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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03898167
Recruitment Status : Enrolling by invitation
First Posted : April 1, 2019
Last Update Posted : February 17, 2020
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Jane Montealegre, Baylor College of Medicine

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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Human Papillomavirus Infection Behavioral: Telephone Recall Behavioral: Mailed HPV Self-Sampling Kit Behavioral: Patient Navigation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2268 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: 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
Actual Study Start Date : February 13, 2020
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
Active Comparator: Telephone Recall
Participants receive a scripted telephone recall from a trained patient navigator on behalf of Harris Health System.
Behavioral: Telephone Recall
Participants receive a scripted telephone recall from a trained patient navigator.

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.
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.

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.
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Screening tests results [ Time Frame: within 6 months of randomization ]
    Results of HPV test using self-collected samples (positive, negative, or inadequate)

  2. 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


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

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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 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

Exclusion Criteria:

  • no valid telephone contact information
  • unable to communicate in English or Spanish
  • currently pregnant
  • history of cervical dysplasia in the past 5 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898167


Locations
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United States, Texas
Harris Health System
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
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Principal Investigator: Jane R Montealegre, PhD Baylor College of Medicine
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Responsible Party: Jane Montealegre, Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT03898167    
Other Study ID Numbers: H-44944
R01MD013715 ( U.S. NIH Grant/Contract )
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jane Montealegre, Baylor College of Medicine:
Screening
Human Papillomavirus Infection
Self-Testing
Additional relevant MeSH terms:
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Papillomavirus Infections
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
DNA Virus Infections
Virus Diseases
Tumor Virus Infections