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To assess associations of psychosocial factors with medication adherence in young adults with youth-onset type 2 diabetes in the Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY2) cohort.Participants (mean age 26 years) completed validated psychosocial measures. Adherence to oral hypoglycemia agents (OHAs) was assessed with 3-monthly unannounced phone pill counts; insulin adherence by self-report. Logistic and linear regressions identified factors associated with "low-adherence" (80% of pills/insulin) controlling for confounders.Of 212 participants taking OHAs (67% female, 39% Hispanic, 36% non-Hispanic Black), 69.8% were low-adherent. After adjustment, beliefs that medicines are necessary was associated with lower odds of low-adherence (p = 0.040, dichotomous). Less self-management support (p = 0.008), no healthcare coverage (p = 0.001), ≥1 (p = 0.008)/≥2 (p = 0.045) need insecurities were associated with higher odds of low-adherence. Factors associated with lower % adherence (continuous) were beliefs that medicines are harmful (p 0.001)/overused (p = 0.007)/less necessary (p = 0.022), low self-management support (p = 0.003), food insecurity (p = 0.036), no healthcare coverage (p 0.001), ≥1 (p = 0.003)/≥2 (p = 0.018) need insecurities. Of 192 taking insulin (69% female, 36% Hispanic, 41% non-Hispanic Black, 16% non-Hispanic white), 37.0% were low-adherent. Beliefs that medicines are overused (p = 0.009), that diabetes is not serious (p = 0.010), low diabetes self-efficacy (p = 0.035), high distress (p = 0.027), low self-management support (p = 0.001), food insecurity (p = 0.020), ≥1 (p = 0.011)/≥2 (p = 0.015) insecurities increased odds of insulin low-adherence.Poor medication adherence, common in young adults with youth-onset type 2 diabetes, is associated with interfering beliefs, diabetes distress and social factors. We must address these factors to develop tailored interventions for this vulnerable group.

BACKGROUND: Primary cytomegalovirus (CMV) infection during pregnancy carries a risk of congenital infection and possible severe sequelae. There is no established intervention for preventing congenital CMV infection. METHODS: In this multicenter, double-blind trial, pregnant women with primary CMV infection diagnosed before 24 weeks’ gestation were randomly assigned to receive a monthly infusion of CMV hyperimmune globulin (at a dose of 100 mg per kilogram of body weight) or matching placebo until delivery. The primary outcome was a composite of congenital CMV infection or fetal or neonatal death if CMV testing of the fetus or neonate was not performed. RESULTS: From 2012 to 2018, a total of 206,082 pregnant women were screened for primary CMV infection before 23 weeks of gestation; of the 712 participants (0.35%) who tested positive, 399 (56%) underwent randomization. The trial was stopped early for futility. Data on the primary outcome were available for 394 participants; a primary outcome event occurred in the fetus or neonate of 46 of 203 women (22.7%) in the group that received hyperimmune globulin and of 37 of 191 women (19.4%) in the placebo group (relative risk, 1.17; 95% confidence interval [CI], 0.80 to 1.72; P = 0.42). Death occurred in 4.9% of fetuses or neonates in the hyperimmune globulin group and in 2.6% in the placebo group (relative risk, 1.88; 95% CI, 0.66 to 5.41), preterm birth occurred in 12.2% and 8.3%, respectively (relative risk, 1.47; 95% CI, 0.81 to 2.67), and birth weight below the 5th percentile occurred in 10.3% and 5.4% (relative risk, 1.92; 95% CI, 0.92 to 3.99). One participant in the hyperimmune globulin group had a severe allergic reaction to the first infusion. Participants who received hyperimmune globulin had a higher incidence of headaches and shaking chills while receiving infusions than participants who received placebo. CONCLUSIONS: Among pregnant women, administration of CMV hyperimmune globulin starting before 24 weeks’ gestation did not result in a lower incidence of a composite of congenital CMV infection or perinatal death than placebo. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Center for Advancing Translational Sciences; ClinicalTrials.gov number, NCT01376778.)

