Gender differences in risk taking behaviors for Chlamydia trachomatis.

Chlamydia trachomatis (CT) is a global problem. We compared the risk taking behaviors for CT infection between men and women. Adults (2299 females, 5559 males) were administered the Risk Behavior Assessment. In women, CT was associated with candidiasis, in men with gonorrhea, genital warts, and syphilis. Risk factors for both genders were trading sex for money, use of marijuana for women, and use of Ecstasy and Viagra for men. Those with CT had higher risk perception for HIV infection and were more likely to obtain HIV testing. Patient teaching and concurrent testing for HIV and CT are imperative.

Comparisons of New HIV Rapid Test Kit Performance.

The development of rapid point-of-care tests for HIV infection has greatly reduced the problem of failure to return for test results. Test manufacturers are now developing test kits that can test for two or even three diseases at the same time, multiple-disease test kits. This study reports on the sensitivity and specificity of HIV tests when included on multi-disease test kits. 1029 participants were recruited from 2011 to 2014. HIV test kit sensitivities ranged from 91.1 to 100%, and the HIV test kit specificities from 99.5 to 100%. The two HIV kits which used oral fluid instead of blood performed well.

A latent class analysis of alcohol and drug use immediately before or during sex among women.

BACKGROUND: Alcohol and drug use by women is related to high-risk sexual practices and protective behaviors. OBJECTIVES: To determine sexual risk and protective behaviors using information about women's drug use immediately before or during sex. METHODS: Latent class analysis using PROC LCA in SAS software was used to determine classes of women using both past 30-day drug use and before or during sex. Participants were recruited from a community-based research site located in a low socio-economic area of Los Angeles County and completed the Risk Behavior Assessment, which elicits information on drug and sex risk behaviors. RESULTS: The Risk Behavior Assessment and HIV and sexually transmitted infections testing was obtained on 812 women. Five distinct groups were identified by PROC LCA: An Abstinent group comprised of 26% of participants; an Alcohol and Marijuana group (16%); an Amphetamine group (11%); a No Sex-with-Alcohol group (37%); and a Poly Drug group (11%). Multinomial logistic regression revealed that sexual behaviors and condom use were different across the five groups: The Alcohol and Marijuana group had a higher odds of vaginal intercourse, while the No Sex-with-Alcohol group was most likely to use condoms for vaginal intercourse. The Poly Drug group had the highest risk for anal intercourse while the Amphetamine and Poly Drug groups had high proportions of women with injection-drug using and men-who-have-sex-with-men sexual partners. CONCLUSION: Identifying women based on drug use immediately before or during sex can help providers understand prevention and risk-reduction practices and interventions for drug-using women.

Pharmacokinetic Properties of a Sufentanil Sublingual Tablet Intended to Treat Acute Pain.

BACKGROUND: Desirable product attributes for treatment of moderate-to-severe acute pain in many medically supervised settings are rapid onset and a route of administration not requiring intravenous access. The pharmacokinetic characteristics of sublingually administered tablets containing 15 or 30 µg of sufentanil are described. METHODS: Blood was sampled from healthy subjects (four studies, 122 subjects) and patients (seven studies, 944 patients). Studies in healthy subjects determined bioavailability, effect of inhibition of cytochrome P450 3A4, and the plasma concentration profile with single and hourly sublingual doses. Studies in patients evaluated effects of weight, age, sex, and organ impairment on apparent clearance. Noncompartmental and mixed-effect population methods were used. RESULTS: Bioavailability of a single sublingual tablet was 52%, decreasing to 35% with repeat dosing. Ketoconazole (CYP3A4 inhibitor) increased maximum plasma concentration 19% and increased the area under the curve 77%. After a single 30-µg dose, plasma concentrations reached the published sufentanil analgesic threshold (24 pg/ml) within 30 min, peaked at 1 h, and then decreased below therapeutic concentrations by ~3 h. With hourly administration, plasma concentrations plateaued by the fifth dose. Time for concentrations to decrease 50% from maximal values was similar after 1 dose (2.5 ± 0.85 h) and 12 doses (2.5 ± 0.72 h). Clearance increased with weight, decreased with age, and was not affected by renal or hepatic impairment. CONCLUSIONS: The time course of a single 30-µg dose was consistent with onset of analgesia and redosing frequency observed in clinical trials. Sublingual sufentanil tablets provide the opportunity to noninvasively and rapidly treat moderate-to-severe pain in a monitored setting.

