STI/HIV testing, STIs, and HIV PrEP use among men who have sex with men (MSM) and men who have sex with men and women (MSMW) in United States, 2019-2022.

BACKGROUND: Routine sexually transmitted infection and human immunodeficiency virus (STI/HIV) testing and HIV pre-exposure prophylaxis (PrEP) use are recommended for men who have sex with men (MSM) at increased risk of HIV. METHODS: Using Healthverity, a large administrative dataset in the United States, we assessed STI/HIV testing, chlamydia and gonorrhea positivity by specimen type, and HIV PrEP use among MSM and men who have sex with men and women (MSMW) at their first visits (index date) for those at increased risk of HIV and STIs from 2019 through 2022. RESULTS: Among 81,716 MSM and MSMW aged 15-64 years at their index date visit, STI testing rates were 57.9% for chlamydia, 58.1% for gonorrhea, and 52.2% for syphilis testing, respectively; 55.5%, 30.9%, and 18.1% had HIV testing, HIV PrEP use, and PrEP initiation, respectively, among the patients who did not have HIV. Of patients with chlamydia and gonorrhea testing, 48% were tested from the genital site only and 25% from three anatomic sites (rectal, pharyngeal, and urogenital). Chlamydia and gonorrhea positivity was 9.8% for chlamydia rectal infection, 7.3% for gonorrhea rectal infection, and 5.3% for gonorrhea pharyngeal infection. CONCLUSION: Our results present current medical services provided during initial clinic visits for MSM and MSMW in private outpatient settings. Our study suggests that the assessment of STI/HIV testing is periodically needed due to the high prevalence of infection, and efforts to promote HIV PrEP for MSM and MSMW in private settings are urgently needed.

Sexually Transmitted Infection and HIV Testing and Diagnosis Among 15- to 44-Year-Old Patients With and Without Opioid Use Disorder.

BACKGROUND: The association between illicit opioid use and prescription opioid misuse and sexually transmitted infections (STIs) has not been examined recently. Our study aimed to explore differences in STI/HIV care, and delivery of recommended testing and diagnoses among patients with and without opioid use disorder (OUD). METHODS: Using 2019 MarketScan commercial claims data, we identified 15- to 44-year-old male and female patients, to assess the percentages of STI/HIV diagnoses (using International Classification of Diseases, Tenth Revision, Clinical Modification ) and screening (using Current Procedure Terminology codes) among patients with or without OUD diagnoses codes. We further assessed STI/HIV testing and diagnoses by demographic factors. RESULTS: We identified 24,724 patients with OUD codes among 7.31 million patients. Both STI/HIV testing and diagnoses were significantly ( P < 0.05) higher among patients with OUD codes versus without: testing percentages were 16.81% versus 12.93% for chlamydia, 22.31% versus 16.62% for gonorrhea, 15.26% versus 7.61% for syphilis, and 18.18% versus 7.60% for HIV; diagnoses were 0.80% versus 0.35% for chlamydia, 0.30% versus 0.11% for gonorrhea, 0.23% versus 0.07% for syphilis, and 0.74% versus 0.33% for HIV. Similarly, among 0.53 million 15- to 24-year-old females who received services suggestive of sexual activity, chlamydia testing was significantly ( P < 0.05) higher among patients with OUD codes versus without (59.78% vs. 55.66%). CONCLUSIONS: Patients with OUD codes have higher percentages of STI/HIV testing and diagnoses codes compared with those without OUD codes. Clinicians may want to consider a comprehensive multidisciplinary (OUD and STI prevention) approach in patient care and provide recommended STI/HIV screening among patients with OUD if not performed.

Underlying Reasons for Primary Care Visits Where Chlamydia Testing Was Performed in the United States, 2019 to 2022.

