Delivering Guideline-Concordant Care for Patients With High-Risk HPV and Normal Cytologic Findings

Abstract

Importance: As US health care systems shift to human papillomavirus (HPV)-based cervical cancer screening, more patients are receiving positive high-risk non-16/18 genotype HPV results and negative for intraepithelial lesion or malignancy (NILM) cytological findings. Risk-based management guidelines recommend 2 consecutive negative annual results to return to routine screening.

Objective: To quantify patterns of surveillance testing and associated outcomes for patients after an HPV-positive results and NILM cytologic findings.

Design, setting, and participants: This cohort study analyzed patients in the METRICS (Multi-level Optimization of the Cervical Cancer Screening Process in Diverse Settings and Populations) cohort of the PROSPR II (Population-Based Research to Optimize the Screening Process) Cervical Consortium. Population-based data were obtained from 3 diverse health care systems (Mass General Brigham [MGB] in Massachusetts, Kaiser Permanente Washington [KPWA] in Washington, and Parkland Health [PH] in Texas) in the METRICS cohort. Participants were patients aged 21 to 65 years who received an HPV-positive (non-16/18 or pooled genotypes) result and NILM cytologic finding from January 2010 to August 2018 and were followed up through December 2019. Data analyses were performed between April 2021 and November 2024.

Main outcomes and measures: Test receipt and outcomes delivered within 16 months after the index result (round 1 surveillance).

Results: The final sample across the 3 health care systems comprised 13 158 female patients (3228 Hispanic or Latine [24.5%], 1990 non-Hispanic African American or Black [15.1%], 749 non-Hispanic Asian [5.7%], and 6559 non-Hispanic White [49.8%] individuals). Sociodemographic characteristics varied by site, with more non-Hispanic White (2277 [63.7%] and 4061 [61.2%]) and commercially insured patients (3137 [87.8%] and 4365 [65.7%]) at KPWA and MGB, and more Hispanic or Latine (1664 [56.5%]) and uninsured patients (2352 [79.9%]) at PH. During round 1 surveillance, 43.7% of patients were tested, of whom 18.2% (2394) had HPV-negative results and NILM cytologic findings and 25.5% (3351) had abnormal results. Many patients remained in the cohort and were untested through round 1 surveillance (overall: 49.4% [6505]; across sites: 39.0% [1395] to 69.4% [2043]), while fewer exited the cohort (overall: 6.9% [908]; across sites: 0.2% [12] to 24.6% [879]). Groups with lower odds of timely testing were younger adults (aged 25-29 vs 30-39 years: adjusted odds ratio [AOR], 0.65; 95% CL, 0.53-0.81), non-Hispanic African American or Black compared with non-Hispanic White patients (AOR, 0.78; 95% CL, 0.68-0.89), and those with Medicaid compared with commercial insurance (AOR, 0.81; 95% CL, 0.72-0.91), while those with a primary care clinician were more likely to have timely testing (AOR, 1.44; 95% CL, 1.21-1.70). Cancer was diagnosed in 10 patients (0.2%) untested in round 1 surveillance compared with 0 cancers in those with an HPV-negative results and NILM cytologic findings.

Conclusions and relevance: This cohort study found that among patients with HPV-positive results and NILM cytologic findings, less than half received a surveillance cotest during the guideline-recommended time frame. Health care systems should monitor annual surveillance and gather evidence on interventions to optimize the delivery of surveillance testing.

Figure 1.. CONSORT Diagram of the PROSPR II METRICS Cohort

ASC-US indicates atypical squamous cells of uncertain significance; HPV, human papillomavirus; HSIL, high-grade squamous intraepithelial lesion; LSIL, low-grade squamous intraepithelial lesion; METRICS, Multi-level Optimization of the Cervical Cancer Screening Process in Diverse Settings and Populations; NILM, negative for intraepithelial lesion or malignancy; PROSPR II, Population-based Research to Optimize the Screening Process.

Figure 2.. Transitions Over Rounds of Surveillance Testing After Index Human Papillomavirus (HPV)–Positive Result and Negative for Intraepithelial Lesion or Malignancy (NILM) Cytologic Finding, Overall and by Health Care System

Round 1 events occurred within 16 months of index result. Round 2 events occurred 22 to 32 months after the index result and within 16 months of the round 1 HPV-negative result and NILM cytologic finding. KPWA indicates Kaiser Permanente Washington; MGB, Mass General Brigham; and PH, Parkland Health. ^aMedian (IQR) time to next event.