Sexual Practices, Drug Use Behaviors, and Prevalence of HIV, Syphilis, Hepatitis B and C, and HTLV-1/2 in Immigrant and Non-immigrant Female Sex Workers in Argentina

Objective To study socio-demographics, sexual practices, drug use behaviors, and prevalences of HIV, syphilis, hepatitis B and C, HTLV-1 and HTLV-2 in immigrant (foreigner) and non-immigrant (local/native) female sex workers (FSW). Design This was a cross-sectional study in immigrant and non-immigrant FSW living in Buenos Aires, Argentina. Participants were interviewed using a standardized questionnaire. Results A total of 625 FSW were enrolled, of whom 169 (27%) were immigrant FSW from Paraguay, the Dominican Republic, Brazil, Peru, and Uruguay. The prevalence of syphilis and hepatitis C was significantly higher among Argentinean FSW than among immigrant FSW. However, hepatitis B prevalence was higher among immigrant FSW. Adjusted risk factor analysis comparing immigrant FSW with Argentinean FSW indicated that marital status (single), occupation (none), fee per sex act (≤US$7), workplace (bar and cabaret), and anal sex with clients were significantly associated with immigrant FSW status. Conclusions Effective HIV/STI prevention and medical care programs need to be tailored to the specific needs of both FSW groups in Argentina.Fil: Bautista, Christian T.. Walter Reed Army Institute of Research; Estados Unidos. US Naval Medical Research Center Detachment; Estados UnidosFil: Pando, María de los Ángeles. Universidad de Buenos Aires. Facultad de Medicina. Departamento de Microbiología. Centro Nacional de Referencia para el Sida; Argentina. University of Maryland; Estados Unidos. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay; ArgentinaFil: Reynaga, Elena. Asociación de Mujeres Meretrices de Argentina; ArgentinaFil: Marone, Ruben. NEXO; ArgentinaFil: Sateren, Warren B.. Walter Reed Army Institute of Research; Estados UnidosFil: Montano, Silvia M.. US Naval Medical Research Center Detachment; Estados UnidosFil: Sanchez, Jose L.. US Naval Medical Research Center Detachment; Estados Unidos. Walter Reed Army Institute of Research; Estados UnidosFil: Ávila, María Mercedes. Universidad de Buenos Aires. Facultad de Medicina. Departamento de Microbiología. Centro Nacional de Referencia para el Sida; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay; Argentin

Do we want more cancer patients on clinical trials If so, what are the barriers to greater accrual

It is often stated that only a small proportion of adult cancer patients participate in clinical trials. This is said to be a bad thing, with calls for more trials to include more patients. Here I argue that whether or not greater accrual to clinical trials would be a good thing depends on the trials we conduct. The vast majority of clinical trials in cancer are currently early phase trials, and most do not lead to further studies even if they have encouraging results. The key metric is thus not the number of patients on clinical trials, but the number on the sort of large, randomized, Phase III trials that can be used as a basis for clinical decisions. I also address two important barriers to greater clinical trial participation. The first barrier is financial: clinical research has long been the poor cousin of basic research, with perhaps no more than a nickel in the cancer research dollar going to clinical research. The second barrier is regulatory: clinical research has become so overburdened by regulation that it takes years to initiate a trial, and dedicated staff just to deal with the paperwork once the trial starts. This not only adds significantly to the costs of clinical research, but scares many young investigators away. It has been estimated that nearly half of all US-sponsored trials are being conducted abroad, and it is plausible that excessive regulation is at least partly responsible. That statistic should serve as a wake-up call to the US clinical research community to implement the recommendations of the now decade-old report of National Cancer Institute Clinical Trials Program Review Group, which largely center around simplifying trials and streamlining trial procedures

Medical Encounter Characteristics of HIV Seroconverters in the US Army and Air Force, 2000–2004

BACKGROUND AND METHODS: Active duty US Army and Air Force military personnel undergo mandatory biennial HIV antibody screening. We compared pre- and post-HIV seroconversion health status by conducting a case-control study, which evaluated all medical encounters and sociodemographic factors among incident HIV seroconverters and HIV-negative controls from June 2000 through February 2004. RESULTS: A total of 274 HIV seroconverters and 6205 HIV-negative personnel were included. In multivariate analysis restricted to male personnel (cases = 261, controls = 5801), single marital status (adjusted odds ratio [AOR] = 14.37), clinical indicators or symptoms within four years of HIV diagnosis (AOR = 6.22), black race (AOR = 5.88), nonindicator clinical syndromes within 2 years of HIV diagnosis (AOR = 3.31), any mental disorder within 4 years of HIV diagnosis (AOR = 3.04), increasing service-connected time (AOR = 1.69), and older age (AOR = 1.12) were associated with HIV diagnosis among males. A prior history of a sexually transmitted infection (STI) was associated with post-HIV seroconversion STI (OR(M-H) = 4.10). Similarly, a prior history of mental disorder was associated with post-HIV seroconversion mental disorder (OR(M-H) = 4.98). Forty-seven (18%) male cases were hospitalized at least once after HIV diagnosis; infectious diseases, and mental disorders made up 53% of initial admissions. CONCLUSIONS: HIV seroconversion was associated with increased health care-seeking behavior, STIs, and mental disorders, some of which may be amenable to screening. The higher STI rate after HIV diagnosis may partially be a consequence of monitoring, but secondary transmission of STI and possibly HIV require further definition and subsequent tailored preventive interventions

