Coronavirus Disease 2019 (COVID-19) Vaccination and Stillbirth in the Vaccine Safety Datalink.

OBJECTIVE: Coronavirus disease 2019 (COVID-19) vaccination is recommended in pregnancy to reduce the risk of severe morbidity from COVID-19. However, vaccine hesitancy persists among pregnant people, with risk of stillbirth being a primary concern. Our objective was to examine the association between COVID-19 vaccination and stillbirth. METHODS: We performed a matched case-control study in the Vaccine Safety Datalink (VSD). Stillbirths and live births were selected from singleton pregnancies among persons aged 16-49 years with at least one prenatal, delivery, or postpartum visit at eight participating VSD sites. Stillbirths identified through diagnostic codes were adjudicated to confirm the outcome, date, and gestational age at fetal death. Confirmed antepartum stillbirths that occurred between February 14, 2021, and February 27, 2022, then were matched 1:3 to live births by pregnancy start date, VSD site, and maternal age at delivery. Associations among antepartum stillbirth and COVID-19 vaccination in pregnancy, vaccine manufacturer, number of vaccine doses received, and vaccination within 6 weeks before stillbirth (or index date in live births) were evaluated using conditional logistic regression. RESULTS: In the matched analysis of 276 confirmed antepartum stillbirths and 822 live births, we found no association between COVID-19 vaccination during pregnancy and stillbirth (38.4% stillbirths vs 39.3% live births in vaccinated individuals, adjusted odds ratio [aOR] 1.02, 95% CI, 0.76-1.37). Furthermore, no association between COVID-19 vaccination and stillbirth was detected by vaccine manufacturer (Moderna: aOR 1.00, 95% CI, 0.62-1.62; Pfizer-BioNTech: aOR 1.00, 95% CI, 0.69-1.43), number of vaccine doses received during pregnancy (1 vs 0: aOR 1.17, 95% CI, 0.75-1.83; 2 vs 0: aOR 0.98, 95% CI, 0.81-1.17), or COVID-19 vaccination within the 6 weeks before stillbirth or index date compared with no vaccination (aOR 1.16, 95% CI, 0.74-1.83). CONCLUSION: No association was found between COVID-19 vaccination and stillbirth. These findings further support recommendations for COVID-19 vaccination in pregnancy.

Randomized Phase II Trial of Imiquimod with or without 9-Valent HPV Vaccine versus Observation in Patients with High-grade Pre-neoplastic Cervical Lesions (NCT02864147).

PURPOSE: We report the results of a randomized phase II trial of imiquimod, a topical immune-response modulator versus imiquimod plus a 9-valent human papillomavirus (HPV) vaccine (9vHPV) versus clinical surveillance in cervical intraepithelial neoplasia (CIN2/3) patients. PATIENTS AND METHODS: We randomly allocated 133 patients with untreated CIN2/3 in equal proportions to a 4-month treatment with self-applied vaginal suppositories containing imiquimod (Arm B) or imiquimod plus a 9vHPV (Arm C) versus clinical surveillance (Arm A). The main outcome was efficacy, defined as histologic regression to CIN1 or less. Secondary outcomes were HPV clearance and tolerability. Exploratory objectives included the comparison of cervical CD4/CD8 T-cell infiltration at baseline, mid-study, and posttreatment by flow cytometry among study arms. RESULTS: Of the 114 evaluable patients 77% and 23% harbored CIN2 and CIN3, respectively. Regression to CIN1 or less was observed in 95% of patients in the imiquimod group (Arm B) compared with 79% in the control/surveillance (Arm A); P = 0.043 and 84% in the imiquimod+9vHPV group (Arm C; P = 0.384 vs. Arm A). Neither of the treatment-arm differences from Arm A reached the prespecified α = 0.025 significance level. No significant differences were noted in the secondary outcome of rate of HPV clearance. The number of tissue-resident memory CD4/CD8 T cells in cytobrush samples demonstrated a >5-fold increase in Arm B/imiquimod when compared with Arm A/surveillance (P < 0.01). In contrast, there was no significant difference in T-cell responses among participants in Arm C when compared with Arm A. Imiquimod treatment was well tolerated. CONCLUSIONS: Although imiquimod induced a higher regression to CIN1 or less and significant increases in CD4/CD8 T cells infiltrating the cervix, it did not meet its prespecified statistical outcome for efficacy. A higher regression rate than expected was observed in the surveillance arm of this prospective trial. Future clinical trials with imiquimod targeting CIN3 patients are warranted.

