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Development of "Advancing People of Color in Clinical Trials Now!": Web-Based Randomized Controlled Trial Protocol

Chung, Alicia; Seixas, Azizi; Williams, Natasha; Senathirajah, Yalini; Robbins, Rebecca; Newsome Garcia, Valerie; Ravenell, Joseph; Jean-Louis, Girardin
BACKGROUND:Participation in clinical trials among people of color remains low, compared with white subjects. This protocol describes the development of "Advancing People of Color in Clinical Trials Now!" (ACT Now!), a culturally tailored website designed to influence clinical trial decision making among people of color. OBJECTIVE:This cluster randomized study aims to test the efficacy of a culturally tailored website to increase literacy, self-efficacy, and willingness to enroll in clinical trials among people of color. METHODS:ACT Now! is a randomized trial including 2 groups: (1) intervention group (n=50) with access to the culturally tailored website and (2) control group (n=50) exposed to a standard clinical recruitment website. Clinical trial literacy and willingness to enroll in a clinical trial will be measured before and after exposure to the website corresponding to their assigned group (intervention or control). Surveys will be conducted at baseline and during the 1-month postintervention and 3-month follow-up. Website architecture and wireframing will be informed by the literature and experts in the field. Statistical analysis will be conducted using a two-tailed t test, with 80% power, at .05 alpha level, to increase clinical trial literacy, self-efficacy, and willingness to enroll in clinical trials 3 months post intervention. RESULTS:We will design a culturally tailored website that will provide leverage for community stakeholders to influence clinical trial literacy, self-efficacy, and willingness to enroll in clinical trials among racial and ethnic groups. ACT Now! applies a community-based participatory research approach through the use of a community steering committee (CSC). The CSC provides input during the research study conception, development, implementation, and enrollment. CSC relationships help foster trust among communities of color. ACT Now! has the potential to fill a gap in clinical trial enrollment among people of color through an accessible web-based website. This study was funded in July 2017 and obtained institutional review board approval in spring 2017. As of December 2019, we had enrolled 100 participants. Data analyses are expected to be completed by June 2020, and expected results are to be published in fall 2020. CONCLUSIONS:ACT Now! has the potential to fill an important gap in clinical trial enrollment among people of color through an accessible web-based website. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov NCT03243071; https://clinicaltrials.gov/ct2/show/NCT00102401. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)/UNASSIGNED:DERR1-10.2196/17589.
PMID: 32673274
ISSN: 1929-0748
CID: 4528372

Underreporting of drug use among electronic dance music party attendees

Palamar, Joseph J; Salomone, Alberto; Keyes, Katherine M
BACKGROUND AND OBJECTIVES/OBJECTIVE:Electronic dance music (EDM) party attendees are at high risk for drug use. However, little is known regarding the extent of underreporting of drug use in this population, in part, because use of synthetic drugs is often associated with unknown exposure to adulterant drugs. We estimated the extent of underreported drug use in this population by comparing self-reported use to hair toxicology results. METHODS:Time-space sampling was used to survey adults entering EDM events at nightclubs and dance festivals in New York City from January through August of 2019. Seven hundred ninety-four adults were surveyed and 141 provided analyzable hair samples. We queried past-year use of >90 drugs and tested hair samples using ultra-high performance liquid chromatography-tandem mass spectrometry. We compared hair test results to past-year self-reported use and adjusted prevalence estimates by defining use as reporting use or testing positive. Correlates of discordant reporting, defined as testing positive after not reporting use, were estimated. RESULTS:Prevalence of drug use increased when considering positive hair tests in estimates, with 43.8% of participants testing positive for at least one drug after not reporting use. For example, based on self-report, cocaine use prevalence was 51.1%, and increased by a factor of 1.6 to a prevalence of 80.0% when adding hair test results to self-report. Younger adults (ages 18-25), black and other/mixed race participants, those reporting "other" sexuality, and those with a college degree were at significantly higher risk for testing positive for drugs not reportedly used. Those who self-reported using more types of drugs were less likely to test positive after not reporting use (adjusted prevalence ratio = 0.53, 95% confidence interval = 0.41-0.68). CONCLUSIONS:We detected underreporting of drug use, particularly cocaine and ketamine. More research is needed to determine whether this is driven by intentional underreporting or unknown exposure through adulterants.
PMID: 32644026
ISSN: 1556-9519
CID: 4533242

