No Kakou, Na Kakou - For Us, By Us: Native Hawaiians and Pacific Islanders Informing Race Data Collection Standards for Hawai'i.

This article describes recommendations for standardized race data collection developed by the Hawai'i Native Hawaiian and Pacific Islander COVID-19 Response, Recovery, and Resilience Team (NHPI 3R Team). These recommendations attempt to address the expressed desires of Native Hawaiians and the diverse Pacific Islander communities in Hawai'i who seek greater visibility in data and research. The Native Hawaiian and Pacific Islander (NHPI) racial category is 1 of the 5 racial categories listed in the 1997 Statistical Policy Directive #15 issued by the Office of Management and Budget (OMB). The OMB directive sets the minimum standard for collection of race data in federal surveys, administrative forms, records, and other data collection. The NHPI 3R Team's recommendation provides a standard for detailed data collection that could improve smaller communities' ability to identify, advocate for, and address their own needs. The article also describes lessons learned through the collaborative and iterative process that was led by members and leaders of NHPI communities impacted by data driven decisions and policies. The NHPI 3R Team focused on expanding and standardizing race data collection as part of their COVID-19 response efforts, but implementation of the recommendations could produce benefits well beyond the pandemic.

Disaggregating Data to Measure Racial Disparities in COVID-19 Outcomes and Guide Community Response - Hawaii, March 1, 2020-February 28, 2021.

Native Hawaiian and Pacific Islander populations have been disproportionately affected by COVID-19 (1-3). Native Hawaiian, Pacific Islander, and Asian populations vary in language; cultural practices; and social, economic, and environmental experiences,† which can affect health outcomes (4).§ However, data from these populations are often aggregated in analyses. Although data aggregation is often used as an approach to increase sample size and statistical power when analyzing data from smaller population groups, it can limit the understanding of disparities among diverse Native Hawaiian, Pacific Islander, and Asian subpopulations¶ (4-7). To assess disparities in COVID-19 outcomes among Native Hawaiian, Pacific Islander, and Asian populations, a disaggregated, descriptive analysis, informed by recommendations from these communities,** was performed using race data from 21,005 COVID-19 cases and 449 COVID-19-associated deaths reported to the Hawaii State Department of Health (HDOH) during March 1, 2020-February 28, 2021.†† In Hawaii, COVID-19 incidence and mortality rates per 100,000 population were 1,477 and 32, respectively during this period. In analyses with race categories that were not mutually exclusive, including persons of one race alone or in combination with one or more races, Pacific Islander persons, who account for 5% of Hawaii's population, represented 22% of COVID-19 cases and deaths (COVID-19 incidence of 7,070 and mortality rate of 150). Native Hawaiian persons experienced an incidence of 1,181 and a mortality rate of 15. Among subcategories of Asian populations, the highest incidences were experienced by Filipino persons (1,247) and Vietnamese persons (1,200). Disaggregating Native Hawaiian, Pacific Islander, and Asian race data can aid in identifying racial disparities among specific subpopulations and highlights the importance of partnering with communities to develop culturally responsive outreach teams§§ and tailored public health interventions and vaccination campaigns to more effectively address health disparities.

Racial and Ethnic Disparities in COVID-19 Incidence by Age, Sex, and Period Among Persons Aged <25 Years - 16 U.S. Jurisdictions, January 1-December 31, 2020.

The COVID-19 pandemic has disproportionately affected racial and ethnic minority groups in the United States. Whereas racial and ethnic disparities in severe COVID-19-associated outcomes, including mortality, have been documented (1-3), less is known about population-based disparities in infection with SARS-CoV-2, the virus that causes COVID-19. In addition, although persons aged <30 years account for approximately one third of reported infections,§ there is limited information on racial and ethnic disparities in infection among young persons over time and by sex and age. Based on 689,672 U.S. COVID-19 cases reported to CDC's case-based surveillance system by jurisdictional health departments, racial and ethnic disparities in COVID-19 incidence among persons aged <25 years in 16 U.S. jurisdictions¶ were described by age group and sex and across three periods during January 1-December 31, 2020. During January-April, COVID-19 incidence was substantially higher among most racial and ethnic minority groups compared with that among non-Hispanic White (White) persons (rate ratio [RR] range = 1.09-4.62). During May-August, the RR increased from 2.49 to 4.57 among non-Hispanic Native Hawaiian and Pacific Islander (NH/PI) persons but decreased among other racial and ethnic minority groups (RR range = 0.52-2.82). Decreases in disparities were observed during September-December (RR range = 0.37-1.69); these decreases were largely because of a greater increase in incidence among White persons, rather than a decline in incidence among racial and ethnic minority groups. NH/PI, non-Hispanic American Indian or Alaska Native (AI/AN), and Hispanic or Latino (Hispanic) persons experienced the largest persistent disparities over the entire period. Ensuring equitable and timely access to preventive measures, including testing, safe work and education settings, and vaccination when eligible is important to address racial/ethnic disparities.

