Immunogenicity of 2-Dose HPV Vaccine Series for Postpartum Women: An Open-Label, Nonrandomized, Noninferiority Trial.

Importance: Postpartum human papillomavirus (HPV) vaccination is a promising strategy to increase HPV vaccination uptake in the US, particularly for reaching vaccine-naive women and those who lack health insurance beyond the pregnancy period. However, completion of the 3-dose vaccine regimen is challenging. Objective: To evaluate the immunogenicity of a 2-dose postpartum HPV vaccination regimen (0 and 6 months) and assess whether it is noninferior to a 3-dose postpartum HPV vaccination regimen (0, 1-2, and 6 months) administered to historical controls. Design, Setting, and Participants: A noninferiority, open-label, nonrandomized immunogenicity trial was conducted from August 4, 2020, to June 23, 2022, of postpartum patients aged 15 to 45 years who delivered at 2 hospitals in Baltimore, Maryland. Historical controls were adolescents and young women aged 16 to 26 years. Intervention: Two doses of the nonavalent HPV vaccine administered 6 months apart. Main Outcomes and Measures: The primary outcome was noninferiority (90% CI, lower bound >0.67) of the geometric mean titer (GMT) ratio for HPV-16 among postpartum women compared with historical controls. Secondary outcomes were noninferiority of GMT ratios for the other 8 HPV types and percentage seroconversion for each HPV type. As a noninferiority trial, the primary analysis used the per-protocol analysis. Results: Of 225 enrolled participants, the mean (SD) age at baseline was 29.9 (6.8) years, and 171 (76.0%) were HPV-16 seronegative at baseline. Of these 171 participants, 129 (75.4%) received a second vaccine dose and completed the subsequent 4-week serologic measurements. Relative to historical controls, the HPV-16 GMT ratio was 2.29 (90% CI, 2.03-2.58). At month 7, HPV-16 GMT was higher after the 2-dose regimen (7213.1 mMU/mL [90% CI, 6245.0-8331.4 mMU/mL]) than among historic controls after the 3-dose regimen (3154.0 mMU/mL [90% CI, 2860.2-3478.0 mMU/mL]). Similarly, the lower bound of the 90% CI of the GMT ratio was above 1 for the 8 HPV types 6, 11, 18, 31, 33, 45, 52, and 58. A total of 118 of 134 women (88.1%) seroconverted for HPV-16 after the first dose; 4 weeks after the second dose, the seroconversion rate was 99% or greater for all HPV types. Conclusions and Relevance: This study suggests that immunogenicity of a 2-dose HPV vaccination regimen given 6 months apart among postpartum women was noninferior to a 3-dose regimen among young historical controls. Most women seroconverted after the first dose of the 2-dose regimen. These results demonstrate that postpartum vaccination using a reduced schedule may be a promising strategy to increase HPV vaccine series completion. Trial Registration: ClinicalTrials.gov Identifier: NCT04274153.

"PrEPping" women's healthcare providers: motivational interviewing to support ending the HIV epidemic.

In 2018, cisgender women accounted for nearly 20% of new HIV infections, with women of color disproportionately affected. HIV pre-exposure prophylaxis uptake, adherence, and persistence are paramount to ending the HIV epidemic, but current strategies to promote it have not improved uptake among women. Alternatively, pre-exposure prophylaxis marketing and implementation have traditionally targeted men who have sex with men and transwomen. Women feel most comfortable turning to their primary care and reproductive health providers for HIV and pre-exposure prophylaxis counseling, but prescribing is the lowest among these providers. Thus, reframing pre-exposure prophylaxis counseling and education strategies is crucial to better engage providers and patients. Motivational interviewing is a person-centered counseling style for eliciting behavior change. Providers use 4 core skills-open-ended questions, affirmation, reflective listening, and summarizing-to empower individuals for behavior change, such as pre-exposure prophylaxis use. Motivational interviewing is brief, individualized, and effective in increasing pre-exposure prophylaxis uptake, regardless of patients' readiness to change. Primary care and reproductive health providers can employ motivational interviewing approaches with pre-exposure prophylaxis counseling to increase uptake among cisgender women and end the HIV epidemic.

