The Development of a WTC Environmental Health Center Pan-Cancer Database.

(1) Background: Recent studies have reported elevated risks of multiple cancers in the World Trade Center (WTC) affected community members (also called WTC "Survivors"). The large variety of WTC-cancers created a need to develop a comprehensive cancer database. This paper describes the development of a pan-cancer database at the WTC Environmental Health Center (EHC) Data Center. (2) Methods: A new REDCap-based pan-cancer database was created using the pathology reports and available biomarker data of confirmed cancer cases after review by a cancer epidemiologist, a pathologist, physicians and biostatisticians. (3) Results: The WTC EHC pan-cancer database contains cancer characteristics and emerging biomarker information for cancers of individuals enrolled in the WTC EHC and diagnosed after 11 September 2001 and up to 31 December 2019 obtained from WTC EHC clinical records, pathological reports and state cancer registries. As of 31 December 2019, the database included 3440 cancer cases with cancer characteristics and biomarker information. (4) Conclusions: This evolving database represents an important resource for the scientific community facilitating future research about the etiology, heterogeneity, characteristics and outcomes of cancers and comorbid mental health conditions, cancer economics and gene-environment interaction in the unique population of WTC survivors.

Characteristics of Cancer Patients in the World Trade Center Environmental Health Center.

The destruction of the World Trade Center (WTC) towers on 11 September 2001 released many tons of aerosolized dust and smoke with potential for carcinogenic exposures to community members as well as responders. The WTC Environmental Health Center (WTC EHC) is a surveillance and treatment program for a diverse population of community members ("Survivors"), including local residents and workers, present in the NYC disaster area on 9/11 or in the days or weeks following. We report a case series of cancers identified in the WTC EHC as of 31 December 2019. Descriptive characteristics are presented for 2561 cancer patients (excluding non-melanoma skin cancer) and 5377 non-cancer WTC-EHC participants who signed informed consent. We identified a total of 2999 cancer diagnoses in 2561 patients: 2534 solid tumors (84.5%) and 465 lymphoid and hematopoietic tissue cancers (15.5%) with forty-one different cancer types. We describe the distribution, frequency, median age of cancer diagnosis and median latency from 9/11 by cancer site. In addition to common cancer types, rare cancers, including male breast cancers and mesotheliomas have been identified. The current study is the first report on cancer characteristics of enrollees at WTC EHC, a federally designated treatment and surveillance program for local community members affected by the 9/11 terrorist attack on the WTC.

Using a 2-stage strategy with respondent-driven sampling to recruit a hard-to-reach population for a placebo microbicide gel clinical trial in Nellore, Andhra Pradesh (India).

Traditional recruitment methods for microbicide efficacy trials are labor intensive and may fail to reach high-risk hard-to-reach populations. We report duration of recruitment and lessons learned from a two-stage process to recruit female sex workers (FSWs) into a placebo microbicide trial, and examined characteristics associated with successful recruitment of peers who screened for and enrolled in the trial. FSWs were first recruited via respondent-driven sampling (RDS) to complete a survey and subsequently invited to screen for enrollment into a placebo microbicide trial taking place at a local clinic. It took 6 months to enroll 267 participants into the trial. Successful recruiters of peers who enrolled were more likely to have enrolled themselves (AOR 2.0, CI 1.3-2.9) and less likely to visit Nellore city (AOR 0.5, CI 0.3-0.9). Recruitment of FSWs via a two-stage recruitment strategy with RDS can be a good option for future clinical trials.

Culture-independent diagnostic testing: have we opened Pandora's box for good?

The ability to accurately and quickly identify microbial agents associated with infectious diseases has been a longstanding and continuous goal of diagnostic microbiology laboratories. Over the course of several decades, technology and testing methodologies in this field have gradually evolved from traditional- or classic-based culture and identification approaches to antigen capture systems and more molecular-oriented applications. Recently, these molecular-based applications have signaled a new era in clinical diagnostic microbiology with the commercial introduction of culture-independent diagnostic testing (CIDT) systems. The first major commercial venture into the CIDT arena involves the detection of acute bacterial gastroenteritis. Several commercial products are now on the market globally with at least 4 Food and Drug Administration approved since January of 2013. These new systems offer the direct detection of a variety of enteropathogens quickly without the need for traditional culture. In Greek mythology, Pandora opened a "jar" or "box" out of curiosity thereby releasing all of humanity's evils most notably diseases and plagues according to Hesiod's Theogony. While not ill-intentioned the only thing left in the box was Hope.

Expedited partner therapy in federally qualified health centers--New York City, 2012.

BACKGROUND: Management of patients' sex partners is a critical element of sexually transmitted disease (STD) control. Expedited partner therapy (EPT), a practice in which patients deliver medication or a prescription directly to their partners, is one option for partner management. As of 2009, New York State law specifically allows EPT for chlamydial infection. Federally qualified health centers (FQHCs) in New York City (NYC) care for patients at risk for STDs. We describe the policies and practices surrounding EPT and other STD management in NYC FQHCs. METHODS: In 2012, we surveyed medical directors at all NYC FQHC parent entities and clinicians at a sample of their corresponding clinical sites about written policies and actual practices regarding EPT for chlamydial infection and other STD management. RESULTS: Twenty-two entities (22/29; 76%) and 51 sites (51/72; 70%) responded to the survey. More than half of entities have a written policy permitting EPT, and 80% of sites provide EPT. Most entity policies allow EPT for, and most sites provide EPT to, adolescents and adults with both opposite-sex and/or same-sex partners. Most sites use electronic health records and provide EPT by prescriptions, and one third of sites do not provide educational materials with EPT. CONCLUSIONS: Our results indicate widespread EPT provision by NYC FQHCs; however, areas for improvement exist, specifically in following guidelines that recommend providing educational materials with EPT and do not recommend EPT for men with male partners. The use of prescriptions for EPT and electronic health records were identified as potential barriers to EPT provision.

