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

Primary Purpose

Cervical Cancer, Human Papillomavirus Infection

Status

Enrolling by invitation

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Telephone Recall

Mailed HPV Self-Sampling Kit

Patient Navigation

About this trial

This is an interventional screening trial for Cervical Cancer focused on measuring Screening, Human Papillomavirus Infection, Self-Testing

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Harris Health System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Telephone Recall

Mailed HPV Self-Sampling Kit

Mailed HPV Self-Sampling Kit + Patient Navigation

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

Primary screening participation

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 Outcome Measures

Screening tests results

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

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

Full Information

NCT ID

NCT03898167

First Posted

March 29, 2019

Last Updated

June 7, 2023

Sponsor

Baylor College of Medicine

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

1. Study Identification

Unique Protocol Identification Number

NCT03898167

Brief Title

Prospective Evaluation of Self-Testing to Increase Screening

Acronym

PRESTIS

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

February 13, 2020 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Baylor College of Medicine

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Cancer, Human Papillomavirus Infection

Keywords

Screening, Human Papillomavirus Infection, Self-Testing

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

2268 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Telephone Recall

Arm Type

Active Comparator

Arm Description

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

Arm Title

Mailed HPV Self-Sampling Kit

Arm Type

Experimental

Arm Description

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.

Arm Title

Mailed HPV Self-Sampling Kit + Patient Navigation

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Telephone Recall

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Mailed HPV Self-Sampling Kit

Intervention Description

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

Intervention Name(s)

Patient Navigation

Intervention Description

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 Outcome Measure Information:

Title

Primary screening participation

Description

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

Time Frame

within 6 months of randomization

Secondary Outcome Measure Information:

Title

Screening tests results

Description

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

Time Frame

within 6 months of randomization

Title

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

Description

Time Frame

within 12 months of screening test result

Other Pre-specified Outcome Measures:

Title

Detection of cervical precancer

Description

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

Time Frame

within 12 months of screening test result

Title

Treatment of cervical precancer

Description

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

Time Frame

within 6 months of diagnosis

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jane R Montealegre, PhD

Organizational Affiliation

Baylor College of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Harris Health System

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

Citations:

PubMed Identifier

33087164

Citation

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.

Results Reference

background

PubMed Identifier

37232493

Citation

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.

Results Reference

result

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Prospective Evaluation of Self-Testing to Increase Screening

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