Human Papillomavirus Vaccination Status and Correlates Among Mid-Adult Women: Connecticut, USA, 2016-2019.

Background: In 2019, the CDC expanded their recommendations for human papillomavirus (HPV) vaccination beyond age 26 years to include shared clinical decision-making (SCDM) among adults aged 27-45 years ("mid-adults"). The purpose of this study was to describe HPV vaccination status among mid-adult women before the implementation of SCDM for HPV vaccination. Methods: A cross-sectional survey was conducted during 2016-2019 in Connecticut, United States, and enrolled women born in 1981 or later (birth cohorts eligible for HPV vaccination). This analysis was restricted to participants aged 27 years and older at the time of the survey. Correlates of vaccination status, sources of vaccine information, and reasons for not receiving the vaccine were examined. Results: Among 298 participants, 64.4% had not received HPV vaccine. Other than age (younger age was associated with being vaccinated), no other demographic or behavioral correlates were associated with vaccination. Compared with unvaccinated women, vaccinated women were more likely to have heard about the HPV vaccine from a doctor (odds ratio [OR] = 3.45, 95% confidence interval [CI]: 2.00-5.88) and less likely to have heard about it from television (OR = 0.23, 95% CI: 0.13-0.41). The main reasons for not being vaccinated were "vaccine not offered" (48%) and "too old" (40%). Conclusions: A majority of mid-adult women in this study were not previously vaccinated against HPV, signaling the large opportunity for SCDM with this population. This may be facilitated by ensuring health care providers and mid-adult women know about the availability and potential benefits of HPV vaccination to inform decision making.

Expedited Partner Therapy: A Multicomponent Initiative to Boost Provider Counseling.

BACKGROUND: Expedited partner therapy prescription remains low and highly variable throughout the United States, leading to frequent reinfections with Chlamydia trachomatis and Neisseria gonorrhoeae . We examined provider counseling on expedited partner therapy before and after an electronic smart tool-based initiative. METHODS: In this quasi-experimental interrupted time-series study, we implemented an initiative of electronic smart tools and education for expedited partner therapy in March 2020. We reviewed the records of patients with chlamydia and/or gonorrhea at an urban, academic obstetrics and gynecology clinic in the preimplementation (March 2019-February 2020) and postimplementation (March 2020-February 2021) groups. Descriptive statistics and an interrupted time-series model were used to compare the percent of expedited partner therapy offered by clinicians to patients in each group. RESULTS: A total of 287 patient encounters were analyzed, 155 preintervention and 132 postintervention. An increase in expedited partner therapy counseling of 13% (95% confidence interval [CI], 2%-24%) was observed before the intervention (27.1% [42 of 155]) versus after the intervention (40.2% [53 of 132]). Significant increases in provider counseling were seen for patients who were single (15%; 95% CI, 3%-26%), 25 years or older (21%; 95% CI, 6%-37%), receiving public insurance (15%; 95% CI, 3%-27%), seen by a registered nurse (18%; 95% CI, 4%-32%), or seen for an obstetrics indication (21%; 95% CI, 4%-39%). No difference was seen in patients' acceptance of expedited partner therapy ( P = 1.00). CONCLUSIONS: A multicomponent initiative focused on electronic smart tools is effective at increasing provider counseling on expedited partner therapy. Further research to understand patient perceptions and acceptance of expedited partner therapy is critical.

Factors associated with receiving results and attending colposcopy in patients with positive HPV screens in Mexico City.

