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1.
AIDS Behav ; 28(9): 3170-3183, 2024 Sep.
Article in English | MEDLINE | ID: mdl-39014029

ABSTRACT

We examined past-year intimate partner violence (IPV), including psychological violence without physical/sexual violence, and health outcomes among people with HIV (PWH) in care in a multi-site U.S. cohort. Between 2016 and 2022, PWH reported 12-month psychological, physical, and sexual IPV in a routine assessment. We used linear and logistic regression models adjusted for age, race/ethnicity, and site to examine relationships with health outcomes. Among 9748 PWH (median age 50 years, 81% cisgender male/16% cisgender female/1% transgender female; 44% non-Hispanic white/36% non-Hispanic Black/15% Hispanic), 9.3% (n = 905) reported any IPV in the past 12 months; half reported psychological IPV without physical/sexual IPV (n = 453). PWH reporting any type of IPV were on average younger than those who did not experience IPV. In adjusted models, any IPV was associated with increased likelihood of unstable housing, HIV viral load detection (HIV viral load ≥ 75 copies/mL), moderate-to-severe depressive symptoms, anxiety with panic symptoms, substance use (methamphetamines, cocaine/crack, illicit opioids, marijuana, heavy episodic/hazardous drinking), and concern about exposure to sexually transmitted infection. PWH reporting any IPV in the past 12 months had 4.2% lower adherence to antiretroviral therapy, 2.4 more HIV-related symptoms, a 1.9 point higher HIV stigma score, and a 9.5% lower quality of life score than those without IPV. We found similar associations among PWH reporting only psychological IPV, without physical/sexual IPV. IPV was common among PWH. Half reporting IPV reported only psychological IPV and had similarly poor outcomes as those reporting physical/sexual IPV, demonstrating the need to assess psychological as well as physical and sexual IPV.


RESUMEN: Examinamos la violencia de la pareja íntima (intimate partner violence, IPV) del año anterior, incluida la violencia psicológica sin violencia física y sexual, así como los resultados sanitarios entre las personas con VIH (people with HIV, PWH) que reciben atención en una cohorte multicéntrica de los Estados Unidos. Entre 2016 y 2022, las PWH informaron situaciones de IPV psicológica, física y sexual durante los 12 meses en una evaluación de rutina. Se utilizaron modelos de regresión lineal y logística ajustados por edad, raza/etnia y centro para examinar las relaciones con los resultados sanitarios. Entre 9748 PWH (mediana de edad de 50 años, 81% de hombres cisgénero/16% de mujeres cisgénero/1% de mujeres transgénero; 44% de blancos no hispanos/36% de negros no hispanos/15% de hispanos), el 9,3% (n = 905) informaron haber sufrido algún tipo de IPV en los últimos 12 meses; la mitad informó situaciones de IPV psicológica sin IPV física y sexual (n = 453). Las PWH que informaron de cualquier tipo de IPV fueron, en promedio, más jóvenes que las que no sufrieron IPV. En los modelos ajustados, cualquier IPV se asoció con una mayor probabilidad de vivienda inestable, detección de carga viral del VIH (carga viral del VIH ≥ 75 copias/ml), síntomas depresivos de moderados a graves, ansiedad con síntomas de pánico, consumo de sustancias (metanfetaminas, cocaína/crack, opioides ilícitos, marihuana, consumo excesivo episódico/peligroso de alcohol) y preocupación por la exposición a infecciones de transmisión sexual. Las PWH que informaron alguna situación de IPV en los últimos 12 meses tuvieron un 4,2% menos de cumplimiento de la terapia antirretrovírica, un 2,4% más de síntomas relacionados con el VIH, una puntuación de estigma del VIH 1,9 puntos más alta y una puntuación de calidad de vida un 9,5% más baja que las que no sufrieron IPV. Se encontraron asociaciones similares entre las PWH que informaron solo IPV psicológica, sin IPV física y sexual. La IPV fue común entre las PWH. La mitad de las personas que informaron IPV solo informaron IPV psicológica y tuvieron resultados igualmente deficientes que los que informaron IPV física y sexual, lo que demuestra la necesidad de evaluar la IPV psicológica, al igual que la IPV física y sexual.


Subject(s)
HIV Infections , Intimate Partner Violence , Humans , Female , Male , Intimate Partner Violence/psychology , Intimate Partner Violence/statistics & numerical data , HIV Infections/psychology , HIV Infections/epidemiology , HIV Infections/drug therapy , Middle Aged , United States/epidemiology , Adult , Sexual Partners/psychology , Risk Factors , Cohort Studies , Viral Load , Depression/epidemiology , Depression/psychology
2.
AIDS Care ; 36(5): 618-630, 2024 May.
Article in English | MEDLINE | ID: mdl-37419138

ABSTRACT

Substance use in people with HIV (PWH) negatively impacts antiretroviral therapy (ART) adherence. However, less is known about this in the current treatment era and the impact of specific substances or severity of substance use. We examined the associations of alcohol, marijuana, and illicit drug use (methamphetamine/crystal, cocaine/crack, illicit opioids/heroin) and their severity of use with adherence using multivariable linear regression in adult PWH in care between 2016 and 2020 at 8 sites across the US. PWH completed assessments of alcohol use severity (AUDIT-C), drug use severity (modified ASSIST), and ART adherence (visual analogue scale). Among 9400 PWH, 16% reported current hazardous alcohol use, 31% current marijuana use, and 15% current use of ≥1 illicit drugs. In multivariable analysis, current methamphetamine/crystal use, particularly common among men who had sex with men, was associated with 10.1% lower mean ART adherence (p < 0.001) and 2.6% lower adherence per 5-point higher severity of use (ASSIST score) (p < 0.001). Current and more severe use of alcohol, marijuana, and other illicit drugs were also associated with lower adherence in a dose-dependent manner. In the current HIV treatment era, individualized substance use treatment, especially for methamphetamine/crystal, and ART adherence should be prioritized.