Clinical trial simulation to evaluate tenofovir disoproxil fumarate/emtricitabine HIV pre-exposure prophylaxis dosing during pregnancy.

Objective: To evaluate upward-adjustment of tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) pre-exposure prophylaxis (PrEP) dosing during pregnancy in order to maintain target plasma concentrations associated with HIV protection. Design: Population pharmacokinetic (PK) modeling and clinical trial simulation (CTS). Material and methods: We developed population pharmacokinetic models for TFV and FTC using data from the Partners Demonstration Project and a PK study of TDF/FTC among cisgender women by Coleman et al., and performed an in-silico simulation. Pregnancy-trimester was identified as a significant covariate on apparent clearance in the optimized final model. We simulated 1,000 pregnant individuals starting standard daily oral TDF/FTC (300 mg/200 mg) prior to pregnancy. Upon becoming pregnant, simulated patients were split into two study arms: one continuing standard-dose and the other receiving double standard-dose throughout pregnancy. Results: Standard-dose trough TFV concentrations were significantly lower in pregnancy compared to pre-pregnancy, with 34.0%, 43.8%, and 65.1% of trough plasma concentrations below the lower bound of expected trough concentrations presumed to be the protective threshold in the 1st, 2nd, and 3rd trimesters, respectively. By comparison, in the simulated double-dose group, 10.7%, 14.4%, and 27.8% of trough concentrations fell below the estimated protective thresholds in the 1st, 2nd, and 3rd trimesters, respectively. The FTC trough plasma concentration during pregnancy was also lower than pre-pregnancy, with 45.2% of the steady-state trough concentrations below the estimated protective trough concentrations of FTC. In the pregnancy-adjusted double-dose group, 24.1% of trough plasma concentrations were lower than protective levels. Conclusions: Our simulation shows >50% of research participants on standard dosing would have 3rd trimester trough plasma TFV concentrations below levels associated with protection. This simulation provides the quantitative basis for the design of prospective TDF/FTC studies during pregnancy to evaluate the safety and appropriateness of pregnancy-adjusted dosing.

Utilizing Digital Health Technology to Increase Sexual Health Care Access: Youth Preferences on Self-Collect, Mail-In Sexually Transmitted Infection Testing in a High Sexually Transmitted Infection Prevalence Area.

PURPOSE: The COVID-19 pandemic highlighted the need for innovative approaches to delivering care. Self-collect, mail-in sexually transmitted infection (STI) testing could address barriers to in-person STI testing, particularly for youth, who bear a disproportionate burden of STIs. This study sought to obtain youth input on the development of a free self-collect, mail-in STI testing program. METHODS: Focus group discussions (n = 5, 45-60 minutes each) were conducted with 28 youth ages 14-19 years old living in Baltimore, Maryland. Focus group discussions were based on a conceptual framework of patient-centered health-care access, and a prototype online program was discussed. Transcribed data were coded thematically. Memos were written to synthesize findings and identify representative quotes. RESULTS: Participants noted existing barriers to in-person STI testing barriers including individual-level (e.g., lack of knowledge), interpersonal-level (e.g., stigma), and structural-level (e.g., financial). Although participants expressed concerns about self-collect, mail-in STI testing (e.g., accuracy of self-swabbing), there was overall acceptance of the program, and many felt it would address current barriers to testing. Opportunities to improve the testing program included all four steps of testing process: kit ordering, receipt of the kit and swabbing, post-testing experience, and communication of results and treatment. Specifically, participants desired expanded shipping options to schools, and mail drop-off points such as lockers and local convenience stores; more transparency about testing and treatment; and hearing directly from health-care providers to assuage any concerns. DISCUSSION: Self-collect, mail-in STI testing was favorable among youth, and could be a viable option for increasing youth access to STI testing.

Structural Racism and Adverse Pregnancy Outcomes Through the Lens of the Maternal Microbiome.