Face masks can be devastating for people with hearing loss [Editorial]

Chodosh, Joshua; Weinstein, Barbara E; Blustein, Jan
PMID: 32646862
ISSN: 1756-1833
CID: 4517362

Park Proximity and Use for Physical Activity among Urban Residents: Associations with Mental Health

Orstad, Stephanie L; Szuhany, Kristin; Tamura, Kosuke; Thorpe, Lorna E; Jay, Melanie
Increasing global urbanization limits interaction between people and natural environments, which may negatively impact population health and wellbeing. Urban residents who live near parks report better mental health. Physical activity (PA) reduces depression and improves quality of life. Despite PA's protective effects on mental health, the added benefit of urban park use for PA is unclear. Thus, we examined whether park-based PA mediated associations between park proximity and mental distress among 3652 New York City residents (61.4% 45 + years, 58.9% female, 56.3% non-white) who completed the 2010-2011 Physical Activity and Transit (PAT) random-digit-dial survey. Measures included number of poor mental health days in the previous month (outcome), self-reported time to walk to the nearest park from home (exposure), and frequency of park use for sports, exercise or PA (mediator). We used multiple regression with bootstrap-generated 95% bias-corrected confidence intervals (BC CIs) to test for mediation by park-based PA and moderation by gender, dog ownership, PA with others, and perceived park crime. Park proximity was indirectly associated with fewer days of poor mental health via park-based PA, but only among those not concerned about park crime (index of moderated mediation = 0.04; SE = 0.02; 95% BC CI = 0.01, 0.10). Investment in park safety and park-based PA promotion in urban neighborhoods may help to maximize the mental health benefits of nearby parks.
PMID: 32645844
ISSN: 1660-4601
CID: 4518012

The Importance of Long-term Care Populations in Models of COVID-19

Pillemer, Karl; Subramanian, Lakshminarayanan; Hupert, Nathaniel
PMID: 32501504
ISSN: 1538-3598
CID: 4469482

Optimizing health literacy to facilitate reproductive health decision-making in adolescent and young adults with cancer

Nahata, Leena; Anazodo, Antoinette; Cherven, Brooke; Logan, Shanna; Meacham, Lillian R; Meade, Cathy D; Zarnegar-Lumley, Sara; Quinn, Gwendolyn P
Despite being considered "standard of care" by many organizations, fertility and reproductive health communications and counseling practices remain inconsistent for adolescents and young adults (AYAs) newly diagnosed with cancer and during survivorship. One factor known to affect how information is provided and received in the medical setting is health literacy. Providers should consider health literacy to optimize reproductive health communication with AYAs as they cope with their diagnosis, understand what it means for their future, process information about treatment options, learn about their potential harmful effects on fertility, make quick decisions about fertility preservation, and navigate a future family planning course. Thus, the objectives of this manuscript are to (a) summarize literature on reproductive health literacy; (b) describe health literacy frameworks; (c) examine ways to assess health literacy; and (d) identify ways to enhance clinician-patient communication in the AYA oncofertility setting.
PMCID:7785658
PMID: 32633029
ISSN: 1545-5017
CID: 5070142

Skeletal Muscle Mitochondrial Dysfunction Is Present in Patients with CKD before Initiation of Maintenance Hemodialysis

Gamboa, Jorge L; Roshanravan, Baback; Towse, Theodore; Keller, Chad A; Falck, Aaron M; Yu, Chang; Frontera, Walter R; Brown, Nancy J; Ikizler, T Alp
BACKGROUND AND OBJECTIVES:Patients with CKD suffer from frailty and sarcopenia, which is associated with higher morbidity and mortality. Skeletal muscle mitochondria are important for physical function and could be a target to prevent frailty and sarcopenia. In this study, we tested the hypothesis that mitochondrial dysfunction is associated with the severity of CKD. We also evaluated the interaction between mitochondrial function and coexisting comorbidities, such as impaired physical performance, intermuscular adipose tissue infiltration, inflammation, and oxidative stress. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS:P magnetic resonance spectroscopy to obtain the phosphocreatine recovery time constant, a measure of mitochondrial function. We measured physical performance using the 6-minute walk test, intermuscular adipose tissue infiltration with magnetic resonance imaging, and markers of inflammation and oxidative stress in plasma. In skeletal muscle biopsies from a select number of patients on maintenance hemodialysis, we also measured markers of mitochondrial dynamics (fusion and fission). RESULTS:=0.001). We found mitochondrial fragmentation and increased content of dynamin-related protein 1, a marker of mitochondrial fission, in skeletal muscles from patients on maintenance hemodialysis (0.86 [0.48-1.35] arbitrary units (A.U.), median [interquartile range]) compared with controls (0.60 [0.24-0.75] A.U.). CONCLUSIONS:Mitochondrial dysfunction is due to multifactorial etiologies and presents prior to the initiation of maintenance hemodialysis, including in patients with CKD stages 3-5.
PMID: 32591419
ISSN: 1555-905x
CID: 5162302