BACKGROUND: In the United States, most chlamydia cases are reported from non-sexually transmitted disease clinics, and there is limited information focusing on the reasons for chlamydia testing in private settings. These analyses describe clinical visits to primary care providers where chlamydia testing was performed to help discern between screening and diagnostic testing for chlamydia. METHODS: Using the largest primary care clinical registry in the United States, the PRIME registry, chlamydia tests were identified using Current Procedural Terminology procedure codes and categorized as diagnostic testing for sexually transmitted infection (STI)-related symptoms, screening for chlamydia, or "other," based on Classification of Diseases, Tenth Revision Evaluation and Management codes selected for visits. RESULTS: Of 120,013 clinical visits with chlamydia testing between January 1, 2019, and December 31, 2022, 70.4% were women; 20.6% were with STI-related symptoms, 59.9% were for screening, and 19.5% for "other" reasons. Of those 120,013 clinical visits with chlamydia testing, the logit model showed that patients were significantly more likely to have STI-related symptoms if they were female than male, non-Hispanic Black than non-Hispanic White, aged 15 to 24 years than aged ≥45 years, and resided in the South than in the Northeast. CONCLUSION: It is important to know what proportion of chlamydial infections is identified through screening programs and to have this information stratified by demographics. The inclusion of laboratory results could further facilitate a better understanding of the impact of chlamydia screening programs on the identification and treatment of chlamydia in private office settings in the United States.

Sexually Transmitted Infection/Human Immunodeficiency Virus, Pregnancy, and Mental Health-Related Services Provided During Visits With Sexual Assault and Abuse Diagnosis for US Medicaid Beneficiaries, 2019.

BACKGROUND: Centers for Disease Control recommends that the decision to provide sexually transmitted infection (STI)/human immunodeficiency virus (HIV) testing and presumptive treatment to patients who report sexual assault and abuse (SAA) be made on an individual basis. METHODS: The 2019 Centers for Medicare & Medicaid Services national Medicaid data set was used. The SAA visits were identified by International Classification of Diseases 10th Revision Clinical Modification (O9A4 for pregnancy-related sexual abuse, T74.2 for confirmed sexual abuse, and Z04.4 for alleged rape). The initial SAA visit was defined as the patient's first SAA-related visit. Medical services were identified by International Classification of Diseases 10th Revision Clinical Modification codes, Current Procedural Terminology codes, and National Drug Code codes. RESULTS: Of 55,113 patients at their initial SAA visits, 86.2% were female; 63.4% aged ≥13 years; 59.2% visited emergency department (ED); all STI/HIV tests were provided in ≤20% of visits; presumptive gonorrhea and chlamydia treatment was provided in 9.7% and 3.4% of visits, respectively; pregnancy test was provided in 15.7% of visits and contraception services was provided in 9.4% of visits; and diagnosed anxiety was provided in 6.4% of visits. Patients who visited ED were less likely to have STI testing and anxiety than those visited non-ED facilities, but more likely to receive presumptive treatment for gonorrhea, testing for pregnancy, and contraceptive services. About 14.2% of patients had follow-up SAA visits within 60 days after the initial SAA visit. Of 7821 patients with the follow-up SAA visits within 60 days, most medical services provided were chlamydia testing (13.8%), gonorrhea testing (13.5%), syphilis testing (12.8%), HIV testing (14.0%); diagnosed anxiety (15.0%), and posttraumatic stress disorder (9.8%). CONCLUSIONS: Current medical services during SAA visits for Medicaid patients are described in this evaluation. More collaboration with staff who handle SAA will improve SAA-related medical services.

Access to Healthcare and the Utilization of Sexually Transmitted Infections Among Homeless Medicaid Patients 15 to 44 Years of Age.