Subject(s)
HIV Infections , Illicit Drugs , Methamphetamine , Substance-Related Disorders , Adult , Male , Humans , HIV Infections/drug therapy , HIV Infections/complications , Substance-Related Disorders/complications , Anti-Retroviral Agents/therapeutic use , Ethanol/therapeutic use , Methamphetamine/therapeutic use , Medication Adherence
3.
Immunohematology ; 37(2): 89-94, 2021 Jun.
Article in English | MEDLINE | ID: mdl-34170644

ABSTRACT

The ABO blood group system includes phenotypes, or subgroups, that differ in the amount of A and B antigens present on the red blood cells (RBCs). These subgroups also differ in the A, B, or H substances present in secretions (for individuals who have the secretor phenotype). B subgroups are very rare and are less frequently reported than A subgroups. Usually, B subgroups are discovered during serologic testing when there is a discrepancy between RBC and serum grouping results. Subgroups of B are usually identified by a reference laboratory using molecular and adsorption-elution methods. This report details a case of a young, healthy, pregnant woman with a B subgroup detected by a small transfusion service using adsorption-elution methods. Serology and genotyping of the ABO gene was performed at a reference laboratory where the serology was consistent with a B subgroup, but no changes were identified in ABO gene sequencing. It is important to correctly identify B subgroups in donors and recipients to help resolve ABO discrepancies and potentially prevent ABO incompatibility in blood transfusion, thus minimizing transfusion reactions.The ABO blood group system includes phenotypes, or subgroups, that differ in the amount of A and B antigens present on the red blood cells (RBCs). These subgroups also differ in the A, B, or H substances present in secretions (for individuals who have the secretor phenotype). B subgroups are very rare and are less frequently reported than A subgroups. Usually, B subgroups are discovered during serologic testing when there is a discrepancy between RBC and serum grouping results. Subgroups of B are usually identified by a reference laboratory using molecular and adsorption-elution methods. This report details a case of a young, healthy, pregnant woman with a B subgroup detected by a small transfusion service using adsorption-elution methods. Serology and genotyping of the ABO gene was performed at a reference laboratory where the serology was consistent with a B subgroup, but no changes were identified in ABO gene sequencing. It is important to correctly identify B subgroups in donors and recipients to help resolve ABO discrepancies and potentially prevent ABO incompatibility in blood transfusion, thus minimizing transfusion reactions.


Subject(s)
Blood Grouping and Crossmatching , Transfusion Reaction , ABO Blood-Group System , Blood Transfusion , Female , Hospitals , Humans , Pregnancy
4.
J Viral Hepat ; 24(10): 865-876, 2017 10.
Article in English | MEDLINE | ID: mdl-28419653

ABSTRACT

The impact of hepatitis C virus (HCV) RNA levels on immune status in chronically HCV mono-infected when compared to HIV/HCV co-infected on antiretroviral therapy (ART) remains poorly understood. A total of 78 African American subjects HCV viraemic/naïve to HCV treatment (33 HCV genotype 1 mono-infected, 45 ART-treated HIV/HCV genotype 1 co-infected) were studied. Clinical and liver enzyme measurements were performed. Whole blood was analysed for immune subset changes by flow cytometry. Peripheral blood mononuclear cells (PBMC) were used for same-day constitutive and in vitro Interferon (IFN)-α-induced signal transducer and activator of transcription (STAT) phosphorylation, K562 target cell lysis and K562 target cell recognition-mediated IFN-γ production. Statistical analysis was performed using R (2.5.1) or JMP Pro 11. While both groups did not differ in the level of liver enzymes, HIV/HCV had higher T-cell activation/exhaustion, and constitutive STAT-1 phosphorylation compared to HCV. In contrast, CD4+ FoxP3+ CD25+ frequency, IFN-αR expression on NK cells, as well as constitutive and IFN-α-induced direct cytotoxicity were lower in HIV/HCV. Linear regression models further supported these results. Finally, increase in HCV viral load and CD4+ T-cell count had an opposite effect between the two groups on NK cell activity and T-cell activation, respectively. HCV viral load in ART-treated HIV/HCV co-infection was associated with greater immune activation/exhaustion and NK dysfunction than HCV viral load alone in HCV mono-infection. The more pronounced immune modulation noted in ART-treated HIV-co-infected/untreated HCV viraemic subjects may impact HCV disease progression and/or response to immunotherapy.


Subject(s)
Coinfection , HIV Infections , Hepacivirus/immunology , Hepatitis C/immunology , Hepatitis C/virology , Killer Cells, Natural/immunology , Lymphocyte Activation/immunology , Viremia , Antiretroviral Therapy, Highly Active , Antiviral Agents/pharmacology , Antiviral Agents/therapeutic use , Biomarkers , CD4 Lymphocyte Count , Cytokines/biosynthesis , Cytotoxicity, Immunologic , Drug Therapy, Combination , Female , HIV Infections/drug therapy , HIV Infections/immunology , HIV Infections/metabolism , HIV Infections/virology , Hepacivirus/drug effects , Hepatitis C/drug therapy , Hepatitis C/metabolism , Humans , Immunophenotyping , Killer Cells, Natural/metabolism , Leukocytes, Mononuclear/drug effects , Leukocytes, Mononuclear/immunology , Leukocytes, Mononuclear/metabolism , Male , Middle Aged , STAT1 Transcription Factor/metabolism , Signal Transduction/drug effects , Viral Load
5.
Diabetes Obes Metab ; 18 Suppl 2: 43-49, 2016 10.
Article in English | MEDLINE | ID: mdl-27393722