Microbiome science offers a glimpse into personalized medicine by characterizing health and disease states according to an individual's microbial signatures. Without a critical examination of the use of race as a variable, microbiome studies may be susceptible to the same pitfalls as other areas of science grounded in racist biology. We will examine the use of race as a biological variable in pregnancy-related microbiome research. Emerging data from studies that investigate the intestinal microbiome in pregnancy suggest strong influence of a poor diet on adverse pregnancy outcomes. Differences in the vaginal microbiome implicated in adverse pregnancy outcomes are frequently attributed to race. We review evidence that links systemic racism to pregnancy health outcome differences with a focus on the vaginal and intestinal microbiomes as well as diet. We also review how structural racism ultimately contributes to inequitable access to healthy food and higher risk environmental exposures among pregnant people of lower socioeconomic status and exacerbates common pregnancy comorbidities.

Association of Neighborhood Economic Status and Race With Developing Pelvic Inflammatory Disease After Sexually Transmitted Infections.

OBJECTIVE: To explore the association of neighborhood-level socioeconomic status (SES) and race with developing pelvic inflammatory disease (PID) after sexually transmitted infection (STI) among female adolescents and young adults in Maryland. METHODS: We used Maryland statewide hospital claims data (outpatient and inpatient visits) for this retrospective cohort study. Female adolescents and young adults aged 15-24 years who had at least one STI from July 1, 2013, to March 31, 2015, were included. A participant entered the cohort on the date of the first STI diagnosis and was followed up until PID occurrence or 3 years after the first STI. Median household income of the participant's residential ZIP code tabulation area was used as the neighborhood-level SES. Discrete-time hazard models were used to estimate the hazard of PID. RESULTS: Of the 2,873 participants, 88.5% were of Black race, and 67.2% were aged 20-24 years. The hazard of PID after an STI among Black women was 1.40 times that of White women (95% CI 1.06-1.85). After adjustment for age, insurance type, and number of STI events, the hazard ratio (HR) did not change. However, adding neighborhood-level SES to the model attenuated the disparity in PID after STI between Black and White women (HR 1.25, 95% CI 0.94-1.67). CONCLUSION: Racial disparities in PID diagnosis are mitigated by neighborhood-level SES.

Clinic-based interventions to increase preexposure prophylaxis awareness and uptake among United States patients attending an obstetrics and gynecology clinic in Baltimore, Maryland.