Homelessness poses a direct threat to public health in the US as many individuals face debilitating health outcomes and barriers to adequate health care. Access to STI care for the homeless Medicaid population of USA has not been well-studied using administrative claims data. Our study aims to compare health services utilization, STI screening and diagnoses among people experiencing homelessness (PEH) vs. those who are non-PEH using ICD10 codes. We used 2019 MarketScan Medicaid claims data to analyze men and women aged 15-44 years with a diagnosis code for PEH (Z59.0), non-PEH (without Z59.0) and assessed their emergency department and outpatient visits and STI/HIV diagnoses and screening rates. We identified 5135 PEH men and 3571 PEH women among 1.3 million men and 2.1 million women in the 2019 US Medicaid database. PEH patients were more likely to have ED visits (94.80% vs 33.04%) and ≥ 20 outpatient clinic visits (60.29% vs 16.16%) than non-PEH patients in 2019. Higher diagnoses were observed for syphilis 1.57% (CI 1.32-1.86) vs 0.11% (CI 0.11-0.11), HIV 3.93% (CI 3.53-4.36) vs 0.41% (CI 0.41-0.42), chlamydia 1.94% (CI 1.66-2.25) vs 0.85% (CI 0.84-0.86) and gonorrhea 1.26% (CI 1.04-1.52) vs. 0.33% (CI 0.33-0.34) (p < 0.0001) among PEH compared to non-PEH. Among PEH, higher STI/HIV diagnoses rates indicate an increase in STI burden and suboptimal STI testing indicates an underutilization of STI services despite having a higher percentage of health care visits compared to non-PEH patients. Focused STI/HIV interventions are needed to address health care needs of PEH patients.

Chlamydia Screening Among Women Aged 15 to 44 Years Who Reported Anal Sex During the Past 12 Months in the United States, 2013 to 2017.

ABSTRACT: Using the 2013-2017 National Survey of Family Growth, 37.6% of women with ≥1 anal sex partner in the last 12 months reported chlamydia testing at unspecified anatomic sites in the past 12 months. Women whose medical provider asked about type of sex (i.e., vaginal, oral, anal), compared with those whose provider did not, reported higher chlamydia testing.

Validation of International Classification of Diseases, Tenth Revision, Clinical Modification Codes for Identifying Cases of Chlamydia and Gonorrhea.

BACKGROUND: While researchers seek to use administrative health data to examine outcomes for individuals with sexually transmitted infections (STIs), the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes used to identify persons with chlamydia and gonorrhea have not been validated. Objectives were to determine the validity of using ICD-10-CM codes to identify individuals with chlamydia and gonorrhea. METHODS: We used data from electronic health records gathered from public and private health systems from October 1, 2015, to December 31, 2016. Patients were included if they were aged 13 to 44 years and received either (1) laboratory testing for chlamydia or gonorrhea or (2) an ICD-10-CM diagnosis of chlamydia, gonorrhea, or an unspecified STI. To validate ICD-10-CM codes, we calculated positive and negative predictive values, sensitivity, and specificity based on the presence of a laboratory test result. We further examined the timing of clinical diagnosis relative to laboratory testing. RESULTS: The positive predictive values for chlamydia, gonorrhea, and unspecified STI ICD-10-CM codes were 87.6%, 85.0%, and 32.0%, respectively. Negative predictive values were high (>92%). Sensitivity for chlamydia diagnostic codes was 10.6%, and gonorrhea was 9.7%. Specificity was 99.9% for both chlamydia and gonorrhea. The date of diagnosis occurred on or after the date of the laboratory result for 84.8% of persons with chlamydia, 91.9% for gonorrhea, and 23.5% for unspecified STI. CONCLUSIONS: Disease-specific ICD-10-CM codes accurately identify persons with chlamydia and gonorrhea. However, low sensitivities suggest that most individuals could not be identified in administrative data alone without laboratory test results.

Mental Health Among Parents of Children Aged <18 Years and Unpaid Caregivers of Adults During the COVID-19 Pandemic - United States, December 2020 and February-⁠March 2021.