ABSTRACT

AIMS: To compare 24-hour fixed-time basal insulin peglispro (BIL) dosing with 8- to 40-hour variable-time BIL dosing for glycaemic control and safety in patients with type 1 diabetes. Primary outcome was non-inferiority of BIL variable-time dosing compared with fixed-time dosing for glycated haemoglobin (HbA1c) change after 12-week treatment (margin = 0.4%). MATERIALS AND METHODS: This Phase 3, open-label, randomized, cross-over study (N = 212) was conducted at 20 centres in the United States. During the 12-week lead-in phase, patients received BIL daily at fixed-times. Two 12-week randomized cross-over treatment phases followed, where patients received BIL dosed at either fixed- or variable-times. During the 4-week safety follow-up, patients received conventional insulins. RESULTS: During the lead-in period, least-squares mean HbA1c decreased from 7.5% to 6.8%. For BIL, variable-time dosing was non-inferior to fixed-time dosing for HbA1c change [least-squares mean difference = 0.06%, 95% confidence interval (-0.01, 0.13)]. In both regimens, HbA1c increased slightly during the cross-over periods, but remained significantly below baseline. Variable- and fixed-time dosing regimens had similar rates of total hypoglycaemia (10.4 ± 0.62 and 10.5 ± 0.67 events/patient/30 days, P = .947) and nocturnal hypoglycaemia (1.3 ± 0.11 and 1.5 ± 0.13 events/patient/30days, P = .060). Comparable proportions of patients achieved HbA1c < 7.0% with variable- [91 (54.5%)] and fixed-time dosing [101 (60.5%)]. CONCLUSIONS: Treatment with BIL allows patients to use flexible dosing intervals from 8 to 40 hours. Glycaemic efficacy (HbA1c), glycaemic variability and hypoglycaemia are similar to fixed-time dosing, suggesting that BIL could potentially provide flexibility in dosing for patients who miss their daily basal insulin.


Subject(s)
Diabetes Mellitus, Type 1/drug therapy , Hypoglycemia/chemically induced , Hypoglycemic Agents/administration & dosage , Insulin Lispro/analogs & derivatives , Polyethylene Glycols/administration & dosage , Adult , Blood Glucose/metabolism , Cross-Over Studies , Diabetes Mellitus, Type 1/metabolism , Drug Administration Schedule , Female , Glycated Hemoglobin/metabolism , Humans , Insulin Lispro/administration & dosage , Least-Squares Analysis , Male , Middle Aged , Treatment Outcome
6.
Diabetes Obes Metab ; 18(11): 1055-1064, 2016 11.
Article in English | MEDLINE | ID: mdl-27349219

ABSTRACT

AIMS: To compare, in a double-blind, randomized, multi-national study, 52- or 78-week treatment with basal insulin peglispro or insulin glargine, added to pre-study oral antihyperglycaemic medications, in insulin-naïve adults with type 2 diabetes. MATERIAL AND METHODS: The primary outcome was non-inferiority of peglispro to glargine with regard to glycated haemoglobin (HbA1c) reduction (margin = 0.4%). Six gated secondary objectives with statistical multiplicity adjustments focused on other measures of glycaemic control and safety. Liver fat content was measured using MRI, in a subset of patients. RESULTS: Peglispro was non-inferior to glargine in HbA1c reduction [least-squares (LS) mean difference: -0.29%, 95% confidence interval (CI) -0.40, -0.19], and had a lower nocturnal hypoglycaemia rate [relative rate 0.74 (95% CI 0.60, 0.91); p = .005), more patients achieving HbA1c <7.0% without nocturnal hypoglycaemia [odds ratio (OR) 2.15 (95% CI 1.60, 2.89); p < .001], greater HbA1c reduction (p < .001), and more patients achieving HbA1c<7.0% [OR 1.97 (95% CI 1.57, 2.47); p < .001]. Total hypoglycaemia rate and fasting serum glucose did not achieve statistical superiority. At 52 weeks, peglispro-treated patients had higher triglyceride (1.9 vs 1.7 mmol/L). alanine transaminase (34 vs 27 IU/L), and aspartate transaminase levels (27 vs 24 IU/L). LS mean liver fat content was unchanged with peglispro at 52 weeks but decreased 3.1% with glargine [difference: 2.6% (0.9, 4.2); p = .002]. More peglispro-treated patients experienced adverse injection site reactions (3.5% vs 0.6%, p < .001). CONCLUSIONS: Compared with glargine at 52 weeks, peglispro resulted in a statistically superior reduction in HbA1c, more patients achieving HbA1c targets, less nocturnal hypoglycaemia, no improvement in total hypoglycaemia, higher triglyceride levels, higher aminotransferase levels, and more injection site reactions.