BACKGROUND: Cisgender women account for 1 of every 5 new US HIV diagnoses, with most cases (85%) attributed to heterosexual contact. HIV preexposure prophylaxis is an effective prevention strategy; however, preexposure prophylaxis awareness and prescriptions among women are low. OBJECTIVE: This study aimed to increase preexposure prophylaxis counseling and uptake among cisgender women attending obstetrics and gynecology clinics. STUDY DESIGN: The study included 3 obstetrics and gynecology clinics within a single health system in a high HIV prevalence region. There were 3 phases: baseline (the 3-month period before the clinical trial that included provider education and training of a registered nurse about preexposure prophylaxis), clinical trial (the 3-month period during which eligible patients were randomized to an active control or preexposure prophylaxis registered nurse intervention), and maintenance (the 3-month period after the trial ended). Electronic medical record clinical decision support tools were available to both arms during the clinical trial, which included best practice alerts, order sets, progress note templates, and written and video preexposure prophylaxis educational materials for patients. In the intervention arm, a preexposure prophylaxis nurse contacted and counseled patients and was equipped to prescribe preexposure prophylaxis. Moreover, this study evaluated the phases through the "reach, effectiveness, adoption, implementation, and maintenance" framework. The primary outcome of the study was effectiveness (eg, percentage of eligible patients with documented HIV prevention counseling in the electronic medical record or preexposure prophylaxis prescriptions). The secondary outcomes included reach (eg, percentage of best practice alerts that providers acted on or the percentage of eligible patients who spoke with the preexposure prophylaxis registered nurse), adoption (eg, percentage of eligible patients with a best practice alert that triggered or the percentage of eligible patients the preexposure prophylaxis registered nurse attempted to contact), and maintenance (eg, percentage of patients with documented HIV prevention counseling or preexposure prophylaxis prescriptions during the maintenance phase). RESULTS: There were 904 unique patients in all phases with a mean age of 28.8±7.7 years, and 416 patients (46%) were pregnant; moreover, 436 patients were randomized in the clinical trial phase. Concerning reach and adoption, best practice alerts were triggered for 100% of eligible encounters; however, the providers acted on 52% of them. The preexposure prophylaxis nurse attempted to contact every patient and successfully spoke with 81.2% of them in the preexposure prophylaxis registered nurse arm. Concerning effectiveness, there were significantly more patients counseled about preexposure prophylaxis in the preexposure prophylaxis registered nurse group than in the active control group (66.5% vs 12.3%, respectively; P<.001), although preexposure prophylaxis prescriptions were equivalent (P=1.0). Among the subgroup of patients who were counseled about preexposure prophylaxis, 18.5% of patients in the active control arm and 3.4% in the preexposure prophylaxis registered nurse arm were prescribed preexposure prophylaxis (P=.02). Concerning maintenance, clinical decision support tools alone resulted in preexposure prophylaxis counseling of 1.0% of patients during the maintenance phase vs 0.6% of patients during the baseline phase and 11.2% of patients during the clinical trial phase (P<.001). Preexposure prophylaxis prescriptions were not statistically different among the 3 phases (P=.096). CONCLUSION: A preexposure prophylaxis nurse effectively increased HIV prevention discussions but did not lead to more preexposure prophylaxis prescriptions than the preexposure prophylaxis-focused clinical decision support tools used by providers. The decrease in preexposure prophylaxis counseling after the trial phase suggests that persistent interventions are needed to maintain effects.

Through Their Eyes: Youth Perspectives on Sexual and Reproductive Health Barriers and Facilitators in Baltimore, Maryland.

PURPOSE: Youth face barriers to sexual and reproductive health (SRH). Few states require the delivery of comprehensive sex education in schools, and youth report challenges with accessing clinical care. We sought to identify youth's perceived barriers and facilitators to SRH in their communities. METHODS: We utilized photovoice, a community-based participatory research methodology. Youth were recruited from high schools in Baltimore, Maryland. Participants were given a tutorial on Photovoice methodology and photography. In groups of 5-7 participants, youth brainstormed questions relevant to their perspective of SRH. Three months were allocated to taking photographs. Participants wrote brief narratives to accompany their photographs, and group level assessment was used for participants to comment on others' photographs. Participants discussed the narratives and comments, created themes, and generated action steps to address barriers to SRH. Further thematic analysis was conducted using NVivo. RESULTS: There were 30 participants aged 14-19 years with 26 self-identifying as female and four nonbinary. Self-identified race/ethnicity included 50% Black/African American, 30% Asian American, and 20% White or Hispanic/Latino. Four domains emerged: desire for societal-level change, community-level change, peer-level change, and positive examples of SRH within their communities (e.g., gender-inclusive spaces and free menstrual products). DISCUSSION: Youth photographs shed light on a strong desire for an improved school environment, in terms of safety, cleanliness, gender-inclusivity, menstrual product access, and SRH education.

An effectiveness-implementation trial protocol to evaluate PrEP initiation among U.S. cisgender women using eHealth tools vs. standard care.