Early during the COVID-19 pandemic, nearly two thirds of unpaid caregivers of adults reported adverse mental or behavioral health symptoms, compared with approximately one third of noncaregivers† (1). In addition, 27% of parents of children aged <18 years reported that their mental health had worsened during the pandemic (2). To examine mental health during the COVID-19 pandemic among U.S. adults on the basis of their classification as having a parenting role (i.e., unpaid persons caring for children and adolescents aged <18 years, referred to as children in this report) or being an unpaid caregiver of adults (i.e., persons caring for adults aged ≥18 years),§ CDC analyzed data from cross-sectional surveys that were administered during December 2020 and February-March 2021 for The COVID-19 Outbreak Public Evaluation (COPE) Initiative.¶ Respondents were categorized as parents only, caregivers of adults only, parents-caregivers (persons in both roles), or nonparents/noncaregivers (persons in neither role). Adjusted odds ratios (aORs) for any adverse mental health symptoms, particularly suicidal ideation, were higher among all respondents who were parents, caregivers of adults, or both compared with respondents who were nonparents/noncaregivers and were highest among persons in both roles (parents-caregivers) (any adverse mental health symptoms: aOR = 5.1, 95% confidence interval [CI] = 4.1-6.2; serious suicidal ideation: aOR = 8.2, 95% CI = 6.5-10.4). These findings highlight that parents and caregivers, especially those balancing roles both as parents and caregivers, experienced higher levels of adverse mental health symptoms during the COVID-19 pandemic than adults without these responsibilities. Caregivers who had someone to rely on for support had lower odds of experiencing any adverse mental health symptoms. Additional measures are needed to improve mental health among parents, caregivers, and parents-caregivers.

Syphilis testing adherence among women with livebirth deliveries: Indianapolis 2014-2016.

BACKGROUND: The number of congenital syphilis (CS) cases in the United States are increasing. Effective prevention of CS requires routine serologic testing and treatment of infected pregnant women. The Centers for Disease Control and Prevention (CDC) recommends testing all pregnant women at their first prenatal visit and subsequent testing at 28 weeks gestation and delivery for women at increased risk. METHODS: We conducted a cross-sectional cohort study of syphilis testing among pregnant women with a livebirth delivery from January 2014 to December 2016 in Marion County, Indiana. We extracted and linked maternal and infant data from the vital records in a local health department to electronic health records available in a regional health information exchange. We examined syphilis testing rates and factors associated with non-testing among women with livebirth delivery. We further examined these rates and factors among women who reside in syphilis prevalent areas. RESULTS: Among 21260 pregnancies that resulted in livebirths, syphilis testing in any trimester, including delivery, increased from 71.7% in 2014 to 86.6% in 2016. The number of maternal syphilis tests administered only at delivery decreased from 16.6% in 2014 to 4.04% in 2016. Among women living in areas with high syphilis rates, syphilis screening rates increased from 79.6% in 2014 to 94.2% in 2016. CONCLUSION: Improvement in prenatal syphilis screening is apparent and encouraging, yet roughly 1-in-10 women do not receive syphilis screening during pregnancy. Adherence to recommendations set out by CDC improved over time. Given increasing congenital syphilis cases, the need for timely diagnoses and prevention of transmission from mother to fetus remains a priority for public health.

Provider Adherence to Syphilis Testing Guidelines Among Stillbirth Cases.

BACKGROUND: The Centers for Disease Control and Prevention (CDC) recommends that all women with a stillbirth have a syphilis test after delivery. Our study seeks to evaluate adherence to CDC guidelines for syphilis screening among women with a stillbirth delivery. METHODS: We used data recorded in electronic health records for women who gave birth between January 1, 2014, and December 31, 2016. Patients were included if they were 18 to 44 years old and possessed an International Classification of Diseases, Ninth Revision or Tenth Revision, Clinical Modification diagnosis of stillbirth. Stillbirth diagnoses were confirmed through a random sample of medical chart reviews. To evaluate syphilis screening, we estimated the proportion of women who received syphilis testing within 300 days before stillbirth, women who received syphilis testing within 30 days after a stillbirth delivery, and women who received syphilis testing both before and after stillbirth delivery. RESULTS: We identified 1111 stillbirths among a population of 865,429 unique women with encounter data available from electronic health records. Among a sample of 127 chart-reviewed cases, only 35 (27.6%) were confirmed stillbirth cases, 45 (35.4%) possible stillbirth cases, 39 (30.7%) cases of miscarriage, and 8 (6.3%) cases of live births. Among confirmed stillbirth cases, 51.4% had any syphilis testing conducted, 31.4% had testing before their stillbirth delivery, 42.9% had testing after the delivery, and only 22.9% had testing before and after delivery. CONCLUSIONS: A majority of women with a stillbirth delivery do not receive syphilis screening adherent to CDC guidelines. Stillbirth International Classification of Diseases codes do not accurately identify cases of stillbirth.

