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.

It Takes a Village: An Interdisciplinary Approach to Preparing Internal Medicine Residents to Care for Patients at the Intersection of Women's Health, Gender-Affirming Care, and Health Disparities.

Objective: To create an interdisciplinary curriculum to teach key topics at the intersection of women's health, gender-affirming care, and health disparities to internal medicine (IM) residents. Materials and Methods: A core team of faculty from IM, Obstetrics and Gynecology, and Surgery partnered with faculty and fellows from other disciplines and with community experts to design and deliver the curriculum. The resulting curriculum consisted of themed half-day modules, each consisting of three to four inter-related topics, updated and repeated on an ∼3-year cycle. Health equity was a focus of all topics. Module delivery used diverse interactive learning strategies. Modules have been presented to ∼175 residents annually, beginning in 2015. To assess the curriculum, we used formative evaluation methods, using primarily anonymous, electronic surveys, and collected quantitative and qualitative data. Most surveys assessed resident learning by quantifying residents' self-reported comfort with skills taught in the module pre- and postsession. Results: Of 131 residents who completed an evaluation in 2022/23, 121 (90%) "somewhat" or "strongly" agreed with their readiness to perform a range of skills taught in the module. In all previous years where pre- and postsurveys were used to evaluate modules, we observed a consistent meaningful increase in the proportion of residents reporting high levels of comfort with the material. Residents particularly valued interactive teaching methods, and direct learning from community members and peers. Conclusion: Our interdisciplinary curriculum was feasible, valued by trainees, and increased resident learning. The curriculum provides a template to address equity issues across a spectrum of women's and gender-affirming care conditions that can be used by other institutions in implementing similar curricula.

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.

Impact of a clinical interventions bundle on uptake of HPV vaccine at an OB/GYN clinic.

INTRODUCTION: HPV vaccine uptake is lowest among young adults. Little is known about the most effective way to decrease missed opportunities (MO) and increase uptake of the vaccine in this vulnerable population. OBJECTIVES: To determine the impact of a clinical intervention bundle on the rate of MO and uptake of the vaccine among young adult women. METHODS: From 2/2014 to 7/2015, an intervention bundle (designating physician and nurse champions, pre-screening patients' charts, empowering nurses to recommend immunization, providing no-cost vaccinations, placing prompts in clinic note templates, eliminating requirement for pre-vaccination pregnancy test) was implemented at an urban, hospital-based OB/GYN clinic. Medical records were reviewed for all vaccine-eligible (non-pregnant, 11-26 years) women seen between 2/2013 and 9/2016. Impact of the bundled interventions on the monthly rates of MO and vaccine uptake was estimated by analyzing immunization trends with an interrupted time-series model using counterfactual comparison groups in order to control for pre-existing trends. RESULTS: There were 6,463 vaccine-eligible visits during our study period. The prevalence of women who had both completed and initiated the series was significantly higher, 20.3% and 29.7% respectively, in the last month, compared to their counterfactuals (p < 0.01). In the last study month, the rate of MO was significantly lower than its counterfactual (19.73 per 100 encounters lower, p < 0.01). Hispanic women had attributable reductions in their rates of MO that were twice that of White women. Statistically significant attributable reductions were also seen among Spanish speakers, publicly insured, and uninsured women. CONCLUSIONS: Implementation of this intervention bundle effectively reduced the monthly rate of MO and increased the prevalence of women who had initiated and completed the HPV vaccine series. The reduction of MO was most drastic among Hispanic, publicly insured and uninsured women compared to White and privately insured.

When Things Go Wrong: Examining the Frequency and Aftermath of Critical Incidents Among OBGYN Residents.

OBJECTIVE: To examine the frequency with which obstetrics and gynecology (OBGYN) residents experience critical incidents (CIs) during residency and participate in postincident debriefing. METHODS: A survey was conducted to examine the frequency of CIs during training, abilities of residents to cope with CIs, and the impact of postincident debriefing. RESULTS: Among the 27 residents who responded (93.1%), 82.6% reported involvement in one ormore CIs during residency. There was a statistically significant difference in the cumulative number of CIs experienced when stratified by level of training. Following a CI, 39.2% of residents reported having an opportunity to debrief and only 30.4% "always" had enough support to cope. Among those who had debriefed, 100% felt that it had helped them to process the incident. CONCLUSION: OBGYN residents frequently experience CIs during their training years. Postincident debriefing is not the norm but is desired and may help residents process difficult clinical situations.