"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.

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.

The cervicovaginal mucus barrier to HIV-1 is diminished in bacterial vaginosis.

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.

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.

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.

Breakdown in the expedited partner therapy treatment cascade: from reproductive healthcare provider to the pharmacist.

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.

Special ambulatory gynecologic considerations in the era of coronavirus disease 2019 (COVID-19) and implications for future practice.

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.

Examining adherence barriers among women with HIV to tailor outreach for long-acting injectable antiretroviral therapy.

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.

Improving Provider Readiness for Intimate Partner Violence Screening.

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.

Molecular Diagnosis of Bacterial Vaginosis: an Update.

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.

Clinical and sexual risk correlates of Mycoplasma genitalium in urban pregnant and non-pregnant young women: cross-sectional outcomes using the baseline data from the Women's BioHealth Study.

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 (ß=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.

Does the Sex Risk Quiz Predict Mycoplasma genitalium Infection in Urban Adolescents and Young Adult Women?

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.

Pharmacy-level barriers to implementing expedited partner therapy in Baltimore, Maryland.

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.

Cervical Cancer Screening for Women With Disabilities: Time for a New Approach?

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.

Rapid Diagnosis of Trichomonas vaginalis by Testing Vaginal Swabs in an Isothermal Helicase-Dependent AmpliVue Assay.

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.

Integrase inhibitors in late pregnancy and rapid HIV viral load reduction.

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.

An Insight Into Cervical Cancer Screening and Treatment Capacity in Sub Saharan Africa.

OBJECTIVE: Approximately 85% of cervical cancer cases and deaths occur in resource-constrained countries where best practices for prevention, particularly for women with HIV infection, still need to be developed. The aim of this study was to assess cervical cancer prevention capacity in select HIV clinics located in resource-constrained countries. MATERIALS AND METHODS: A cross-sectional survey of sub-Saharan African sites of 4 National Institutes of Health-funded HIV/AIDS networks was conducted. Sites were surveyed on the availability of cervical cancer screening and treatment among women with HIV infection and without HIV infection. Descriptive statistics and χ or Fisher exact test were used as appropriate. RESULTS: Fifty-one (65%) of 78 sites responded. Access to cervical cancer screening was reported by 49 sites (96%). Of these sites, 39 (80%) performed screening on-site. Central African sites were less likely to have screening on-site (p = .02) versus other areas. Visual inspection with acetic acid and Pap testing were the most commonly available on-site screening methods at 31 (79%) and 26 (67%) sites, respectively. High-risk HPV testing was available at 29% of sites with visual inspection with acetic acid and 50% of sites with Pap testing. Cryotherapy and radical hysterectomy were the most commonly available on-site treatment methods for premalignant and malignant lesions at 29 (74%) and 18 (46%) sites, respectively. CONCLUSIONS: Despite limited resources, most sites surveyed had the capacity to perform cervical cancer screening and treatment. The existing infrastructure of HIV clinical and research sites may provide the ideal framework for scale-up of cervical cancer prevention in resource-constrained countries with a high burden of cervical dysplasia.

Over-screening for chlamydia and gonorrhea among urban women age ≥25 years.

OBJECTIVE: The purpose of this study was to determine the prevalence of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) in older women who are at increased risk of sexually transmitted infections (STIs) based on community STI prevalence. Additionally, we explored the associations between STI risk factors and CT/NG to determine the percentage of women who were over-screened. STUDY DESIGN: We conducted a retrospective chart review of women ≥25 years old who were either tested or screened for CT/NG during a gynecology visit at an urban teaching institution. Pregnancy and HIV infection were exclusion criteria. Descriptive statistics, univariate analyses, and logistic regression were performed. RESULTS: Of 658 eligible women, the median age of those positive for CT/NG was 30 years (range, 26-41 years). Chlamydia and gonorrhea prevalence was 1.7% (11/658 women) and 0.3% (2/658 women), respectively. All positive results were captured by testing women of any age who reported symptoms or an STI exposure and by screening women who were ≤40 years old. After adjustment of data for age, we found that symptomatic women were 3 times more likely to test positive for CT/NG (adjusted odds ratio, 3.4; 95% confidence interval, 1.1-10.3) and that STI-exposed women were 10 times more likely to test positive for CT/NG (adjusted odds ratio, 10; 95% confidence interval, 1.9-52.5). In asymptomatic non-STI-exposed women, nonmonogamous relationship (P = 1.0), abnormal examination results (P = 1.0), and previous STI (P = .35) were not associated with CT/NG. Over-screening occurred in 21% of women (141/658), all of whom were menopausal, had a hysterectomy, or were >40 years old. CONCLUSION: CT/NG prevalence among older women was low, even in a community of high STI prevalence. More than 20% of women could have avoided CT/NG evaluation without impacting the detection of positive results in our clinic cohort. Over-screening occurred among asymptomatic, non-STI-exposed women who were menopausal, had a hysterectomy, and were >40 years old.

Preconception counseling and care in the setting of HIV: clinical characteristics and comorbidities.

OBJECTIVE: To describe the demographic and clinical characteristics of HIV-infected individuals and HIV-affected couples who were referred for preconception counseling (PCC) at a large urban US-based HIV clinic. METHODS: Electronic medical records were reviewed for HIV-infected individuals and HIV-affected couples. Medical, reproductive, surgical, psychosocial, and family history data were abstracted. Univariate analyses were done. RESULTS: There were 8 single HIV-infected women and 100 HIV-affected couples who underwent PCC. HIV-infected women were older (mean age 35 years versus 32 years, P = 0.06), were more likely to smoke (23% versus 0%, P < 0.01), and had more medical comorbidities (57% versus 33%, P = 0.04) than HIV-uninfected women. The majority of couples were serodiscordant (77%), and of these couples, 32% had a detectable plasma viral load and 33% report inconsistent condom use. CONCLUSIONS: HIV-infected women have a number of medical and psychosocial issues, including those related to HIV that may increase the risk of adverse pregnancy outcomes and HIV perinatal and sexual transmission. PCC is an important intervention to optimize maternal management to improve perinatal outcomes and minimize transmission risks.