Efficacy and safety of sublingual ramelteon as an adjunctive therapy in the maintenance treatment of bipolar I disorder in adults: A phase 3, randomized controlled trial.

BACKGROUND: The optimal long-term management strategy for bipolar I disorder patients is not yet established. Evidence supports the rationale for circadian rhythm regulation to prevent mood episode relapse in bipolar patients. This study evaluated the efficacy and safety of a new sublingual formulation of the melatonin receptor agonist ramelteon (ramelteon SL) as adjunctive therapy in the maintenance treatment of bipolar I patients. METHODS: In a double-blinded trial in the United States and Latin America, adult bipolar I disorder patients stable for ≥ 8 weeks before baseline and with a mood episode 8 weeks to 9 months before screening, were randomized to once-daily ramelteon SL 0.1mg (n = 164), 0.4mg (n = 160), or 0.8mg (n = 154), or placebo (n = 164), in addition to their existing treatment. The primary endpoint was time from randomization to relapse of symptoms. The prespecified futility criterion in a planned, unblinded, independent interim analysis was the failure of all ramelteon SL doses to achieve a conditional power ≥ 30% compared with placebo. RESULTS: No significant differences between any dose of ramelteon SL and placebo were observed. The study was terminated after meeting the futility criteria. Ramelteon SL was well tolerated, with a safety profile consistent with that for oral ramelteon. LIMITATIONS: A low rate of relapse events precluded detection of any statistically significant difference between groups. CONCLUSIONS: The study failed to demonstrate the efficacy of ramelteon SL as adjunctive maintenance therapy for bipolar disorder. Interim analyses for futility in clinical studies are valuable in preventing unnecessary exposure of subjects to interventions.

HIV prevention and education in state prison systems: an update.

The prevalence rate of HIV infection in jails and prisons is approximately 5 times the rate in the U.S. general population. The authors surveyed state prison officials to assess HIV testing and HIV prevention policies--specifically voluntary testing, group HIV prevention counseling, and peer education--in the 50 states and to determine whether those policies are associated with the characteristics of the state and its prison population.

Driving to better health: cancer and cardiovascular risk assessment among taxi cab operators in Chicago.

While a number of investigations of the health of taxi cab drivers have been conducted in Europe, Asia, and Africa, virtually none have been conducted in the United States. We undertook a survey of taxi cab operators in the Chicago area to understand better their health status and health promotion practices. The survey was completed by a convenience sample of 751 Chicago taxi drivers. Taxi drivers had low rates of insurance coverage, fruit and vegetable consumption, and physical activity compared with the general Chicago population. Participation in cancer screening tests was also lower for this group. A high proportion of taxi drivers are immigrants. They tend to be highly educated and report a readiness to engage in more health-promoting behaviors. Further research is needed to develop a targeted intervention for this population.

Perception of risk of HIV and sexual risk behaviours among students in the United States, Turkey and South Africa.

The aim of this study was to examine HIV sexual risk behaviours and perception of HIV risk among 1 095 students from the United States of America (US), Turkey and South Africa. Randomly selected students who were enrolled in general education courses completed a structured questionnaire. Results revealed statistically significant differences in specific HIV-related sexual behaviours among students from the three countries and among male and female students in each country. A higher percentage of US and South African students engage in HIV risky sexual behaviours compared with their Turkish counterparts, and a higher percentage of female students in the US and South Africa engage in HIV sexual risk behaviours compared with their male colleagues. A higher proportion of Turkish male students engaged in sexual risk behaviours compared with their female counterparts. The perception of HIV risk was low among US and Turkish students, and high among South African students. There was no agreement between engaging in risky sexual behaviour and self-perception of HIV risk among South African female students, while agreement was poor for US male and female students, Turkish male and female students, and South African male students. The observed optimistic bias needs to be considered in the design and implementation of HIV prevention programmes for these populations.

Development and evaluation of a psychometric instrument designed to assess HIV risk behaviors of prison inmates.

Clinicians and researchers interested in HIV interventions for prisoners lack an appropriate psychometric instrument to assess HIV risk behaviors. This study evaluated the readability and internal consistency of a questionnaire designed to assess such behaviors. The questionnaire was administered to 277 inmates. The Flesch Reading Ease score was 78.3 with a Flesch-Kincaid grade level of 3.7, suggesting limited comprehension difficulties. Internal consistency was evaluated by determining Cronbach's alpha (Calpha) for total items and for each subscale. Following factor analyses, 25 items converged into five subscales and combined they account for 72% of the variance. The overall Calpha was .86 and the subscales Calpha ranged from .82 to .98. Findings reveal that the questionnaire is internally consistent and suitable for use with prisoners with low literacy skills. The use of this instrument for intervention studies in prisons has the potential to reduce inmates' HIV risk behaviors.

Body art practices among inmates: Implications for transmission of bloodborne infections.