Background: The United States' (U.S.) initiative to End the HIV Epidemic aims to reduce new HIV infections in areas of high HIV prevalence. Despite national efforts to reduce HIV incidence, cisgender women continue to represent approximately one out of every five new HIV diagnoses in the U.S. Taking pre-exposure prophylaxis (PrEP) is an effective HIV prevention strategy; however, PrEP initiation among cisgender women is suboptimal, with only 10% of eligible women receiving PrEP prescriptions in 2019. Methods: We designed a trial to test the effectiveness of interventions to increase PrEP initiation, while evaluating the implementation strategy (hybrid type II trial) in seven obstetrics and gynecology (OB/GYN) clinics (two federally qualified health centers, three community-based, and two academic) in Baltimore, Maryland. A total of 42 OB/GYN providers will be enrolled and randomized (1:1:1) into one of three clinical trial arms (standard of care, patient-level intervention, or multi-level intervention). Eligible patients of enrolled providers will receive a sexual health questionnaire before their appointment through the electronic health record's (EHR) patient portal. The questionnaire will be scored in three tiers (low, moderate, and high) to assess HIV risk. Patients at low risk will be offered an HIV test only, while those who score medium or high risk will be included in the clinical trial and assigned to the clinical trial arm associated with their provider. Differences in PrEP initiation, our primary outcome, across the three arms will be analyzed using generalized linear mixed-effect models with logistic regression. We will adjust results for demographic differences observed between arms and examine PrEP initiation stratified by patient's and provider's race and ethnicity.Additionally, a comprehensive economic analysis for each intervention will be conducted. Discussion: We hypothesize that gathering information on sensitive sexual behaviors electronically, communicating HIV risk in an understandable and relatable format to patients and OB/GYN providers, and deploying EHR alerts will increase PrEP initiation and HIV testing. Trial Registration: The trial is registered with ClinicalTrials.gov (NCT05412433) on 09 June 2022. https://clinicaltrials.gov/ct2/show/NCT05412433?term=NCT05412433&draw=2&rank=1.

Advancing Access to Care through Digital Health: Perspectives from Youth on a Novel Platform to Increase Access to Sexual and Reproductive Health Care and Education for Adolescents and Young Adults.

STUDY OBJECTIVE: Youth account for half of new sexually transmitted infections (STIs) in the United States annually. Barriers to STI prevention include a lack of accurate sexual and reproductive health (SRH) education and low STI testing. We sought to obtain youth feedback on a digital health platform prototype designed to address these barriers. METHODS: The platform prototype included SRH content, free STI testing and treatment, and anonymous question submission. Five focus group discussions, each lasting 45-60 minutes with 5-6 youth living in a high-prevalence STI region (Baltimore, Maryland), were conducted. Thematic analysis was conducted. RESULTS: There were 28 participants with a mean age of 15.9 years (range 14-19), among whom 89% self-identified as female, 57% Black/African American, 29% Asian American, 14% White, and 7% Hispanic/Latino. Youth felt that the prototype platform was comprehensive and understandable. They suggested adding peer reviews to increase trustworthiness. CONCLUSION: Youth reported that the platform (violetproject.org) was an acceptable tool for SRH education and STI testing. Participants expressed enthusiasm and willingness to use the platform as a reliable SRH educational tool to combat medical misinformation on the Internet and a non-clinic-based source of STI testing. This platform could fill gaps in access to SRH care and education for youth.

Understanding Perceived Risks and Sexual Behavior Among Adolescents and Young Adults During the COVID-19 Pandemic.

PURPOSE: We sought to describe the relationship between COVID-19 risk perception and sexual behaviors among urban adolescents and young adults (AYA). METHODS: Data were collected from 159 urban AYAs on COVID-19 risk perception, COVID-19 infections and deaths, romantic relationships, and sexual behavior during the stay-at-home order using a telephone survey. RESULTS: Seventy-nine percent of the study participants engaged in sexual intercourse during the stay-at-home order. Only 38% of these used condoms during their last sexual encounter. Experiencing COVID-19 positivity within their social circle was not related to COVID-19 testing. Concern for COVID-19 infection or experiencing a COVID-19 diagnosis or death in one's social circles was not associated with sexual intercourse or condom use. DISCUSSION: Urban AYA remained at risk for sexually transmitted infections, and COVID-19, given high baseline community rates of sexually transmitted infections and COVID-19, low condom use, and low COVID-19 risk perception at the time of the survey.

Interaction of Depot Medroxyprogesterone Acetate and Tenofovir Disoproxil Fumarate/Emtricitabine on Peripheral Blood Mononuclear Cells and Cervical Tissue Susceptibility to HIV Infection and Pharmacokinetics.