Attention Deficit Hyperactivity Disorder, Aggression, and Illicit Stimulant Use: Is This Self-Medication?

This study compares adults with and without attention deficit hyperactivity disorder (ADHD) on measures of direct and displaced aggression and illicit drug use. Three hundred ninety-six adults were administered the Wender Utah Rating Scale, the Risk Behavior Assessment, the Aggression Questionnaire (AQ), and the Displaced Aggression Questionnaire (DAQ). Those with ADHD were higher on all scales of the AQ and DAQ, were younger at first use of amphetamines, and were more likely to have ever used crack and amphetamines. A Structural Equation Model found a significant interaction in that for those with medium and high levels of verbal aggression, ADHD predicts crack and amphetamine. Follow-up logistic regression models suggest that blacks self-medicate with crack and whites and Hispanics self-medicate with amphetamine when they have ADHD and verbal aggression.

Tasimelteon for non-24-hour sleep-wake disorder in totally blind people (SET and RESET): two multicentre, randomised, double-masked, placebo-controlled phase 3 trials.

BACKGROUND: Most totally blind people have non-24-hour sleep-wake disorder (non-24), a rare circadian rhythm disorder caused by an inability of light to reset their circadian pacemaker. In two consecutive placebo-controlled trials (SET and RESET), we assessed safety and efficacy (in terms of circadian entrainment and maintenance) of once-daily tasimelteon, a novel dual-melatonin receptor agonist. METHODS: We undertook the placebo-controlled, randomised, double-masked trials in 27 US and six German clinical research centres and sleep centres. We screened totally blind adults (18-75 years of age), who were eligible for the randomisation phase of SET if they had a non-24-hour circadian period (τ) of 24·25 h or longer (95% CI greater than 24·0 and up to 24·9 h), as calculated from measurements of urinary 6-sulphatoxymelatonin rhythms. For SET, we used block randomisation to assign patients (1:1) to receive tasimelteon (20 mg) or placebo every 24 h at a fixed clock time 1 h before target bedtime for 26 weeks. Patients who entered the open-label group receiving tasimelteon in SET or who did not meet the SET inclusion criteria but did meet the RESET inclusion criteria were screened for RESET. A subset of the patients who entered the open-label group before the RESET study and who had eligible τ values were screened for RESET after completing the open-label treatment. In RESET, we withdrew tasimelteon in a randomised manner (1:1) in patients who responded (ie, entrained) after a tasimelteon run-in period. Entrainment was defined as having τ of 24·1 h or less and a 95% CI that included 24·0 h. In SET, the primary endpoint was the proportion of entrained patients, assessed in the intention-to-treat population. The planned step-down primary endpoint assessed the proportion of patients who had a clinical response (entrainment at month 1 or month 7 plus clinical improvement, measured by the Non-24 Clinical Response Scale). In RESET, the primary endpoint was the proportion of non-entrained patients, assessed in the intention-to-treat population. Safety assessments included adverse events and clinical laboratory measures, assessed in all treated patients. These trials are registered with ClinicalTrials.gov, numbers NCT01163032 and NCT01430754. FINDINGS: Between Aug 25, 2010, and July 5, 2012, we screened 391 totally blind patients for SET, of whom 84 (22%) were assigned to receive tasimelteon (n=42) or placebo (n=42). Two patients in the tasimelteon group and four in the placebo group discontinued the study before τ was measured, due to adverse events, withdrawal of consent, and a protocol deviation. Circadian entrainment occurred in eight (20%) of 40 patients in the tasimelteon group compared with one (3%) of 38 patients in the placebo group at month 1 (difference 17%, 95% CI 3·2-31·6; p=0·0171). Nine (24%) of 38 patients showed a clinical response, compared with none of 34 in the placebo group (difference 24%, 95% CI 8·4-39·0; p=0·0028). Between Sept 15, 2011, and Oct 4, 2012, we screened 58 patients for eligibility in RESET, 48 (83%) of whom had τ assessed and entered the open-label tasimelteon run-in phase. 24 (50%) patients entrained, and 20 (34%) were enrolled in the randomisation phase. Two (20%) of ten patients who were withdrawn to placebo remained entrained compared with nine (90%) of ten who continued to receive tasimelteon (difference 70%, 95% CI 26·4-100·0; p=0·0026). No deaths were reported in either study, and discontinuation rates due to adverse events were comparable between the tasimelteon (3 [6%] of 52 patients) and placebo (2 [4%] of 52 patients) treatment courses. The most common side-effects associated with tasimelteon in SET were headache (7 [17%] of 42 patients given tasimelteon vs 3 [7%] of 42 patients given placebo), elevated liver enzymes (4 [10%] vs 2 [5%]), nightmares or abnormal dreams (4 [10%] vs none), upper respiratory tract infection (3 [7%] vs none], and urinary tract infections (3 [7%] vs 1 [2%]). INTERPRETATION: Once-daily tasimelteon can entrain totally blind people with non-24; however, continued tasimelteon treatment is necessary to maintain these improvements. FUNDING: Vanda Pharmaceuticals.

