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Rachel L. Winer

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University of Washington · Epidemiology

Active 2003–2026

h-index33
Citations7.7k
Papers14769 last 5y
Funding$9.5M1 active
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About

Rachel L. Winer is a Professor in the Department of Epidemiology at the University of Washington. Her research interests are centered on the epidemiology and prevention of human papillomavirus (HPV) infections and HPV-related cancers. Her current projects focus on understanding the epidemiology and natural history of HPV infections, evaluating the impact of HPV vaccines in young men who have sex with men, developing strategies to increase HPV vaccine coverage in underserved populations, and exploring novel approaches to enhance the uptake and effectiveness of cervical cancer screening. Dr. Winer's work aims to improve public health outcomes related to HPV and cervical cancer through epidemiological research and preventive strategies.

Research topics

  • Medicine
  • Internal medicine
  • Immunology
  • Demography
  • Environmental health
  • Gynecology
  • Clinical psychology
  • Gerontology
  • Psychiatry

Selected publications

  • Efficacy and durability of immediate versus delayed single-dose HPV vaccination for persistent infection among young women in Kenya: a randomized, blinded, cross-over clinical trial

    Nature Communications · 2026-05-11

    articleOpen access

    Evidence is needed for single-dose human papillomavirus (HPV) vaccine efficacy (VE) durability to support vaccination guidelines. In this randomized crossover trial (NCT03675256), healthy young women aged 15-20 years, recruited through community-based screening in Kenya, were randomly allocated to immediate nonavalent or bivalent HPV vaccination and delayed control at month 30/36 (age 17-23 years), or immediate control and delayed nonavalent HPV vaccination. Cervical swabs collected every six months were tested for HPV DNA to determine incident persistent HPV infection. The primary outcome was VE at 54 months, estimated among participants who were HPV naive at enrollment vaccination using Cox proportional hazards models with time-varying covariates for HPV vaccine status and time; negative coefficients for time since vaccination indicate durability. For incident persistent HPV 16/18 infections, 104 were detected: 93 pre-crossover and 11 post-crossover; HPV 16/18 VE was 99.3% (95% CI: 96.2,99.9%). For incident persistent HPV 16/18/31/33/45/52/58, 117 infections occurred: 103 pre-crossover and 14 post-crossover; HPV 16/18/31/33/45/52/58 VE was 98.9% (95% CI: 94.9,99.8%). Coefficients for time since vaccination were -0.0014 (95% CI: -0.0027,-0.0002) for HPV 16/18 and -0.0016 (95% CI: -0.0028,-0.0004) for HPV 16/18/31/33/45/52/58. Single-dose HPV vaccination is highly efficacious ( > 98%) and durable over 54 months in young women.

  • Cost-Effectiveness of HPV Self-Testing Options for Cervical Cancer Screening

    JAMA Network Open · 2025-10-01 · 4 citations

    articleOpen accessSenior authorCorresponding

    Importance: Mailing human papillomavirus (HPV) self-sampling kits to underscreened individuals increases cervical cancer screening and can be cost-effective. However, cost-effectiveness has not been evaluated across other screening histories. Objective: To conduct an economic evaluation of mailed HPV self-sampling among members of a US health care system with adherent, overdue, or unknown screening histories. Design, Setting, and Participants: This economic evaluation was a cost-effectiveness analysis (CEA) and budget impact analysis (BIA) based on results of a randomized clinical trial (RCT) conducted between November 20, 2020, to July 29, 2022, in an integrated health care system in Washington State. Intervention delivery costs were calculated from Kaiser Permanente Washington and Medicare perspectives and used wellness-based or screening-only visit costs. Participants included female members aged 30 to 64 years identified through electronic medical records. Data were analyzed from August 1, 2022, to July 29, 2025. Intervention: Members were randomized by screening history. Adherent participants were assigned to 4 groups: usual care (UC), patient reminders, clinician electronic health record [HER] alerts), education (UC and mailed educational materials), direct mail (UC, education, and mailed self-sampling kit), or opt-in (UC, education, and mailed invitation to request kit). Overdue participants were assigned to 3 groups: UC, education, or direct mail. Participants with unknown adherence were assigned to UC, education, or opt-in. Main Outcome and Measures: Primary RCT outcome was screening completion 6 months postrandomization. CEA outcome was incremental cost-effectiveness ratio for screening completion. BIA outcome was annual program implementation cost over 4 years. Results: Analyses included 31 355 individuals (mean [SD] age, 45.9 [10.4] years). Among screening adherent members, direct mail dominated all other strategies (more effective and cost-saving). Among overdue members, direct mail was also more effective than UC and generated an additional completed screen at a cost ranging from -$19 (95% CI, -$21 to -$16) (cost saving) to $63 (95% CI, $39 to $87) depending on cost basis and visit type. Among unknown members, opt-in generally dominated UC (more effective and cost-saving). The BIA indicated that although the screening adherent subgroup had the largest year 1 program budget, its budget declined fastest and, by year 4, was lowest among the 3 subgroups. Conversely, the smallest annual budget decreases were among eligible individuals with unknown history. Conclusions and Relevance: In this economic analysis of a randomized clinical trial, directly mailing HPV kits to individuals who were screening adherent and overdue for screening was economically dominant over other strategies. Program costs declined rapidly over 4 years. Results support directly mailing HPV kits to eligible individuals as an effective, efficient, and affordable outreach strategy.