BACKGROUND: Depot medroxyprogesterone acetate (DMPA) is a widely used contraceptive method. HIV pre-exposure prophylaxis with emtricitabine and tenofovir disoproxil fumarate (F/TDF) is highly effective in reducing HIV acquisition in women. We sought to determine the impact of DMPA on F/TDF pharmacokinetics and pharmacodynamics. METHODS: Twelve healthy premenopausal cisgender women were enrolled and each completed 4 sequential conditions: (1) baseline, (2) steady-state F/TDF alone, (3) steady-state F/TDF + DMPA, and (4) DMPA alone. Assessments included clinical, pharmacokinetic, viral infectivity (ex vivo challenge of peripheral blood mononuclear cells by X4- and R5-tropic green fluorescent protein pseudoviruses and cervical tissue by HIV BaL ), endocrine, immune cell phenotyping, and renal function. RESULTS: Compared with baseline, F/TDF (± DMPA) significantly decreased both %R5- and X4-infected CD4 T cells and F/TDF + DMPA decreased cervical explant p24 (all P < 0.05). The %R5- and X4-infected CD4 T cells were higher during DMPA alone than during F/TDF periods and lower than baseline (not statistically significant). Cervical explant p24 fell between baseline and F/TDF values (not statistically significant). There were neither statistically significant differences in F/TDF pharmacokinetics, including total or renal clearance of either antiviral drug, nor changes in glomerular filtration rate with the addition of DMPA. There were few immune cell phenotypic differences across conditions. CONCLUSIONS: F/TDF decreased HIV infection in both challenge assays, whereas DMPA alone did not enhance HIV infection in either challenge assay. DMPA did not alter F/TDF pharmacokinetics or renal function.

Provider Perspectives on HIV Pre-Exposure Prophylaxis Service Disruptions and Adaptations During the COVID-19 Pandemic in Baltimore, Maryland: A Qualitative Study.

The COVID-19 pandemic continues driving unprecedented disruptions to health care provision, including HIV pre-exposure prophylaxis (PrEP) services. We explored service provider experiences promoting and prescribing PrEP to marginalized populations during the COVID-19 pandemic in Baltimore, Maryland. In February to April 2021, we facilitated four virtual focus group discussions with 20 PrEP providers, representing various professional cadres and practice settings. Employing an iterative, team-based thematic analysis, we identified salient enablers and constraints to PrEP promotion, initiation, and maintenance in the COVID-19 era, along with innovative adaptations to PrEP service delivery. Discussants described attenuated demands for PrEP early in the pandemic, exemplified by high PrEP discontinuation rates. This was attributed to changes in clients' sexual behaviors and shifting priorities, including caregiving responsibilities, during the pandemic. Substantial systems-level disruptions impacting PrEP provision were identified, including outreach service suspension, personnel shortages, and facility restrictions on face-to-face visits. Providers emphasized that these disruptions, though occurring early in the pandemic, had protracted impacts on PrEP accessibility. The transition to telemedicine rendered health care services, including PrEP, more accessible/convenient to some clients and expeditious to providers. However, structural barriers to telehealth engagement (telephone/internet access), coupled with limitations of the virtual care environment (difficulty establishing rapport), impeded efforts to equitably promote and prescribe PrEP. Expanding the PrEP outreach workforce and availing alternatives to telemedicine (e.g., community-based PrEP provision, specimen self-collection) could facilitate PrEP care continuity, especially as COVID-19 transitions from an acute to a protracted health crisis.

Developing Educational Animations on HIV Pre-exposure Prophylaxis (PrEP) for Women: Qualitative Study.

