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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., (Copyright © 2024 Elsevier Inc. All rights reserved.)

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.

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., (Copyright © 2023 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2023 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.)

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., Competing Interests: Financial Disclosure The authors did not report any potential conflicts of interest., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.)

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., (Copyright © 2023. Published by Elsevier Inc.)

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., Competing Interests: Conflicts of Interest The authors have no conflicts of interest to disclose., (Copyright © 2023. Published by Elsevier Inc.)

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., Competing Interests: CH holds two patents related to HIV prevention and is founder of Prionde Biopharma, LLC, an HIV prevention product company. RB serves as a consultant for Advanced Bioscience Laboratories (NIAID). RS is the recipient of grant funding from Gilead Sciences, Inc. and ViV Healthcare, managed by MedStar Health. MM is the recipient of grant funding from Gilead Sciences, Inc. and Merck. CH is the recipient of grant funding from Gilead Sciences, Inc. and Merck. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2023 Scott, Yu, Marzinke, Coleman, Hendrix and Bies.)

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., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2023 Izadi, Mmeje, Drabo, Perin, Martin and Coleman.)

Competing Interests: We declare no competing interests.

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., (Copyright © 2022 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

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.

Competing Interests: Financial Disclosure Jenell S. Coleman holds investments in a cannabis exchange-traded fund. The other author did not report any potential conflicts of interest.

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., Competing Interests: Conflict of Interest and Sources of Funding: M.E.T., K.A.C., J.H.B., T.L.N., and J.S.C. were supported by the National Institutes of Health R01HD092013. R.W. and J.S.C. were supported by R01HD092013-03S1. C.A.G. was supported by U54EB007958, National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health; and U-01 068613, National Institute of Allergy and Infectious Diseases, National Institutes of Health. Mycoplasma genitalium test kits were donated by Hologic. C.A.G. has received previous research grants from Hologic., (Copyright © 2021 American Sexually Transmitted Diseases Association. All rights reserved.)

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., Competing Interests: Financial Disclosure Jenell S. Coleman holds investments in a cannabis exchange-traded fund. The other authors did not report any potential conflicts of interest., (Copyright © 2022 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

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., Competing Interests: Conflict of Interest and Sources of Funding: This work was generously supported by an unrestricted grant from Hologic, Inc., to Johns Hopkins University and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (T32HD052459; principal investigator: M. Trent; funded: J. Ronda). Investigators M. Trent, J. Perin, and C.A. Gaydos were also supported by the National Institute of Nursing Research (5R01NR013507). Aside from this grant, Dr. Trent also receives research support through a material transfer agreement with SpeeDx, LLC, through Johns Hopkins University and serves on the Trojan Sexual Health Advisory Council (Church & Dwight, Inc.). Dr. Gaydos reports receiving research funding grants from Hologic and receiving speaker funding for educational lectures. The other coauthors declare that they have no competing interests., (Copyright © 2021 American Sexually Transmitted Diseases Association. All rights reserved.)

Purpose: The objectives of this study were to evaluate the feasibility and efficacy of fractional CO 2 laser therapy in gynecologic cancer survivors., Methods: This was a pilot, multi-institutional randomized sham-controlled trial of women with gynecologic cancers with dyspareunia and/or vaginal dryness. Participants were randomized to fractional CO 2 laser treatment or sham laser treatment. The primary aim was to estimate the proportion of patients who had improvement in symptoms based on the Vaginal Assessment Scale (VAS). Secondary aims included changes in sexual function assessed using the Female Sexual Functioning Index (FSFI) and urinary symptoms assessed using the the Urinary Distress Inventory (UDI-6)., Results: Eighteen women participated in the study, ten in the treatment arm and eight in the sham arm. The majority of participants had stage I (n = 11, 61.1 %) or II (n = 3, 16.7 %) endometrial cancer with adenocarcinoma histology (n = 9, 50 %). In total, 15 (83.3 %) of the participants completed all treatments and follow-up visit. There was no difference in the change in the median VAS score from baseline to follow-up. However, there was an improvement in change in the median total FSFI score with treatment compared with sham (Δ 6.5 vs -0.3, p = 0.02). The change in the median UDI-6 score was lower in the treatment arm (Δ -14.6 vs -2.1, p = 0.17), but this was not statistically significant. There were no reported serious adverse events., Conclusions: Fractional CO 2 laser therapy is feasible in gynecologic cancer survivors, with preliminary evidence of safety. In addition, there was preliminary evidence of improvement in sexual function compared with sham treatment. Clinicaltrial.gov Identifier: NCT03372720 (OSU-17261; NCI-2017-02051)., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Competing Interests: Financial Disclosure Charlotte A. Gaydos disclosed receiving funding and grant support from Hologic for an educational lecture and research on Mycoplasma genitalium. The other authors did not report any potential conflicts of interest.