Decline in Frequency of Newborn Male Circumcision After Change in Medicaid Coverage Status in Selected States in the United States.

OBJECTIVES: Male circumcision is linked to a reduction in the risk of HIV infection, sexually transmitted infections, penile inflammatory skin disorders, cancers, urinary tract infections, and other complications. We examined the extent to which the change in circumcision recommendation by the American Academy of Pediatrics in 1999 and Medicaid coverage status in states affected the total number of procedures performed. METHODS: We used data from the Nationwide Inpatient Sample for 1998-2011 collected annually by the Healthcare Cost and Utilization Project. We examined data on all male births in the United States with Medicaid and private health insurance. We then categorized births into 4 groups: (1) births with newborn male circumcision procedure, (2) births with Medicaid or private health insurance, (3) births that occurred in states where Medicaid coverage for newborn male circumcision was removed, and (4) births that occurred before or after the policy change. We used multivariable logistic regression to estimate the adjusted odds of newborn male circumcision. RESULTS: In the 10 states where a change in Medicaid policy occurred, circumcision frequency had a mean percentage-point decrease of 21.4% among Medicaid beneficiaries and 3.2% among private health insurance beneficiaries from before to after the policy change. In states where coverage was maintained, the change in circumcision frequency was negligible for Medicaid and private health insurance beneficiaries. These changes resulted in an estimated 163 456 potential circumcisions not performed. CONCLUSION: Decreases in newborn male circumcision frequency correlated with the Medicaid policy change for the procedure. Efforts should be made to reduce barriers for cost-effective preventive procedures that promote health, such as newborn male circumcision.

Marijuana use and pneumonia risk in a cohort of HIV-infected and HIV-uninfected men.

BACKGROUND: The prevalence of marijuana use is increasing in the United States. Marijuana smoking has been shown to impair the microbicidal activity of alveolar macrophages and decrease the number of ciliated epithelial cells in the bronchi with a parallel increase in the number of mucus-secreting surface epithelial cells, which may increase the risk of pneumonia. However, it remains unclear whether there is an association between smoking marijuana and pneumonia. METHODS: Using data from the Multicenter AIDS Cohort Study (MACS), a long-term observational cohort study of men who have sex with men in the United States, we used Cox proportional hazards models to estimate the risk of pneumonia among HIV-infected (n = 2784) and HIV-uninfected (n = 2665) men from 1984 to 2013, adjusted for time-varying and fixed baseline covariates. RESULTS: Weekly or daily marijuana use was not significantly associated with increased risk of pneumonia among HIV-uninfected men (adjusted hazard ratio; 95% confidence limits: 0.83, 0.56-1.23). In the disaggregated dose-response analysis, daily use (0.68, 0.34-1.35) was associated with a lower point estimate than weekly use [0.99, 0.79-1.25]. CONCLUSION: Marijuana smoking was not associated with a significant increase in risk of pneumonia among HIV-infected or HIV-uninfected men.

Longitudinal Intra- and Inter-individual variation in T-cell subsets of HIV-infected and uninfected men participating in the LA Multi-Center AIDS Cohort Study.

