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

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

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