Subject(s)
Diabetes Mellitus, Type 2/drug therapy , Hypoglycemic Agents/administration & dosage , Insulin Glargine/administration & dosage , Insulin Lispro/analogs & derivatives , Polyethylene Glycols/administration & dosage , Administration, Oral , Aged , Blood Glucose/drug effects , Blood Glucose/metabolism , Circadian Rhythm , Diabetes Mellitus, Type 2/blood , Double-Blind Method , Drug Therapy, Combination , Fasting/blood , Female , Humans , Hypoglycemic Agents/adverse effects , Insulin Glargine/adverse effects , Insulin Lispro/administration & dosage , Insulin Lispro/adverse effects , Male , Middle Aged , Polyethylene Glycols/adverse effects
7.
Anesth Analg ; 122(4): 1070-8, 2016 Apr.
Article in English | MEDLINE | ID: mdl-26836134

ABSTRACT

BACKGROUND: Diagnostic and interventional procedures are often facilitated by moderate procedure-related sedation. Many studies support the overall safety of this sedation; however, adverse cardiovascular and respiratory events are reported in up to 70% of these procedures, more frequently in very young, very old, or sicker patients. Monitoring with pulse oximetry may underreport hypoventilation during sedation, particularly if supplemental oxygen is provided. Capnometry may result in false alarms during sedation when patients mouth breathe or displace sampling devices. Advanced monitor use during sedation may allow event detection before complications develop. This 2-part pilot study used advanced monitors during planned moderate sedation to (1) determine incidences of desaturation, low respiratory rate, and deeper than intended sedation alarm events; and (2) determine whether advanced monitor use is associated with fewer alarm events. METHODS: Adult patients undergoing scheduled gastroenterology or interventional radiology procedures with planned moderate sedation given by dedicated sedation nurses under the direction of procedural physicians (procedural sedation team) were monitored per standard protocols (electrocardiography blood pressure, pulse oximetry, and capnometry) and advanced monitors (acoustic respiratory monitoring and processed electroencephalograpy). Data were collected to computers for analysis. Advanced monitor parameters were not visible to teams in part 1 (standard) but were visible to teams in part 2 (advanced). Alarm events were defined as desaturation-SpO2 ≤92%; respiratory depression, acoustic respiratory rate ≤8 breaths per minute, and deeper than intended sedation, indicated by processed electroencephalograpy. The number of alarm events was compared. RESULTS: Of 100 patients enrolled, 10 were excluded for data collection computer malfunction or consent withdrawal. Data were analyzed from 90 patients (44 standard and 46 advanced). Advanced had fewer total alarms than standard (Wilcoxon-Mann-Whitney = 2.073, P = 0.038; Wilcoxon-Mann-Whitney odds, 1.67; 95% confidence interval [CI], 1.04-2.88). Similar numbers of standard and advanced had ≥1 alarm event (Wald difference, -10.2%; 95% CI, -26.4% to 7.0%; P = 0.237). Fewer advanced patients had ≥1 respiratory depression event (Wald difference, -22.1%; 95% CI, -40.9% to -2.4%; P = 0.036) or ≥1 desaturation event (Wald difference, -24.2%; 95% CI, -42.8% to -3.6%; P = 0.021); but there was no significant difference in deeper than intended sedation events (Wald difference, -1.38%; 95% CI, -20.21% to 17.49%; P = 0.887). CONCLUSIONS: Use of advanced monitoring parameters during planned moderate sedation was associated with fewer alarm events, patients experiencing desaturation, and patients experiencing respiratory depression alarm events. This pilot study suggests that further study into the safety and outcome impacts of advanced monitoring during procedure-related sedation is warranted.


Subject(s)
Clinical Alarms/standards , Conscious Sedation/methods , Endoscopy, Gastrointestinal , Radiology, Interventional , Conscious Sedation/adverse effects , Endoscopy, Gastrointestinal/adverse effects , Female , Humans , Male , Middle Aged , Pilot Projects
8.
Am J Physiol Lung Cell Mol Physiol ; 308(3): L259-69, 2015 Feb 01.
Article in English | MEDLINE | ID: mdl-25480336

ABSTRACT

Endothelial dysfunction underlies the pathophysiology of vascular disorders such as acute lung injury (ALI) syndromes. Recent work has identified the Abl family kinases (c-Abl and Arg) as important regulators of endothelial cell (EC) barrier function and suggests that their inhibition by currently available pharmaceutical agents such as imatinib may be EC protective. Here we describe novel and differential effects of imatinib in regulating lung pathophysiology in two clinically relevant experimental models of ALI. Imatinib attenuates endotoxin (LPS)-induced vascular leak and lung inflammation in mice but exacerbates these features in a mouse model of ventilator-induced lung injury (VILI). We next explored these discrepant observations in vitro through investigation of the roles for Abl kinases in cultured lung EC. Imatinib attenuates LPS-induced lung EC permeability, restores VE-cadherin junctions, and reduces inflammation by suppressing VCAM-1 expression and inflammatory cytokine (IL-8 and IL-6) secretion. Conversely, in EC exposed to pathological 18% cyclic stretch (CS) (in vitro model of VILI), imatinib decreases VE-cadherin expression, disrupts cell-cell junctions, and increases IL-8 levels. Downregulation of c-Abl expression with siRNA attenuates LPS-induced VCAM-1 expression, whereas specific reduction of Arg reduces VE-cadherin expression in 18% CS-challenged ECs to mimic the imatinib effects. In summary, imatinib exhibits pulmonary barrier-protective and anti-inflammatory effects in LPS-injured mice and lung EC; however, imatinib exacerbates VILI as well as dysfunction in 18% CS-EC. These findings identify the Abl family kinases as important modulators of EC function and potential therapeutic targets in lung injury syndromes.


