Human Papillomavirus Vaccine Effectiveness by Age, Age at Vaccination, and Timing of Vaccination Relative to Age at First Sex Among Men Who Have Sex With Men—Seattle, Washington, 2018 to 2020

Sexually Transmitted Diseases · 2025-06-02 · 1 citations

BACKGROUND: We evaluated human papillomavirus (HPV) vaccine effectiveness (VE) against prevalent anal HPV among men who have sex with men (MSM) by age, age at vaccination, and age at vaccination relative to age at first sex. METHODS: Residual anal specimens from 1092 MSM aged 18 to 45 years attending a Seattle, Washington, sexual health clinic in 2018 to 2020 were tested for 28 HPV types. Demographic, clinical, sexual behavioral, and HPV vaccination data were extracted from clinic and electronic medical records. We calculated adjusted prevalence ratios (aPRs) and 95% confidence intervals (CIs) for associations between vaccination (≥1 dose of any HPV vaccine) and quadrivalent HPV vaccine (4vHPV)-type infection, by age group (18-26, 27-35, 36-45 years), vaccination age (among age groups 18-26, 27-35 years), and vaccination age relative to first sex (among those 18-26 years). Analyses were adjusted for race and ethnicity, preexposure prophylaxis use for HIV prevention, and lifetime number of sex partners. Vaccine effectiveness was calculated as (1 - aPR) × 100. RESULTS: Among persons aged 18 to 26 years, 4vHPV-type HPV prevalence was lower among those vaccinated before first sex (aPR, 0.12 [95% CI, 0.02-0.87]; VE, 88%) or at <18 years of age (aPR, 0.22 [95% CI, 0.07-0.68]; VE, 78%) versus unvaccinated, but no VE was observed in those vaccinated at 18 to 26 years of age. Among persons aged 27 to 35 years, 4vHPV-type HPV prevalence was lower among those vaccinated at 18 to 26 years of age versus unvaccinated (aPR, 0.56 [95% CI, 0.36-0.87]; VE, 44%). No VE was observed in persons aged 27 to 35 or 36 to 45 years who were vaccinated at >26 years of age. CONCLUSIONS: Results highlight the importance of routine HPV vaccination in adolescence and support efforts to increase catch-up vaccination among MSM.

Vaccine Effectiveness Against Anal HPV Infection Among Men With HIV Who Have Sex With Men Attending Sexual Health Clinics in Three US Cities, 2018–2023

JAIDS Journal of Acquired Immune Deficiency Syndromes · 2025-05-08 · 2 citations

BACKGROUND: Men who have sex with men (MSM) with HIV are disproportionately affected by human papillomavirus (HPV) and related diseases. We assessed HPV vaccine effectiveness (VE) against anal HPV among MSM with HIV. METHODS: During 2018-2023, residual anal specimens from MSM with HIV, aged 18-45 years, attending sexual health clinics in three U.S. cities were collected and tested for HPV. Demographic and vaccination information were obtained from clinic records or immunization registries. Timing of vaccination relative to HIV acquisition was unknown. Log-binomial regression was used to calculate adjusted prevalence ratios (aPR) and 95% confidence intervals (CI) for associations between vaccination (≥1 dose) and quadrivalent vaccine (4vHPV)-type infection, adjusting for city. Models were stratified by age group (18-26, 27-45 years). VE was calculated as (1-aPR) x 100. RESULTS: Among 224 persons aged 18-26 years, 54% were vaccinated. Compared with unvaccinated persons, 4vHPV-type prevalence was lower in those vaccinated at age <18 (aPR=0.31, 95% CI:0.14-0.72, VE=69%) and ≥2 years before specimen collection (aPR=0.54, 95% CI:0.31-0.92, VE=46%). Among 700 persons aged 27-45 years, 17% were vaccinated. Compared with unvaccinated persons, 4vHPV-type prevalence was lower in those vaccinated at ages 18-26 (aPR=0.63, 95% CI:0.45-0.89, VE=37%) and ≥2 years before specimen collection (aPR=0.63, 95% CI:0.46-0.86, VE=37%). CONCLUSIONS: While timing of vaccination relative to HIV acquisition was unknown, we found significant VE against prevalent HPV infection in adult MSM with HIV. Within each age group, VE was higher with younger age at vaccination.

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

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

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.

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

Journal of General Internal Medicine · 2025-12-18

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.

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

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

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

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.

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

Patient Education and Counseling · 2025-10-04

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

2025-09-01

<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.

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

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

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

2025-09-02

&lt;div&gt;AbstractBackground:&lt;p&gt;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.&lt;/p&gt;Methods:&lt;p&gt;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.&lt;/p&gt;Results:&lt;p&gt;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 &gt;75% disease extent had corresponding HPV-16/18 E6–positive samples, whereas none of 30 persons with &lt;25% extent did.&lt;/p&gt;Conclusions:&lt;p&gt;The HPV-16/18 E6 oncoprotein has potential utility as a triage biomarker for identifying and prioritizing lesions at the highest risk for progression.&lt;/p&gt;Impact:&lt;p&gt;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.&lt;/p&gt;&lt;/div&gt;