NCT06577220

Prospective Evaluation of Self-Testing to Increase Screening (PRESTIS) Asian/Asian American Women Supplement

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 Asian/Asian American Women

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: Female
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Regularly attending for Pap test cervical cancer screening in a clinic is often unfeasible and/or unacceptable to many women and persons with a cervix. This study is a supplement to increase representation of Asian and Asian American women in a pragmatic clinical trial that 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 and persons with a cervix. 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. The parent study (NCT03898167) 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. A supplemental accrual of Asian/Asian American persons (target n=240) was added to increase representation of this subpopulation in the parent trial.

Conditions

• Cervical Cancer
• Human Papillomavirus Infection

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-09-28
• Primary completion: 2025-01-24
• Completion: 2026-01-24
• First posted: 2024-08-29
• Last updated: 2025-10-14

Locations

1 site across 1 country: United States