Prospective Evaluation of Self-Testing to Increase Screening

NCT ID: NCT03898167

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2474 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-13
• Study Completion Date: 2025-03-31

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.

Conditions

Cervical Cancer; Human Papillomavirus Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

Telephone Recall

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

Group Type: ACTIVE_COMPARATOR

Telephone Recall

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

Telephone Recall

Intervention Type: BEHAVIORAL

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

Mailed HPV Self-Sampling Kit

Intervention Type: 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 + 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.

Group Type: EXPERIMENTAL

Telephone Recall

Intervention Type: BEHAVIORAL

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

Mailed HPV Self-Sampling Kit

Intervention Type: 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

Intervention Type: 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.

Interventions

Telephone Recall

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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Jane Montealegre

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jane R Montealegre, PhD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

Harris Health System

Houston, Texas, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 33087164 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37316815 (View on PubMed)

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.

Reference Type: RESULT

PMID: 37232493 (View on PubMed)

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.

Reference Type: RESULT

PMID: 37935320 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 40478588 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01MD013715

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01MD013715-04S2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-44944

Identifier Type: -

Identifier Source: org_study_id