The Proportion of Young Women Tested for Chlamydia Who Had Urogenital Symptoms in Physician Offices.

Using National Ambulatory Medical Care Survey data from 2006 to 2015, we estimated the proportions of young women tested for chlamydia who were symptomatic (urogenital symptoms) or asymptomatic in physician offices. Among women tested for chlamydia, the proportions of women with and without urogenital symptoms were 31.6% and 59.2%, respectively.

Provider Adherence to Syphilis Testing Recommendations for Women Delivering a Stillbirth.

OBJECTIVE: To assess overall adherence to Centers for Disease Control and Prevention and American College of Obstetrics and Gynecology recommended guidelines for syphilis testing among women who delivered a stillbirth and compare it with other tests recommended for stillbirth evaluation. METHODS: We used MarketScan claims data with 40 million commercially insured and 8 million Medicaid enrollees annually to estimate prenatal care and follow-up testing among women who had stillbirths between January 1, 2013, and December 24, 2013. Stillbirth was identified if women had any International Classification of Disease, Ninth Revision codes related to a stillbirth outcome. Among women with stillbirths, we estimated the proportions of women who received prenatal care and prenatal syphilis testing within 280 days before stillbirth, and testing at the time of stillbirth (syphilis testing, complete blood count, placental examination and autopsy) using Physician's Current Procedural Terminology codes. RESULTS: We identified 3672 Medicaid-insured women and 6023 commercially insured women with stillbirths in 2013. Approximately, 61.7% of Medicaid-insured women and 66.0% of commercially insured women had claims data indicating prenatal syphilis testing. At the time of stillbirth, Medicaid-insured and commercially insured women had similar rates of syphilis testing (6.5% vs 9.3%), placental examination (61.6% vs 57.8%), and complete blood count (31.9% vs 37.6%). Autopsies were too infrequent to be reported. Approximately, 34.6% of Medicaid-insured women and 29.7% of commercially insured women had no syphilis testing either prenatally or at the time of stillbirth. CONCLUSIONS: Syphilis testing among women after stillbirth was less than 10%, illustrating limited adherence to Centers for Disease Control and Prevention and American College of Obstetrics and Gynecology recommendations. Such low prenatal and delivery syphilis testing rates may impact the number of stillbirth cases identified as congenital syphilis cases and reported to the national surveillance system. Our results emphasize the need to improve syphilis testing to improve diagnosis of syphilitic stillbirths, identify women with syphilis infection, and provide treatment to these women to avoid syphilis-related adverse outcomes.

Using Reported Rates of Sexually Transmitted Diseases to Illustrate Potential Methodological Issues in the Measurement of Racial and Ethnic Disparities.

BACKGROUND: Racial disparities in the burden of sexually transmitted diseases (STDs) have been documented and described for decades. Similarly, methodological issues and limitations in the use of disparity measures to quantify disparities in health have also been well documented. The purpose of this study was to use historic STD surveillance data to illustrate four of the most well-known methodological issues associated with the use of disparity measures. METHODS: We manually searched STD surveillance reports to find examples of racial/ethnic distributions of reported STDs that illustrate key methodological issues in the use of disparity measures. The disparity measures we calculated included the black-white rate ratio, the Index of Disparity (weighted and unweighted by subgroup population), and the Gini coefficient. RESULTS: The 4 examples we developed included illustrations of potential differences in relative and absolute disparity measures, potential differences in weighted and nonweighted disparity measures, the importance of the reference point when calculating disparities, and differences in disparity measures in the assessment of trends in disparities over time. For example, the gonorrhea rate increased for all minority groups (relative to whites) from 1992 to 1993, yet the Index of Disparity suggested that racial/ethnic disparities had decreased. CONCLUSIONS: Although imperfect, disparity measures can be useful to quantify racial/ethnic disparities in STDs, to assess trends in these disparities, and to inform interventions to reduce these disparities. Our study uses reported STD rates to illustrate potential methodological issues with these disparity measures and highlights key considerations when selecting disparity measures for quantifying disparities in STDs.