We identified patient and healthcare system factors related to receipt of screening results and attendance to colposcopy among patients with positive screening results in a cervical cancer screening program in Mexico City, Mexico. We analyzed data from 1,351 patients with high-risk human papillomavirus (HPV)-positive results from two screening demonstration studies conducted between 2017 and 2018. Factors associated with receipt of screening results and with adherence to a colposcopy appointment were identified using multivariable logistic regression. Participants had a median age of 40 years (IQR = 32-48), 60% had less than high school education, and 74% had a previous Pap screening in the last 5 years. Fifty-five percent of participants retrieved their screening results at the healthcare facility (HCF) without any reminder. Providing an email address for contact information, attending a HCF with family medicine, and receiving care from experienced nurses were associated with greater adherence to obtaining screening test results. Fifty-seven percent of participants attended their first scheduled colposcopy appointment. Providing a phone number improved adherence to colposcopy, whereas longer travel times between the HCF and the colposcopy clinic was associated with a decrease in colposcopy adherence. Having a Pap test in the last 5 years was positively associated with better compliance with both outcomes. Securing contact information may help to overcome barriers to future follow-up. Additional research is necessary on strategies for obtaining screening test results and scheduling appointments, which may help address barriers to access, such as limited staff availability, distance from the clinic, and travel costs.

Disparities in adherence to retesting guidelines in women with Trichomonas vaginalis infection.

BACKGROUND: Trichomoniasis is the most prevalent nonviral sexually transmitted infection in the United States. Numerous studies have shown disproportionately higher prevalence rates in non-Hispanic Black women. Because of the high rates of reinfection, the Centers for Disease Control and Prevention recommends retesting women treated for trichomoniasis. Despite these national guidelines, there are few studies examining adherence to retesting recommendations for patients with trichomoniasis. Adherence to retesting guidelines has been shown in other infections to be an important determinant of racial disparities. OBJECTIVE: This study aimed to describe Trichomonas vaginalis infection rates, evaluate adherence to retesting guidelines, and examine characteristics of women who were not retested according to the guidelines in an urban, diverse, hospital-based obstetrics and gynecology clinic population. STUDY DESIGN: We conducted a retrospective cohort study of patients from a single hospital-based obstetrics and gynecology clinic who were tested for Trichomonas vaginalis between January 1, 2015 and December 31, 2019. Descriptive statistics were used to examine guideline-concordant testing for reinfection among patients with trichomoniasis. Multivariable logistic regression was used to identify characteristics associated with testing positive and with appropriate retesting. Subgroup analyses were performed for patients who were pregnant and tested positive for Trichomonas vaginalis. RESULTS: Among the 8809 patients tested for Trichomonas vaginalis, 799 (9.1%) tested positive at least once during the study. Factors associated with trichomoniasis included identifying as non-Hispanic Black (adjusted odds ratio, 3.13; 95% confidence interval, 2.52-3.89), current or former tobacco smoking (adjusted odds ratio, 2.27; 95% confidence interval, 1.94-2.65), and single marital status (adjusted odds ratio, 1.96; 95% confidence interval, 1.51-2.56). Similar associated factors were found in the pregnant subgroup analysis. For women with trichomoniasis, guideline-concordant retesting rates were low across the entire population, with only 27% (214/799) of patients retested within the recommended time frame; 42% (82/194) of the pregnant subgroup underwent guideline-concordant retesting. Non-Hispanic Black women had significantly lower odds of undergoing guideline-recommended retesting than non-Hispanic White women (adjusted odds ratio, 0.54; 95% confidence interval, 0.31-0.92). Among patients tested according to guideline recommendations, we found a high rate of Trichomonas vaginalis positivity at retesting: 24% in the entire cohort (51/214) and 33% in the pregnant subgroup (27/82). CONCLUSION: Trichomonas vaginalis infection was identified at a high frequency in a diverse, urban hospital-based obstetrics and gynecology clinic population. Opportunities exist to improve on equitable and guideline-concordant retesting of patients with trichomoniasis.

Uptake of Cervical Cancer Screening Among Female Patients Using a Mobile Medical Clinic.