Objective The objective of this study is to evaluate whether there is an association between in-utero exposure to nicotine and subsequent hearing dysfunction. Patients and Methods Secondary analysis of a multicenter randomized trial to prevent congenital cytomegalovirus (CMV) infection among gravidas with primary CMV infection was conducted. Monthly intravenous immunoglobulin hyperimmune globulin therapy did not influence the rate of congenital CMV. Dyads with missing urine, fetal or neonatal demise, infants diagnosed with a major congenital anomaly, congenital CMV infection, or with evidence of middle ear dysfunction were excluded. The primary outcome was neonatal hearing impairment in one or more ears defined as abnormal distortion product otoacoustic emissions (DPOAEs; 1 to 8 kHz) that were measured within 42 days of birth. DPOAEs were interpreted using optimized frequency-specific level criteria. Cotinine was measured via enzyme-linked immunosorbent assay kits in maternal urine collected at enrollment and in the third trimester (mean gestational age 16.0 and 36.7 weeks, respectively). Blinded personnel ran samples in duplicates. Maternal urine cotinine >5 ng/mL at either time point was defined as in-utero exposure to nicotine. Multivariable logistic regression included variables associated with the primary outcome and with the exposure (p Results Of 399 enrolled patients in the original trial, 150 were included in this analysis, of whom 46 (31%) were exposed to nicotine. The primary outcome occurred in 18 (12%) newborns and was higher in nicotine-exposed infants compared with those nonexposed (15.2 vs. 10.6%, odds ratio [OR] 1.52, 95% confidence interval [CI] 0.55–4.20), but the difference was not significantly different (adjusted odds ratio [aOR] = 1.0, 95% CI 0.30–3.31). This association was similar when exposure was stratified as heavy (>100 ng/mL, aOR 0.72, 95% CI 0.15–3.51) or mild (5–100 ng/mL, aOR 1.28, 95% CI 0.33–4.95). There was no association between nicotine exposure and frequency-specific DPOAE amplitude. Conclusion In a cohort of parturients with primary CMV infection, nicotine exposure was not associated with offspring hearing dysfunction assessed with DPOAEs. Key Points

Aim: To identify psychosocial factors in young adults (mean age 26 yrs) that predict medication adherence 1 year later in the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY2) observational study. Methods: Validated psychosocial measures (attitudes, beliefs, self-efficacy, distress, depression, anxiety, self-management support, needs insecurities) were completed at baseline (T1) . Medication adherence was assessed at T1 and 1 year later (T2) . Adherence to oral hypoglycemia agents (OHA) was assessed with 3 monthly unannounced phone pill counts. Insulin adherence was self-report. Adherence was defined categorically (≥ 80% pills/insulin=high adherent; < 80% = low adherent) and continuously (% adherence) . Logistic and linear regressions assessed psychosocial measures as predictors of adherence group (high vs. low) and % adherence, controlling for potential confounders. Results: OHA adherence: Mean scores declined from T1 to T2 (57.9% vs. 51.4%, p=0.004; N=171) . In adjusted multivariable analyses, more concerns about diabetes medications (e.g. long-term effects) (p=0.035) and lack of healthcare coverage (p=0.043) predicted higher odds of being low adherent. Beliefs that medications are harmful (p=0.004) or overused (p=0.002) , lack of healthcare coverage (p Conclusions: Negative beliefs about medicines and unmet material needs predicted poorer OHA adherence. Negative beliefs, low support and distress predicted lower insulin adherence. These factors may be targets for future interventions. Disclosure P.M.Trief: None. S.Kalichman: None. D.Uschner: None. L.M.Fette: None. H.Wen: None. K.Drews: None. B.Anderson: None. J.D.Bulger: None. R.S.Weinstock: Research Support; Boehringer Ingelheim International GmbH, Dexcom, Inc., Diasome, Eli Lilly and Company, Insulet Corporation, Kowa Pharmaceuticals America, Inc., Medtronic, Novo Nordisk, Tandem Diabetes Care, Inc., Tolerion, Inc. Funding National Institute of Diabetes and Digestive and Kidney Diseases (RO1DK110456, U01-DK61212, U01-DK61230, U01-DK61239, U01-DK61242, and U01-DK61254)

ImportanceReal-world data are needed to assess incidence and factors associated with breakthrough SARS-CoV-2 infections following vaccination.ObjectiveEstimate incidence of breakthrough infections and assess associations with risk factors using self-reported data from a large NC population sample.DesignProspective observational cohort study utilizing daily online survey data to capture information about COVID-19 symptoms, testing, and vaccination status.SettingSix health care systems in North Carolina with data collected between January 15, 2021 and September 24, 2021.ParticipantsAdult study participants who reported full vaccination with a COVID-19 mRNA or J&J non-replicating viral vector vaccine (n =16,020).ExposuresPotential community exposure to SARS-CoV-2.Main Outcome and MeasuresSelf-reported breakthrough infection.ResultsSARS-CoV-2 infection after vaccination was self-reported in 1.9% of participants, with an incidence rate of 7.3 per 100,000 person-years. Younger age (45-64 vs. 18-44: HR (95% CI) = 0.65 (0.51 - 0.82); 65+ vs. 18-44: HR (95% CI) = 0.59 (0.39 - 0.90)), and vaccination with J&J Ad26.COV2.S were associated with a higher risk of breakthrough infection compared to vaccination with Pfizer BNT162b2 (Ad26.COV2.S vs. BNT162b2: HR (95% CI) = 2.23 (1.40 - 3.56)), while participants vaccinated with mRNA-1273 (mRNA-1273 vs. BNT162b2: HR (95% CI) = 0.69 (0.50 – 0.96) and those residing in urban counties experienced a lower rate of SARS-CoV-2 breakthrough infection compared with those from suburban (HR (95% CI) = 1.39 (1.01 – 1.90) or rural (HR (95% CI) = 1.57 (1.16 – 2.11) counties. There was no significant association between breakthrough infection and participant sex, race, healthcare worker status, prior COVID-19 infection, routine mask use, or overall vaccination rate in the county of residence.Conclusions and RelevanceThis NC community-based observational study showed that the proportion of the cohort who self-report breakthrough SARS-CoV-2 infections was 7.3 events per 100,000 person-years. Younger adults, those vaccinated with J&J Ad26.COV2.S, and those residing in suburban or rural counties were at higher risk of breakthrough infections and should be targeted for additional risk mitigation strategies to decrease community transmission.Trial RegistrationThe COVID-19 Community Research Partnership is listed in clinicaltrials.gov (NCT04342884).Key PointsQuestionWhat are the characteristics of those with breakthrough infections after SARS-CoV-2 vaccination in North CarolinaãFindingsIn this NC-based observational study of 16,020 participants, 1.9% self-reported a positive SARS-CoV-2 viral test at least 2 weeks following full vaccination, reflecting an event rate of 7.3 infections per 100,000 person years. Rates were higher among younger participants, participants from more rural areas in North Carolina, and those vaccinated with J&J Ad26.COV2.S.MeaningOur results show a relatively low rate of COVID-19 infection following full vaccination. Younger adults and those vaccinated with J&J Ad26.COV2.S should be targeted for additional risk mitigation strategies.