Subject(s)
Anti-Inflammatory Agents/pharmacology , Benzamides/pharmacology , Piperazines/pharmacology , Pyrimidines/pharmacology , Ventilator-Induced Lung Injury/drug therapy , Animals , Anti-Inflammatory Agents/therapeutic use , Benzamides/therapeutic use , Biomechanical Phenomena , Capillary Permeability/drug effects , Cells, Cultured , Cytokines/biosynthesis , Drug Evaluation, Preclinical , Endothelium, Vascular/drug effects , Endothelium, Vascular/immunology , Endothelium, Vascular/physiopathology , Humans , Imatinib Mesylate , Lipopolysaccharides/pharmacology , Lung/blood supply , Lung/drug effects , Lung/immunology , Male , Mice, Inbred C57BL , Piperazines/therapeutic use , Proto-Oncogene Proteins c-abl/metabolism , Pyrimidines/therapeutic use , Stress, Physiological , Ventilator-Induced Lung Injury/immunology , alpha-Fetoproteins/metabolism
9.
Am J Public Health ; 105(3): e81-7, 2015 Mar.
Article in English | MEDLINE | ID: mdl-25602861

ABSTRACT

OBJECTIVES: We evaluated the impact of the New York City restaurant letter-grading program on restaurant hygiene, food safety practices, and public awareness. METHODS: We analyzed data from 43,448 restaurants inspected between 2007 and 2013 to measure changes in inspection score and violation citations since program launch in July 2010. We used binomial regression to assess probability of scoring 0 to 13 points (A-range score). Two population-based random-digit-dial telephone surveys assessed public perceptions of the program. RESULTS: After we controlled for repeated restaurant observations, season of inspection, and chain restaurant status, the probability of scoring 0 to 13 points on an unannounced inspection increased 35% (95% confidence interval [CI]=31%, 40%) 3 years after compared with 3 years before grading. There were notable improvements in compliance with some specific requirements, including having a certified kitchen manager on site and being pest-free. More than 91% (95% CI=88%, 94%) of New Yorkers approved of the program and 88% (95% CI=85%, 92%) considered grades in dining decisions in 2012. CONCLUSIONS: Restaurant letter grading in New York City has resulted in improved sanitary conditions on unannounced inspection, suggesting that the program is an effective regulatory tool.


Subject(s)
Food Inspection/standards , Food Safety/methods , Restaurants/standards , Sanitation/standards , Data Collection , Food Inspection/methods , Humans , New York City , Program Evaluation , Public Opinion , Regression Analysis , Restaurants/classification , Sanitation/classification
10.
Diabetes Obes Metab ; 16(6): 510-8, 2014 Jun.
Article in English | MEDLINE | ID: mdl-24298995

ABSTRACT

AIMS: To compare efficacy and safety of two, once-daily basal insulin formulations [insulin lispro protamine suspension (ILPS) vs. insulin glargine (glargine)] added to oral antihyperglycaemic medications (OAMs) and exenatide BID in suboptimally controlled type 2 diabetes (T2D) patients. METHODS: This 24-week, open-label, multicentre trial randomized patients to bedtime ILPS (n = 171) or glargine (n = 168). Non-inferiority of ILPS versus glargine was assessed by comparing the upper limit of 95% confidence intervals (CIs) for change in haemoglobin A1c (HbA1c) from baseline to week 24 (adjusted for baseline HbA1c) with non-inferiority margin 0.4%. RESULTS: Non-inferiority of ILPS versus glargine was demonstrated: least-squares mean between-treatment difference (ILPS minus glargine) (95% CI) was 0.22% (0.06, 0.38). Mean HbA1c reduction was less for ILPS- versus glargine-treated patients (-1.16 ± 0.84 vs. -1.40 ± 0.97%, p = 0.008). Endpoint HbA1c < 7.0% was achieved by 53.7% (ILPS) and 61.7% (glargine) (p = NS). Overall hypoglycaemia rates (p = NS) and severe hypoglycaemia incidence (p = NS) were similar. Nocturnal hypoglycaemia rate was higher in patients treated with ILPS versus glargine (p = 0.004). Weight gain was similar between groups (ILPS: 0.27 ± 3.38 kg; glargine: 0.66 ± 3.93 kg, p = NS). Endpoint total insulin doses were lower in patients treated with ILPS versus glargine (0.30 ± 0.17 vs. 0.37 ± 0.17 IU/kg/day, p < 0.001). CONCLUSIONS: ILPS was non-inferior to glargine for HbA1c change over 24 weeks, but was associated with less HbA1c reduction and more nocturnal hypoglycaemia. Treat-to-target basal insulin therapy improves glycaemic control and is associated with minimal weight gain when added to OAMs and exenatide BID for suboptimally controlled T2D.


Subject(s)
Diabetes Mellitus, Type 2/drug therapy , Hyperglycemia/drug therapy , Hypoglycemic Agents/administration & dosage , Insulin Lispro/administration & dosage , Insulin, Long-Acting/administration & dosage , Administration, Oral , Adolescent , Adult , Aged , Diabetes Mellitus, Type 2/metabolism , Female , Glycated Hemoglobin/metabolism , Humans , Hyperglycemia/metabolism , Hypoglycemia/chemically induced , Hypoglycemic Agents/adverse effects , Insulin Glargine , Insulin Lispro/adverse effects , Insulin, Long-Acting/adverse effects , Male , Middle Aged , Protamines/administration & dosage , Protamines/adverse effects , Treatment Outcome , Weight Gain , Young Adult
11.
J Med Virol ; 84(6): 885-9, 2012 Jun.
Article in English | MEDLINE | ID: mdl-22499010

