Factors Associated With COVID-19 Vaccine Acceptance Among Patients Receiving Care at a Federally Qualified Health Center.

BACKGROUND: COVID-19 vaccine hesitancy in the United States is high, with at least 63 million unvaccinated individuals to date. Socioeconomically disadvantaged populations experience lower COVID-19 vaccination rates despite facing a disproportionate COVID-19 burden. OBJECTIVE: To assess the factors associated with COVID-19 vaccine acceptance among under-resourced, adult patients. METHODS: Participants were patients receiving care at a Federally Qualified Health Center (FQHC) in St. Paul, Minnesota. Data were collected via multiple modes over 2 phases in 2020 (self-administered electronic survey) and 2021 (study team-administered survey by telephone, self-administered written survey) to promote diversity and inclusion for study participation. The primary outcome was COVID-19 vaccine acceptance. Using logistic regression analysis, associations between vaccine acceptance and factors including risk perception, concerns about the COVID-19 vaccine, social determinants of health (SDOH), co-morbidities, pandemic-induced hardships, and stress were assessed by adjusted odds ratios (AORs) and 95% confidence intervals (CI). RESULTS: One hundred sixty-eight patients (62.5% female; mean age [SD]: 49.9 [17.4] years; 32% <$20 000 annual household income; 69%

mHealth Intervention for Promoting Hypertension Self-management Among African American Patients Receiving Care at a Community Health Center: Formative Evaluation of the FAITH! Hypertension App.

BACKGROUND: African American individuals are at a higher risk of premature death from cardiovascular diseases than White American individuals, with disproportionate attributable risk from uncontrolled hypertension. Given their high use among African American individuals, mobile technologies, including smartphones, show promise in increasing reliable health information access. Culturally tailored mobile health (mHealth) interventions may promote hypertension self-management among this population. OBJECTIVE: This formative study aimed to assess the feasibility of integrating an innovative mHealth intervention into clinical and community settings to improve blood pressure (BP) control among African American patients. METHODS: A mixed methods study of African American patients with uncontrolled hypertension was conducted over 2 consecutive phases. In phase 1, patients and clinicians from 2 federally qualified health centers (FQHCs) in the Minneapolis-St Paul, Minnesota area, provided input through focus groups to refine an existing culturally tailored mHealth app (Fostering African-American Improvement in Total Health! [FAITH!] App) for promoting hypertension self-management among African American patients with uncontrolled hypertension (renamed as FAITH! Hypertension App). Phase 2 was a single-arm pre-post intervention pilot study assessing feasibility and patient satisfaction. Patients receiving care at an FQHC participated in a 10-week intervention using the FAITH! Hypertension App synchronized with a wireless BP monitor and community health worker (CHW) support to address social determinants of health-related social needs. The multimedia app consisted of a 10-module educational series focused on hypertension and cardiovascular risk factors with interactive self-assessments, medication and BP self-monitoring, and social networking. Primary outcomes were feasibility (app engagement and satisfaction) and preliminary efficacy (change in BP) at an immediate postintervention assessment. RESULTS: In phase 1, thirteen African American patients (n=9, 69% aged ≥50 years and n=10, 77% women) and 16 clinicians (n=11, 69% aged ≥50 years; n=14, 88% women; and n=10, 63% African American) participated in focus groups. Their feedback informed app modifications, including the addition of BP and medication tracking, BP self-care task reminders, and culturally sensitive contexts. In phase 2, sixteen African American patients were enrolled (mean age 52.6, SD 12.3 years; 12/16, 75% women). Overall, 38% (6/16) completed ≥50% of the 10 education modules, and 44% (7/16) completed the postintervention assessment. These patients rated the intervention a 9 (out of 10) on its helpfulness in hypertension self-management. Qualitative data revealed that they viewed the app as user-friendly, engaging, and informative, and CHWs were perceived as providing accountability and support. The mean systolic and diastolic BPs of the 7 patients decreased by 6.5 mm Hg (P=.15) and 2.8 mm Hg (P=.78), respectively, at the immediate postintervention assessment. CONCLUSIONS: A culturally tailored mHealth app reinforced by CHW support may improve hypertension self-management among underresourced African American individuals receiving care at FQHCs. A future randomized efficacy trial of this intervention is warranted. TRIAL REGISTRATION: ClinicalTrials.gov NCT04554147; https://clinicaltrials.gov/ct2/show/NCT04554147.