BACKGROUND: Despite experiencing the second-highest rate of HIV incidence in the United States, pre-exposure prophylaxis (PrEP) use remains low among Black women due, in part, to a lack of patients' awareness and providers' knowledge. OBJECTIVE: Our goal was to design animated educational tools informed by patients and women's health providers to address these barriers, specifically for women at risk for HIV. METHODS: Two animation storyboards about PrEP for women were created by academic stakeholders (eg, HIV clinical experts, educators, and HIV peer counselors), one for patients and one for providers. Four focus groups with community members from Baltimore, Maryland and four with women's health providers (eg, obstetrician/gynecologists, midwives, nurse practitioners, and peer counselors) at an academic center were conducted to discuss the storyboards. Transcripts were analyzed using conventional content analysis, and themes were incorporated into the final versions of the animations. RESULTS: Academic stakeholders and 30 focus group participants (n=16 female community members and n=14 women's health providers) described important themes regarding PrEP. The themes most commonly discussed about the patient animation were understandability of side effects, HIV risk factors, messaging, PrEP access, and use confidence. Provider animation themes were indications for PrEP, side effects, and prescribing confidence. CONCLUSIONS: We created two PrEP animations focused on women. Stakeholder feedback highlighted the importance of ensuring the understandability and applicability of PrEP educational materials while including necessary information to facilitate use or prescribing confidence. Both community members and women's health providers reported greater use confidence after viewing the animations.

Medical Cannabis for Gynecologic Pain Conditions: A Systematic Review.

OBJECTIVE: The endocannabinoid system is involved in pain perception and inflammation. Cannabis contains delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD), which are cannabinoids that bind to endocannabinoid system receptors. A fatty acid amide called palmitoylethanolamide (PEA) enhances endogenous cannabinoids. Given that use of medical cannabis is increasing, we sought to characterize patterns of cannabis use for gynecologic pain and its effectiveness as an analgesic. DATA SOURCES: We searched PubMed, EMBASE, Scopus, Cochrane, and ClinicalTrials.gov using terms for "woman," "cannabis," and "pain" or "pelvic pain" or "endometriosis" or "bladder pain" or "cancer." The search was restricted to English-language articles published between January 1990 and April 2021 and excluded animal studies. METHODS OF STUDY SELECTION: The initial search yielded 5,189 articles with 3,822 unique citations. Studies were included if they evaluated nonpregnant adult women who used cannabinoids for gynecologic pain conditions (eg, chronic pelvic pain, vulvodynia, endometriosis, interstitial cystitis, malignancy). Study types included were randomized controlled trials (RCTs), cohort studies, and cross-sectional studies. Covidence systematic review software was used. TABULATION, INTEGRATION, AND RESULTS: Fifty-nine studies were considered for full review, and 16 met inclusion criteria. Prevalence of cannabis use ranged from 13% to 27%. Most women ingested or inhaled cannabis and used cannabis multiple times per week, with dosages of THC and CBD up to 70 mg and 2,000 mg, respectively. Sixty-one to 95.5% reported pain relief. All six prospective cohort studies and one RCT of PEA-combination medications reported significant pain relief, and the average decrease in pain after 3 months of treatment was 3.35±1.39 on the 10-point visual analog scale. However, one fatty acid amide enzyme inhibitor RCT did not show pain reduction. CONCLUSION: Survey data showed that most women reported that cannabis improved pain from numerous gynecologic conditions. Cohort studies and an RCT using PEA-combination medications reported pain reduction. However, interpretation of the studies is limited due to varying cannabis formulations, delivery methods, and dosages that preclude a definitive statement about cannabis for gynecologic pain relief. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42021248057.

Mycoplasma genitalium Infection Is Not Associated With Genital Tract Inflammation Among Adolescent and Young Adult Women in Baltimore, Maryland.

