NEJM: How does an HPV self-collection program impact screenings?

A mailed and clinic-based human papillomavirus (HPV) self-collection program modestly increased cervical cancer screening rates and reduced reliance on pelvic examinations in a large United States health system, according to an evaluation published in the New England Journal of Medicine Catalyst. The findings highlighted both the potential and the implementation challenges of expanding self-collection as a population-level screening strategy.¹

Cervical cancer remains largely preventable, yet screening rates in the United States have declined in recent years, falling from 83% in 2015 to 76% in 2023. The disease is almost entirely caused by persistent infection with high-risk HPV types, particularly HPV-16 and HPV-18. Early detection through screening is critical, as hundreds of thousands of precancerous lesions are treated annually, underscoring the importance of effective screening programs.

Self-collection as an alternative option for HPV screening

Historically, cervical cancer screening has relied on clinician-collected samples obtained during pelvic examinations. However, HPV self-collection, which became an approved method by the FDA in 2024, has emerged as an alternative approach that may improve access, particularly for individuals who face barriers to in-clinic care.

This approach was then backed by an updated guideline in January 2026 from the Health Resources and Services Administration, which now includes patient self-collection as an option for cervical cancer screening.² The updated guidance was endorsed by the American College of Obstetricians & Gynecologists in April 2026.³

RELATED: Akiva Novetsky, MD & Kimberly Gecsi, MD break down cervical cancer updates

In the study, researchers evaluated the real-world implementation of an HPV self-collection program within Kaiser Permanente Washington, an integrated health system in Washington state. The program included both mailed kits and opportunistic in-clinic distribution for individuals aged 30 to 64 years who were at average risk for cervical cancer and due or overdue for screening.¹

During the preimplementation period (July 1 to December 31, 2022), 48,511 individuals were not up to date with screening. In the postimplementation period (October 1, 2023, to March 31, 2024), 47,333 individuals remained overdue. Screening completion increased significantly following program launch, with an unadjusted mean difference of 2.2 percentage points.

Although the increase was statistically significant, the magnitude of improvement was smaller than that observed in prior clinical trials conducted within the same health system, which reported gains of up to 14.1 percentage points. Researchers attributed this difference to several implementation challenges.

In total, 5963 of 47,333 eligible individuals (12.6%) were mailed self-collection kits during the 6-month evaluation period, and 1494 of those kits (25.1%) were returned and processed. A coding error initially excluded patients who were more than one year overdue for screening, limiting program reach. Additionally, some patients may not have had sufficient time to complete screening because of the fixed follow-up period used in the analysis.

Despite these limitations, the program substantially changed how screening was delivered. Before implementation, all screening (100%) involved clinician-collected samples obtained during pelvic examinations. After implementation, 62.6% of screenings were clinician-collected, while 37.4% were completed with vaginal self-collected HPV tests.

This shift contributed to a 29.4% reduction in pelvic examinations, decreasing from 7200 before the program to 5082 afterward. Researchers noted that reducing the need for pelvic exams could improve access to care and allow clinicians to focus on other patient needs during visits.

Interviews and site visits indicated that many clinicians appreciated the reduced time spent on pelvic examinations and the flexibility to address other health concerns.

“The response from clinicians and patients has been extremely positive,” said Beverly Green, MD, MPH, a family physician at Washington Permanente Medical Group and senior investigator at Kaiser Permanente Washington Health Research Institute, in a statement.

Patients were also reported to find self-collection acceptable or preferable, particularly those facing barriers such as transportation, child care responsibilities, or discomfort with in-clinic procedures.

The program also maintained strong follow-up systems for patients with positive test results. Completion rates for diagnostic colposcopy among individuals with high-risk HPV-16 or HPV-18 were comparable to those observed in prior trials and significantly higher than preprogram levels.

However, the evaluation also identified challenges. Clinicians reported concerns about screening quality and demonstrated knowledge gaps regarding the accuracy of HPV self-collection and primary HPV testing. Operational issues included the need for improved documentation, standardized workflows, and adaptations to laboratory and electronic health record systems to process self-collected samples efficiently.

Limitations

The authors emphasized several limitations of the study. As a pragmatic, observational pre–post evaluation, the analysis could not establish causality or account for broader time trends. The study was conducted within a well-resourced integrated health system with advanced infrastructure, including dedicated staff for patient follow-up, which may limit generalizability to other settings. Additionally, incomplete data capture and the inability to align follow-up time with individual kit distribution may have underestimated the program’s impact. Residual implementation challenges, including coding errors and incomplete outreach, also affected results.

The findings suggested that HPV self-collection could modestly increase screening uptake and reduce reliance on pelvic examinations in real-world settings. While the observed improvement was smaller than in controlled trials, the program demonstrated feasibility and acceptability among both patients and clinicians.

The approach can address implementation barriers, such as ensuring complete outreach, improving clinician education, and optimizing workflows, which could enhance the effectiveness of HPV self-collection programs. As adoption expands, this approach may play a role in improving access to cervical cancer screening and reducing disparities in preventive care.

“This is a real-world example of a learning health care system in action,” said senior author Paula Lozano, MD, PhD, codirector of the ACT Center and senior associate medical director for research and translation with Kaiser Permanente Washington, in a news release.

“We are using research evidence to inform implementation, continuously evaluate performance, and iterate to better meet the needs of patients and clinicians,” added Lozano.

References

1. Green BB, Mogk J, Crawford-Gallagher B, et al. Impact of a clinic- and mail-based cervical cancer human papillomavirus self-collect screening program. NEJM Catalyst. 2026;7(6). doi:10.1056/CAT.25.0420
   
2. Fitch J. HRSA updates cervical cancer screening guidelines. Contemporary OB/GYN. January 13, 2026. Accessed May 20, 2026. https://www.contemporaryobgyn.net/view/hrsa-updates-cervical-cancer-screening-guidelines
3. Fitch J. Akiva Novetsky, MD & Kimberly Gecsi, MD break down cervical cancer updates. Contemporary OB/GYN. May 8, 2026. Accessed May 20, 2026. https://www.contemporaryobgyn.net/view/akiva-novetsky-md-kimberly-gecsi-md-break-down-cervical-cancer-updates