Establishing a SARS-CoV-2 (COVID-19) Drive-Through Collection Site: A Community-Based Participatory Research Partnership With a Federally Qualified Health Center.

The COVID-19 pandemic has disproportionately affected underserved and minority populations in the United States. This is partially attributable to limited access to diagnostic testing from deeply rooted structural inequities precipitating higher infection and mortality rates. We describe the process of establishing a drive-through collection site by leveraging an academic-community partnership between a medical institution and a federally qualified health center in Minnesota. Over 10 weeks, 2006 COVID-19 tests were provided to a socioeconomically disadvantaged population of racial/ethnic minorities and low-income essential workers.

Changes in Manufacturing Processes of Biologic Therapies Can Alter the Immunogenicity Profile of the Product.

Manufacturing process changes may alter the characteristics of a protein therapeutic. In 2009, somatropin (version 1.0), a recombinant human growth hormone therapeutic, underwent a manufacturing update (version 1.1). The immunogenicity of somatropin version 1.1 as a daily subcutaneous injection was evaluated in 2014 in a prospective, open-label, single-arm clinical study of treatment-naive pediatric patients with idiopathic human growth hormone deficiency for 1 year. The primary end point was the proportion of patients who developed antidrug antibodies (ADAs) after treatment. Eighty-two patients were enrolled. The mean (SD) treatment duration was 347 (53) days. The incidence of ADAs was 3.7%. No neutralizing antibodies were observed in the three patients with ADA-positive samples. Two patients (2.6%) had growth attenuation, but they were not ADA positive. The manufacturing changes for somatropin version 1.1 resulted in a similar safety and efficacy profile compared with somatropin version 1.0 and a different immunogenicity profile with a lower incidence of ADAs.

Evaluating Unconscious Bias: Speaker Introductions at an International Oncology Conference.

PURPOSE: In a professional setting, the introduction of female speakers without their professional title may have an impact on the public's perception of the female speaker. We examined how professional titles were used during speakers' introductions at the ASCO Annual Meeting. METHODS: We conducted a retrospective, observational study of video-archived speaker introductions at the 2017 and 2018 ASCO Annual Meetings. A "professional address" was defined as the professional title followed by the speaker's full name or last name. Multivariable logistic regressions were used to identify factors associated with the form of address. RESULTS: Of 2,511 videos reviewed, 781 met inclusion criteria. Female speakers were addressed less often by their professional title compared with male speakers (62% v 81%; P < .001). Males were less likely to use a professional address when introducing female speakers compared with females when introducing male speakers (53% v 80%; P < .01). When women performed speaker introductions, no gender differences in professional address were observed (75% v 82%; P = .13). Female speakers were more likely to be introduced by first name only (17% v 3%; P < .001). Male introducers were more likely to address female speakers by first name only compared with female introducers (24% v 7%; P < .01). In a multivariable regression including gender, degree, academic rank, and geographic location of the speaker's institution, male speakers were more likely to receive a professional address compared with female speakers (odds ratio, 2.43; 95% CI, 1.71 to 3.47; P < .01). CONCLUSION: When introduced by men, female speakers were less likely to receive a professional address and more likely to be introduced by first name only compared with their male peers.

Assessment of placental transfer and the effect on embryo-fetal development of a humanized monoclonal antibody targeting lymphotoxin-alpha in non-human primates.

An enhanced embryo-fetal development study was conducted in cynomolgus monkeys using pateclizumab, a humanized IgG1 monoclonal antibody (mAb) targeting lymphotoxin-alpha. Pateclizumab administration between gestation days (GD) 20 and 132 did not induce maternal or developmental toxicities. The ratio of fetal-to-maternal serum concentration of pateclizumab was 0.73% on GD 50 and 61% by GD 139. Decreased fetal inguinal lymph node-to-body weight ratio was present in the high-dose group without microscopic abnormalities, a change attributable to inhibition of lymphocyte recruitment, which is a pharmacologic effect of pateclizumab during late lymph node development. The effect was observed in inguinal but not submandibular or mesenteric lymph nodes; this was attributed to differential susceptibility related to sequential lymph node development. Placental transfer of therapeutic IgG1 antibodies; thus, begins during the first trimester in non-human primates. Depending on the potency and dose levels administered, antibody levels in the fetus may be pharmacologically or toxicologically relevant.