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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
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

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

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

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)
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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
No
Studies a U.S. FDA-regulated Device Product
No
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
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.
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
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
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
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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