ABSTRACT

Although analytical treatment interruption is used as a strategy to test immunotherapeutic agents in HIV-infection, it may pose a risk for study participants. The potential risks of short-term interruption of antiretroviral therapy (ART) during treatment with an autologous dendritic cell immune-based therapy (AGS-004-001) were assessed using data from a subgroup of subjects in the strategies for management of antiretroviral therapy (SMART) study with matched eligibility criteria. A retrospective subgroup analysis of the SMART study population using the eligibility criteria and treatment stopping rules of AGS-004-001 study was analyzed. Key inclusion criteria for AGS-004-001 study were applied to the data collected from participants of the SMART study. There were 440 of 2,720 on the drug conservation arm and 436 of 2,752 on the viral suppression arm that matched the AGS-004-001 inclusion criteria and were used in the SMART subgroup analysis. In the first 16 weeks following randomization into the SMART study there were no deaths in either subgroup. There were two AIDS-related events in the drug conservation subgroup and one in the viral suppression subgroup, making the overall risk of AIDS-related events 2 per 100 person years (0.005%) and 1 per 100 person years (0.002%) in the two subgroups, respectively. There were 6/440 subjects (1.4%) in the drug conservation subgroup and 4/436 subjects (0.92%) in the viral suppression subgroup who experienced Grade 2 adverse events. These results demonstrated that analytical treatment interruption within the context of highly selective, closely monitored studies assessing the antiviral activity of immune-based agents should be an acceptable strategy for at least 16 weeks.


Subject(s)
HIV Infections/therapy , Immunotherapy/methods , Adult , Female , Humans , Male , Middle Aged , Retrospective Studies , Risk Assessment , Withholding Treatment
12.
Ultrasound Obstet Gynecol ; 39(4): 444-51, 2012 Apr.
Article in English | MEDLINE | ID: mdl-21728205

ABSTRACT

OBJECTIVE: To evaluate the utility of magnetic resonance imaging (MRI) in diagnosing structural injury in primiparous women at risk for pelvic floor injury. METHODS: This was an observational study of 77 women who underwent 3T MRI after delivery. Women were operationally defined as high risk (n = 45) for levator ani muscle tears (risk factors: second-stage labor > 150 min or < 30 min, anal sphincter tear, forceps, maternal age > 35 years and birth weight > 4000 g) or low risk (n = 32): vaginally delivered without these risk factors (n = 12); delivered by Cesarean section after second-stage labor > 150 min (n = 14) or delivered by Cesarean section without labor (n = 6). All women were imaged using fluid-sensitive MRI sequences. Two musculoskeletal radiologists reviewed images for bone marrow edema, fracture, pubic symphysis measurements and levator ani tear. RESULTS: MRI showed pubic bone fractures in 38% of women at high risk for pelvic floor injury and in 13% of women at low risk for pelvic floor injury (χ(2) (3) = 9.27, P = 0.03). Levator ani muscle tears were present in 44% of the high-risk women and in 9% of the low-risk women (χ(2) (3) = 11.57, P = 0.010). Bone marrow edema in the pubic bones was present in 61% of women studied across delivery categories. Complex patterns of injury included combinations of bone marrow edema, fractures, levator ani tears and pubic symphysis injuries. No MRI-documented injuries were present in 18% of women at high risk and 44% at low risk for pelvic floor injury (χ(2) (1) = 6.2, P = 0.013). CONCLUSIONS: Criteria identifying primiparous women at risk for pelvic floor injury can predict increased risk of bone and soft tissue changes at the pubic symphysis. Fluid-sensitive MRI has utility for differential diagnosis of structural injury in postpartum women.


Subject(s)
Bone Marrow Diseases/diagnosis , Delivery, Obstetric/adverse effects , Edema/diagnosis , Magnetic Resonance Imaging , Pelvic Floor/injuries , Pubic Bone/injuries , Adult , Bone Marrow Diseases/pathology , Cesarean Section , Diagnosis, Differential , Edema/pathology , Female , Humans , Infant, Newborn , Parity , Pelvic Floor/pathology , Pregnancy , Pubic Bone/pathology , Retrospective Studies , Risk Assessment , Risk Factors
13.
Sex Transm Infect ; 87(4): 279-82, 2011 Jun.
Article in English | MEDLINE | ID: mdl-21385892

ABSTRACT

OBJECTIVE: To estimate the numbers of female sex workers (FSW) and men who have sex with men (MSM) in San Salvador, El Salvador. DESIGN AND METHODS: A capture-recapture exercise was conducted among MSM and FSW in San Salvador in 2008. The first capture was done by distributing key chains to both MSM and FSW populations through local non-governmental organizations (NGO) that work with these groups. The second capture was done during the course of an integrated behavioural and biological survey (IBBS) using respondent-driven sampling (RDS). The proportion receiving a key chain estimated from the IBBS study was adjusted by RDS-derived weights. RESULTS: The first capture included 400 FSW and 400 MSM. Of the 624 MSM interviewed in the IBBS, 36 (5.8% crude; 3.2% adjusted RDS) had received the key chain. The estimated population size of MSM in San Salvador was 12 480 (95% CI 7235 to 17 725). Of the 663 FSW interviewed in the IBBS, 39 (5.9% crude; 6.9% adjusted RDS) had received the key chain. The estimated number of FSW was 5765 (95% CI 4253 to 7277). CONCLUSIONS: The capture-recapture exercise was successfully linked to an IBBS to obtain city-level population sizes for MSM and FSW, providing valuable information at a low cost. Size estimates are crucial for programme planning for national AIDS programmes, NGOs and stakeholders working with these populations and for HIV projection models.