INTRODUCTION: Although cervical cancer causes morbidity, it can be prevented if diagnosed early; previous research has shown lower rates of screening in patients with health-related social needs by self-report data. This study assessed cervical cancer screening uptake among female patients with health-related social needs who access care through a community-based mobile medical clinic. METHODS: A retrospective cohort was developed of all cis-female patients aged 21-65 years who sought care at the mobile medical clinic between January 1, 2016 and December 31, 2019, and their medical data were captured from the electronic health record. Bivariate and multivariate logistic regression (performed in 2022/2023) were used to investigate correlates of ever having received cervical cancer screening and of being up to date with cervical cancer screening. RESULTS: Less than half of the 1,455 patient cohort had ever undergone Pap testing. In the multivariate model, ever having received cervical cancer screening was directly associated with being Hispanic or Black, living with HIV, and having received human papillomavirus vaccination. People who currently smoke showed significantly lower odds of ever having had cervical cancer screening than people who have never smoked. Patients who were single or had other marital status had lower adjusted odds of being up to date as well as those with a substance use history and those with unstable housing. CONCLUSIONS: Cervical cancer screening rates in this community-based mobile medical clinic model were low, highlighting a need for increased attention to screening in this high-risk population. Mobile medical clinics have increased screening uptake internationally, and this model could be adopted domestically to promote screening to patients who access health care in various settings.

Optimizing menstrual health and hygiene management in the U.S.: A mixed-methods study of the barriers and the role of healthcare professionals.

OBJECTIVE: Menstrual health (MH) practices have been understudied in the U.S. This study aimed to assess patient and medical staff views of MH. METHODS: The mixed-methods approach included medical staff and patient surveys, and patient interviews on MH experiences. Quantitative survey data generated descriptive statistics. Thematic content analysis (TCA) evaluated qualitative interviews. Convergent Parallel Triangulation Analysis (CPTA) evaluated both datasets in tandem. RESULTS: The medical staff survey's response rate was 72% (54 participants/75 invited staff). Only 7% (4/54) of staff consistently asked patients about menstrual products (MP), while 54% (29/54) were concerned about patients affording MP. The patient survey's response rate was 90% (186/207); 22% (40/186) of respondents showed MH insecurity, which was associated with annual income <$30,000 (p < 0.01); 45% (85/186) missed commitments during menses; 53% (98/186) never discussed MP with healthcare providers. To reach thematic saturation 10/17 invited patients were interviewed. Five themes were identified through TCA: menstruation as a social barrier; menstrual education comes from a variety of sources; MP choice is a balance of comfort, cost, and convenience; patients value relationships with their providers; adolescence is the window for establishing MH. Three threads were identified through CPTA: MH insecurity is common; MH screening and education are limited; menstruation impacts patients' ability to engage in daily activities. CONCLUSION: A holistic approach toward MH is needed; education and screening are inconsistent. Comprehensive MH can enhance a patient's understanding of and capacity to advocate for their health. These findings are specific to this population and may not be generalizable.

Pilot Implementation of a Health Equity Checklist to Improve the Identification of Equity-Related Adverse Events.

OBJECTIVE: To establish a sustainable and trackable process to delineate the role of social determinants of health, bias, and racism in adverse gynecologic events. METHODS: The existing process entails monthly reviews of adverse events. Each case is assessed for preventability, harm, and standards of care. The equity-focused process consists of: 1) creation of a standardized health equity checklist; 2) application of the checklist to each gynecologic adverse event beginning on September 1, 2020; 3) collection of event review data in a secure central digital repository; 4) review of the cases to understand apparent causes of the event; 5) exploration of areas for improvement by using standard fields; and 6) identification of specific ideas for change. RESULTS: Within 15 months, 46 safety events were identified by standard criteria. Twenty-four of the cases were deemed preventable. Of the 24, there were 12 cases in which social determinants of health or bias or both social determinants of health and bias were identified playing a role. Diagnostic delays and care delays were attributed to social determinants of health and implicit bias. Our process has mapped areas of infrastructure as well as the need for culture improvement and has also highlighted the need for restorative work on addressing implicit bias and improving approaches to shared decision making. CONCLUSION: Through the use of a health equity checklist, we have illustrated the feasibility of creating a systematic and trackable process to begin delineating the role of social determinants of health, bias, and racism in adverse gynecologic events.