Background: The rising incidence rates of sexually transmitted infections in the United States highlight the need for concurrent treatment of patients and their sexual partners. Expedited partner therapy allows healthcare providers to offer antibiotic prescriptions or medications to an index patient for distribution to their sexual partner(s) without evaluating the partner. We hypothesized that there was a gap between expedited partner therapy policy at the state level and its downstream implementation by community pharmacists., Objective: The objectives of our study were to evaluate pharmacists' expedited partner therapy knowledge and practices in 41 expedited partner therapy-permissible US states, to determine whether there were differences in practice based on the length of time expedited partner therapy was permissible in the state and chlamydia incidence rates, and to measure the cost of expedited partner therapy treatment., Study Design: A randomized cohort of pharmacists (n=335) was invited to complete a telephone interview from November 2017 through January 2018. Descriptive statistics were calculated and stratified by early, mid, and late expedited partner therapy-adopter status based on the year of the state's expedited partner therapy enactment and the state's chlamydia incidence rate. Fisher's exact test and 1-way analyses of variance were used to compare measures across strata., Results: We had 143 pharmacists (42.7%) agree to complete the survey. Among our respondents, 40.6% (n=58/143) indicated that they were aware of expedited partner therapy; 14.7% (n=21/143) reported that they had ever received an expedited partner therapy prescription, and 97% (n=139/143) reported that they would dispense an expedited partner therapy prescription if they received 1 in the future. These findings were stable across the 6 strata defined by early, mid, or late expedited partner therapy-adopter and high or low incidence rates of chlamydia status. Mean cost of azithromycin 1000 mg and cefixime 400 mg for treatment of chlamydia and gonorrhea was $22.17 (95% confidence interval, 20.29-24.05) and $30.46 (95% confidence interval, 28.65-32.26), respectively., Conclusion: Fewer than one-half of the pharmacists were aware of expedited partner therapy. A small minority of pharmacists reported ever having received an expedited partner therapy prescription, regardless of the length of time expedited partner therapy had been legal in their states and the incidence of chlamydia. However, almost all pharmacists reported that they would dispense an expedited partner therapy prescription if they received 1. Additionally, costs were high for expedited partner therapy for self-pay patients. These data suggest that there are opportunities to increase expedited partner therapy utilization by healthcare providers, patients, and pharmacists., (Copyright © 2020 Elsevier Inc. All rights reserved.)

The coronavirus disease 2019 pandemic has altered medical practice in unprecedented ways. Although much of the emphasis in obstetrics and gynecology to date has been on the as yet uncertain effects of coronavirus disease 2019 in pregnancy and on changes to surgical management, the pandemic has broad implications for ambulatory gynecologic care. In this article, we review important ambulatory gynecologic topics such as safety and mental health, reproductive life planning, sexually transmitted infections, and routine screening for breast and cervical cancer. For each topic, we review how care may be modified during the pandemic, provide recommendations when possible on how to ensure continued access to comprehensive healthcare at this time, and discuss ways that future practice may change. Social distancing requirements may place patients at higher risk for intimate partner violence and mental health concerns, threaten continued access to contraception and abortion services, affect prepregnancy planning, interrupt routine screening for breast and cervical cancer, increase risk of sexually transmitted infection acquisition and decrease access to treatment, and exacerbate already underlying racial and minority disparities in care and health outcomes. We advocate for increased use of telemedicine services with increased screening for intimate partner violence and depression using validated questionnaires. Appointments for long-acting contraceptive insertions can be prioritized. Easier access to patient-controlled injectable contraception and pharmacist-provided hormonal contraception can be facilitated. Reproductive healthcare access can be ensured through reducing needs for ultrasonography and laboratory testing for certain eligible patients desiring abortion and conducting phone follow-up for medication abortions. Priority for in-person appointments should be given to patients with sexually transmitted infection symptoms, particularly if at risk for complications, while also offering expedited partner therapy. Although routine mammography screening and cervical cancer screening may be safely delayed, we discuss society guideline recommendations for higher-risk populations. There may be an increasing role for patient-collected human papillomavirus self-samples using new cervical cancer screening guidelines that can be expanded considering the pandemic situation. Although the pandemic has strained our healthcare system, it also affords ambulatory clinicians with opportunities to expand care to vulnerable populations in ways that were previously underutilized to improve health equity., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Long-acting (LA) injectable antiretroviral therapy (ART) has been found non-inferior to daily oral ART in Phase 3 trials. LA ART may address key barriers to oral ART adherence and be preferable to daily pills for some people living with HIV. To date, women have been less represented than men in LA ART research. Using longitudinal data from the Women's Interagency HIV Study (WIHS) cohort of women living with HIV in the United States, we examined barriers and facilitators of daily oral ART adherence that may be related to or addressed by LA ART., Methods: We conducted a secondary analysis of WIHS cohort data from 1998 to 2017 among participants seen for at least 4 visits since 1998 who reported using ART at least once (n = 2601). Two dichotomous outcomes, patient-reported daily oral ART adherence and viral suppression were fit using generalized linear models, examining the role of socio-demographic and structural factors., Results: At study enrollment, the median age was 40.5 years, 63% of participants were African American and 22% were Latina. The majority (82%) reported taking ART more than 75% of the time and 53% were virally suppressed. In multivariate analysis, several sub-groups of women had lower odds of reported adherence and viral suppression: 1) younger women (adherence aOR: 0.71; viral suppression aOR: 0.63); 2) women who inject drugs (adherence aOR: 0.38; viral suppression aOR: 0.50) and those with moderate (adherence aOR: 0.59; viral suppression aOR: 0.74) and heavy alcohol consumption (adherence aOR: 0.51; viral suppression aOR: 0.69); 3) those with depressive symptoms (adherence aOR: 0.61; viral suppression aOR: 0.76); and 4) those with a history of going on and off ART (adherence aOR: 0.62, viral suppression aOR: 0.38) or changing regimens (adherence aOR: 0.83, viral suppression aOR: 0.56)., Conclusions: Current injectable contraceptive users (vs. non-users) had greater odds of oral ART adherence (aOR: 1.87) and viral suppression (aOR: 1.28). Findings identify profiles of women who may benefit from and be interested in LA ART. Further research is warranted focused on the uptake and utility of LA ART for such key subpopulations of women at high need for innovative approaches to achieve sustained viral suppression.

