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BACKGROUND: For patients with clinically node-positive (cN+) breast cancer undergoing neoadjuvant chemotherapy (NAC), retrieving previously clipped, biopsy-proven positive lymph nodes during sentinel lymph node biopsy [i.e., targeted axillary dissection (TAD)] may reduce false negative rates. However, the overall utilization and impact of clipping positive nodes remains uncertain. PATIENTS AND METHODS: We retrospectively analyzed cN+ ISPY-2 patients (2011-2022) undergoing axillary surgery after NAC. We evaluated trends in node clipping and associations with type of axillary surgery [sentinel lymph node (SLN) only, SLN and axillary lymph node dissection (ALND), or ALND only] and event-free survival (EFS) in patients that were cN+ on a NAC trial. RESULTS: Among 801 cN+ patients, 161 (20.1%) had pre-NAC clip placement in the positive node. The proportion of patients that were cN+ undergoing clip placement increased from 2.4 to 36.2% between 2011 and 2021. Multivariable logistic regression showed nodal clipping was independently associated with higher odds of SLN-only surgery [odds ratio (OR) 4.3, 95% confidence interval (CI) 2.8-6.8, p < 0.001]. This was also true among patients with residual pathologically node-positive (pN+) disease. Completion ALND rate did not differ based on clip retrieval success. No significant differences in EFS were observed in those with or without clip placement, both with or without successful clip retrieval [hazard ratio (HR) 0.85, 95% CI 0.4-1.7, p = 0.7; HR 1.8, 95% CI 0.5-6.0, p = 0.3, respectively]. CONCLUSION: Clip placement in the positive lymph node before NAC is increasingly common. The significant association between clip placement and omission of axillary dissection, even among patients with pN+ disease, suggests a paradigm shift toward TAD as a definitive surgical management strategy in patients with pN+ disease after NAC.
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BACKGROUND: Internal mammary lymphadenopathy (IML) plays a role in breast cancer stage and prognosis. We aimed to evaluate method of IML detection, how IML impacts response to neoadjuvant chemotherapy (NAC), and oncologic outcomes. METHODS: We evaluated patients enrolled in the I-SPY-2 clinical trial from 2010 to 2022. We captured the radiographic method of IML detection (magnetic resonance imaging [MRI], positron emission tomography/computed tomography [PET/CT], or both) and compared patients with IML with those without. Rates of locoregional recurrence (LRR), distant recurrence (DR) and event-free survival (EFS) were compared by bivariate analysis. RESULTS: Of 2095 patients, 198 (9.5%) had IML reported on pretreatment imaging. The method of IML detection was 154 (77.8%) MRI only, 11 (5.6%) PET/CT only, and 33 (16.7%) both. Factors associated with IML were younger age (p = 0.001), larger tumors (p < 0.001), and higher tumor grade (p = 0.027). Pathologic complete response (pCR) was slightly higher in the IML group (41.4% vs. 34.0%; p = 0.03). There was no difference in breast or axillary surgery (p = 0.41 and p = 0.16), however IML patients were more likely to undergo radiation (68.2% vs. 54.1%; p < 0.001). With a median follow up of 3.72 years (range 0.4-10.2), there was no difference between IM+ versus IM- in LRR (5.6% vs. 3.8%; p = 0.25), DR (9.1% vs. 7.9%; p = 0.58), or EFS (61.6% vs. 57.2%; p = 0.48). This was true for patients with and without pCR. CONCLUSIONS: In this large cohort of patients treated with NAC, outcomes were not negatively impacted by IML. We demonstrated that IML influences treatment selection but is not a poor prognostic indicator when treated with modern NAC and multidisciplinary disease management.
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BACKGROUND: Youth living with HIV (YLH) have an increased risk for psychosocial stressors that can affect their antiretroviral (ARV) adherence. We examined factors associated with self-reported ARV adherence among YLH ages 12-24 years old. SETTING: YLH (N = 147) were recruited in Los Angeles, CA, and New Orleans, LA from 2017 to 2020. METHODS: YLH whose self-reported recent (30 days) ARV adherence was "excellent" or "very good" were compared with nonadherent YLH on sociodemographic, clinical, and psychosocial factors using univariate and multivariate analyses. RESULTS: Participants were predominantly male (88%), and 81% identified as gay, bisexual, transgender, queer, or other. The mean duration on ARV was 27 months (range 0-237 months). Most YLH (71.2%) self-reported being adherent, and 79% of those who self-reported adherence were also virally suppressed (<200 copies/mL). Multivariate analysis indicated being adherent was significantly associated with white race [aOR = 8.07, confidence intervals (CI): 1.45 to 74.0], Hispanic/Latinx ethnicity [aOR = 3.57, CI: 1.16 to 12.80], more social support [aOR = 1.11, CI: 1.05 to 1.18], and being on ARV for a shorter duration [aOR = 0.99, CI: 0.97 to 0.99]. Mental health symptoms, substance use, age, and history of homelessness or incarceration were unrelated to adherence. CONCLUSIONS: Enhancing efforts to provide support for adherence to non-white youth, and those with limited social support and who have been on ARV treatment longer, may help increase viral suppression among YLH.