A Randomized Trial Comparing the Pharmacokinetics, Safety, and Tolerability of DFN-02, an Intranasal Sumatriptan Spray Containing a Permeation Enhancer, With Intranasal and Subcutaneous Sumatriptan in Healthy Adults.

OBJECTIVE/BACKGROUND: Intranasal sumatriptan (Imitrex® ) may be an alternative for patients who refuse injections and cannot tolerate oral agents, but due to low bioavailability and slow absorption, the clinical utility of the currently marketed formulation is limited, highlighting an unmet need for an effective non-oral migraine medication with a rapid onset of action. To overcome the slow absorption profile associated with intranasal administration, we evaluated the impact of 1-O-n-Dodecyl-ß-D-Maltopyranoside (DDM, Intravail A-3™), a permeation enhancer, on sumatriptan's pharmacokinetic profile by comparing the pharmacokinetic characteristics of two commercial sumatriptan products, 4 mg subcutaneous and 6 mg subcutaneous in healthy adults, with DFN-02 - a novel intranasal agent comprised of sumatriptan 10 mg plus 0.20% DDM. We also determined the pharmacokinetic characteristics of DDM and evaluated its safety and tolerability. METHODS: We conducted two studies: a randomized, three-way crossover study comparing monodose and multidose devices for delivery of single doses of DFN-02 with commercially available intranasal sumatriptan 20 mg in 18 healthy, fasted adults, and an open-label, randomized, single-dose, three-way crossover bioavailability study comparing DFN-02 with 4 mg and 6 mg subcutaneous sumatriptan in 78 healthy, fasted adults. In the study comparing DFN-02 with IN sumatriptan, subjects received a single dose of DFN-02 (sumatriptan 10 mg plus DDM 0.20%) via monodose and multidose delivery systems with at least 5 days between treatments. In the comparison with SC sumatriptan, subjects received a single dose of each treatment with at least 3 days between treatments. In both studies, blood was sampled for pharmacokinetic evaluation of sumatriptan and DDM through 24 hours post-dose; safety and tolerability were monitored throughout. RESULTS: In the comparison with commercially available intranasal sumatriptan 20 mg, DFN-02 had a more rapid absorption profile; tmax was 15 minutes for DFN-02 monodose, 10.2 minutes for DFN-02 multidose, and 2.0 hours for commercially available intranasal sumatriptan 20 mg. Compared with 4 and 6 mg subcutaneous sumatriptan, DFN-02's median tmax (10 minutes) was significantly earlier (15 minutes; P < .0001). Mean sumatriptan exposure metrics were similar for DFN-02 and 4 mg sumatriptan: AUC0-2 : 35.12 and 44.82 ng*hour/mL, respectively; AUC0-∞ : 60.70 and 69.21 ng*hour/mL, respectively; Cmax : 51.79 and 49.07 ng/mL, respectively. With 6 mg subcutaneous sumatriptan, these exposure metrics were about 50% larger (AUC0-2 : 67.17 ng*hour/mL; AUC0-∞ : 103.78 ng*hour/mL; Cmax : 72.75 ng/mL). Inter-subject variability of AUC0-2 , AUC0-∞ , and Cmax was 42-58% for DFN-02, 15-22% for 4 mg subcutaneous sumatriptan, and 15-25% for 6 mg subcutaneous sumatriptan. DDM exposure was low (mean Cmax : 1.63 ng/mL), tmax was 30 minutes, and it was undetectable by 4 hours. There were no serious adverse events, discontinuations due to adverse events, or remarkable findings for vital signs, physical examinations (including nasal and injection site examinations), or clinical laboratory assessments. The overall incidence of adverse events was comparable across treatments, and all treatment-related events were mild in severity. Adverse events occurring in ≥10% of subjects were dysgeusia (19%), headache (18%), nausea (15%), paresthesia (15%), and dizziness (12%). CONCLUSIONS: In healthy subjects, DFN-02, an intranasal spray containing 10 mg sumatriptan plus DDM, had a more rapid absorption profile than commercially available intranasal sumatriptan 20 mg, and systemic exposure from a single-dose administration of DFN-02 was similar to 4 mg SC sumatriptan and two-thirds that of 6 mg SC sumatriptan. With DFN-02, plasma sumatriptan peaked 5 minutes earlier than with both subcutaneous formulations. Systemic exposure to sumatriptan was similar with DFN-02 and 4 mg subcutaneous sumatriptan; both yielded lower systemic exposure than 6 mg subcutaneous sumatriptan. Systemic exposure to DFN-02's excipient DDM was short-lived. DFN-02's safety and tolerability appear to be comparable to subcutaneous sumatriptan. Addition of a permeation enhancer improved the absorption profile compared with commercially available intranasal sumatriptan 20 mg.