Practice guidelines on pre-exposure prophylaxis (PrEP) for HIV serodiscordant couples recommend PrEP when the viral load of the partner living with HIV is either detectable or unknown. However, adherence to combination antiretroviral therapy is inconsistent, and research has found that individuals vulnerable to HIV place value on additional protective barriers. We conducted a prospective cohort study to assess the feasibility, perceptions, and adherence associated with periconceptional PrEP use among females without HIV and their male partners living with HIV across four academic medical centers in the United States. We performed descriptive statistics, McNemar's test of marginal homogeneity to assess discordance in female/male survey responses, and Spearman's correlation to determine associations between dried blood spot levels and female self-reported adherence to PrEP. We enrolled 25 women without HIV and 24 men living with HIV (one male partner did not consent to the study). Women took PrEP for a median of 10.9 months (interquartile range 3.8-12.0) and were generally adherent. In total, 87% of women (20/23) had a dried blood spot with >700 fmol/punch or ≥4 doses/week, 4% (1/23) at 350-699 fmol/punch or 2-3 doses/week, and 9% (2/23) at <350 fmol/punch or <2 doses/week (correlation between drug levels and adherence is based on prior data). Dried blood spot levels closely aligned with self-reported adherence (Spearman's rho = 0.64, p  = 0.001). There were 10 pregnancies among 8 participants, 4 of which resulted in spontaneous abortions. There was one preterm delivery (36 5/7 weeks), no congenital abnormalities, and no HIV transmissions. Ten couples (40%) were either lost to follow-up or ended the study early. Overall, women attempting conception with male partners living with HIV in the United States are interested and able to adhere to PrEP as an additional tool for safer conception.

Bacterial vaginosis (BV), a condition in which the vaginal microbiota consists of community of obligate and facultative anaerobes rather than dominated by a single species of Lactobacillus, affects ~30% of women in the US. Women with BV are at 60% increased risk for HIV acquisition and are 3-times more likely to transmit HIV to an uninfected partner. As cervicovaginal mucus (CVM) is the first line of defense against mucosal pathogens and the home of the resident vaginal microbiota, we hypothesized the barrier function of CVM to HIV may be diminished in BV. Here, we characterized CVM properties including pH, lactic acid content, and Nugent score to correlate with the microbiota community composition, which was confirmed by 16S rDNA sequencing on a subset of samples. We then quantified the mobility of fluorescently-labeled HIV virions and nanoparticles to characterize the structural and adhesive barrier properties of CVM. Our analyses included women with Nugent scores categorized as intermediate (4-6) and BV (7-10), women that were either symptomatic or asymptomatic, and a small group of women before and after antibiotic treatment for symptomatic BV. Overall, we found that HIV virions had significantly increased mobility in CVM from women with BV compared to CVM from women with Lactobacillus crispatus-dominant microbiota, regardless of whether symptoms were present. We confirmed using nanoparticles and scanning electron microscopy that the impaired barrier function was due to reduced adhesive barrier properties without an obvious degradation of the physical CVM pore structure. We further confirmed a similar increase in HIV mobility in CVM from women with Lactobacillus iners-dominant microbiota, the species most associated with transitions to BV and that persists after antibiotic treatment for BV. Our findings advance the understanding of the protective role of mucus and highlight the interplay between vaginal microbiota and the innate barrier function mucus., Competing Interests: The authors have declared that no competing interests exist.

Adverse perinatal outcomes are a significant contributor to neonatal and infant deaths. Mental illness, substance use disorders, and interpersonal trauma are often prevalent within obstetrical populations. Previous literature has documented the individual associations between these psychosocial factors and adverse perinatal outcomes. The co-occurrence of these three psychosocial factors might represent a syndemic among pregnant women, although they have not been described as such in the literature. Analysis of the interrelatedness and aggregate effect of these factors may allow for a more effective screening process that may reduce adverse perinatal outcomes. The objective of this article is to examine whether psychosocial factors (mental illness, substance use disorders, and interpersonal trauma) were independently and synergistically associated with adverse perinatal outcomes. This is a retrospective cohort study of 1,656 pregnant women at a single institution. Perinatal outcome and psychosocial data were abstracted from each participant's electronic medical record. Univariate and bivariate analyses, and multiple logistic regression were performed. Mean age was 27.5 ( SD = 6.2) years. The majority was Black (60.6%) and single (58%). Psychosocial factors were reported in 35% of women. The incidence of adverse perinatal outcomes increased with greater number of psychosocial factors: 21.2% if no psychosocial factor, 27.0% if one psychosocial factor, 27.4% if two, and 35.3% if all three (for trend, p = .01). Women who reported all three psychosocial factors had twice the odds of adverse perinatal outcomes (adjusted odds ratio = 2.04, 95% confidence interval = [1.09, 3.81], p = .03) compared with those who reported none. Our data suggest there is a synergistic relationship between the psychosocial factors that is associated with increased adverse perinatal outcomes. A validated screening tool is needed to stratify patient's risk of adverse perinatal outcomes based on psychosocial factors. Such screening could lead to tailored interventions that could decrease adverse perinatal outcomes.

The success of fecal microbiota transplant (FMT) in treating recurrent Clostridioides difficile infection has led to growing excitement about the potential of using transplanted human material as a therapy for a wide range of diseases and conditions related to microbial dysbiosis. We anticipate that the next frontier of microbiota transplantation will be vaginal microbiota transplant (VMT). The composition of the vaginal microbiota has broad impact on sexual and reproductive health. The vaginal microbiota in the "optimal" state are one of the simplest communities, dominated by one of only a few species of Lactobacillus. Diversity in the microbiota and the concomitant depletion of lactobacilli, a condition referred to as bacterial vaginosis (BV), is associated with a wide range of deleterious effects, including increased risk of acquiring sexually transmitted infections and increased likelihood of having a preterm birth. However, we have very few treatment options available, and none of them curative or restorative, for "resetting" the vaginal microbiota to a more protective state. In order to test the hypothesis that VMT may be a more effective treatment option, we must first determine how to screen donors to find those with minimal risk of pathogen transmission and "optimal" vaginal microbiota for transplant. Here, we describe a universal donor screening approach that was implemented in a small pilot study of 20 women. We further characterized key physicochemical properties of donor cervicovaginal secretions (CVS) and the corresponding composition of the vaginal microbiota to delineate criteria for inclusion/exclusion. We anticipate that the framework described here will help accelerate clinical studies of VMT.

