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1.
Sex Transm Dis ; 2024 Apr 11.
Article in English | MEDLINE | ID: mdl-38602774

ABSTRACT

BACKGROUND: In the United States (US), most chlamydia cases are reported from non-STD 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 US, the PRIME registry, chlamydia tests were identified using Current Procedural Terminology (CPT) procedure codes and categorized as either diagnostic testing for sexually transmitted infection (STI) related symptoms, screening for chlamydia, or "other", based on ICD-10 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 15-24 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 are identified through screening programs and to have this information stratified by demographics. The inclusion of lab 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.

2.
Article in English | MEDLINE | ID: mdl-38629470

ABSTRACT

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.

3.
Sex Transm Dis ; 50(7): 425-431, 2023 07 01.
Article in English | MEDLINE | ID: mdl-36940194

ABSTRACT

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.


Subject(s)
Chlamydia Infections , Gonorrhea , HIV Infections , Sex Offenses , Sexually Transmitted Diseases , Pregnancy , Humans , Aged , Female , United States/epidemiology , Male , Gonorrhea/diagnosis , Gonorrhea/epidemiology , HIV , Medicaid , Mental Health , Medicare , Sexually Transmitted Diseases/diagnosis , Sexually Transmitted Diseases/epidemiology , HIV Infections/diagnosis , HIV Infections/epidemiology
4.
J Community Health ; 47(5): 853-861, 2022 10.
Article in English | MEDLINE | ID: mdl-35819549

ABSTRACT

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.


Subject(s)
Chlamydia Infections , Gonorrhea , HIV Infections , Ill-Housed Persons , Sexually Transmitted Diseases , Adolescent , Adult , Chlamydia Infections/diagnosis , Chlamydia Infections/epidemiology , Delivery of Health Care , Female , Gonorrhea/epidemiology , HIV Infections/diagnosis , HIV Infections/epidemiology , HIV Infections/prevention & control , Humans , Male , Medicaid , Sexually Transmitted Diseases/diagnosis , Sexually Transmitted Diseases/epidemiology , Sexually Transmitted Diseases/prevention & control , Young Adult
5.
Am J Med ; 135(2): 196-201, 2022 02.
Article in English | MEDLINE | ID: mdl-34655542

ABSTRACT

BACKGROUND: Previous studies have shown that sexually transmitted infections (STI) and human immunodeficiency virus (HIV) testing has varied, but STI prevalence was not estimated among patients during their health care visits in which a high-risk sexual partnership was documented. This study estimated gonorrhea, chlamydia, syphilis, and HIV testing rates and chlamydia and gonorrhea prevalence. METHODS: From the de-identified commercial claims data of OptumLabs Data Warehouse, we identified men and women aged 15-60 years classified as having high-risk sexual relationships as diagnosis codes: Z72.51 for opposite-sex, Z72.52 for same-sex, and Z72.53 for same-and-opposite-sex relationships, stratified by gender, age group, region, type of health plan, and HIV status. We estimated STI testing rate and prevalence for chlamydia and gonorrhea among patients with high-risk sexual relationships. HIV testing was assessed only in high-risk sexual relationship patients without HIV. RESULTS: Among 8.2 million females and 7.3 million males aged 15-60 years in the database from 2016 to 2019, 115,884 patients (0.7% of female, 0.8% of male) including 3,535 patients with HIV were diagnosed with high-risk sexual relationships. The testing rates for gonorrhea, chlamydia, syphilis, and HIV were 69.4% (confidence interval [CI]: 69.1-69.7), 68.9% (CI: 68.6-69.2), 43.4% (CI: 43.1-43.7), and 41.7% (CI: 41.4-42.0), respectively. Among patients with valid chlamydia and gonorrhea tests, 7.2% (CI: 7.0-7.5) and 2.6% (CI: 2.4-2.8) had positive chlamydia and gonorrhea test results, respectively, and varied by type of high-risk sexual relationship. CONCLUSIONS: Our study findings of suboptimal STI screening among patient in high-risk sexual relationships are consistent with previous studies. Administrative records confirmed by lab results indicate a need for STI counseling, testing, and treatment among patients who are diagnosed with high-risk sexual relationships with same-sex, opposite-sex, or same-and-opposite sex partners.