BACKGROUND: Mycoplasma genitalium (MG) is a prevalent sexually transmitted infection, but little is known about the associated inflammatory signatures in the genital tract of adolescents and young adult women. METHODS: Adolescents and young adult women aged 13 to 24 years were recruited. Demographic information, sexual behavior history, and medical history were collected. Vaginal swab samples were tested for MG, Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, bacterial vaginosis, and measurement of 13 cytokines, chemokines, and antimicrobial proteins. Vaginal cytokine concentrations were compared by MG infection status. The strength of associations between multiple factors and MG infection was evaluated. RESULTS: Of 215 participants, 16.7% (95% confidence interval [CI], 12.0%-22.4%) had MG infection. Inflammation was not associated with MG infection (P > 0.05). M. genitalium infection was associated with C. trachomatis infection (adjusted prevalence ratio [aPrR], 3.02; 95% CI, 1.69-5.39), bisexual behavior in the past 3 months (aPrR, 2.07; 95% CI, 1.18-3.64), genitourinary symptoms (aPrR, 2.06; 95% CI, 1.22-3.49), and self-reported Black race (aPrR, 3.53; 95% CI, 1.11-11.18). CONCLUSIONS: Higher levels of genital tract cytokines were not associated with MG infection. C. trachomatis infection, bisexual behavior, self-reported Black race, and genitourinary symptoms were associated with an increased likelihood of MG infection.

Pregnant Individuals' Views on Fetal Tissue Research in the United States.

OBJECTIVE: Fetal tissue research has driven significant medical advances but remains publicly contentious in the United States. The views of pregnant individuals in the United States regarding the donation of fetal tissue offer an important and previously unexplored perspective on this issue. METHODS: We conducted a secondary analysis of data from two separate, broader qualitative studies. Pregnant and recently pregnant individuals (N=79) from clinical sites at the University of North Carolina at Chapel Hill, Johns Hopkins University, and Massachusetts General Hospital were interviewed individually using a semi-structured guide addressing a range of issues related to infectious disease research and pregnancy, including the acceptability of fetal tissue research. Interviews were transcribed, coded, and analyzed for emergent themes. RESULTS: Among this sample of predominantly Black (61%), reproductive-aged pregnant and recently pregnant participants, the majority (72%) generally supported fetal tissue research. The following three themes were identified: choice, respect, and meaning. Respondents discussed the deeply personal nature of decisions surrounding fetal tissue research, emphasizing the importance of informed consent and respect for the person's emotional state when approaching for consent. The ways in which participants regarded how to respectfully handle fetal tissue also shaped views about the acceptability of donation, both for and against. For many participants, fetal tissue donation to research represented one way of ascribing meaning to pregnancy termination or loss. CONCLUSION: Among this diverse sample of pregnant and recently pregnant individuals, most were supportive of fetal tissue donation for research. A better understanding of pregnant individuals' views on this topic may lead to policies and practices that are congruent with the needs and values of people facing decisions regarding the disposition of fetal remains.

Maternal and Fetal Outcomes in an Observational Cohort of Women With Mycoplasma genitalium Infections.

BACKGROUND: Despite evidence that Mycoplasma genitalium (MG) is a risk factor for adverse outcomes in pregnancy, screening in pregnant women is not currently recommended. METHODS: Pregnant women between the ages of 13 and 29 years were recruited during their routine prenatal visits, screened for sexually transmitted infections (STIs) and followed for 1 year. We compared women with MG to those with no STIs, excluding women with STIs other than MG (Chlamydia trachomatis [CT], Neisseria gonorrhoeae [NG], or Trichomonas vaginalis [TV]) unless they were also codiagnosed with MG. Adverse outcomes were extracted from participants' medical records and compared between women with MG and those without STIs using exact or nonparametric approaches. Estimated differences were also adjusted for demographics using propensity scores with linear and logistic regression, where appropriate. We exclude women with MG and CT, NG, or TV diagnosis for primary analysis. RESULTS: Of 281 participants enrolled from September 2015 until July 2019, 51 (18.1%) were diagnosed with MG. Of 51 women with MG, 12 (24%) were also diagnosed with CT, NG, or TV. All women with MG were offered treatment with azithromycin; however, only 28 (55%) were documented to receive treatment. Women with MG had similar outcomes to those with no STIs with a few exceptions. Average birth weight was lower among women with MG alone compared with women with no STIs when excluding coinfections (169-g difference, 15-323). CONCLUSIONS: Our results indicate that MG is common in pregnant women and often presents as a coinfection. More research using population-based designs is needed to determine whether screening or treatment for women at risk for low birth weight or coinfections is warranted.