Background: Intimate partner violence (IPV) is a significant public health issue. Healthcare providers (e.g., nurses, advanced practice nurses, physicians, social workers) have a unique opportunity to prevent and reduce IPV through screening and referral. The objective of this project was to determine the impact of education and a brief screening tool integrated into the electronic medical record (EMR) on readiness to screen for IPV., Methods: An intervention was implemented that included the EMR integration of a screening tool, creation of an automated resource telephone system and healthcare provider IPV screening and response education. Readiness for screening was evaluated pre- and postintervention using the Domestic Violence Health Care Provider Survey Scale (DVHCPSS), which is scored cumulatively and by each of six domains. An unpaired Student's t test was performed., Results: Mean age (31-40 years of age) and years of clinical practice (11-15 years) was the same for pre- (n = 96) and postintervention (n = 83) survey respondents. There was an overall significant increase in screening readiness (p = .003) with significant improvement in "professional role resistance/fear of offending the patient" (p < .0001), "blame victim items" (p = .0029), "perceived self-efficacy" (p = .0064), and "victim/provider safety" (p = .003)., Linking Evidence to Action: Adopting and integrating a validated IPV screening tool into the EMR combined with education was associated with an improvement in overall readiness for IPV screening. Reducing and preventing IPV through universal screening and referral can be accomplished by embedding a standardized readily accessible validated IPV screening tool in the EMR., (© 2019 Sigma Theta Tau International.)

The scientific and ethical importance of including women of reproductive age in biomedical research is widely acknowledged. Concerns about preventing fetal exposure to research interventions have motivated requirements for contraception among reproductive aged women in biomedical studies-often irrespective of risks and benefits or a woman's actual potential for pregnancy, raising important questions about when such requirements are appropriate. The perspectives of women themselves on these issues are largely unexplored. We conducted 140 interviews, 70 in the U.S. and 70 in Malawi, with women either living with or at-risk for HIV, exploring their views about the practice of requiring contraception in clinical trials. A majority of women interviewed from both countries indicated overall support for the practice, with seven themes characterizing advantages and disadvantages raised: reproductive control, health effects, prevention of fetal harm, burden on women, deferral to authority, autonomy regarding enrollment and birth control method, and relationship concerns. While women in the US frequently raised prevention of fetal harm as a key advantage, many other positives noted by women in both countries were related to contraception use in general, not specific to a trial context. With regard to disadvantages, U.S. women tended to focus on biomedical risks such as side effects and impact on fertility, whereas Malawian women focused on the social risks of contraception requirements, including violations of trust in marital relations and suspicions of potential infidelity. Given the potential benefits and burdens highlighted, contraception in research should be sensitive to actual fetal risk assessments; directed where justified at optimizing effective pregnancy prevention; responsive to women's reproductive preferences; and made available as an ancillary benefit even where risk thresholds do not justify requirement-in order to facilitate trials that are both ethical and robustly oriented around the interests and lives of women who will participate in them., Competing Interests: The authors have declared that no competing interests exist.

To help eliminate perinatal HIV transmission, the US Department of Health and Human Services recommends against breastfeeding for women living with HIV, regardless of viral load or combined antiretroviral therapy (cART) status. However, cART radically improves HIV prognosis and virtually eliminates perinatal transmission, and breastfeeding's health benefits are well-established. In this setting, pregnancy is increasing among American women with HIV, and a harm reduction approach to those who breastfeed despite extensive counseling is suggested. We assess the evidence and ethical justification for current policy, with attention to pertinent racial and health disparities. We first review perinatal transmission and breastfeeding data relevant to US infants. We compare hypothetical risk of HIV transmission from breastmilk to increased mortality from sudden infant death syndrome, necrotizing enterocolitis and sepsis from avoiding breastfeeding, finding that benefits may outweigh risks if mothers maintain undetectable viral load on cART. We then review maternal health considerations. We conclude that avoidance of breastfeeding by women living with HIV may not maximize health outcomes and discuss our recommendation for revising national guidelines in light of autonomy, harm reduction and health inequities.

Introduction: Currently, the United States (U.S.) recommends that infants born to women living with HIV (WLHIV) be fed formula, whereas many low-resource settings follow the World Health Organization's recommendation to exclusively breastfeed with ongoing antiretroviral therapy. Evidence on infant feeding among WLHIV in high-resource countries suggest that these contrasting recommendations create challenges for providers and patients. Our study used multiple methods to understand providers' infant feeding perspectives on caring for their pregnant and post-partum WLHIV in the U.S., Methods: We sent a survey (n = 93) to providers across the U.S. who have cared for WLHIV. A subset of survey participants opted into a follow-up qualitative interview (n = 21). These methods allowed us to capture a broad understanding of provider attitudes via the survey and more nuanced qualitative interviews. The study was completed prior to an updated breastfeeding section of the U.S. Perinatal Guidelines., Results: The majority of providers (66.7%) discussed infant feeding intent with their patients using open-ended questions. Many also discussed alternative feeding methods (37.6%) and disclosure avoidance strategies (34.4%). Over 75% (95% confidence interval (CI): 65.1 to 84.2) of participants reported that a WLHIV asked if she could breastfeed her child, and 29% (95% CI 20 to 40.3) reported caring for a patient who breastfed despite recommendations against breastfeeding. Providers reported that their patients' primary concern was stigma associated with not breastfeeding (58%), while providers were primarily concerned about medication adherence during breastfeeding (70%). Through qualitative analysis, four overarching categories emerged that reflect providers' sentiments, including (1) U.S. guidelines inadequately addressing WLHIV's desire to breastfeed; (2) negotiating patient autonomy amidst complex feeding situations; (3) harm reduction approaches to supporting WLHIV in breastfeeding; and (4) providers anticipating multilayered patient stigmatization., Conclusions: The majority of provider respondents cared for a WLHIV who desired to breastfeed, and a third had WLHIV who breastfed despite recommendations against it. Providers found that the status of U.S. guidelines and their incongruity with WHO guidelines left them without adequate resources to support WLHIV's infant feeding decisions. Our findings provide important insight to inform professional associations' discussions about public health policy as they consider future directions for infant feeding guidelines among WLHIV., (© 2019 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.)