A Randomized, Controlled Pilot Study of a Single-Session Psychoeducation Treatment for Urban, Culturally Diverse, Trauma-Exposed Adults.

This randomized pilot study aimed to determine whether a single session of psychoeducation improved mental health outcomes, attitudes toward treatment, and service engagement among urban, impoverished, culturally diverse, trauma-exposed adults. Sixty-seven individuals were randomly assigned to a single-session psychoeducation treatment or a delayed treatment comparison control group. The control group was found to be superior to the treatment group at posttest with respect to symptoms of posttraumatic stress disorder, anxiety, and occupational and family disability. At follow-up, all participants had completed the psychoeducation treatment, and a mixed-effects model indicated significant improvements over time in symptoms of posttraumatic stress disorder, anxiety, depression, somatization, and attitudes toward treatment. Ninety-eight percent of the participants reported the psychoeducation was helpful at follow-up. Participants also reported a 19.1% increase in mental health service utilization at follow-up compared with baseline. Implications for treatment and future research are discussed.

Using the Bem and Klein Grid Scores to Predict Health Services Usage by Men.

We examined the association between scores on the Bem Sex Roles Inventory (BSRI), Klein Sexual Orientation Grid, and utilization of hospital inpatient services, emergency departments, and outpatient clinic visits in the past 12 months among 53 men (mean age 39 years). The femininity subscale score on the BSRI, ever having had gonorrhea and age were the three variables identified in a multivariate linear regression significantly predicting use of total health services. This supports the hypothesis that sex roles can assist our understanding of men's use of health services.

Psychometric Properties of the Milestones of Recovery Scale-Older Adult Version.

The Milestones of Recovery Scale (MORS) is a tool that mental health professionals can use to track clients' recovery. It has been shown to have good reliability and validity in an adult population. It is important to demonstrate its psychometric properties among the elderly. This study assessed the reliability and validity of the MORS among a multi-ethnic (52 % White) sample of adults 54 and older (M = 67) at several mental health agencies in California. The clients, N = 432, were assessed by two raters each at two time points 2 weeks apart. Ratings were obtained on the MORS, the modified Global Assessment of Functioning scale (mGAF), and the Multnomah Community Ability Scale (MCAS). The MORS demonstrated acceptable reliability: inter-rater r = .65 and test-retest r = .71; the mGAF was .56 and .79; the MCAS was .66 and .85. The validity of the MORS was also supported: mGAF-MORS r = .68 and MCAS-MORS r = .74. This study lends support for the use of the MORS in older adult populations. In addition, this is the first report of the psychometric properties of the MCAS with an entirely older adult sample.