Reference Ranges for the Clinical Laboratory Derived from a Rural Population in Kericho, Kenya

The conduct of Phase I/II HIV vaccine trials internationally necessitates the development of region-specific clinical reference ranges for trial enrolment and participant monitoring. A population based cohort of adults in Kericho, Kenya, a potential vaccine trial site, allowed development of clinical laboratory reference ranges. Lymphocyte immunophenotyping was performed on 1293 HIV seronegative study participants. Hematology and clinical chemistry were performed on up to 1541 cohort enrollees. The ratio of males to females was 1.9∶1. Means, medians and 95% reference ranges were calculated and compared with those from other nations. The median CD4+ T cell count for the group was 810 cells/µl. There were significant gender differences for both red and white blood cell parameters. Kenyan subjects had lower median hemoglobin concentrations (9.5 g/dL; range 6.7–11.1) and neutrophil counts (1850 cells/µl; range 914–4715) compared to North Americans. Kenyan clinical chemistry reference ranges were comparable to those from the USA, with the exception of the upper limits for bilirubin and blood urea nitrogen, which were 2.3-fold higher and 1.5-fold lower, respectively. This study is the first to assess clinical reference ranges for a highland community in Kenya and highlights the need to define clinical laboratory ranges from the national community not only for clinical research but also care and treatment

Use of the National Cancer Data Base to develop clinical trials accrual targets that are appropriate for minority ethnicity patients

BACKGROUND Disparities in cancer outcome among different subsets of the American population related to ethnic background have been well documented. Clinical trials represent the most powerful strategy for improving cancer treatments, but racial and ethnic minority patients are frequently underrepresented among patients accrued to these protocols. Proof of comparable efficacy for a promising cancer therapy in different groups of patients requires diversity in the clinical trial populations so that study results will be generalizable. Appropriate targets for accrual of minority ethnicity patients have not previously been defined. METHODS The National Cancer Database (NCDB) is maintained jointly by the American Cancer Society and the American College of Surgeons. Information submitted by tumor registries throughout the United States represents an estimated 70% of newly diagnosed cancer cases. The authors analyzed NCDB reports on ethnic distribution of patients with breast, prostate, nonsmall cell lung, and colorectal cancer, stratified by stage of disease at diagnosis. RESULTS African Americans with cancer of the breast and prostate had the most notable patterns of disproportionate representation among populations with advanced-stage disease. The authors compiled a table of suggested accrual targets for selected solid-organ cancers based on NCDB stage-specific reports. CONCLUSIONS Clinical trial results will be more meaningful if participating patients reflect the site- and stage-specific populations that are under study. The authors recommended that clinical trial investigators incorporate accrual targets for minority ethnicity populations into the study design. Cancer 2006. © 2005 American Cancer Society.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/49271/1/21592_ftp.pd

Reference Intervals in Healthy Adult Ugandan Blood Donors and Their Impact on Conducting International Vaccine Trials

BACKGROUND: Clinical trials are increasingly being conducted internationally. In order to ensure enrollment of healthy participants and proper safety evaluation of vaccine candidates, established reference intervals for clinical tests are required in the target population. METHODOLOGY/PRINCIPAL FINDINGS: We report a reference range study conducted in Ugandan adult blood bank donors establishing reference intervals for hematology and clinical chemistry parameters. Several differences were observed when compared to previously established values from the United States, most notably in neutrophils and eosinophils. CONCLUSIONS/SIGNIFICANCE: In a recently conducted vaccine trial in Uganda, 31 percent (n = 69) of volunteers screened (n = 223) were excluded due to hematologic abnormalities. If local reference ranges had been employed, 83% of those screened out due to these abnormalities could have been included in the study, drastically reducing workload and cost associated with the screening process. In addition, toxicity tables used in vaccine and drug trial safety evaluations may need adjustment as some clinical reference ranges determined in this study overlap with grade 1 and grade 2 adverse events