State Variation in Enrollment Gap, Sexual Activity, and Chlamydia Testing Rate Among Young Medicaid Women.

OBJECTIVES: To assess state variations in eligibility criteria based on enrollment length and sexual activity on chlamydia testing rates among Medicaid female enrollees aged 15 to 25 years and potential impact of the representatives of testing rates. METHODS: We used 2010 Medicaid Analytic eXtract to estimate and compare the overall and state-level prevalence of gaps in coverage of ≥ 2 consecutive months, service utilization associated with sexuality, and chlamydia testing rates among Medicaid female enrollees aged 15 to 25 years who had ≥ 1 month of the full scope of Medicaid benefits and had ≥ 1 health service claim. The chlamydia testing rate was calculated as the proportion of sexually active Medicaid female enrollees who received a chlamydia test in 2010. RESULTS: Of 5.7 million women aged 15 to 25 years enrolled in Medicaid in 2010, 42.3% had a 2-month gap of enrollment coverage in 2010. The proportion of women who had a 2-month gap varied from 26.1% to 73.2% across states. The proportion of women identified as sexually active was 59.8% among women who had a 2-month gap and 57.1% among women who had no 2-month gap. The chlamydia testing rate was 44.0% among sexually active women with a 2-month gap and 44.2% among sexually active women without a 2-month gap. Eleven states had ≥10% difference in sexual activity or chlamydia testing rates between women with a 2-month gap and women without a 2-month gap. CONCLUSIONS: States which exclude a substantial proportion of Medicaid enrollees from inclusion in the chlamydia testing denominator may have less representative testing estimates because those excluded tend to be women aged 19 to 25 years.

Racial Differences in Receipt of Chlamydia Testing Among Medicaid-Insured Women in 2013.

OBJECTIVE: To estimate the percentage of young, sexually active Medicaid-insured women who were tested for chlamydia by age, race/ethnicity, and history of sexually transmitted disease (STD) diagnosis. METHODS: We used the medical diagnostic and procedural codes from Truven Health MarketScan Medicaid claims data from 10 states in 2012 and 2013 to estimate the rates of chlamydia testing in 2013 and previous STD diagnosis (diagnosed in 2012) among Medicaid-insured women aged 15-25 years who were sexually active in 2013. We also used a logit model to assess the association between chlamydia testing and women's age, race/ethnicity, and previous STD diagnosis. RESULTS: Overall, among approximately 261,000 Medicaid-insured women aged 15-25 years in 2013 who were classified as sexually active, 50.2% were tested for chlamydia in 2013. The chlamydia testing rate was 45.6% for white women and 57.5% for black women. The chlamydia testing rate was 63.5% for women diagnosed as having an STD in 2012 and 46.8% for women not diagnosed as having an STD in 2012. The chlamydia testing rate was significantly (P < 0.05) associated with previous STD diagnosis, age, and race/ethnicity in our logit model. CONCLUSIONS: Higher chlamydia testing rates among black women can be explained in part by higher rates of previous STD diagnoses. Our finding that black women have the highest chlamydia testing rates is encouraging, as improved access to STD prevention services among racial/ethnic minorities can help to reduce racial/ethnic disparities in STDs. However, chlamydia screening remains an underused preventive health service for young women of all racial and ethnic groups.

Trends in Selected Measures of Racial and Ethnic Disparities in Gonorrhea and Syphilis in the United States, 1981-2013.