Frequent Pap testing is recommended among women living with HIV (WLWH) due to their elevated risk for cervical cancer. However, there are few recent longitudinal evaluations of utilization and determinants of Pap testing among WLWH. Medical and pathology records of WLWH seen at Johns Hopkins Hospital between 2005 and 2014 were assessed using Prentice, Williams, Peterson models. Of 554 WLWH in care for ≥ 18 months, 79% received Pap testing, however only 11% consistently received Pap testing at the recommended interval. Some women (5%) were consistently under-screened (tested at longer intervals) and 21% did not receive any Pap testing at during follow-up. WLWH with decreased likelihood of screening included older women, injection drug users, whites and those who had lived for longer with HIV. In contrast, only women with a prior abnormal Pap result were more likely to receive Pap testing. CD4 cell count and health insurance were not significant determinants. Although many WLWH in care received Pap testing, some WLWH were unscreened or underscreened. Determinants of Pap testing for WLWH include socio-demographic factors and a prior abnormal result; these present potential targets in an urban HIV care setting for closer monitoring and directed interventions to improve utilization among WLWH., (Copyright © 2018 The Authors. Published by Elsevier B.V. All rights reserved.)

Background: Mycoplasma genitalium (MG) is a common sexually transmitted infection (STI), but there are limited strategies to identify individuals at risk of MG. Previously, a sex risk quiz was used to predict STIs including Chlamydia trachomatis, Neisseria gonorrhoeae, and/or Trichomonas vaginalis. The original quiz categorized individuals 25 years or younger as at risk of STIs, but the Centers for Disease Control and Prevention identifies females younger than 25 years as at risk of STIs. In this study, the quiz was changed to categorize females younger than 25 years as high risk. The objective was to determine if the age-modified risk quiz predicted MG infection., Methods: A cross-sectional analysis of a prospective longitudinal study was performed including female adolescents and young adults (AYAs) evaluated in multiple outpatient clinics. Participants completed an age-modified risk quiz about sexual practices. Scores ranged from 0 to 10 and were categorized as low risk (0-3), medium risk (4-7), and high risk (8-10) based on the STI prevalence for each score. Vaginal and/or endocervical and/or urine specimens were tested for MG, T. vaginalis, C. trachomatis, and N. gonorrhoeae using the Aptima Gen-Probe nucleic amplification test., Results: There were 693 participants. Most participants reported having 0 to 1 sexual partners in the last 90 days (91%) and inconsistent condom use (84%). Multivariable logistic regression analysis controlling for race, education, and symptom status demonstrated that a medium-risk score predicted MG infection among AYAs younger than 25 years (adjusted odds ratio, 2.56 [95% confidence interval, 1.06-6.18])., Conclusion: A risk quiz may be useful during clinical encounters to identify AYA at risk of MG.

Women with disabilities are underscreened for cervical cancer compared with the general population, likely because, in part, of both emotional and physical challenges associated with Pap testing. Women with certain disabilities often require an examination under anesthesia to undergo a speculum examination. However, anesthesia is not without risks and the perioperative experience can be burdensome to patients and caregivers. Either self-collected or provider-collected samples for human papillomavirus (HPV) testing might be better tolerated by patients, and recent evidence suggests that it is a suitable primary screening strategy. The Society of Gynecologic Oncology and the American Society for Colposcopy and Cervical Pathology published an Interim Guidance Report outlining using primary HPV testing as an option for women 25 years and older. More recently, the US Preventive Services Task Force released a recommendation statement that included the option to use oncogenic HPV testing alone for women aged 30 to 65 years. We encourage clinical researchers and professional organizations to evaluate primary HPV screening among women with disabilities to advise providers about how to best perform cervical cancer screening without the need for a speculum examination. We cannot ignore the screening disparity experienced by this population, and advocating for screening approaches that reduce patient and caregiver burden would be a step in the right direction.

Clinical research to inform the evidence base to guide nonobstetrical care during pregnancy is critically important for the well-being of women and their future offspring. Conversations about regulations for such research, including whether paternal consent should ever be required, should be informed by the perspectives of those most affected, namely, pregnant women. We conducted in-depth interviews with 140 pregnant women living with or at risk of HIV-70 in Malawi, 70 in the United States-exploring their views on requiring paternal consent for pregnant women's participation in trials offering the prospect of direct benefit solely to the fetus. The majority of women supported such a requirement; others raised concerns. A trio of themes-the father's or pregnant woman's rights, fetal protection, and gender/relationship dynamics-characterized views both supporting and against a paternal consent requirement, expanding the range of considerations that should inform approaches to paternal involvement in research with pregnant women.

