research study; trial overlapped with COVID-19 pandemic; patient navigators were unblinded; trial was not powered to test differences in follow-up; samples were tested using the non-FDA approved Aptima HPV test; FDA approved self-collection in clinical settings following completion of trial.

Results Point of Contact

• Title: Dr. Jane Montealegre
• Organization: The University of Texas MD Anderson Cancer Center

jrmontealegre@mdanderson.org

713-792-0919

Study Officials

• Jane R Montealegre, PhD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: March 29, 2019
• First Posted: April 1, 2019
• Study Start: February 13, 2020
• Primary Completion: March 1, 2024
• Study Completion: March 31, 2025
• Last Updated: September 4, 2025
• Results First Posted: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: De-identified data are available to study team members now and will be made available until primary, secondary and exploratory analyses are complete.
• Access Criteria: Listed on IRB-approved protocol.

Locations

US (1)