BACKGROUND: Unsterile body art practices among inmates in prison have been implicated in the transmission of bloodborne viruses. The objectives of this study were to determine the prevalence of tattooing and body piercing among inmates, identify factors associated with receiving a tattoo in prison, and explore the contexts of tattooing and body piercing in prison. METHODS: A cross-sectional survey was conducted among randomly selected inmates in 17 state prisons in Illinois; a convenient sample of recently released exprisoners in Chicago, IL, participated in focus group discussions (FGDs). RESULTS: A total of 1819 (1293 men and 526 women) inmates participated in the survey, and 47 exprisoners participated in the FGDs. Sixty-seven percent of the survey sample had tattoos, and 60% had body piercings. More men (19.3%) than women (8.7%) had received tattoos in prison (odds ratio, 0.40; 95% confidence interval: 0.29-0.56); prevalence of body piercing in prison was low (1.3%) and similar for men and women. Factors associated with tattooing in prison include incarceration for 1 year or longer and having had sex in prison among both men and women; nonheterosexual identity for women only; and for men, being 30-39 years old; incarcerated 4 or more times; having a history of sharing needles, multiple vaginal sex partners, and inconsistent condom use in the 6 months before arrest. Focus groups provided information on body art practices in prison. Inmates had a variety of reasons for getting body art, equipment was often shared, and cleansing agents were not readily available. CONCLUSION: Tattooing and body piercing practices exist in prison and could constitute risks for transmission of bloodborne viral infections. Interventions to reduce these risks are discussed.

HIV sexual risk behaviors and perception of risk among college students: implications for planning interventions.

BACKGROUND: The college environment offers great opportunity for HIV high-risk behaviors, including unsafe sex and multiple partnerships. While the overall incidence of HIV infection has seen some decline in recent years, rates of HIV infection among young adults have not seen a proportionate decline. As in the general population, African American young adults have been disproportionately affected by the HIV/AIDS epidemic. This study examined the sexual risk behaviors and perception of HIV risk of students in a predominantly African American commuter urban university in the Midwest. METHODS: Students enrolled in randomly selected general education courses completed a paper and pencil survey. Data were collected in Fall 2007, and univariate, bivariate, and multivariate analyses were conducted using SPSS for Windows v.16. RESULTS: The sample included 390 students, the majority (83%) of whom were never married and 87% were sexually experienced. Among males reporting male partnerships those who used marijuana (OR = 17.5, p = 0.01) and those who used alcohol along with illegal drugs (OR = 8.8, p = 0.03) were significantly more likely to report multiple partnerships. Among females reporting male partnerships, those 30 years and older were significantly less likely (OR = 0.09, p = 0.03) to report having multiple male partners. There were significant differences in condom use last sex (p = 0.01) and consistent condom use (p = 0.002) among the different age groups. Older students were less likely to report condom use. Females age 30 years and older (OR = 3.74, p = 0.05) and respondents age 2029 years (OR = 2.41, p = 0.03) were more likely to report inconsistent condom use than those below 20 years. Marijuana use was correlated with inconsistent condom use (p = 0.02) and alcohol with not using condom last sex among females. Perception of HIV risk was generally poor with 54% of those age 30 years and older, 48.1% of 2029 year olds, and 57.9% of those below the age of 20 years perceived themselves as not having any chance of being infected with HIV. Predictors of moderate/good perception of HIV risk were drug and alcohol use, inconsistent condom use, and multiple partnerships. CONCLUSION: Students in the study sample engaged in various HIV risk behaviors but have a poor appreciation of their risk of HIV infection. While low rates of condom use was a problem among older students (30 years and older), multiple partnerships were more common among younger students, and marijuana and alcohol use were related to low condom use among females. Our findings support the need for targeted HIV prevention interventions on college campuses.

Relationship between incarceration frequency and human immunodeficiency virus risk behaviors of African American inmates.

OBJECTIVE: We examined the relationship between frequency of incarceration and preincarceration risk behaviors and determined the demographic factors associated with risk behaviors among a sample of African American inmates. METHODS: We surveyed 229 (102 female and 127 male) randomly selected inmates. Risk behaviors between inmates serving their first prison sentence and those who had been incarcerated in prison more than once were compared using the chi2 test. Multivariate logistic regression analysis was used to determine factors associated with risk behaviors. RESULTS: For most risk behaviors, there were no significant differences between inmates serving their first prison sentence and inmates incarcerated more than once; however, male inmates who had been incarcerated more than once were more likely to report having had multiple vaginal sex partners (OR, 2.42; 95% CI, 1.10-5.32; P = .03). No demographic variable was found to be independently associated with risk behaviors. CONCLUSIONS: Frequency of incarceration did not affect preincarceration human immunodeficiency virus (HIV) risk behaviors among this sample of African American inmates. HIV prevention efforts should be directed at addressing the individual and structural factors associated with high-risk behaviors among African Americans.

Gender differences in HIV risk behaviors of inmates.

BACKGROUND: Incarcerated men and women differ in their views on HIV prevalence rates and susceptibility and their ability to prevent HIV infection. The objective of this study was to assess sex and gender differences in HIV risk behaviors of inmates in order to better support the consideration of gender in the development of HIV prevention interventions for the incarcerated population. METHODS: A survey of 1819 inmates was conducted using a structured questionnaire. Self-reported HIV risk behaviors of 526 women and 1293 men during incarceration were compared. Bivariate analyses were done to identify gender differences in demographic characteristics and HIV risk behaviors. Logistic regression was used to determine factors associated with engaging in sexual intercourse in prison. RESULTS: Mean age was higher for women than men (p = 0.05), and >50% of participants were African Americans. More women than men reported that they engaged in sexual intercourse (p < 0.001); however, men were more likely to report anal sex (p < 0.001). There were no sex differences in injection drug use. Women who identified as bisexual or lesbian, those who had been currently incarcerated for at least 1 year, and those who received tattoos in prison were more likely to report sexual intercourse. The only independent risk factor identified for men was being currently incarcerated for at least 7 years. CONCLUSIONS: There are gender differences in HIV risk behaviors of inmates during incarceration. The findings in this study suggest that inmates may benefit from gender-specific HIV interventions while incarcerated and in the community subsequent to release.