  • The Role of Human Papillomavirus E6 Oncoprotein as a Biomarker in Anal Cancer Screening in Persons Living with HIV

    Cancer Epidemiology Biomarkers & Prevention · 2025-07-11

    articleOpen accessSenior author

    BACKGROUND: Molecular biomarkers could enhance anal cancer screening accuracy in people living with human immunodeficiency virus. We assessed the performance of human papillomavirus (HPV) 16/18 E6 oncoprotein in detecting anal high-grade squamous intraepithelial lesions (HSIL) in men living with human immunodeficiency virus. METHODS: We analyzed clinical data from 125 clinic visits of 82 men living with human immunodeficiency virus who underwent high-resolution anoscopy in Seattle, Washington (2015-2016), including the presence and extent of HSIL. Anal brush specimens were tested for high-risk HPV DNA, with HPV-16/18-positive samples further tested for E6 oncoprotein. Sensitivity, specificity, positive predictive value, and negative predictive value of HPV-16/18 E6 oncoprotein for HSIL were calculated, along with prevalence ratios with 95% confidence intervals. RESULTS: Forty-eight (38.4%) samples were HPV-16/18 positive, including three E6 positive. Forty-nine (39.2%) samples had corresponding HSIL. Specificity and positive predictive value of HPV-16/18 E6 for HSIL was 100%, and the prevalence ratio was 7.33 (95% confidence interval, 2.44-22.07) for HPV-16/18 E6-positive versus high-risk HPV-negative samples. Sensitivity for HSIL, however, was only 6.1%, with a moderate negative predictive value (62.3%). Two of four persons with HSILs with >75% disease extent had corresponding HPV-16/18 E6-positive samples, whereas none of 30 persons with <25% extent did. CONCLUSIONS: The HPV-16/18 E6 oncoprotein has potential utility as a triage biomarker for identifying and prioritizing lesions at the highest risk for progression. IMPACT: People living with human immunodeficiency virus are at an increased risk of anal cancer and would benefit from improved screening methods. Further research may elucidate the role of HPV-16/18 E6 oncoprotein in anal cancer prevention, alone or combined with other biomarkers.

  • Experience with Cervical Cancer Screening and Views on HPV Self-Sampling Among Somali American Women

    Journal of General Internal Medicine · 2025-12-18

    articleOpen accessSenior author

    BACKGROUND: Somali American women have lower cervical cancer screening rates than the general US population. Human papillomavirus (HPV) testing on self-collected samples (HPV self-sampling) has the potential to address cervical cancer screening disparities affecting Somali American women. This study aimed to understand Somali American women's perspectives on cervical cancer screening and HPV self-sampling. METHODS: Forty-four Somali American women participated in six focus groups. Participants were between 30 and 65 years old and were eligible for cervical cancer screening. The discussions focused on women's experiences with cervical cancer screening, barriers to screening, views on HPV self-sampling, and recommendations to increase screening participation. FINDINGS: While some participants' prior experiences with cervical cancer screening were positive, many reported coercive, distressing, and frightening experiences with screening. A range of barriers was reported, and these included fear, distrust, low awareness of cervical cancer, modesty concerns, being circumcised, and limited access, including not being offered screening. Participants viewed HPV self-sampling favorably, with minor concerns about test validity or ability to collect samples correctly. Overall, participants felt HPV self-sampling should be routinely offered to all Somali American patients. CONCLUSION: Offering HPV self-sampling to Somali American women could be an important tool to address barriers related to modesty and access to care and may be most effective implemented alongside education to raise awareness about cervical cancer. This modality may be particularly important for patients who have had traumatic or coercive screening experiences and for patients who have experienced female genital circumcision. CLINICAL TRIAL REGISTRATION: NCT05453006.

