Prospective Evaluation of Self-Testing to Increase Screening (PRESTIS)
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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 : September 2, 2020
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Condition or disease | Intervention/treatment | Phase |
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Cervical Cancer Human Papillomavirus Infection | Behavioral: Telephone Recall Behavioral: Mailed HPV Self-Sampling Kit Behavioral: Patient Navigation | Not Applicable |
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 |

Arm | Intervention/treatment |
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Active Comparator: Telephone Recall
Participants receive a scripted telephone recall from a trained patient navigator on behalf of Harris Health System.
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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.
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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.
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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 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
- Screening tests results [ Time Frame: within 6 months of randomization ]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 [ 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
- Detection of cervical precancer [ Time Frame: within 12 months of screening test result ]Histologically-confirmed cervical intraepithelial neoplasia grade II or greater (CIN2+)
- 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

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.
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 |
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
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

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
United States, Texas | |
Harris Health System | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Jane R Montealegre, PhD | Baylor College of Medicine |
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: | September 2, 2020 |
Last Verified: | August 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Supporting Materials: |
Study Protocol |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Screening Human Papillomavirus Infection Self-Testing |
Papillomavirus Infections Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site |
Neoplasms Uterine Cervical Diseases Uterine Diseases DNA Virus Infections Virus Diseases Tumor Virus Infections |