Subject(s)
Chlamydia Infections/epidemiology , Gonorrhea/epidemiology , HIV Infections/diagnosis , Sexual Partners , Syphilis/epidemiology , Adolescent , Adult , Contact Tracing , Data Collection , Female , HIV Testing , Humans , Male , Mass Screening/methods , Middle Aged , Prevalence , Young Adult
6.
Viruses ; 13(12)2021 12 03.
Article in English | MEDLINE | ID: mdl-34960695

ABSTRACT

We have developed a monoclonal antibody (mAb) cocktail (ZRC-3308) comprising of ZRC3308-A7 and ZRC3308-B10 in the ratio 1:1 for COVID-19 treatment. The mAbs were designed to have reduced immune effector functions and increased circulation half-life. mAbs showed good binding affinities to non-competing epitopes on RBD of SARS-CoV-2 spike protein and were found neutralizing SARS-CoV-2 variants B.1, B.1.1.7, B.1.351, B.1.617.2, and B.1.617.2 AY.1 in vitro. The mAb cocktail demonstrated effective prophylactic and therapeutic activity against SARS-CoV-2 infection in Syrian hamsters. The antibody cocktail appears to be a promising candidate for prophylactic use and for therapy in early COVID-19 cases that have not progressed to severe disease.


Subject(s)
Antibodies, Monoclonal, Humanized/immunology , COVID-19/therapy , SARS-CoV-2/immunology , Animals , Antibodies, Monoclonal, Humanized/therapeutic use , Antibodies, Neutralizing/immunology , Antibodies, Neutralizing/therapeutic use , Antibody Affinity , Binding Sites , COVID-19/prevention & control , Cricetinae , Disease Models, Animal , Epitopes , Humans , Immunization, Passive , Mesocricetus , Mutation , SARS-CoV-2/genetics , Spike Glycoprotein, Coronavirus/genetics , Spike Glycoprotein, Coronavirus/immunology , COVID-19 Serotherapy
7.
BMC Pregnancy Childbirth ; 21(1): 739, 2021 Oct 30.
Article in English | MEDLINE | ID: mdl-34717575

ABSTRACT

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.


Subject(s)
Guideline Adherence , Guidelines as Topic , Pregnancy Complications, Infectious/diagnosis , Prenatal Diagnosis/statistics & numerical data , Syphilis Serodiagnosis/statistics & numerical data , Syphilis/diagnosis , Adolescent , Adult , Cohort Studies , Cross-Sectional Studies , Female , Humans , Indiana/epidemiology , Live Birth/epidemiology , Pregnancy , Young Adult
8.
MMWR Morb Mortal Wkly Rep ; 70(24): 879-887, 2021 Jun 18.
Article in English | MEDLINE | ID: mdl-34138835

ABSTRACT

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.


Subject(s)
COVID-19/psychology , Caregivers/psychology , Mental Disorders/epidemiology , Parents/psychology , Adolescent , Adult , Aged , COVID-19/epidemiology , Caregivers/economics , Caregivers/statistics & numerical data , Female , Health Surveys , Humans , Male , Middle Aged , United States/epidemiology , Young Adult
9.
Sex Transm Dis ; 48(6): e77-e80, 2021 06 01.
Article in English | MEDLINE | ID: mdl-32976357

ABSTRACT

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.


Subject(s)
Chlamydia Infections , Chlamydia , Adolescent , Adult , Chlamydia Infections/diagnosis , Chlamydia Infections/epidemiology , Female , Humans , Mass Screening , Research , Sexual Behavior , Sexual Partners , United States/epidemiology , Young Adult
10.
Sex Transm Dis ; 48(5): 335-340, 2021 05 01.
Article in English | MEDLINE | ID: mdl-32740450

ABSTRACT

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.