  • Promoting cervical cancer screening via a mailed HPV self-collection kit: Reactions from screeners and non-screeners

    Patient Education and Counseling · 2025-10-04

    articleSenior author
  • Supplementary Figure S1 from The Role of Human Papillomavirus E6 Oncoprotein as a Biomarker in Anal Cancer Screening in Persons Living with HIV

    2025-09-02

    articleOpen accessSenior author

    &lt;p&gt;Supplementary Figure S1 is a flowchart Flowchart showing participant enrollment, sample inclusion, and clinical outcomes.&lt;/p&gt;

  • Implementing primary care-based in-clinic HPV self-sampling to increase cervical cancer screening rates

    2025-09-01

    articleOpen access

    <h3>Context</h3> HPV self-testing is FDA approved and can be offered by primary care clinics as a cervical cancer screening option. The Isbaar Project implemented HPV self-testing in 2023 in three primary care clinics, and conducted the first U.S. evaluation of in-clinic HPV self-sampling as a strategy for increasing screening and addressing screening disparities. <h3>Objective</h3> Assess the effect of implementing HPV self-sampling in primary care clinics on cervical cancer screening uptake, both overall and in Somali-American patients. <h3>Study Design and Analysis</h3> Hybrid Type 2 effectiveness-implementation study. <h3>Setting or Dataset</h3> U.S. Midwest urban primary care clinics. <h3>Population Studied</h3> Patients attending three primary care intervention clinics and 37 control clinics. <h3>Intervention/Instrument</h3> Intervention components included self-testing instructions; clinical staff training materials; and workflow guidance, referral processes, and results reporting/communication. <h3>Outcome Measures</h3> We used Kaplan-Meier methods to calculate 12-month screening completion and difference-in-difference Cox proportional hazards regression to compare screening changes 12-months pre-/post-implementation in intervention versus control clinics (overall and restricting to Somali-Americans), adjusting for age, screening history, and social vulnerability index (SVI). <h3>Results</h3> Intervention (N=5,661) versus control (N=61,577) patients were younger (mean 44.4 versus 47.1 years), more likely to have no prior screening documented (66.5% versus 62.8%), had higher SVI scores (44.1% versus 13.0% in highest quartile), and a higher proportion were Somali-American (34.4% versus 2.3%). Somali-Americans attending intervention versus control clinics also had higher SVI scores (53.5% versus 30.3% in highest quartile). 12-month screening increased overall from 22.0%-34.4% pre-/post-implementation in intervention versus 54.5%-57.2% in control clinics (difference-in-difference adjusted hazard ratio [aHR]:1.39, 95% CI:1.25-1.55), and 17.2%-31.5% pre-/post-implementation in intervention versus 63.6%-66.0% in control clinics in Somali-Americans (difference-in-difference aHR:1.80, 95% CI:1.40-2.32). <h3>Conclusions</h3> Offering in-clinic HPV self-sampling in primary care increased cervical screening overall and in Somali-Americans.

  • IPVS Consensus Statement on The Natural History of Cervical Human Papillomavirus Infection

    The Journal of Infectious Diseases · 2025-11-12 · 3 citations

    article

    BACKGROUND: Changes in cervical type-specific human papillomavirus (HPV) detection may reflect both natural variation in detectability and recent infection or clearance. METHODS: The Policy Committee of the International Papillomavirus Society (IPVS) convened a multidisciplinary working group to review scientific evidence and terminology related to the natural history of cervical type-specific HPV infections. RESULTS: The group proposes an updated model that distinguishes 3 cervical states: no HPV infection, undetectable HPV infection, and detectable HPV infection. An undetectable HPV infection refers to either a state of low viral genome load below the cutoff of the assay used or to a particular state of viral latency. These 2 states are virtually indistinguishable, and viral latency remains a topic of ongoing research and debate. The transition from HPV not detected to HPV detected is consistent with several possible events, including (i) acquisition from a partner, (ii) autoinoculation, (iii) transition from undetected to detected HPV infection, and (iv) transient deposition of viral material. Conversely, the transition from HPV detected to HPV not detected is consistent with (i) viral clearance, (ii) transition from detected to undetected HPV infection, and (iii) inadequate sampling. The likelihood of each possible explanation depends on context, including screening history, exposure, age, and immune status. CONCLUSIONS: By distinguishing true cervical states from observed test results, the updated model acknowledges uncertainties that complicate the interpretation of HPV test result patterns in research and practice. Adopting this model may improve clarity and ensure consistency in scientific and clinical communication about cervical HPV infections.

  • Evaluation of an implementation support program for rural communities using a two-tiered, embedded framework

    Cancer Causes & Control · 2025-07-30

    article
  • Supplementary Table S1 from The Role of Human Papillomavirus E6 Oncoprotein as a Biomarker in Anal Cancer Screening in Persons Living with HIV

    2025-09-02

    articleOpen accessSenior author

    &lt;p&gt;Supplementary Table S1 shows HPV subtypes detected with HRA HSIL disease extent&lt;/p&gt;

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