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Abstract Background: In global settings, self-sampling for human papillomavirus (HPV) testing is associated with a pooled 2-fold increase in cervical cancer screening participation over usual care among underscreened persons. The Prospective Evaluation of Self-Testing to Increase Screening (PRESTIS) Trial is the first pragmatic randomized controlled trial (RCT) in the U. S. to evaluate the effectiveness of mailed at-home self-sampling for HPV testing in a safety net health system setting. Safety net systems provide care to medically underserved individuals at elevated cervical cancer risk. We hypothesized that patients who were mailed a self-sampling kit would have greater screening participation compared with those receiving usual care; and that patient navigation, a patient-centered intervention to address barriers to care, would further increase participation. Methods: PRESTIS is a three-arm pragmatic RCT of n=2, 270 patients in a U. S. safety net health system who are under-screened for cervical cancer (i. e. , no Pap in 3. 5 years or Pap/HPV co-test in 5. 5 years). Eligible participants were identified through the electronic health record (EHR) and randomized to arms: 1) telephone recall to provider-performed screening (usual care) ; 2) telephone recall + mailed self-sampling kit for HPV testing; or 3) telephone recall + mailed self-sampling kit + telephone-based patient navigation. Self-sampled swabs were tested for high-risk (HR) -HPV. HR-HPV+ patients were navigated to clinical follow-up. The primary outcome, incidence of screening participation, was ascertained by EHR review at 6 months post-randomization and defined as return of a completed kit or attendance for provider-performed screening. Results: Participants were enrolled 02/2020-08/2023. Primary outcomes have been ascertained for n=2, 115 participants. Participants were predominantly Hispanic/Latina (68. 6%) ; 53. 4% indicated Spanish as primary language; and 60. 3% were uninsured. Mean age was 47. 9 years (SD: 10. 4 years) ; median time since last screening test was 9. 5 years (range: 1. 6-21. 7 years). In intent-to-treat analyses, screening participation was 15. 3% (95% CI 13. 0% - 17. 9%) in Arm 1; 44. 0% (40. 4% - 47. 6%) in Arm 2; and 51. 4% (47. 7% - 55. 0%) in Arm 3. Relative incidence of screening in Arms 2 and 3 versus Arm 1 was 2. 90 (2. 42 - 3. 47) and 3. 36 (2. 82 - 4. 01), respectively. Relative incidence of screening in Arm 3 versus Arm 2 was 1. 16 (1. 04 - 1. 29). Conclusion: Compared with usual care, mailed at-home self-sampling increased screening participation among an under-screened population by almost three-fold when used alone and over 3. 3-fold when combined with telephone-based patient navigation. After FDA approval, self-sampling for HR-HPV testing has the potential to dramatically increase participation in cervical cancer screening in underserved populations. Citation Format: Jane R. Montealegre, Elizabeth Y. Chiao, Matthew L. Anderson, Susan G. Hilsenbeck, Shaun Bulsara, Susan L. Parker, Maria Daheri, Trisha L. Amboree, Kathleen M. Schmeler, Maria L. Jibaja-Weiss, Mohammad Zare, Ashish A. Deshmukh, Michael E. Scheurer. Mailed at-home self-sampling for HPV testing increases screening participation among under-screened patients in a U. S. safety net health system: Results of the PRESTIS trial abstract. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts) ; 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84 (6Suppl): Abstract nr 3942.
Montealegre et al. (Fri,) studied this question.