Subject(s)
Homosexuality, Male/statistics & numerical data , Population Surveillance/methods , Sex Work/statistics & numerical data , Adult , Aged , Data Collection/methods , El Salvador/epidemiology , Female , Humans , Male , Middle Aged , Young Adult
14.
J Am Coll Radiol ; 18(10): 1430-1438, 2021 10.
Article in English | MEDLINE | ID: mdl-34171227

ABSTRACT

BACKGROUND: Radiology does not routinely solicit feedback on radiology reports. The aim of the study is to report the feasibility and initial results of a multi-institutional quality improvement project implementing patient and provider feedback for radiology reports. METHODS: A HIPAA-compliant, institutional review board-waived quality improvement effort at two institutions obtaining patient and provider feedback for radiology reports was implemented from January 2018 to May 2020. INTERVENTION: A two-question survey (quantitative review and open text box feedback) was embedded into the electronic health records for patients and providers. Text-based feedback was evaluated, and patterns of feedback were categorized: thoroughness of reports, error in reports, timeliness of reports, access to reports, desire for patient summary, and desire for key images. We performed the χ2 test for categorical variables. P < .05 was considered significant. RESULTS: Of 367 responses, patients provided 219 of 367 (60%), and providers provided 148 of 367 (40%) of the feedback. A higher proportion of patients reported satisfaction with reports (76% versus 65%, P = .023) and provided more feedback compared with providers (71% versus 50%, P < .0001). Both patients and providers commented on the thoroughness of reports (12% of patients versus 9% of providers) and errors in reports (8% of patients and 9% of providers). Patients disproportionately commented on timeliness of reports (11%) and access to the reports (6%) compared with providers (3% each). In addition, 7% of patients expressed a desire for patient summaries. CONCLUSION: Report-specific patient and provider feedback demonstrate the feasibility of embedding surveys into electronic medical records. Up to 9% of the feedback addressed an error in reports.


Subject(s)
Quality Improvement , Radiology , Electronic Health Records , Feedback , Humans , Surveys and Questionnaires
15.
Trans R Soc Trop Med Hyg ; 115(2): 188-189, 2021 01 28.
Article in English | MEDLINE | ID: mdl-33440002

ABSTRACT

Limited attention to tackling neglected tropical diseases (NTDs) through the lenses of gender, equity, ethnicity and human rights inadvertently undermines progress due to the exclusion of subgroups in populations living in conditions of vulnerability. Supporting national NTD programmes to make equity analysis part of their routine activities and revitalising intersectoral collaboration will be essential to achieve effective, sustainable service delivery with a person-centred approach. Gender, equity, human rights and ethnic equality for NTD programmes should therefore be incorporated in multisectoral engagements.


Subject(s)
Ethnicity , Tropical Medicine , Human Rights , Humans , Neglected Diseases/prevention & control
16.
medRxiv ; 2021 Dec 08.
Article in English | MEDLINE | ID: mdl-34909782

ABSTRACT

OBJECTIVES: To define the incidence of clinically-detected COVID-19 in people with HIV (PWH) in the US and evaluate how racial and ethnic disparities, comorbidities, and HIV-related factors contribute to risk of COVID-19. DESIGN: Observational study within the CFAR Network of Integrated Clinical Systems cohort in 7 cities during 2020. METHODS: We calculated cumulative incidence rates of COVID-19 diagnosis among PWH in routine care by key characteristics including race/ethnicity, current and lowest CD4 count, and geographic area. We evaluated risk factors for COVID-19 among PWH using relative risk regression models adjusted with disease risk scores. RESULTS: Among 16,056 PWH in care, of whom 44.5% were Black, 12.5% were Hispanic, with a median age of 52 years (IQR 40-59), 18% had a current CD4 count < 350, including 7% < 200; 95.5% were on antiretroviral therapy, and 85.6% were virologically suppressed. Overall in 2020, 649 PWH were diagnosed with COVID-19 for a rate of 4.94 cases per 100 person-years. The cumulative incidence of COVID-19 was 2.4-fold and 1.7-fold higher in Hispanic and Black PWH respectively, than non-Hispanic White PWH. In adjusted analyses, factors associated with COVID-19 included female sex, Hispanic or Black identity, lowest historical CD4 count <350 (proxy for CD4 nadir), current low CD4/CD8 ratio, diabetes, and obesity. CONCLUSIONS: Our results suggest that the presence of structural racial inequities above and beyond medical comorbidities increased the risk of COVID-19 among PWHPWH with immune exhaustion as evidenced by lowest historical CD4 or current low CD4:CD8 ratio had greater risk of COVID-19.

17.
J Exp Med ; 140(4): 939-53, 1974 Oct 01.
Article in English | MEDLINE | ID: mdl-4610077

ABSTRACT

The modulation or loss of thymus-leukemia (TL) antigenicity from the surfaces of mouse RADA1 leukemia cells and normal thymocytes during incubation with TL antibody in vitro at 37 degrees C was investigated by cytotoxicity, immunofluorescence, and immunoelectron microscopy. The fate of bivalent and monovalent antibody during modulation was visualized by fluorescence microscopy. Considerable antibody remained bound to the cell surface after modulation, bivalent antibody being displaced topographically into "patches" and "caps" while monovalent antibody was only slightly aggregated on the cell surface. Some antibody was internalized, presumably by pinocytosis, and was sequestered into the Golgi region of the cell. Capping usually occurred over the pole of the cell opposite from the Golgi region, which may explain the lack of extensive pinocytosis of modulating bivalent antibody. Since modulation with monovalent antibody occurs without patch or cap formation, gross topographical redistribution of TL antigen-antibody complexes is not required for modulation, although more subtle displacement of these complexes may be involved. Modulation was demonstrable by cytotoxicity with guinea pig C' but not with absorbed rabbit C', indicating that modulated TL antigens remain bound to the cell surface. A heat-labile factor in TL antiserum and in mouse serum in general is responsible for "blocking" the cytolytic interaction of guinea pig C' with modulated TL antigen-antibody complexes.