BACKGROUND: The purpose of this study was to examine selected measures of racial and ethnic disparities in the reported incidence of syphilis and gonorrhea from 1981 to 2013 in the United States. METHODS: For each year, from 1981 to 2013, we calculated values for 5 disparity measures (Gini coefficient, 2 versions of the index of disparity, population attributable proportion, and the black-to-white rate ratio) for 5 racial/ethnic categories (non-Hispanic white, non-Hispanic black, Hispanic, American Indian/Alaska Native, and Asian/Pacific Islander). We also examined annual and 5-year changes to see if the disparity measures agreed on the direction of change in disparity. RESULTS: With a few exceptions, the disparity measures increased from 1981 to 1993 and decreased from 1993 to 2013, whereas syphilis and gonorrhea rates decreased for most groups from 1981 to 1993 and increased from 1993 to 2013. Overall, the disparity measures we examined were highly correlated with one another, particularly when examining 5-year changes rather than annual changes in disparity. For example, all 5 measures agreed on the direction of change in the disparity of syphilis in 56% of the annual comparisons and in 82% of the 5-year comparisons. CONCLUSIONS: Although the disparity measures we examined were generally consistent with one another, these measures can sometimes yield divergent assessments of whether racial/ethnic disparities are increasing or decreasing for a given sexually transmitted disease from one point in time to another, as well as divergent assessments of the relative magnitude of the change.

TAK-228 (formerly MLN0128), an investigational oral dual TORC1/2 inhibitor: A phase I dose escalation study in patients with relapsed or refractory multiple myeloma, non-Hodgkin lymphoma, or Waldenström's macroglobulinemia.

The PI3K/AKT/mTOR signaling pathways are frequently dysregulated in multiple human cancers, including multiple myeloma (MM), non-Hodgkin lymphoma (NHL), and Waldenström's macroglobulinemia (WM). This was the first clinical study to evaluate the safety, tolerability, maximal-tolerated dose (MTD), dose-limiting toxicity (DLT), pharmacokinetics, and preliminary clinical activity of TAK-228, an oral TORC1/2 inhibitor, in patients with MM, NHL, or WM. Thirty-nine patients received TAK-228 once daily (QD) at 2, 4, 6, or 7 mg, or QD for 3 days on and 4 days off each week (QDx3d QW) at 9 or 12 mg, in 28-day cycles. The overall median age was 61.0 years (range 46-85); 31 patients had MM, four NHL, and four WM. Cycle 1 DLTs occurred in five QD patients (stomatitis, urticaria, blood creatinine elevation, fatigue, and nausea and vomiting) and four QDx3d QW patients (erythematous rash, fatigue, asthenia, mucosal inflammation, and thrombocytopenia). The MTDs were determined to be 4 mg QD and 9 mg QDx3d QW. Thirty-six patients (92%) reported at least one drug-related toxicity; the most common grade ≥3 drug-related toxicities were thrombocytopenia (15%), fatigue (10%), and neutropenia (5%). TAK-228 exhibited a dose-dependent increase in plasma exposure and no appreciable accumulation with repeat dosing; mean plasma elimination half-life was 6-8 hr. Of the 33 response-evaluable patients, one MM patient had a minimal response, one WM patient achieved partial response, one WM patient had a minor response, and 18 patients (14 MM, two NHL, and two WM) had stable disease. These findings encourage further studies including combination strategies.

The Significant Impact of Different Insurance Enrollment Criteria on the HEDIS Chlamydia Screening Measure for Young Women Enrolled in Medicaid and Commercial Insurance Plans.

OBJECTIVE: The impact of length of enrollment in a health plan on eligibility of women under the Healthcare Effectiveness Data and Information Set (HEDIS) chlamydia screening measure is not fully understood. We assessed the representativeness of the measure among the proportion of women aged 15 to 24 years with a gap in coverage for Medicaid and commercial health insurance. METHODS: Truven Health Marketscan Medicaid and commercial health insurance data from 2006 to 2012 were used to make comparisons between proportions of women with a gap in coverage to those enrolled in insurance plans for different numbers of months. RESULTS: Approximately 48% of Medicaid-insured women and 31% of commercially insured women had an at least 2-month gap that disqualified them from eligibility for inclusion in the HEDIS chlamydia screening measure. Extending eligibility to women with at least 6 months of coverage, regardless of gap, would increase the proportion of insured women included in the HEDIS measure to 76% (from 52%) for Medicaid and 83% (from 69%) for commercial insurance, without much effect on chlamydia testing rate. This would make the measure more representative of all insured women. CONCLUSIONS: The large proportion of young women who had a 2-month or greater gap in coverage in Medicaid had a significant impact on the overall representativeness of the current HEDIS chlamydia screening measure.