Objective: Research exploring the clinical and sexual risk correlates is essential to define universal standards for screening and management for Mycoplasma genitalium (MG). The objective of this study is to determine the baseline prevalence of MG and associated clinical risks using cross-sectional data., Methods: Adolescent and young adult women 13-29 years were recruited during clinical visits during which biological specimens were collected for Neisseriagonorrhoeae (NG) and Chlamydia trachomatis (CT) testing to provide vaginal specimens for MG and Trichomonasvaginalis (TV) testing. Demographic, clinical and sexual risk data were collected after obtaining written consent. MG was tested using the Hologic Gen-Probe transcription-mediated amplification-MG analyte-specific reagent assay and TV by the Aptima TV assay. Bivariate analyses were used to evaluate differences in MG prevalence based on pregnancy status, demographic factors, clinical symptoms, concurrent STI and sexual risk behaviour quiz score (maximum score=10)., Results: 483 patients with a mean age of 22.4 years (SD 3.6) were enrolled. Most participants were not pregnant (66%) and asymptomatic (59%). MG was the most common STI (MG 16%, TV 9%, CT 8%, NG 1%). Neither pregnancy nor symptoms were predictive of STI positivity. Thirty-five percent of non-pregnant and 45% of pregnant adolescents ≤19 years were positive for any STI. Participants with MG were 3.4 times more likely to be co-infected with other STIs compared with those with other STIs (OR 3.4, 95% CI 1.17 to 10.3, P=0.021). Mean risk quiz scores for STI positive women were six points higher than those who were STI negative (β=0.63, 95% CI 0.36 to 0.90, P<0.001). There were no differences in risk scores for MG-positive participants compared with other STI positivity., Conclusion: MG infection was common, associated with STI co-infection and often asymptomatic, and pregnancy status did not confer protection., Competing Interests: Competing interests: MT reports grants from Hologic, Inc, grants from National Institutes of Health, during the conduct of the study; personal fees and other from Church & Dwight, Inc, outside the submitted work. CAG reports grants from Hologic, Inc, grants from National Institutes of Health, during the conduct of the study., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Bacterial vaginosis (BV) is the most common cause of vaginal discharge in reproductive-age women. BV has been associated with poor reproductive outcomes such as preterm delivery, the acquisition of sexually transmitted infections, including HIV, and pelvic inflammatory disease. BV represents the acquisition of a diverse community of anaerobic and facultative bacteria and a reduction in lactobacilli. It can be diagnosed using several tests ranging from clinical indicators, point-of-care tests, and molecular assays. Molecular technologies are objective, are able to detect fastidious bacteria, enable quantitation, and are ideal for self-collected vaginal swabs. This paper reviews the currently available BV diagnostic tests in the United States., (Copyright © 2018 American Society for Microbiology.)

Background: Addressing record high rates of Chlamydia trachomatis incidence in the United States requires the utilization of effective strategies, such as expedited partner therapy, to reduce reinfection and further transmission. Expedited partner therapy, which can be given as a prescription or medication, is a strategy to treat the sexual partners of index patients diagnosed with a sexually transmitted infection without prior medical evaluation of the partners., Objective: There are multiple steps in the prescription-expedited partner therapy cascade, and we sought to identify pharmacy-level barriers to implementing prescription-expedited partner therapy for Chlamydia trachomatis treatment., Study Design: We used spatial analysis and ArcGIS, a geographic information system, to map and assess geospatial access to pharmacies within Baltimore, MD, neighborhoods with the highest rates of Chlamydia trachomatis (1180.25-4255.31 per 100,000 persons). Expedited partner therapy knowledge and practices were collected via a telephone survey of pharmacists employed at retail pharmacies located in these same neighborhoods. Cost of antibiotic medication in US dollars was collected., Results: Census tracts with the highest Chlamydia trachomatis incidence rates had lower median pharmacy density than other census tracts (26.9 per 100,000 vs 31.4 per 100,000, P < .001). We identified 25 pharmacy deserts. Areas defined as pharmacy deserts had larger proportions of black and Hispanic or Latino populations compared with non-Hispanic whites (93.1% vs 6.3%, P < .001) and trended toward higher median Chlamydia trachomatis incidence rates (1170.0 per 100,000 vs 1094.5 per 100,000, P = .110) than non-pharmacy desert areas. Of the 52 pharmacies identified, 96% (50 of 52) responded to our survey. Less than a fifth of pharmacists (18%, 9 of 50) were aware of expedited partner therapy for Chlamydia trachomatis. Most pharmacists (59%, 27 of 46) confirmed they would fill an expedited partner therapy prescription. The cost of a single dose of azithromycin (1 g) ranged from 5.00 to 39.99 US dollars (median, 30 US dollars)., Conclusion: Limited geographic access to pharmacies, lack of pharmacist awareness of expedited partner therapy, and wide variation in expedited partner therapy medication cost are potential barriers to implementing prescription-expedited partner therapy. Although most Baltimore pharmacists were unaware of expedited partner therapy, they were generally receptive to learning about and filling expedited partner therapy prescriptions. This finding suggests the need for wide dissemination of educational material targeted to pharmacists. In areas with limited geographic access to pharmacies, expedited partner therapy strategies that do not depend on partners physically accessing a pharmacy merit consideration., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Objective: Although preexposure prophylaxis with oral tenofovir (TFV) disoproxil fumarate/emtricitabine reduces HIV acquisition rates, poor adherence to and acceptability of daily vaginal gels have led to development of vaginal film formulations to improve adherence and, potentially, to enable episodic use., Study Design: In this 2-arm, cross-over study of a fast-dissolving tenofovir film (40 mg) compared with a previously studied semisolid tenofovir 1% gel (40 mg), 10 healthy women received a single vaginal dose of each study product. Clinical, pharmacokinetic, and antiviral assessments were performed over 1 week after dose., Results: Nine of 10 participants experienced mild to moderate adverse effects, similar between products, with no severe adverse events or events attributed to study products. TFV concentrations after film dosing exceeded concentrations after gel dosing in plasma between 8 and 24 hours (P ≤ 0.02). TFV concentrations in cervicovaginal fluid and both TFV and TFV diphosphate concentrations in cervical tissue homogenates were higher after film dosing (all P values < 0.04). The differences ranged from median (interquartile range) 2.9-fold (1.1, 9.0; midvaginal cervicovaginal fluid) to 4.4-fold (2.9, 7.7; plasma). Neither film nor gel demonstrated reduced cervical tissue biopsy infectivity after ex vivo HIV challenge., Conclusion: Single-dose tenofovir film demonstrated consistently higher concentrations in plasma and cervicovaginal samples when compared with gel during the first day after dosing. Single-dose cervical tissue TFV-diphosphate concentrations at 5 hours exceeded steady-state concentrations previously reported with daily oral Truvada dosing. Tenofovir film may provide an alternative to tenofovir oral and gel formulations. Clinical efficacy remains to be tested.