To assess the intra-individual and inter-individuals biological variation and the effect of aging on lymphocyte T-cells subsets.We assessed lymphocyte phenotypes (CD3, CD4, and CD8 T-cells) in 89 HIV-1-infected and 88 uninfected white non-Hispanic men every 6 months, to examine the biological variation for those measurements, and the average change in lymphocyte phenotype over 34 years.The markers showed significant intra-individuality in HIV-infected and uninfected individuals with index of individuality of <1.4. No mean changes were seen over the 34 years, with the exception of percentage CD4T-cells in HIV-uninfected individuals.In the pre-HAART era, HIV-infected individuals experienced an increase in mean absolute CD3 T-cell numbers (11.21 cells/µL, P = 0.02) and absolute CD8 T-cell numbers (34.57 cell/µl, P < .001), and in the percentage of CD8 T-cells (1.45%, P < .001) per year and a significant decrease in mean absolute CD4 T-cell numbers (23.68 cells/µl, P < .001) and in the percentage of CD4 T-cells (1.49%, P < .001) per year.In the post-HAART era, no changes in mean levels were observed in absolute CD3 T-cell count (P = .15) or percentage (P = .99). Significant decreases were seen in mean count (8.56 cells/µl, P < .001) and percentage (0.59%, P < .001) of CD8 T-cells, and increases in mean absolute count (10.72 cells/µl, P < .001) and percentage (0.47%, P < .001) of CD4 T-cells.With the exception of CD4 (%), no average changes per year were seen in lymphocyte phenotype of HIV-uninfected men. The results of coefficients of variation of intra and inter-individuals of this study can be useful for HIV-1 infection monitoring and in addition the observation could be a useful guide for intra- and inter-individual coefficient variations, and establishing quality goal studies of different blood biomarkers in healthy and other diseases.

Biological variation of immunological blood biomarkers in healthy individuals and quality goals for biomarker tests.

BACKGROUND: Cytokines, chemokines, adipocytokines, soluble cell receptors, and immune activation markers play an important role in immune responsiveness and can provide prognostic value since they reflect underlying conditions and disease states. This study was undertaken to investigate the components of biological variation for various laboratory tests of blood immunological biomarkers. RESULTS: Estimates of intra-individual coefficient of variation (CVI) and inter-individual coefficient of variation (CVG) were examined for blood immunological biomarkers. Biomarkers with CVI < 10% for both genders were CD3, CD4, and CD8 T-cells, serum levels of soluble cluster of differentiation 14 (sCD14), sCD163, and soluble glycoprotein 130 (sgp130). The CVI for serum levels of adiponectin, interleukin-1 receptor antagonist (IL-1Ra), macrophage inflammatory protein 1 beta (MIP-1ß), soluble CD40 Ligand (sCD40L), soluble interleukin-2 receptor alpha (sIL-2Rα), soluble interleukin-6 receptor (sIL-6R), soluble tumor necrosis factor receptor II (sTNF-RII), and tumor necrosis factor alpha (TNF-α) were between 11 and 20%. Biomarkers with CVG < 20% were CD3 T-cell, and serum concentrations of sCD14, sCD40L, and sgp130. The biomarkers with CVG > 40% were adiponectin, IL-1ra, leptin, MIP-1ß, sCD163, and sIL-2Rα. CONCLUSION: The biological variations of biomarkers have important monitoring value for longitudinal investigation and are essential for quality specification of tests that are performed in the laboratory. The CVI was relatively small while CVG was comparatively large and mean values of each biomarker vary between subjects. The individuality of biomarkers significantly influences reference interval values. A majority of the biomarkers in this study had strong individuality and the result of each biomarker should be cautiously interpreted if using established reference interval values. Comparison of a patient's test result with previous ones may be more useful than the usage of conventional reference values.

30-Year Longitudinal Study of Hematological Parameters of HIV-1 Negative Men Participating in Los Angeles Multicenter AIDS Cohort Study (MACS).

BACKGROUND: Clinicians often use population-based reference intervals (RIs) when interpreting patient results. However, this method can present problems if the analyte in question has wide variability from person to person. METHODS: We examined the biological variation of routine hematologic markers in 82 white non-Hispanic men every 6 months during a 30-year period, to determine the usefulness of population-based RIs and age-related decline of hematological markers. RESULTS: Many of these markers showed significant person-to-person differences (index of individuality <1.4 in 10/11 markers) and change over time with a decrease in mean for white blood cells (WBCs), red blood cells (RBCs), hemoglobin, hematocrit, platelets, and neutrophils. The mean increased for monocytes, mean corpuscular volume (MCV), and mean corpuscular hemoglobin (MCH) (all P <.05). CONCLUSION: Longitudinal analysis demonstrated significant decline in hematologic marker counts, with the exception of MCV and MCH. Establishment of a personalized baseline for hematologic assessments may be more useful to clinicians than previous methods.