Health Disparities in Uterine Cancer: Report From the Uterine Cancer Evidence Review Conference.

The Centers for Disease Control and Prevention recognized the need for educational materials for clinicians on the prevention and early diagnosis of gynecologic cancers. The American College of Obstetricians and Gynecologists convened a panel of experts in evidence review from the Society for Academic Specialists in General Obstetrics and Gynecology and content experts from the Society of Gynecologic Oncology to review relevant literature, best practices, and existing practice guidelines for the development of evidence-based educational materials for women's health care clinicians about uterine cancer. This article is the evidence summary of the literature review of health disparities and inequities related to uterine cancer. Substantive knowledge gaps are noted and summarized to provide guidance for future research.

Executive Summary of the Uterine Cancer Evidence Review Conference.

The Centers for Disease Control and Prevention recognized the need for educational materials for clinicians on the prevention and early diagnosis of gynecologic cancers. The American College of Obstetricians and Gynecologists convened a panel of experts in evidence review from the Society for Academic Specialists in General Obstetrics and Gynecology and content experts from the Society of Gynecologic Oncology to review relevant literature, best practices, and existing practice guidelines as a first step toward developing evidence-based educational materials for women's health care clinicians about uterine cancer. Panel members conducted structured literature reviews, which were then reviewed by other panel members and discussed at a virtual meeting of stakeholder professional and patient advocacy organizations in January 2021. This article is the evidence summary of the relevant literature and existing recommendations to guide clinicians in the prevention, early diagnosis, and special considerations of uterine cancer. Substantive knowledge gaps are noted and summarized to provide guidance for future research.

Overlapping needs for sexual and reproductive health and HIV prevention in women with substance use disorders.

OBJECTIVES: Women with substance use disorders have high unmet needs for HIV prevention and drug treatment and face challenges accessing care for other unique health issues, including their sexual and reproductive health. METHODS: We did a cross-sectional evaluation of sexual and reproductive health behaviors and outcomes among women with substance use disorders, who were enrolled in one of two concurrent clinical trials of pre-exposure prophylaxis for HIV prevention. Descriptive analyses and bivariate logistic regression were used to assess factors driving contraceptive use, and other essential sexual and reproductive health services utilization and outcomes. RESULTS: Among 226 women, 173 (76.5%) were of reproductive age. Most women had histories of unintended pregnancy (79.2%) or miscarriage (45.1%) and high HIV risk behaviors (53.5%). Most (61%) participants did not use any form of contraception at the time of assessment, although few (15%) reported pregnancy intentions. In bivariate models, ongoing criminal justice involvement was associated with 2.22 higher odds of not using contraception (95% confidence interval = 1.09-4.53; p = 0.03) and hazardous drinking was protective against not using contraception (odds ratio = 0.33, 95% confidence interval = 0.13-0.81; p = 0.02). Contraception use was not significantly associated with any other individual characteristics or need factors. CONCLUSIONS: This is the first study that identifies the unmet sexual and reproductive health needs of women with substance use disorders who are engaging with pre-exposure prophylaxis. We found that women accessed some health services but not in a way that holistically addresses the full scope of their needs. Integrated sexual and reproductive care should align women's expressed sexual and reproductive health intentions with their behaviors and outcomes, by addressing social determinants of health.

Menstrual Health and Hygiene among Adolescents in the United States.

