24 research outputs found
Gender differences in sexual behaviors, sexual partnerships, and HIV among drug users in New York City
Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/48789/1/absalon_gender differences in sexual behaviors_2006.pd
A Comparison of HIV Seropositive and Seronegative Young Adult Heroin- and Cocaine- Using Men Who Have Sex with Men in New York City, 2000-2003
The purpose of this analysis was to determine the prevalence and correlates
of HIV infection among a street-recruited sample of heroin- and cocaine-using men
who have sex with men (MSM). Injection (injecting â¤3 years) and non-injection drug
users (heroin, crack, and/or cocaine use <10 years) between 18 and 40 years of age were
simultaneously street-recruited into two cohort studies in New York City, 2000â2003,
by using identical recruitment techniques. Baseline data collected among young adult
men who either identified as gay/bisexual or reported ever having sex with a man were
used for this analysis. Nonparametric statistics guided interpretation. Of 95 heroin/
cocaine-using MSM, 25.3% tested HIV seropositive with 75% reporting a previous
HIV diagnosis. The majority was black (46%) or Hispanic (44%), and the median age
was 28 years (range 18â40). HIV-seropositive MSM were more likely than seronegatives
to be older and to have an HIV-seropositive partner but less likely to report current
homelessness, illegal income, heterosexual identity, multiple sex partners, female partners,
and sex for money/drug partners than seronegatives. These data indicate high HIV
prevalence among street-recruited, drug-using MSM compared with other injection
drug use (IDU) subgroups and drug-using MSM; however, lower risk behaviors were
found among HIV seropositives compared with seronegatives. Large-scale studies
among illicit drug-using MSM from more marginalized neighborhoods are warranted.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/40372/2/Fuller_A Comparison of HIV Seropositive and Seronegative_2005.pd
Maternal and neonatal data collection systems in low- and middle-income countries: Scoping review protocol
Background: Pregnant women and neonates represent one of the most vulnerable groups, especially in low- and middle-income countries (LMICs). A recent analysis reported that most vaccine pharmacovigilance systems in LMICs consist of spontaneous (passive) adverse event reporting. Thus, LMICs need effective active surveillance approaches, such as pregnancy registries. We intend to identify currently active maternal and neonatal data collection systems in LMICs, with the potential to inform active safety electronic surveillance for novel vaccines using standardized definitions. Methods: A scoping review will be conducted based on established methodology. Multiple databases of indexed and grey literature will be searched with a specific focus on existing electronic and paper-electronic systems in LMICs that collect continuous, prospective, and individual-level data from antenatal care, delivery, neonatal care (up to 28 days), and postpartum (up to 42 days) at the facility and community level, at the national and district level, and at large hospitals. Also, experts will be contacted to identify unpublished information on relevant data collection systems. General and specific descriptions of Health Information Systems (HIS) extracted from the different sources will be combined and duplicated HIS will be removed, producing a list of unique statements. We will present a final list of Maternal, Newborn, and Child Health systems considered flexible enough to be updated with necessary improvements to detect, assess and respond to safety concerns during the introduction of vaccines and other maternal health interventions. Selected experts will participate in an in-person consultation meeting to select up to three systems to be further explored in situ. Results and knowledge gaps will be synthesized after expert consultation.Fil: Berrueta, Mabel. Instituto de Efectividad ClĂnica y Sanitaria; ArgentinaFil: Bardach, Ariel Esteban. Consejo Nacional de Investigaciones CientĂficas y TĂ©cnicas. Oficina de CoordinaciĂłn Administrativa Parque Centenario. Centro de Investigaciones en EpidemiologĂa y Salud PĂşblica. Instituto de Efectividad ClĂnica y Sanitaria. Centro de Investigaciones en EpidemiologĂa y Salud PĂşblica; ArgentinaFil: Ciapponi, AgustĂn. Consejo Nacional de Investigaciones CientĂficas y TĂ©cnicas. Oficina de CoordinaciĂłn Administrativa Parque Centenario. Centro de Investigaciones en EpidemiologĂa y Salud PĂşblica. Instituto de Efectividad ClĂnica y Sanitaria. Centro de Investigaciones en EpidemiologĂa y Salud PĂşblica; ArgentinaFil: Xiong, Xu. University of Tulane; Estados UnidosFil: Stergachis, Andy. University of Washington; Estados UnidosFil: Zaraa, Sabra. University of Washington; Estados UnidosFil: Buekens, Pierre. University of Tulane; Estados UnidosFil: Absalon, Judith. No especifĂca;Fil: Anderson, Steve. No especifĂca;Fil: Althabe, Fernando. Instituto de Efectividad ClĂnica y Sanitaria; Argentina. Consejo Nacional de Investigaciones CientĂficas y TĂ©cnicas; ArgentinaFil: Madhi, Shabir A.. No especifĂca;Fil: McClure, Elizabeth. No especifĂca;Fil: Munoz, Flor M.. No especifĂca;Fil: Mwamwitwa, Kissa W.. No especifĂca;Fil: Nakimuli, Annettee. No especifĂca;Fil: Clark Nelson, Jennifer. No especifĂca;Fil: Noguchi, Lisa. No especifĂca;Fil: Panagiotakopoulos, Lakshmi. No especifĂca;Fil: Sevene, Esperanca. No especifĂca;Fil: Zuber, Patrick. No especifĂca;Fil: Belizan, Maria. No especifĂca;Fil: Bergel, Eduardo. No especifĂca;Fil: Rodriguez Cairoli, Federico. No especifĂca;Fil: Castellanos, Fabricio. No especifĂca;Fil: Ciganda, Alvaro. No especifĂca;Fil: Comande, Daniel. No especifĂca;Fil: Pingray, Veronica. No especifĂca
Concomitant administration of meningococcal vaccines with other vaccines in adolescents and adults: a review of available evidence