Physician Experiences and Understanding of Genomic Sequencing in Oncology

The amount of information produced by genomic sequencing is vast, technically complicated, and can be difficult to interpret. Appropriately tailoring genomic information for nonâ geneticists is an essential next step in the clinical use of genomic sequencing. To initiate development of a framework for genomic results communication, we conducted eighteen qualitative interviews with oncologists who had referred adult cancer patients to a matched tumorâ normal tissue genomic sequencing study. In our qualitative analysis, we found varied levels of clinician knowledge relating to sequencing technology, the scope of the tumor genomic sequencing study, and incidental germline findings. Clinicians expressed a perceived need for more genetics education. Additionally, they had a variety of suggestions for improving results reports and possible resources to aid in results interpretation. Most clinicians felt genetic counselors were needed when incidental germline findings were identified. Our research suggests that more consistent genetics education is imperative in ensuring the proper utilization of genomic sequencing in cancer care. Clinician suggestions for results interpretation resources and results report modifications could be used to improve communication. Cliniciansâ perceived need to involve genetic counselors when incidental germline findings were found suggests genetic specialists could play a critical role in ensuring patients receive appropriate followâ up.Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/147187/1/jgc40187.pd

Costs of cancer care for use in economic evaluation: a UK analysis of patient-level routine health system data.

BACKGROUND: The rising financial burden of cancer on health-care systems worldwide has led to the increased demand for evidence-based research on which to base reimbursement decisions. Economic evaluations are an integral component of this necessary research. Ascertainment of reliable health-care cost and quality-of-life estimates to inform such studies has historically been challenging, but recent advances in informatics in the United Kingdom provide new opportunities. METHODS: The costs of hospital care for breast, colorectal and prostate cancer disease-free survivors were calculated over 15 months from initial diagnosis of cancer using routinely collected data within a UK National Health Service (NHS) Hospital Trust. Costs were linked at patient level to patient-reported outcomes and registry-derived sociodemographic factors. Predictors of cost and the relationship between costs and patient-reported utility were examined. RESULTS: The study population included 223 breast cancer patients, 145 colorectal and 104 prostate cancer patients. The mean 15-month cumulative health-care costs were £12 595 (95% CI £11 517-£13 722), £12 643 (£11 282-£14 102) and £3722 (£3263-£4208), per-patient respectively. The majority of costs occurred within the first 6 months from diagnosis. Clinical stage was the most important predictor of costs for all cancer types. EQ-5D score was predictive of costs in colorectal cancer but not in breast or prostate cancer. CONCLUSION: It is now possible to evaluate health-care cost using routine NHS data sets. Such methods can be utilised in future retrospective and prospective studies to efficiently collect economic data

Longitudinal association of gonorrhea and bacterial vaginosis with repeat chlamydia diagnosis among U.S. Army females:a retrospective cohort analysis

Background Historically, sexually transmitted infections have affected the health of the U.S. military. To determine whether gonorrhea, bacterial vaginosis, genital herpes, and trichomoniasis are predictors of repeat chlamydia diagnoses among U.S. Army women, medical data reported into the Defense Medical Surveillance System during the 2006–2012 period were analyzed. Methods For all inpatient and outpatient medical records, the first and second International Classification of Diseases, version 9 (ICD-9) diagnostic positions were reviewed for each chlamydia case to determine the occurrence of repeat diagnoses. The Andersen-Gill regression model, an extension of the Cox model for multiple failure-time data, was used to study associations between predictors and repeat chlamydia diagnoses. Results Among 28,201 women with a first chlamydia diagnosis, 5145 (18.2%), 1163 (4.1%), 267 (0.9%), and 88 (0.3%) had one, two, three, and four or more repeat diagnoses, respectively. Overall, the incidence of repeat chlamydia was 8.31 cases per 100 person-years, with a median follow-up time of 3.39 years. Gonorrhea (hazard ratio (HR) = 1.58, 95% CI: 1.44–1.73) and bacterial vaginosis (HR = 1.40, 95% CI: 1.09–1.79) were significant predictors for repeat chlamydia. These estimated hazard ratios were attenuated, but remained significant, after controlling for age, race/ethnicity, marital status, and military rank. No significant association was found for genital herpes (HR = 1.13, 95% CI: 0.55–2.29) and trichomoniasis (HR = 1.43, 95% CI: 0.43–4.68). Conclusions This large cohort study suggests that gonorrhea and bacterial vaginosis were associated with repeat chlamydia diagnoses among U.S. Army women. These findings can be used in formulating new interventions to prevent repeat chlamydia diagnoses