Subject(s)
Antibodies, Neoplasm , Antigen-Antibody Complex , Antigens, Neoplasm , Leukemia/immunology , T-Lymphocytes/immunology , Animals , Antibodies, Anti-Idiotypic , Antigen-Antibody Reactions , Antilymphocyte Serum , Binding Sites, Antibody , Cell Membrane/immunology , Complement System Proteins , Cytotoxicity Tests, Immunologic , Fluorescent Antibody Technique , Histocompatibility Antigens , Immunoglobulin Fab Fragments , Mice , Microscopy, Electron , Pinocytosis
18.
Sex Transm Infect ; 86 Suppl 2: ii35-42, 2010 Dec.
Article in English | MEDLINE | ID: mdl-21106513

ABSTRACT

BACKGROUND: HIV surveillance systems aim to monitor trends of HIV infection, the geographical distribution and its magnitude, and the impact of HIV. The quality of HIV surveillance is a key element in determining the uncertainty ranges around HIV estimates. This paper aims to assess the quality of HIV surveillance systems in low- and middle-income countries in 2009 compared with 2007. METHODS: Four dimensions related to the quality of surveillance systems are assessed: frequency and timeliness of data; appropriateness of populations; consistency of locations and groups; and representativeness of the groups. An algorithm for scoring the quality of surveillance systems was used separately for low and concentrated epidemics and for generalised epidemics. RESULTS: The number of countries categorised as fully functioning in 2009 was 35, down from 40 in 2007. 47 countries were identified as partially functioning, while 56 were categorised as poorly functioning. When compared with 2007, the quality of HIV surveillance remains similar. The number of ANC sites in sub-Saharan Africa has increased over time. The number of countries with low and concentrated epidemics that do not have functioning HIV surveillance systems has increased from 53 to 56 between 2007 and 2009. CONCLUSION: Overall, the quality of surveillance in low- and middle-income countries has remained stable. Still too many countries have poorly functioning surveillance systems. Several countries with generalised epidemics have conducted more than one population-based survey which can be used to confirm trends. In countries with concentrated or low-level epidemics, the lack of data on high-risk populations remains a challenge.


Subject(s)
Data Collection/standards , Developing Countries/statistics & numerical data , Epidemics/statistics & numerical data , HIV Infections/epidemiology , Adolescent , Adult , Data Collection/trends , Humans , Middle Aged , Research Design , Sentinel Surveillance , Young Adult
19.
Eat Weight Disord ; 15(4): e208-18, 2010 Dec.
Article in English | MEDLINE | ID: mdl-21406944

ABSTRACT

The aims of this seven-year longitudinal study of 228 girls (9- and 13-yr olds) were to examine 1) the predictive value of eating attitudes, a wish to be thinner, dieting, perfectionism, self-esteem and Body Mass Index; 2) the girls' parents' eating attitudes and perfectionism in relation to the development of disturbed eating attitudes, seven years later; and 3) whether normal body weight, healthy eating attitudes and low perfectionism together with high self-esteem might operate as protective factors for the later development of disturbed eating attitudes. The pre-adolescent girls (9-yr olds) "wish to be thinner" and fathers' EAT scores contributed most to the prediction of disturbed eating attitudes seven years later. Corresponding analysis for the adolescent girls (13-yr olds) showed that a "wish to be thinner" and mothers' rating on perfectionism contributed most to the prediction of disturbed eating attitudes seven years later. Protective factors were low BMI and more healthy eating attitudes - especially moderated by high selfesteem, and a low-to-medium degree of perfectionism. High self-esteem appeared to be a protective factor when the girls had a high degree of perfectionism. These results suggest that it is important to focus on healthy eating attitudes at home to prevent overweight in early childhood, enhance self-esteem and to take a critical stand toward the thinness ideal in our society.


Subject(s)
Body Image , Feeding Behavior/psychology , Feeding and Eating Disorders/psychology , Parents/psychology , Personality , Adolescent , Attitude to Health , Body Mass Index , Child , Female , Humans , Longitudinal Studies , Male , Risk Factors , Self Concept , Surveys and Questionnaires
20.
AJNR Am J Neuroradiol ; 41(1): 183-188, 2020 01.
Article in English | MEDLINE | ID: mdl-31831464

ABSTRACT

Patients with spinal muscular atrophy often have complete interlaminar osseous fusion, precluding lumbar puncture via the standard interlaminar approach. Recently, we have developed a new coaxial curved-needle variation of fluoroscopy-guided transforaminal lumbar puncture for intrathecal injections in this patient population. Between October 2017 and November 2018, fifty-nine consecutive transforaminal lumbar punctures using this technique were performed in 12 patients with spinal muscular atrophy for intrathecal nusinersen injection, with a 100% technical success rate and no C1-2 punctures required. One major complication occurred, consisting of a post-dural puncture headache, which required a therapeutic transforaminal epidural blood patch. Two minor complications occurred, both of which involved inadvertent puncture of a dorsal muscular arterial branch, without clinical sequelae. A fluoroscopy-guided curved-needle transforaminal approach is an effective technique for lumbar puncture in difficult cases, such as in this cohort of patients with spinal muscular atrophy and complete interlaminar osseous fusion undergoing intrathecal nusinersen injections.


Subject(s)
Injections, Spinal/instrumentation , Muscular Atrophy, Spinal/drug therapy , Needles , Oligonucleotides/administration & dosage , Radiography, Interventional/instrumentation , Adolescent , Adult , Child , Female , Fluoroscopy/instrumentation , Fluoroscopy/methods , Humans , Injections, Spinal/methods , Male , Muscular Atrophy, Spinal/pathology , Radiography, Interventional/methods , Young Adult
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