Objective: To estimate the proportion of women at increased risk of sexual human immunodeficiency virus (HIV) acquisition during pregnancy in a high HIV incidence urban setting to identify those who may be eligible for pre-exposure prophylaxis., Methods: We conducted a retrospective cohort study of women who received prenatal care at a large academic center in 2012. Univariable analyses and multiple logistic regression models were built to identify correlates for pre-exposure prophylaxis eligibility., Results: Among 1,637 pregnant women, mean age was 27.6 years (SD 6.3), 59.7% were African American, and 56.0% were single. Based on the Centers for Disease Control and Prevention's guidelines, more than 10% of women were at increased risk for HIV acquisition during pregnancy and eligible for pre-exposure prophylaxis. Younger [adjusted odds ratio (OR) 0.9/1-year increase, 95% CI 0.8-0.9], single (adjusted OR 2.4, 95% CI 1.2-4.8), African American women (adjusted OR 3.3, 95% CI 1.6-6.7) with higher parity (adjusted OR 1.3/one-child increase, 95% CI 1.1-1.5), and who smoked regularly during pregnancy (adjusted OR 1.8, 95% CI 1.0-3.0) had greater odds of being eligible for pre-exposure prophylaxis at any time during pregnancy., Conclusions: Pregnancy is a vulnerable period during which some heterosexual women in urban settings have a high risk for HIV acquisition and stand to benefit from pre-exposure prophylaxis.

While preexposure prophylaxis with oral tenofovir/emtricitabine reduces HIV acquisition rates, poor adherence to and acceptability of vaginal gels and the potential for evolving drug resistance have led to development of vaginal film formulations and other antiretroviral drugs, respectively, including the non-nucleoside reverse transcriptase inhibitor dapivirine. In this two-arm crossover study of a novel fast-dissolving dapivirine film and a previously studied semisolid dapivirine gel, 10 healthy women received a single 1.25 mg vaginal dose of each study product; one withdrew after the first dose. Clinical, pharmacokinetic, and antiviral pharmacodynamic assessments (ex vivo HIV-BaL challenge of tissue explants) were performed over 168 h postdose. Six of ten participants experienced mild to moderate adverse effects, similar between products, with no severe adverse events or adverse events attributed to study products. There were no statistically significant differences in plasma, cervicovaginal fluid (CVF), or cervical tissue dapivirine concentrations between the gel and film (all p > .05). CVF dapivirine concentrations were 1.5 and 6 log 10 greater than tissue and plasma concentrations, respectively (p < .001). Both film and gel demonstrated reduced cervical tissue infectivity after ex vivo HIV challenge 5 h postdose, compared to baseline and 72-h postdose biopsies (p < .05 for gel, p = .06 for film). There was no difference in ex vivo explant HIV challenge between gel and film. The dapivirine film and gel performed similarly in terms of tolerability, pharmacokinetics, and antiviral effect. Dapivirine film may provide an alternative to pharmacokinetically comparable dapivirine gel formulations. Effectiveness remains to be tested.

HIV testing is an effective intervention that is used for reducing perinatal HIV transmission. Centers for Disease Control and Prevention recommends a second HIV test during the third trimester of pregnancy for women in settings with an elevated HIV incidence (≥17 cases per 100,000 person-years). We conducted a retrospective cohort study at a single hospital in Baltimore, Maryland, to determine whether a second HIV test was done and to compare HIV retesting with mandated syphilis retesting. Of women who delivered at this hospital, 98.8% received prenatal care. Descriptive, bivariate, and multivariable analyses were performed. Among 1632 women, mean age was 27.6 years (standard deviation: 6.3), 59.6% were black, and 55.5% were single. HIV retesting was done in 28.4% of women, which was significantly less often compared with the state-mandated syphilis retesting (78.7%, p < 0.001). The odds of having an HIV retest were 15 times higher among women who received prenatal care at a teaching clinic [adjusted odds ratio (aOR): 15.58; 95% confidence interval (CI): 11.12-21.81], and they were lower among women with private insurance (aOR: 0.54, 95% CI: 0.34-0.86). The odds of having a syphilis retest were twice as high among women who received prenatal care at a faculty practice (aOR: 2.17; 95% CI: 1.53-3.09), and they were lower among women with private insurance (aOR: 0.61, 95% CI: 0.43-0.88). Emphasizing an "opt-out" HIV retesting approach through state laws may minimize risk perception, and this is one strategy that can be considered in areas of high HIV incidence to reach the goal of eliminating perinatal HIV transmission in the United States.

Background: The AmpliVue Trichomonas Assay (Quidel) is a new Federal Drug Administration-cleared rapid test for qualitative detection of Trichomonas vaginalis (TV) DNA in female vaginal specimens. The assay is based on BioHelix's helicase-dependent amplification isothermal technology in conjunction with a disposable lateral-flow detection device, with a total turnaround time of approximately 45 minutes., Objective: The objective of this study was to compare the performance of this new assay to wet preparation and culture as well as to another Federal Drug Administration-cleared nucleic acid amplification assay., Methods: Four clinician collected vaginal swabs were obtained from women attending sexually transmitted disease, family planning, and OB/GYN clinics and tested by AmpliVue Trichomonas Assay and comparator tests: saline microscopy, TV culture (InPouch), and Aptima TV. AmpliVue Trichomonas Assay results were compared with a composite positive comparator (CPC) as determined by the results from culture and/or wet mount microscopic examination. At least one of either the wet preparation or culture reference test results was required to be positive to establish CPC., Results: A total of 992 patients, 342 symptomatic and 650 asymptomatic patients, were included in the study. Results for AmpliVue for all women combined compared with saline microscopy and culture as a CPC yielded a sensitivity of 100%. Specificity for all women was 98.2%. Overall percent agreement versus Aptima TV was 97.8%. Sensitivity for AmpliVue compared with Aptima was 90.7% %, whereas specificity was 98.9%., Conclusions: The rapid AmpliVue Trichomonas Assay performed as well as microscopy and culture, and had comparable sensitivity and specificity to another nucleic acid amplification test for the detection of TV. This study provided evidence of new diagnostic options and indicated very good performance of amplified testing for detection of TV in symptomatic and asymptomatic women.