Sexually transmitted infections and reproductive health morbidity in a cohort of female sex workers screened for a microbicide feasibility study in Nellore, India.

UNLABELLED: Women constitute 38% of India's 2.4 million HIV-infected persons. Microbicides are potential HIV-prevention products currently undergoing clinical trials for efficacy. A four-month placebo vaginal gel trial was conducted in Nellore, India to determine the feasibility of recruiting a suitable cohort of female sex workers (FSWs) for a future vaginal microbicide efficacy trial. We report on the HIV and STI prevalence and reproductive health (RH) morbidity of FSWs screened for the trial.   RESULTS: 529 FSWs completed screening procedures; of those 33.6% were found ineligible.  The mean age was 30.9 years; 68.6% women were married and 57.5% were home-based FSWs.  Self-reported symptoms included abnormal vaginal discharge (31.6%), genital itching (3.4%), uterine mass/prolapse (3%) and painful intercourse (2.6%).  Gynecological surgery was reported by 73.2% of participants; of those 10.5% had undergone a hysterectomy. Female sterilization was the most commonly reported contraceptive method. Pelvic examination showed vaginal discharge (50.7%), cervical discharge (5.3%), uterine/vaginal wall prolapse (2.6%), and cervical mass/nodule/vesicles/genital warts (4.2%). Common epithelial findings included erythema (79.1%) and vesicles/bullae (6%); 46% of participants had Papanicolaou tests graded as inflammatory and 1.1% as malignant. HSV-2 was the mostly commonly detected STI (60.7%) followed by HIV (5.3%), syphilis (2.8%), chlamydia (2.2%), gonorrhoea (0.7%) and trichomoniasis (15.5%).  RTIs were more common: bacterial vaginosis (27.8%) and candidiasis (18.9%). CONCLUSIONS:  The low HIV prevalence and high RH morbidity in the population makes this site unsuitable for a future phase 2 or 3 microbicide efficacy trial.  HIV prevention programs targeting this population should include access to RH services.

Female sex workers, male circumcision and HIV: a qualitative study of their understanding, experience, and HIV risk in Zambia.

Several sub-Saharan African countries, including Zambia, have initiated national voluntary medical male circumcision (MC) programs to reduce HIV incidence. In-depth interviews were conducted with twenty female sex workers (FSWs) in Lusaka to examine their understanding of MC and experiences with circumcised clients. Knowledge of MC was derived primarily through informal sources, with very few FSWs reporting exposure to MC educational campaigns. MC was not widely believed to be protective against HIV, however it was viewed by some as protective against STIs. Three FSWs reported having sex with recently circumcised clients, and most reported that men often used their MC status to try to convince FSWs to forego condoms. Findings suggest that FSWs, already at high risk for HIV infection, may face additional pressure toward higher risk behavior as a result of MC. As MC services are expanded, programs should support FSWs' efforts to protect themselves by providing information about what MC can--and cannot--offer for HIV/STI infection prevention.

An evaluation of methods to improve the reporting of adherence in a placebo gel trial in Andhra Pradesh, India.

Female sex workers (FSWs) were recruited for a 4-month placebo vaginal gel trial in Nellore, India. Two experiments explored if prior knowledge of biomarkers for unprotected sex and insertion of gel applicators would yield more accurate self-reports. A third experiment compared self-reports of gel use and adherence levels between FSWs randomly assigned to interactive voice response survey (IVRS) and those assigned to paper diaries. Prior knowledge of biomarkers did not improve accuracy of self-reported condom or gel use, nor did it affect actual adherence. Of those who tested positive for the presence of semenogelin in the vagina, 76% reported no unprotected sex in the previous 48 h. Overall, women reported using gel on 90% of days whereas the biomarker indicated gel use on fewer than 50% of days. Compliance to IVRS was low, despite familiarity with mobile phone technology. Additional explorations with other populations are needed.

Characteristics of female sex workers in southern India willing and unwilling to participate in a placebo gel trial.

Respondent-driven sampling was used to recruit female sex workers (FSWs) for a community survey conducted in southern India. After survey completion, participants were given a brochure describing a clinical trial that entailed daily use of a placebo vaginal gel for four months. This study assessed predictors of screening among survey respondents, predictors of enrollment among those eligible for the trial, and predictors of visit attendance and retention among those enrolled. FSWs who reported having symptoms of sexually transmitted infections (STI), engaging in sex work in the past month, and living in a subdistrict easily accessible by public transportation with a high concentration of FSWs, were more likely to screen. FSWs who had never been tested for HIV were more likely to enroll. This analysis suggests that the primary reason FSWs participated in the trial was a desire for health care-not other factors hypothesized to be important, e.g., HIV risk perception and poverty status.