Application of the Extended Health Control Belief Model to Predict Hepatitis A and B Vaccinations.

BACKGROUND: Adult vaccination compliance rates vary according to sample and type of vaccine administered (influenza, pneumococcal). This study looked at vaccination of a community sample of low-income, minority adults. METHODS: Nurses offered free vaccination for hepatitis A and B in the form of the combined Twinrix vaccine to adults on a walk-in basis. In addition to dosing information, participants completed the Risk Behavior Assessment, the Coping Strategies Indicator and the Cardiovascular Risk Assessment. Skaff's extended Health Belief Model was used as the theoretical framework. Count regression was used to model receipt of one, two, or three doses. RESULTS: The majority of participants were male with a mean age of 40 years. The distribution of doses was: 173 individuals (27.6%) received one dose only, 261 (41.7%) received two doses, and 191 (30.5%) received three doses of vaccine. The multivariate count regression model including being male, having previously been told by a health care provider that one has syphilis, having severe negative emotions, and perceived social support were associated with participants' receiving fewer doses of hepatitis vaccine. A greater problem-solving score was associated with a higher number of vaccine doses received. CONCLUSION: Despite free vaccinations offered in an easily accessible community setting, the majority of participants failed to complete the hepatitis vaccine series. More effort is needed to get adult men to participate in hepatitis vaccination clinics. Additional research is necessary to understand barriers other than cost to adults receiving vaccination.

An Electronic Daily Diary Study of Anal Intercourse in Drug-Using Women.

Women (N = 138) with histories of illicit drug use were recruited into an electronic diary study that used Android smartphones for data collection. The diary was to be completed each day for 12 weeks using an "app" created in HTML5 and accessed over the Internet via smartphone. Data collection included information on sexual behaviors with up to 10 partners per day and contextual factors surrounding sexual behavior such as drug use before/after, type of sexual behavior (oral, vaginal, anal), and other activities such as using condoms for vaginal and anal intercourse and use of sexual lubricants. The sample was predominantly African American (58 %); 20 % Latina, 20 % White and 2 % reported as Other. Most women reported either less than a high school education (33 %) or having a high school diploma (33 %). The mean age was 39 years (SD = 11.78). Anal intercourse occurred on days when women also reported using illicit drugs, specifically methamphetamine and cocaine. Anal intercourse was not an isolated sexual activity, but took place on days when vaginal intercourse and giving and receiving oral sex also occurred along with illicit drug use. Anal intercourse also occurred on days when women reported they wanted sex. HIV prevention interventions must address the risks of anal intercourse for women, taking into account concurrent drug use and sexual pleasure that may reduce individual harm-reduction behaviors.

Why women engage in anal intercourse: results from a qualitative study.

This study used qualitative methods to assess why women engage in heterosexual anal (receptive) intercourse (AI) with a male partner. Four focus groups which comprised women from diverse ethnicities were conducted. All groups were digitally recorded for transcription; transcripts were analyzed using the methods of grounded theory to determine themes. Women's reasons for engaging in anal intercourse with a male partner can be described in broad categories including that the women wanted to have anal intercourse, either because of their own desire, to please a male partner, or they were responding to a quid pro quo situation. The riskiness of AI was assessed within relationship contexts. Past experience with AI including emotional and physical reactions was identified. Among the negative physical experiences of AI were pain and disliking the sensation, and uncomfortable side effects, such as bleeding of the rectum. Negative emotional experiences of AI included feelings of shame, disgust, and being offended by something her male partner did, such as spitting on his penis for lubrication. Positive physical experiences included liking the sensation. Many of the women also endorsed positive emotional experiences of AI, including that it was more intimate than vaginal sex, and that it was something they reserved only for special partners. The majority of AI episodes were unplanned and not discussed prior to initiation. Pain during AI was mitigated by the use of lubricants or illicit drugs. Even those women who found pleasure in AI expressed a preference for vaginal intercourse.

Medical service use among individuals receiving HIV prevention services in Los Angeles County.