STUDY OBJECTIVE: Menstrual health in adolescents has been understudied in the United States. We aimed to assess patient and provider perspectives surrounding menstrual health management and screening. DESIGN: Our mixed-methods approach consisted of provider surveys, patient surveys, and patient interviews. SETTING: Participants were recruited from a pediatric gynecology practice or an adolescent medicine clinic at an urban tertiary academic center. PARTICIPANTS: Providers were pediatrics faculty or residents. Patients aged 13-24 years were eligible. INTERVENTION: Participants completed an anonymous survey or semi-structured interview about their experiences with menstrual health. MAIN OUTCOME MEASURES: Descriptive statistics and thematic content analysis were used for quantitative and qualitative data, respectively. Convergent parallel analysis elucidated key findings in both data sets. RESULTS: The provider survey response rate was 65% (69/106); 15% (9/69) of providers consistently asked patients about menstrual products, whereas 44% (27/68) were concerned patients could not afford products. The patient survey response rate was 85% (101/119); 19% (19/101) of respondents reported menstrual hygiene insecurity, 55% (55/101) missed commitments during menses, and 45% (45/101) discussed menstrual products with providers. Fifteen patients were invited for qualitative interviews; 10 were conducted, and thematic saturation occurred. Interviews highlighted the importance of comprehensive early menstrual health education and providers' role in menstrual management. CONCLUSION: Adolescence is a crucial point of entry into health care. Because taboos surrounding menstruation could limit access to health care, menstrual health education must be emphasized. Menstrual health education is provided piecemeal by parents, schools, and providers. Current practice should be reevaluated to consider comprehensive educational approaches in which health care leads.

Unindicated cervical cancer screening in adolescent females within a large healthcare system in the United States.

BACKGROUND: Current consensus recommendations are to not initiate cervical cancer screening for immunocompetent adolescent females before 21 years of age. This is in part because of the very low rate of 0.8 per 100,000 new cervical cancer cases diagnosed among women aged between 20 to 24 years. Timely human papillomavirus vaccination further decreases the incidence of cervical cancer to 4 cases per 100,000 persons by the age of 28 years. Screening before 21 years of age has demonstrated no clear benefit in cancer risk reduction or outcomes. In addition, unindicated screening among adolescents can lead to patient harm and increasing costs to the healthcare system. OBJECTIVE: It is important to assess the rates of overutilization of cervical cancer screening and to identify areas where improvements have occurred and where further opportunities exist. This study aimed to assess the trends over time and the practice and provider factors associated with unindicated cervical cancer screening tests in adolescent females within the largest healthcare system in the state. STUDY DESIGN: Cross-sectional data from patients aged 13 to 20 years who underwent cervical cancer screening between January 1, 2012, and December 31, 2018, across a large multihospital health system were reviewed. All cervical cancer screening results were included. The incidence rate of unindicated screening was analyzed over 6-month intervals using the Poisson regression analysis. RESULTS: The study included data from 118 providers and 794 women. Among the 900 screening results, most (90%) were unindicated: 87% with unindicated cytology testing alone and 14% with unindicated human papillomavirus testing. Screening tests were collected from patients aged 13 to 20 years, many of whom had multiple unindicated cytology tests, with 25 patients having ≥3 tests before the age of 21 years. Most results of cytology testing were negative for intraepithelial lesion or malignancy (77%). Moreover, 52 invasive diagnostic or therapeutic procedures (49 colposcopies and 3 conizations) were performed, of which 45 (87%) followed an unindicated screening test. Between 2012 and 2018, the incidence rate of unindicated cytology decreased by 33% (12.6 to 8.5 unindicated cytology per 1000 encounters). The incidence rate of unindicated screening was lower in the academic setting than in the community setting (incidence rate ratio, 0.43; P<.01). Even with decreases in the overall rates of unindicated screening throughout the study period, there were still 58 unindicated screening tests performed in the final year of this study. CONCLUSION: Despite substantial reductions in unindicated screening for women aged <21 years, there remained areas for improvement. Our data reflected practices of guideline nonadherence up to 7 years after the 2012 guideline. Now, with a new series of changes to the guidelines, which may be even more challenging for patients and providers, it is more important than ever to utilize evidence-based strategies to improve guideline dissemination and adherence.

Patterns of recommended vaccine receipt among women ages 24-45 years: a cross-sectional analysis.