Subject(s)
Chlamydia , Gonorrhea , Sexually Transmitted Diseases , Adolescent , Adult , Gonorrhea/diagnosis , Gonorrhea/epidemiology , Humans , International Classification of Diseases , Predictive Value of Tests , Sexually Transmitted Diseases/diagnosis , Sexually Transmitted Diseases/epidemiology , Young Adult
11.
Int J STD AIDS ; 32(1): 30-37, 2021 01.
Article in English | MEDLINE | ID: mdl-32998639

ABSTRACT

Surveillance of gonorrhea (GC), the second most common notifiable disease in the United States, depends on case reports. Population-level data that contain the number of individuals tested in addition to morbidity are lacking. We performed a cross-sectional analysis of data obtained from individuals tested for GC recorded in a sexually transmitted disease (STD) registry in the state of Indiana. Descriptive statistics were performed, and a Poisson generalized linear model was used to evaluate the number of individuals tested for GC and the positivity rate. GC cases from a subset of the registry were compared to CDC counts to determine the completeness of the registry. A total of 1,870,811 GC tests were linked to 627,870 unique individuals. Individuals tested for GC increased from 54,334 in 2004 to 269,701 in 2016; likewise, GC cases increased from 2,039 to 5,997. However, positivity rate decreased from 3.75% in 2004 to 2.22% in 2016. The difference in the number of GC cases captured by the registry and those reported to the CDC was not statistically significant (P = 0.0665). Population-level data from an STD registry combining electronic medical records and public health case data may inform STD control efforts. In Indiana, increased testing rates appeared to correlate with increased GC morbidity.


Subject(s)
Gonorrhea/diagnosis , Sexually Transmitted Diseases/epidemiology , Adolescent , Adult , Cross-Sectional Studies , Female , Gonorrhea/epidemiology , Humans , Indiana/epidemiology , Male , Morbidity , Registries , Retrospective Studies , Sexually Transmitted Diseases/diagnosis , Young Adult
12.
J Adolesc Health ; 69(1): 121-126, 2021 07.
Article in English | MEDLINE | ID: mdl-33280976

ABSTRACT

PURPOSE: This study aimed to evaluate the receipt of chlamydia and gonorrhea screening among women aged 15-24 years undergoing long-acting reversible contraception (LARC) insertion. METHODS: We used the 2016-2017 MarketScan commercial claims data set to identify sexually active women aged 15-24 years with LARC insertion in 2017 and had ≥12 months of insurance coverage before the date of LARC insertion. Sexual activity (defined by Healthcare Effectiveness Data and Information Set chlamydia testing measure) and LARC insertion, including intrauterine device (IUD) and implant insertion, were identified by applicable International Classification of Disease, Tenth Revision, Healthcare Common Procedure Coding System, and Current Procedural Terminology codes. We evaluated chlamydia and gonorrhea testing performed in the preceding 12 months or at the time of LARC insertion among sexually active women aged 15-24 years. RESULTS: We identified 37,331sexually active women aged 15-24 years with LARC insertion. Among these women, overall chlamydia testing was more frequent among women initiating an IUD (77.8%) than implant initiators (67.8%), p < .001. A similar pattern was seen for gonorrhea testing (80.0% for IUD users, 71.1% for implant users), p < .001. Among sexually active women without chlamydia and gonorrhea testing within the 12 months before the date of insertion, IUD users were more frequently tested for chlamydia (1,410 [20.9%] vs. 433 [9.2%]; p < .001) and for gonorrhea (1,206 [20.0%] vs. 374 [8.9%]; p < .001) than implant users on the day of LARC insertion. CONCLUSIONS: Our results showed that approximately one in four sexually active women undergoing LARC insertion had not received recommended chlamydia and gonorrhea screening past year. Health care providers may use LARC-related visits as an opportunity to educate patients about, and to offer, chlamydia and gonorrhea screening if they had not been screened in the past 12 months.


Subject(s)
Chlamydia , Contraceptive Agents, Female , Gonorrhea , Intrauterine Devices , Long-Acting Reversible Contraception , Female , Gonorrhea/diagnosis , Humans
13.
Sex Transm Dis ; 47(10): 686-690, 2020 10.
Article in English | MEDLINE | ID: mdl-32936603

ABSTRACT

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.