To develop and internally validate a noninvasive method for the prediction of congenital cytomegalovirus (CMV) infection after primary maternal CMV infection.We conducted a secondary analysis of a multicenter randomized placebo-controlled trial of CMV hyperimmune globulin to prevent congenital infection. Women were eligible if they had primary CMV infection, defined as detectable plasma CMV-specific immunoglobulin (Ig)M and CMV-specific IgG with avidity less than 50% before 24 weeks of gestation or IgG seroconversion before 28 weeks, and were carrying a singleton fetus without ultrasonographic findings suggestive of CMV infection. Antibody assays were performed in a single reference laboratory. Congenital infection was defined as CMV detection in amniotic fluid, neonatal urine or saliva, or postmortem tissue. Using backward elimination, we developed logit models for prediction of congenital infection using factors known at randomization. The performance of the model was assessed using leave-one-out cross-validation (a method of internal validation).Of 399 women enrolled in the trial, 344 (86%) had informative data for this analysis. Congenital infection occurred in 68 pregnancies (20%). The best performing model included government-assisted insurance, IgM index 4.5 or higher, IgG avidity less than 32%, and whether CMV was detectable by polymerase chain reaction in maternal plasma at the time of randomization. Cross-validation showed an average area under the curve of 0.76 (95% CI 0.70-0.82), indicating moderate discriminatory ability. More parsimonious one-, two-, and three-factor models performed significantly less well than the four-factor model. Examples of prediction with the four-factor model: for a woman with government-assisted insurance, avidity less than 32%, IgM index 4.5 or higher, and detectable plasma CMV, probability of congenital infection was 0.69 (95% CI 0.53-0.82); for a woman with private insurance, avidity 32% or greater, IgM index less than 4.5, and undetectable plasma CMV, probability of infection was 0.03 (95% CI 0.02-0.07).We developed models to predict congenital CMV infection in the presence of primary maternal CMV infection and absence of ultrasonographic findings suggestive of congenital infection. These models may be useful for patient counseling and decision making.

OBJECTIVE To estimate whether maternal sense of control in labor is associated with breastfeeding at 4-8 weeks postpartum. METHODS This is a secondary analysis of data from a multicenter randomized controlled trial of elective induction of labor at 39 weeks of gestation in low-risk nulliparous women. In this trial, women completed the Labor Agentry Scale, a validated measure of women's feelings of control over the childbirth process, 6-96 hours after delivery. The Labor Agentry Scale score, which is higher with more perceived control during childbirth, was analyzed both as a continuous and a categorical variable (quintiles). Self-reported breastfeeding at 4-8 weeks postpartum was categorized as exclusive breastfeeding, breastfeeding and formula feeding, or exclusive formula feeding. Women were included in this analysis if they labored, filled out a Labor Agentry Scale questionnaire, had a neonate who survived until the postpartum visit, and provided information on infant feeding. Multinomial logistic regression was used to adjust for confounders. RESULTS Of 5,185 women, 32.9% (n=1,705) were exclusively breastfeeding, 31.2% (n=1,620) were breastfeeding and formula feeding, and 35.9% (n=1,860) were exclusively formula feeding 4-8 weeks after delivery. Overall Labor Agentry Scale score ranged from 34 to 203 (median 167, interquartile range 145-182). The median Labor Agentry Scale score was 169 (interquartile range 151-183) for women exclusively breastfeeding, 166 (interquartile range 142-182) for women who were breastfeeding and formula feeding, and 164 (interquartile range 142-181) for women who were only formula feeding (P