Objectives: We sought to evaluate preconception counseling (PCC) through a qualitative examination of the experiences of couples with serodiscordant human immunodeficiency virus (HIV) status desiring pregnancy., Methods: Patients involved in HIV-serodiscordant relationships who received PCC between January 2013 and January 2015 were recruited to participate in 40-minute semistructured telephone interviews. Participants were asked about their experiences with PCC and the impact of counseling on their knowledge of safer conception strategies and reproductive decisions. Two researchers independently coded interview transcripts, and delineated common ideas to generate emerging themes from participants' responses., Results: Eleven respondents completed the interviews, including nine women and two men. Six respondents were HIV positive. Our thematic analysis revealed that patients gained knowledge and confidence through PCC that conception was both possible and safe. They had varied reactions to assisted reproductive technologies that correlated with income level, and explored complicated weighing of personal risk of HIV transmission. Patients reported major challenges including poor access to PCC, difficulty identifying peak fertility periods, and lack of long-term conception follow-up., Discussion: PCC is a valuable resource for patients involved in HIV-serodiscordant relationships. We recommend the following opportunities for improvement: developing practical safer conception clinical and counseling guidelines for HIV-affected couples, increasing patient access to and awareness of PCC services, distributing more helpful resources to identify peak fertility, and providing long-term support for patients., (Copyright © 2015 Jacobs Institute of Women's Health. Published by Elsevier Inc. All rights reserved.)

Objective: To determine the feasibility of using quantitative changes in vaginal permeability to small molecules as a measure of candidate microbicide toxicity., Study Design: Controlled, open-labeled, prospective study. Seven healthy women received a single vaginal dose of hydroxyethylcellulose gel (HEC), nonoxynol-9 (N-9) or K-Y Jelly. Each gel was radiolabeled with a small molecule ((99m)Tc-DTPA) followed by 12-h blood and urine collection. Pharmacokinetic (PK) parameters of (99m)Tc-DTPA were calculated to compare the impact of each gel on vaginal permeability. Each woman served as her own control. The Friedman test with post hoc Wilcoxon test was used to detect differences among the gels., Results: Vaginal permeability of (99m)Tc-DTPA was highest for the N-9 radiolabel. N-9 plasma area under the concentration curve was 2.7-fold higher (p=.04), and peak concentration was threefold higher (p=.04) compared to HEC. There were no significant PK parameter differences between HEC and K-Y Jelly or between N-9 and K-Y Jelly. Cumulative dose-adjusted median (interquartile range) 12-h timed urine gamma activity was 66.70 × 10(-4)μCi (27.90-152.00) following HEC dosing, 103.00 × 10(-4)μCi (98.20-684.00) following N-9 gel dosing and 20.30 × 10(-4)μCi (11.10-55.90) following K-Y gel dosing. The differences between urine HEC and K-Y Jelly (p=.047) and between N-9 and K-Y Jelly (p=.016) were statistically significant., Conclusions: It is feasible to measure differences in vaginal permeability among vaginal gels using a radiolabeled small molecule, though there are permeability differences that require a nuanced understanding of gel composition to interpret the results., Implications: Establishing the safety of both vehicle and active pharmaceutical ingredient is an essential task in microbicide development, to be determined as soon as possible. This study suggests that a combination of microbicide toxicity assessments, that is, cervicovaginal permeability, inspection and histopathology, may need to be studied simultaneously., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: Minimizing time to HIV viral suppression is critical in pregnancy. Integrase strand transfer inhibitors (INSTIs), like raltegravir, are known to rapidly suppress plasma HIV RNA in nonpregnant adults. There are limited data in pregnant women., Objective: We describe time to clinically relevant reduction in HIV RNA in pregnant women using INSTI-containing and non-INSTI-containing antiretroviral therapy (ART) options., Study Design: We conducted a retrospective cohort study of pregnant HIV-infected women in the United States from 2009 through 2015. We included women who initiated ART, intensified their regimen, or switched to a new regimen due to detectable viremia (HIV RNA >40 copies/mL) at ≥20 weeks gestation. Among women with a baseline HIV RNA permitting 1-log reduction, we estimated time to 1-log RNA reduction using the Kaplan-Meier estimator comparing women starting/adding an INSTI in their regimen vs other ART. To compare groups with similar follow-up time, we also conducted a subgroup analysis limited to women with ≤14 days between baseline and follow-up RNA data., Results: This study describes 101 HIV-infected pregnant women from 11 US clinics. In all, 75% (76/101) of women were not taking ART at baseline; 24 were taking non-INSTI containing ART, and 1 received zidovudine monotherapy. In all, 39% (39/101) of women started an INSTI-containing regimen or added an INSTI to their ART regimen. Among 90 women with a baseline HIV RNA permitting 1-log reduction, the median time to 1-log RNA reduction was 8 days (interquartile range [IQR], 7-14) in the INSTI group vs 35 days (IQR, 20-53) in the non-INSTI ART group (P < .01). In a subgroup of 39 women with first and last RNA measurements ≤14 days apart, median time to 1-log reduction was 7 days (IQR, 6-10) in the INSTI group vs 11 days (IQR, 10-14) in the non-INSTI group (P < .01)., Conclusion: ART that includes INSTIs appears to induce more rapid viral suppression than other ART regimens in pregnancy. Inclusion of an INSTI may play a role in optimal reduction of HIV RNA for HIV-infected pregnant women presenting late to care or failing initial therapy. Larger studies are urgently needed to assess the safety and effectiveness of this approach., Competing Interests: The authors report no relevant financial conflicts of interest., (Copyright © 2016 Elsevier Inc. All rights reserved.)