Subject(s)
Syphilis , Adolescent , Adult , Centers for Disease Control and Prevention, U.S. , Female , Humans , Mass Screening , Pregnancy , Pregnancy Complications, Infectious/diagnosis , Pregnancy Complications, Infectious/epidemiology , Stillbirth/epidemiology , Syphilis/diagnosis , Syphilis/epidemiology , Syphilis Serodiagnosis , United States/epidemiology , Young Adult
14.
Clin Pharmacol Drug Dev ; 8(5): 637-646, 2019 07.
Article in English | MEDLINE | ID: mdl-30168905

ABSTRACT

TAK-117 (also known as MLN1117 or serabelisib) is an orally available inhibitor of phosphoinositide 3-kinase alpha being developed for treatment of solid tumors. This clinical study in healthy subjects assessed the relative bioavailability of a TAK-117 tablet compared with a capsule formulation (part 1) and the effect of food (part 2) and intragastric pH modulation (part 3) on TAK-117 pharmacokinetics. In part 1, subjects received single doses of 900 mg TAK-117 under fasting conditions as capsules and tablets on 2 different occasions in random order. In part 2, subjects received a single dose of 600 mg TAK-117 under fed (high-fat meal) or fasted conditions on 2 different occasions in random order. In part 3, subjects received a single dose of 900 mg TAK-117 alone and in combination with lansoprazole in a fixed sequence. Blood samples were collected up to 72 hours after each TAK-117 dose. The geometric mean ratios (90% confidence intervals) for the area under the TAK-117 plasma concentration-time curves were 1.53 (0.93-2.51) for tablets versus capsules, 1.50 (1.00-2.25) for fed versus fasted, and 0.02 (0.01-0.04) for TAK-117 plus lansoprazole compared with TAK-117 alone. The most common adverse event was nausea, the incidence of which was reduced when TAK-117 was administered with food despite the increased systemic exposure. The incidence of all adverse events was reduced when TAK-117 was administered with lansoprazole, which was consistent with the substantial reduction in bioavailability. Intersubject variability of TAK-117 was high. Careful management of intragastric pH-modulatory concomitant medications and food intake may be required.


Subject(s)
Benzoxazoles/pharmacokinetics , Enzyme Inhibitors/administration & dosage , Imidazoles/pharmacokinetics , Morpholines/pharmacokinetics , Pyridines/pharmacokinetics , Administration, Oral , Adult , Area Under Curve , Benzoxazoles/administration & dosage , Benzoxazoles/adverse effects , Biological Availability , Capsules/pharmacokinetics , Drug Administration Schedule , Drugs, Investigational , Enzyme Inhibitors/adverse effects , Enzyme Inhibitors/pharmacokinetics , Fasting/blood , Female , Healthy Volunteers , Humans , Imidazoles/administration & dosage , Imidazoles/adverse effects , Male , Morpholines/administration & dosage , Morpholines/adverse effects , Pyridines/administration & dosage , Pyridines/adverse effects , Tablets/pharmacokinetics , Young Adult
15.
Sex Transm Dis ; 45(9): e72-e74, 2018 09.
Article in English | MEDLINE | ID: mdl-29664767

ABSTRACT

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.


Subject(s)
Chlamydia Infections/epidemiology , Female Urogenital Diseases/epidemiology , Adolescent , Adult , Asymptomatic Diseases , Chlamydia Infections/diagnosis , Female , Female Urogenital Diseases/diagnosis , Health Care Surveys , Humans , Mass Screening , Physicians' Offices , United States/epidemiology , Young Adult
16.
Sex Transm Dis ; 44(11): 685-690, 2017 11.
Article in English | MEDLINE | ID: mdl-28876321

ABSTRACT

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.