Timely provision of medical services among communities at increased risk of HIV infection is crucial to detect the infection and to further prevent the spread of HIV. In the US, about one third of HIV cases were identified in the later stage of infection. The current study utilized the Gelberg-Andersen behavioral model for predicting medical service use among people who were at risk of HIV infection. The candidate variables included: social support, attitudinal, and behavioral variables. The data were collected from clients of HIV prevention agencies in Los Angeles County in 2004 who participated in the Countywide Risk Assessment Survey (CRAS). Using a logistic regression model, the study suggested that factors that were positively associated with use of medical services included living in a treatment center/halfway house or mission/shelter, experience of physical/sexual abuse, and ever receiving HIV testing/counseling. Factors inversely associated with medical service use were male gender, education, and consumption of alcohol. Analysis was conducted using SAS 9.3. Most of the findings are consistent with the Gelberg-Andersen model. The exception was that victims of physical or sexual abuse were more likely to use services instead of less likely as predicted by the model.

Targeting hematologic malignancies by inhibiting E-selectin: A sweet spot for AML therapy?

E-selectin, a cytoadhesive glycoprotein, is expressed on venular endothelial cells and mediates leukocyte localization to inflamed endothelium, the first step in inflammatory cell extravasation into tissue. Constitutive marrow endothelial E-selectin expression also supports bone marrow hematopoiesis via NF-κB-mediated signaling. Correspondingly, E-selectin interaction with E-selectin ligand (sialyl Lewisx) on acute myeloid leukemia (AML) cells leads to chemotherapy resistance in vivo. Uproleselan (GMI-1271) is a carbohydrate analog of sialyl Lewisx that blocks E-selectin binding. A Phase 2 trial of MEC chemotherapy combined with uproleselan for relapsed/refractory AML showed a median overall survival of 8.8 months and low (2%) rates of severe oral mucositis. Clinical trials seek to confirm activity in AML and mitigation of neutrophil-mediated adverse events (mucositis and diarrhea) after intensive chemotherapy. In this review we summarize E-selectin biology and the rationale for uproleselan in combination with other therapies for hematologic malignancies. We also describe uproleselan pharmacology and ongoing clinical trials.

Development of the perceived risk of HIV scale.

Past studies have used various methods to assess perceived risk of HIV infection; however, few have included multiple items covering different dimensions of risk perception or have examined the characteristics of individual items. This study describes the use of Item Response Theory (IRT) to develop a short measure of perceived risk of HIV infection scale (PRHS). An item pool was administered by trained interviewers to 771 participants. Participants also completed the risk behavior assessment (RBA) which includes items measuring risky sexual behaviors, and 652 participants completed HIV testing. The final measure consisted of 8 items, including items assessing likelihood estimates, intuitive judgments and salience of risk. Higher scores on the PRHS were positively associated with a greater number of sex partners, episodes of unprotected sex and having sex while high. Participants who tested positive for HIV reported higher perceived risk. The PRHS demonstrated good reliability and concurrent criterion-related validity. Compared to single item measures of risk perception, the PRHS is more robust by examining multiple dimensions of perceived risk. Possible uses of the measure and directions for future research are discussed.

Substance use patterns among high-risk American Indians/Alaska Natives in Los Angeles County.

BACKGROUND: Substance abuse among American Indians/Alaska Natives (AI/ANs) is a significant and long-standing health problem in the U.S. Two-thirds of American AIs/ANs reside in the urban setting. However, studies analyzing substance use characteristics among urban AI/ANs are very limited. METHODS: Substance use patterns among a sample of AI/ANs (n = 77) and other ethnic/racial groups in Los Angeles County at high risk of substance abuse were analyzed utilizing three datasets from programs targeting individuals at high risk for substance abuse and risky sexual behaviors. RESULTS: Compared to all other ethnic/racial groups, AI/ANs demonstrated significantly younger age of onset of alcohol, marijuana, methamphetamine, and "other" drug use, higher correlations of age of first use of amphetamine with a measure of the drug's reinforcement, and higher mean number of illicit drug injections in the 30 days before being interviewed. CONCLUSIONS: Results from this study highlight a critical need for furthering our understanding of substance abuse problems among urban AI/ANs.