Claims for Contraceptive Services and Chlamydia and Gonorrhea Testing Among Insured Adolescent and Young Adult Females in the United States.

Objective: To examine claims for reversible prescription contraceptives and chlamydia and gonorrhea testing among commercially and Medicaid-insured adolescent and young adult (AYA) females in the United States. Methods: Using IBM MarketScan Research Databases, we identified sexually active, nonpregnant AYA (15- to 24-year-old) females enrolled in 2018. We examined claims for reversible prescription contraceptives and chlamydia and gonorrhea testing, using drug names and diagnosis/procedure codes, by age-group in commercially and Medicaid-insured separately and by race/ethnicity in Medicaid-insured. Results: Among 15- to 19-year-old and 20- to 24-year-old females, 67.2% and 67.9% of commercially insured and 57.3% and 54.0% of Medicaid-insured, respectively, had claims for reversible prescription contraceptives in 2018. Across insurance types among both age-groups, the most common claim for contraceptives was prescription for combined oral contraceptives. Among Medicaid-insured 15- to 19-year-olds, claims for contraceptives ranged from 42.6% for Hispanic females to 63.4% for non-Hispanic White females; among Medicaid-insured 20- to 24-year-olds, claims ranged from 50.4% for non-Hispanic Black females to 57.0% for non-Hispanic White females. Approximately half of the commercially and Medicaid-insured females had claims for chlamydia and gonorrhea testing. Non-Hispanic Black females had the highest percentages of claims for chlamydia testing (56.3% among 15- to 19-year-olds and 61.1% among 20- to 24-year-olds) and gonorrhea testing (61.6% among 15- to 19-year-olds and 64.9% among 20- to 24-year-olds). Conclusion: Approximately, two-thirds of commercially insured and more than half of Medicaid-insured, sexually active, nonpregnant AYA females had claims for reversible prescription contraceptives. Race/ethnicity data were available for Medicaid-insured females, and there were differences in claims for contraceptives and chlamydia and gonorrhea testing by race/ethnicity. Half of the AYA females had claims for chlamydia and gonorrhea testing suggesting missed opportunities.

Mycophenolic acid glucuronide is transported by multidrug resistance-associated protein 2 and this transport is not inhibited by cyclosporine, tacrolimus or sirolimus.

1. The purpose of this study was to investigate the contribution of MRP2 to the efflux of mycophenolic acid (MPA), and its phenyl glucuronide (MPAG) and acyl glucuronide (AcMPAG) metabolites, using Madin-Darby canine kidney II cells stably transfected with human MRP2 gene (MDCKII/MRP2 cells). 2. Compared to parental MDCKII cells, MPAG was significantly translocated from basolateral (BL) to apical (AP) side in MDCKII/MRP2 cells, indicating MPAG is a substrate for MRP2. AcMPAG is highly translocated from BL to AP side in both cells, suggesting that AcMPAG is actively secreted possibly through an efflux transporter other than MRP2. Appreciable translocation of MPA was not observed in MDCKII/MRP2 cells. 3. Furthermore, using MRP2-expressing Sf9 membrane vesicles, the Michaelis-Menten constant (Km) value for MRP2-mediated MPAG transport was calculated at 224.2 ± 42.7 µM. In the vesicle system, cyclosporine, tacrolimus and sirolimus did not inhibit the uptake of MPAG via MRP2. 4. These findings indicate that only MPAG not MPA and AcMPAG is a substrate for MRP2 and that the interaction between MPAG and concomitantly administered immunosuppressive agents does not occur at MRP2 level.