BACKGROUND: Vaccine receipt among mid-adults remains low, with only one quarter of adults being up to date for all recommended vaccines. It is important to understand the myriad factors that influence vaccine receipt among mid-adult women to address these low rates. METHODS: We conducted a cross-sectional analysis of data from women ages 24-45 years collected as part of an ongoing case-control study of the effectiveness of HPV vaccine. We examined associations between demographic characteristics and healthcare utilization and receipt of individual vaccines and combinations of multiple vaccines using logistic regression analyses for three routinely recommended vaccines: tetanus, influenza and HPV. RESULTS: Among the 309 women enrolled in the study, only 19 (6.2%) were up to date for all three recommended vaccines and 41 (13.3%) had not received any of the recommended vaccines. A greater number of health care visits in the past year was associated with receipt of influenza (aOR = 6.37, 95% CI = 2.53, 16.1) and tetanus (aOR = 2.17, 95% CI = 1.14, 4.12) vaccines. White women were more likely to have received HPV vaccine (aOR = 2.39, 95% CI = 1.07, 5.36). CONCLUSIONS: Uptake of recommended vaccines is low among young and mid-adult women. There is a need for greater understanding of the underlying factors influencing vaccine receipt in this population.

Effectiveness of HPV vaccine by age at vaccination and number of doses: protocol for a population-based matched case-control study.

INTRODUCTION: In 2006, the first human papillomavirus (HPV) vaccine was approved by the Food and Drug Administration in the USA based on pre-licensure clinical trials that found it to be highly efficacious at preventing persistent infection and precancerous, high-grade cervical lesions (HGCLs) caused by viral types the vaccine protects against. However, the real-world effectiveness of HPV vaccines as used in clinical practice may be quite different from the efficacy found in pre-licensure clinical trials. More than 10 years have passed since the introduction of the vaccine programme. It is critical to determine if the full benefits of HPV are being realised in real-world settings. METHODS AND ANALYSIS: The objectives of this study were to estimate the effectiveness of HPV vaccines as used in real-world clinical settings and to determine the degree to which the vaccine's effectiveness varies based on age at the time of immunisation and the number of doses received. The study will be a population-based, matched case-control study. Cases will be women with newly diagnosed HGCL associated with HPV types 16 and 18. Matched controls will be women with a normal Pap test result, matched individually to cases in a 2:1 ratio by age, a practice and date of testing. Medical records will be reviewed to determine dates of receipt of the HPV vaccine for all participants. We will use multivariate conditional logistic regression to control for potential confounders. ETHICS AND DISSEMINATION: This protocol presents minimal risk to the subjects. This protocol has received approval from the Institutional Review Board of Yale University (HIC: 1502015308), and a Health Insurance Portability and Accountability Act (HIPAA) Waiver of Authorisation has been granted to allow investigators to recruit subjects for the study. Findings will be disseminated through peer-reviewed, open-access scientific journals and conference presentations.

Association of Inadvertent 9-Valent Human Papillomavirus Vaccine in Pregnancy With Spontaneous Abortion and Adverse Birth Outcomes.