COVID-19 transforms health care through telemedicine: evidence from the field

Mann, Devin M; Chen, Ji; Chunara, Rumi; Testa, Paul A; Nov, Oded
This study provides data on the feasibility and impact of video-enabled telemedicine use among patients and providers and its impact on urgent and non-urgent health care delivery from one large health system (NYU Langone Health) at the epicenter of the COVID-19 outbreak in the United States. Between March 2nd and April 14th 2020, telemedicine visits increased from 369.1 daily to 866.8 daily (135% increase) in urgent care after the system-wide expansion of virtual health visits in response to COVID-19, and from 94.7 daily to 4209.3 (4345% increase) in non-urgent care post expansion. Of all virtual visits post expansion, 56.2% and 17.6% urgent and non-urgent visits, respectively, were COVID-19-related. Telemedicine usage was highest by patients aged 20-44, particularly for urgent care. The COVID-19 pandemic has driven rapid expansion of telemedicine use for urgent care and non-urgent care visits beyond baseline periods. This reflects an important change in telemedicine that other institutions facing the COVID-19 pandemic should anticipate.
PMID: 32324855
ISSN: 1527-974x
CID: 4402342

Development of Brain Networks In Utero: Relevance for Common Neural Disorders

Thomason, Moriah E
Magnetic resonance imaging, histological, and gene analysis approaches in living and nonliving human fetuses and in prematurely born neonates have provided insight into the staged processes of prenatal brain development. Increased understanding of micro- and macroscale brain network development before birth has spurred interest in understanding the relevance of prenatal brain development to common neurological diseases. Questions abound as to the sensitivity of the intrauterine brain to environmental programming, to windows of plasticity, and to the prenatal origin of disorders of childhood that involve disruptions in large-scale network connectivity. Much of the available literature on human prenatal neural development comes from cross-sectional or case studies that are not able to resolve the longitudinal consequences of individual variation in brain development before birth. This review will 1) detail specific methodologies for studying the human prenatal brain, 2) summarize large-scale human prenatal neural network development, integrating findings from across a variety of experimental approaches, 3) explore the plasticity of the early developing brain as well as potential sex differences in prenatal susceptibility, and 4) evaluate opportunities to link specific prenatal brain developmental processes to the forms of aberrant neural connectivity that underlie common neurological disorders of childhood.
PMID: 32305217
ISSN: 1873-2402
CID: 4396672

Age of Sexual Debut among Young Gay-identified Sexual Minority Men: The P18 Cohort Study

Halkitis, Perry N; LoSchiavo, Caleb; Martino, Richard J; De La Cruz, Blas Martin; Stults, Christopher B; Krause, Kristen D
Age of sexual debut is a critical health indicator for young sexual minority men (YSMM), associated with an increased likelihood of HIV acquisition, use of alcohol, tobacco, and other substances, and psychological distress. This study examined the age of same-sex sexual debut for five sexual behaviors in a sample of racially/ethnically and socioeconomically diverse gay-identified YSMM in New York City. The mean age of sexual debut of any behavior was 14.5 years old and 19% of the sample reported sexual debut prior to age 13. Overall, mutual masturbation occurred at the youngest mean age, followed by performed oral, received oral, receptive anal, and insertive anal intercourse. There were significant differences by race/ethnicity and perceived familial socioeconomic status (SES), such that Black and Hispanic/Latino men had earlier ages of debut for performed oral and receptive and insertive anal sex, while upper SES men had later ages of debut for receptive and insertive anal intercourse. These findings are relevant to trends in HIV incidence in the U.S., which are highest among Black and Hispanic/Latino YSMM and may be associated with earlier age of sexual debut. These findings also underscore a need for comprehensive and inclusive sex education at younger ages.
PMID: 32609010
ISSN: 1559-8519
CID: 4504312