Prospective Evaluation of Self-Testing to Increase Screening

Cervical Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03898167
• Other study ID #: H-44944
• Secondary ID: R01MD013715
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 13, 2020
• Est. completion date: May 2024

Study information

• Verified date: June 2023
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2268
• Est. completion date: May 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Human Papillomavirus Infection
• Papillomavirus Infections
• Uterine Cervical Neoplasms

Intervention

Behavioral:
• Telephone Recall
Participants receive a scripted telephone recall from a trained patient navigator.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Harris Health System	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

Parker SL, 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. E — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Detection of cervical precancer	Histologically-confirmed cervical intraepithelial neoplasia grade II or greater (CIN2+)	within 12 months of screening test result
Other	Treatment of cervical precancer	Treatment of histologically-confirmed cervical intraepithelial neoplasia grade II or greater (CIN2+) per American Society for Colposcopy and Cervical Pathology guidelines	within 6 months of diagnosis
Primary	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	within 6 months of randomization
Secondary	Screening tests results	Results of HPV test using self-collected samples (positive, negative, or inadequate)	within 6 months of randomization
Secondary	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	within 12 months of screening test result