Invasive meningococcal disease (IMD), a rapidly progressing and potentially fatal illness, disproportionately affects adolescents and young adults. While IMD is best prevented by vaccination, vaccine uptake in these groups is low. An evidence-based understanding of the safety and effectiveness of concomitant vaccination of meningococcal vaccines, including the newer MenB protein vaccines and the more established MenACWY conjugate vaccines, with other vaccines recommended for adolescents and young adults may help maximize vaccination opportunities. We identified 21 studies assessing concomitant administration of meningococcal vaccines with other vaccines in adolescents and adults. Although studies varied in methodology, concomitant administration generally did not affect immunogenicity of the meningococcal or coadministered vaccines. In some cases, reactogenicity increased following concomitant administration, but no definitive safety concerns were raised. In general, data suggest that meningococcal vaccines can be safely and effectively coadministered with other vaccines
Modeling excess zeroes in an integrated analysis of vaccine safety
In prophylactic vaccine studies in healthy populations, many subjects do not experience a single adverse event (AE). Thus, the number of AEs observed in such clinical trials may be difficult to model because of an excess of zeroes relative to the parametric distributions assumed. To determine which type of modeling provides a better fit for observed AE data, a variety of models were applied to data from an integrated safety database from clinical trials of the meningococcal vaccine MenB-FHbp (Trumenba®, bivalent rLP2086; Pfizer Inc, Philadelphia, PA). MenB-FHbp was the first vaccine approved in the United States to prevent meningococcal serogroup B disease in individuals aged 10 to 25 years. Specifically, this report presents an integrated analysis of AEs from 8 randomized controlled trials that compared MenB-FHbp to placebo or active controls. The number of AEs occurring from dose one to 30 days after the last dose was analyzed. Six models were compared: standard Poisson and negative binomial models and their corresponding zero-inflation and hurdle models. Models were evaluated for their ability to predict the number of AEs and by goodness-of-fit statistics. Models based on the Poisson distribution were a poor fit. The zero-inflated negative binomial model and negative binomial hurdle model provided the closest fit. These results suggest that zero-inflated or hurdle models may provide a better fit to AE data from healthy populations compared with conventional parametric models
Integrating HIV Prevention Activities into the HIV Medical Care Setting: A Report from the NYC HIV Centers Consortium
Effects of Darunavir/Ritonavir-Based Therapy on Metabolic and Anthropometric Parameters in Women and Men Over 48 Weeks
Gender-based differences in lipids have been noted in antiretroviral clinical trials. We present the metabolic and anthropometric data from the GRACE (Gender, Race And Clinical Experience) study by gender. Treatment-experienced adults received darunavir/ritonavir (DRV/r) 600/100 mg twice daily, plus a background regimen, over 48 weeks. Fasting blood samples were obtained for lipid, glucose, and insulin measurements at baseline and at weeks 24 and 48/early discontinuation. Anthropometric measurements were taken at baseline and at weeks 12, 24, and 48/discontinuation. The Assessment of Body Change and Distress questionnaire was administered at baseline and regular intervals. Descriptive statistics as well as comparisons using a Wilcoxon rank-sum test are reported. Four hundred twenty-nine patients (women, n=287; men, n=142) enrolled in GRACE; 94 women (32.8%) and 33 men (23.2%) discontinued the trial. Median changes in triglycerides from baseline to week 48 were higher in men (25 mg/dL versus 8 mg/dL; p=0.006); the mean change in triglycerides was higher in men than in women in all racial subgroups. Other lipid and glucose level changes were similar between genders. Anthropometric parameters increased for both genders, with larger increases in women. Patients' perceptions of body changes concurred with physical measurements. The proportion of women who were “satisfied” or “very satisfied” with their bodies increased from 45.2% to 57.8% from baseline to week 48 (p=0.005), while the proportion of men who were “satisfied” or “very satisfied” with their bodies increased from 56.3% to 61.5% from baseline to week 48 (p=0.317). DRV/r-based therapy was associated with small to moderate changes in metabolic parameters, and few between-gender differences were observed. Levels of self-reported, body-related distress improved for women and men over 48 weeks
Recruitment and Retention of Diverse Populations in Antiretroviral Clinical Trials: Practical Applications from the Gender, Race And Clinical Experience Study
BACKGROUND: Women, particularly women of color, remain underrepresented in antiretroviral (ARV) clinical trials. To evaluate sex-based differences in darunavir/ritonavir-based therapy, the Gender, Race And Clinical Experience (GRACE) study was designed to enroll and retain a high proportion of women representative of the racial/ethnic demographics of women with HIV/AIDS in the United States. The recruitment and retention strategies used in GRACE are described in this article.
METHODS: Recruitment and retention strategies targeting women included selecting study sites that focused on women, involving community consultants, site-specific enrollment plans, access to other ARV drugs, study branding, site and patient toolkits, targeted public relations, site grants for patient support, and subsidized child care and transportation.
RESULTS: The recruitment strategies were successful; 287 (67%) women were enrolled, primarily women of color (black, n=191 [67%], Hispanic, n=60 [21%]). Despite the focus on retention, a greater proportion of women (32.8%) discontinued compared with men (23.2%).
CONCLUSIONS: The successes of GRACE in enrolling a representative population of women were rooted in pretrial preparation, engagement of community advisors, enrollment quotas, choice of study sites and site support. Lessons learned from GRACE may be applied to future study design. Further focus on factors that influence discontinuation is warranted