Stability of cytokines, chemokines and soluble activation markers in unprocessed blood stored under different conditions.

BACKGROUND: Biomarkers such as cytokines, chemokines, and soluble activation markers can be unstable when processing of blood is delayed. The stability of various biomarkers in serum and plasma was investigated when unprocessed blood samples were stored for up to 24h at room and refrigerator temperature. METHODS: Blood was collected from 16 healthy volunteers. Unprocessed serum, EDTA and heparinized blood was stored at room (20-25°C) and refrigerator temperature (4-8°C) for 0.5, 2, 4, 6, 8, and 24h after collection before centrifugation and separation of serum and plasma. Samples were batch tested for various biomarkers using commercially available immunoassays. Statistically significant changes were determined using the generalized estimating equation. RESULTS: IFN-γ, sIL-2Rα, sTNF-RII and ß2-microglobulin were stable in unprocessed serum, EDTA and heparinized blood samples stored at either room or refrigerator temperature for up to 24h. IL-6, TNF-α, MIP-1ß and RANTES were unstable in heparinized blood at room temperature; TNF-α, and MIP-1ß were unstable in unprocessed serum at room temperature; IL-12 was unstable in unprocessed serum at refrigerator temperature; and neopterin was unstable in unprocessed EDTA blood at room temperature. IL-1ra was stable only in unprocessed serum at room temperature. CONCLUSION: All the biomarkers studied, with the exception of IL-1ra, were stable in unprocessed EDTA blood stored at refrigerator temperature for 24h. This indicates that blood for these biomarkers should be collected in EDTA and if delays in processing are anticipated the unseparated blood should be stored at refrigerator temperature until processing.

Association of Blood Biomarkers of Bone Turnover in HIV-1 Infected Individuals Receiving Anti-Retroviral Therapy (ART).

OBJECTIVE: To evaluate the association of bone turnover biomarkers with blood levels of alkaline phosphatase (ALP), bone-specific alkaline phosphatase (BAP), osteocalcin (OC), tartrate-resistant acid phosphatase (TRAP), parathyroid hormone (PTH), and other blood markers in HIV-1 infected men receiving anti-retroviral therapy (ART). Advances in the treatment of HIV-1 infection have extended the life span of HIV-1 infected individuals. However, these advances may come at the price of metabolic side effects and bone disorders, including premature osteopenia, osteoporosis and osteonecrosis. METHODS: Analyses of Ostase BAP, osteocalcin, and TRAP in blood were measured in three groups of MACS participants: 35 HIV-1 infected men on ART (A); 35 HIV-1- infected men not on ART (B); and 34 HIV-1 uninfected men (C). RESULTS: The mean and standard deviation results for groups A, B, and C were 19.7 ± 6.56, 17.2 ± 3.96, and 16.9 ± 5.78 for ostase BAP; 7.9 ± 9.53, 8.5 ± 8.30, and 5.5 ± 1.65 for osteocalcin; and 3.9 ± 1.04, 3.1 ± 0.81, and 2.5 ± 0.59 for TRAP, respectively. Simple and multivariate analyses showed significant differences in mean TRAP and BAP concentrations between the three groups. In addition strong correlations between blood levels of Ostase BAP and TRAP (r=0.570, p=0.0004), and between blood levels of Ostase BAP and PTH (r=0.436, P=0.0098) for HIV-1 infected men on ART were observed. CONCLUSION: New strategies for measurement of blood and urine biochemical markers of bone formation and resorption during bone turnover can be useful for clinical monitoring of treatment of HIV-1 infected patients. Recently developed methods for measuring serum levels of TRAP and Ostase BAP represent superior laboratory tools for assessing the hyperactivity of osteoclasts, osteoblasts and bone loss in HIV-1 infected individuals receiving ART. Measurements of TRAP and BAP as bone turnover biomarkers are economical and are important for monitoring bone metabolism during ART and the need for osteoporosis treatment.