Subject(s)
Guideline Adherence/statistics & numerical data , Insurance, Health , Mass Screening/statistics & numerical data , Pregnancy Complications, Infectious/diagnosis , Prenatal Diagnosis/statistics & numerical data , Stillbirth/epidemiology , Syphilis/diagnosis , Adolescent , Adult , Autopsy , Centers for Disease Control and Prevention, U.S. , Female , Health Care Surveys , Humans , Incidence , Insurance, Health/statistics & numerical data , Medical Record Linkage , Practice Guidelines as Topic , Pregnancy , Pregnancy Complications, Infectious/economics , Pregnancy Complications, Infectious/epidemiology , Prenatal Diagnosis/economics , Syphilis/complications , Syphilis/economics , Syphilis/epidemiology , United States , Young Adult
17.
Sex Transm Dis ; 44(9): 513-518, 2017 09.
Article in English | MEDLINE | ID: mdl-28809767

ABSTRACT

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.


Subject(s)
Gonorrhea/ethnology , Health Status Disparities , Sexually Transmitted Diseases/ethnology , Black People/statistics & numerical data , Gonorrhea/epidemiology , Hispanic or Latino/statistics & numerical data , Humans , Minority Groups/statistics & numerical data , Sexually Transmitted Diseases/epidemiology , White People/statistics & numerical data
18.
J Adolesc Health ; 61(4): 440-445, 2017 Oct.
Article in English | MEDLINE | ID: mdl-28754585

ABSTRACT

PURPOSE: To assess impact of the 2009 American College of Obstetricians and Gynecologists (ACOG) Pap guideline changes on chlamydia testing rates among sexually active young women. METHODS: The study included sexually active women aged 15-25 years enrolled in commercial health plans from 2005 to 2014. We identified sexually active women by diagnosis, procedure, and drug codes in inpatient, outpatient, and drug claims databases. We identified Pap tests and chlamydia tests among sexually active adolescents (15-20 years) and young adults (21-25 years) over time. Using piecewise regression models, we compared the change in chlamydia testing rates before and after 2009 ACOG guidelines. RESULTS: From 2005 to 2014, chlamydia testing rates in sexually active women increased from 23% to 37% among adolescents and from 24% to 43% among young adults. Although the overall increase in chlamydia testing was positive, the annual rate of change in chlamydia testing (slope) decreased significantly after the 2009 ACOG guideline change from 1.9% before to 1.0% after for adolescents (p < .05) and from 2.5% to 1.7% for young adults (p < .05). CONCLUSIONS: Although chlamydia test rates are increasing among sexually active women aged 15-25 years from 2005 to 2014, the slower growth in chlamydia testing rate after 2009 may relate to the change in the Pap testing guidelines. Our finding that more than half of sexually active women aged 15-25 years did not have chlamydia testing and that the rate of increased chlamydia testing slowed after 2009 suggests that interventions to improve chlamydia testing apart from combining with Pap testing are still needed.


Subject(s)
Chlamydia Infections/diagnosis , Mass Screening/trends , Papanicolaou Test/statistics & numerical data , Practice Guidelines as Topic , Sexual Behavior , Vaginal Smears/statistics & numerical data , Adolescent , Adult , Chlamydia Infections/epidemiology , Chlamydia Infections/prevention & control , Databases, Factual , Female , Humans , Logistic Models , Retrospective Studies , United States/epidemiology , Young Adult
19.
Sex Transm Dis ; 43(11): 661-667, 2016 11.
Article in English | MEDLINE | ID: mdl-27893593

ABSTRACT

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.


Subject(s)
Gonorrhea/epidemiology , Health Status Disparities , Syphilis/epidemiology , Adolescent , Adult , Asian People , Black People , Ethnicity , Female , Gonorrhea/ethnology , Hispanic or Latino , Humans , Indians, North American , Minority Groups , New York/epidemiology , Syphilis/ethnology , White People , Young Adult
20.
Sex Transm Dis ; 43(10): 595-8, 2016 10.
Article in English | MEDLINE | ID: mdl-27626186

ABSTRACT

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.


Subject(s)
Chlamydia Infections/diagnosis , Adolescent , Adult , Centers for Medicare and Medicaid Services, U.S. , Databases, Factual , Female , Humans , Medicaid , Sexual Behavior , United States , Young Adult
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