Importance: The 9-valent human papillomavirus (9vHPV) vaccine is recommended for individuals through age 26 years and may be administered to women up to age 45 years. Data on 9vHPV vaccine exposures during pregnancy are limited. Objective: To evaluate the associations between 9vHPV vaccine exposures during pregnancy or peripregnancy and selected pregnancy and birth outcomes (spontaneous abortion [SAB], preterm birth, small-for-gestational age [SGA] birth, and major structural birth defect). Design, Setting, and Participants: This cohort study analyzed data from 7 participating health systems in the Vaccine Safety Datalink. The cohort comprised pregnancies among girls and women aged 12 to 28 years that ended between October 26, 2015, and November 15, 2018. Singleton pregnancies that ended in a live birth, stillbirth, or SAB were included. Exposures: Vaccine exposure windows were distal (9vHPV or 4vHPV vaccine administered from 22 to 16 weeks before last menstrual period [LMP]), peripregnancy (9vHPV vaccine administered from 42 days before LMP until LMP), and during pregnancy (9vHPV vaccine administered from LMP to 19 completed weeks' gestation). Primary comparisons were (1) girls and women with 9vHPV vaccine exposures during pregnancy vs those with 4vHPV or 9vHPV distal vaccine exposures, (2) girls and women with vaccine exposures peripregnancy vs those with 4vHPV or 9vHPV distal vaccine exposures, and (3) girls and women with 9vHPV vaccine exposures during pregnancy or peripregnancy vs those with 4vHPV or 9vHPV distal vaccine exposure. Main Outcomes and Measures: Spontaneous abortions were confirmed based on medical record review and adjudication. Preterm and SGA births were identified from electronic health record and birth data. Major structural birth defects were based on diagnostic codes using a validated algorithm. Inverse probability weighting was used to balance the covariates. Time-dependent covariate Cox proportional hazards regression models and Poisson regression were used to estimate the associations between 9vHPV vaccine exposures and pregnancy and birth outcomes. Results: The final cohort included 1493 pregnancies among girls and women with a mean (SD) maternal age of 23.9 (2.9) years. Of these pregnancies, 445 (29.8%) had exposures to the 9vHPV vaccine during pregnancy, 496 (33.2%) had exposures to the 9vHPV vaccine peripregnancy, and 552 (37.0%) had 4vHPV or 9vHPV distal vaccine exposures. The 9vHPV vaccine administered during pregnancy was not associated with increased risk for SAB (hazard ratio, 1.12; 95% CI, 0.66-1.93) compared with distal vaccine exposures. Findings were similar for 9vHPV vaccine exposures peripregnancy (relative risk [RR], 0.72; 95% CI, 0.42-1.24). Among live births (n = 1409), 9vHPV vaccine exposures during pregnancy were not associated with increased risks for preterm birth (RR, 0.73; 95% CI, 0.44-1.20) or SGA birth (RR, 1.31; 95% CI, 0.78-2.20). Results were similar regarding the association between 9vHPV vaccine exposures peripregnancy and preterm birth (RR, 0.72; 95% CI, 0.45-1.17) and SGA birth (RR, 1.10; 95% CI, 0.65-1.88). Birth defects were rare in all exposure groups, occurring in about 1% of live births with available infant data. Conclusions and Relevance: This study found that 9vHPV vaccine exposures during or around the time of pregnancy were uncommon and not associated with SABs or selected adverse birth outcomes. These findings can inform counseling for inadvertent 9vHPV vaccine exposures.

Inpatient Immunization With HPV Vaccine: A Qualitative Study With Postpartum Women.

INTRODUCTION: Rates of immunization with human papillomavirus (HPV) vaccine among adolescent and young adult females remain suboptimal. There is a continued need to focus on catch-up immunization. Some hospitals in the United States have implemented inpatient postpartum HPV immunization programs (IPP-HPV) as part of a strategy to improve rates of catch-up immunization. Patients' perspectives are critical to facilitating broad adoption of IPP-HPV. The objectives of this study were to understand the experiences and perspectives of postpartum women recommended to receive HPV vaccine before hospital discharge and to identify facilitators of and barriers to program implementation. METHODS: We conducted in-depth semistructured interviews with postpartum women eligible for IPP-HPV. We used purposive sampling to ensure representation across race, ethnicity, and language. Interviews were analyzed using an iterative thematic approach. RESULTS: The median age of participants (n = 24) was 22 years (range, 15-26 years), and six had declined the inpatient dose of HPV vaccine. Overall, women viewed IPP-HPV favorably. Facilitators of program implementation included viewing HPV vaccine as prevention, normalization of the vaccine, convenience of IPP-HPV, and the experience of a patient-centered approach. Barriers included the peripartum environment and associated stress, vaccine hesitancy, and a lack of both awareness of and knowledge about HPV vaccine. CONCLUSIONS: IPP-HPV immunization is a strategy well-received by women for improving rates of catch-up immunization. The implementation of such programs may be optimized by increasing awareness that the vaccine is available and recommended for postpartum women, and by using a patient-centered approach that is sensitive to the needs of postpartum patients.