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Infecções por HIV , Humanos , Masculino , Adolescente , Criança , Adulto Jovem , Adulto , Feminino , Infecções por HIV/tratamento farmacológico , Infecções por HIV/psicologia , Adesão à Medicação/psicologia , Antirretrovirais/uso terapêutico , Terapia Antirretroviral de Alta Atividade , Comportamento SexualRESUMO
BACKGROUND: Sexually transmitted infections (STIs) among youth aged 12 to 24 years have doubled in the last 13 years, accounting for 50% of STIs nationally. We need to identify predictors of STI among youth in urban HIV epicenters. METHODS: Sexual and gender minority (gay, bisexual, transgender, gender-diverse) and other youth with multiple life stressors (homelessness, incarceration, substance use, mental health disorders) were recruited from 13 sites in Los Angeles and New Orleans (N = 1482). Self-reports and rapid diagnostic tests for STI, HIV, and drug use were conducted at 4-month intervals for up to 24 months. Machine learning was used to identify predictors of time until new STI (including a new HIV diagnosis). RESULTS: At recruitment, 23.9% of youth had a current or past STI. Over 24 months, 19.3% tested positive for a new STI. Heterosexual males had the lowest STI rate (12%); African American youth were 23% more likely to acquire an STI compared with peers of other ethnicities. Time to STI was best predicted by attending group sex venues or parties, moderate but not high dating app use, and past STI and HIV seropositive status. CONCLUSIONS: Sexually transmitted infections are concentrated among a subset of young people at highest risk. The best predictors of youth's risk are their sexual environments and networks. Machine learning will allow the next generation of research on predictive patterns of risk to be more robust.
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BACKGROUND: Community health workers (CHWs) can supplement professional medical providers, especially in rural settings where resources are particularly scarce. Yet, outcomes of studies evaluating CHWs effectiveness have been highly variable and lack impact when scaled nationally. This study examines if child and maternal outcomes are better when existing government CHWs, who are perinatal home visitors, receive ongoing enhanced supervision and monitoring, compared to standard care. METHODS AND FINDINGS: A cluster randomized controlled effectiveness trial was conducted comparing outcomes over 2 years when different supervision and support are provided. Primary health clinics were randomized by clinic to receive monitoring and supervision from either (1) existing supervisors (Standard Care (SC); n = 4 clinics, 23 CHWs, 392 mothers); or (2) supervisors from a nongovernmental organization that provided enhanced monitoring and supervision (Accountable Care [AC]; n = 4 clinic areas, 20 CHWs, 423 mothers). Assessments were conducted during pregnancy and at 3, 6, 15, and 24 months post-birth with high retention rates (76% to 86%). The primary outcome was the number of statistically significant intervention effects among 13 outcomes of interest; this approach allowed us to evaluate the intervention holistically while accounting for correlation among the 13 outcomes and considering multiple comparisons. The observed benefits were not statistically significant and did not show the AC's efficacy over the SC. Only the antiretroviral (ARV) adherence effect met the significance threshold established a priori (SC mean 2.3, AC mean 2.9, p < 0.025; 95% CI = [0.157, 1.576]). However, for 11 of the 13 outcomes, we observed an improvement in the AC compared to the SC. While the observed outcomes were not statistically significant, benefits were observed for 4 outcomes: increasing breastfeeding for 6 months, reducing malnutrition, increasing ARV adherence, and improving developmental milestones. The major study limitation was utilizing existing CHWs and being limited to a sample of 8 clinics. There were no major study-related adverse events. CONCLUSIONS: Supervision and monitoring were insufficient to improve CHWs' impact on maternal and child outcomes. Alternative strategies for staff recruitment and narrowing the intervention outcomes to the specific local community problems are needed for consistently high impact. TRIAL REGISTRATION: Clinicaltrials.gov, NCT02957799.
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Instituições de Assistência Ambulatorial , Agentes Comunitários de Saúde , Criança , Feminino , Gravidez , Humanos , África do Sul , Antirretrovirais , MãesRESUMO
BACKGROUND: South African mothers confront synergistic challenges from depression, alcohol use, and HIV/AIDS. The importance of maternal functioning for child development motivates interventions, yet long-term outcomes seldom are tracked. Furthermore, little is known about trajectories and the role of social-cultural factors in maternal depression and alcohol use across parenthood in low- and middle-income countries. METHODS: We examined maternal outcomes at 5- and 8-years' post-birth, from the Philani Intervention Program (PIP), a randomized controlled trial of a prenatally-initiated home visiting intervention lasting through 6 months' post-birth which yielded some benefits for children and mothers through 3 years. Longitudinal Bayesian mixed-effects models assessed intervention effects for maternal depression and alcohol use from pre-birth through 8 years post-birth. We plotted trajectories of depression and alcohol use and analyzed their relationship over time. RESULTS: Maternal benefits appeared limited and intervention outcomes differed at 5 and 8 years. Reduced depression in PIP versus standard care (SC) mothers at 3 years disappeared by 5 and 8 years. Depression prevalence declined from 35.1% prenatally to 5.5% at 8 years, independent of intervention or alcohol use. Alcohol use in both groups rebounded from a post-birth nadir; fewer PIP than SC mothers drank alcohol and reported problematic use at 5 but not 8 years. HIV+ prevalence did not differ by condition and increased from 26% to 45% over the reported period. CONCLUSIONS: Dissipation of early child benefits from home visiting by age 8 years likely reflects lack of durable change in maternal behaviors compounded by social-cultural factors and cumulative effects of community deprivation. High prenatal rates warrant screening and treatment for depression in standard antenatal care. Low-and-middle income countries may need sustained interventions, including alcohol use reduction, to capitalize on initial gains from targeted interventions and address community social-cultural factors. HIV/AIDS continues to spread in this population.
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Síndrome da Imunodeficiência Adquirida , Depressão , Criança , Feminino , Gravidez , Humanos , África do Sul/epidemiologia , Depressão/epidemiologia , Teorema de Bayes , Seguimentos , Mães , Visita DomiciliarRESUMO
BACKGROUND: Human papillomavirus (HPV) is epidemic among young people, especially those at highest risk of acquiring HPV-related cancers. METHODS: Youth aged 14-24 years old (N = 1628) were recruited from 13 clinics, community agencies, and social media sites in Los Angeles, California, and New Orleans, Louisiana, that specialized in serving sexual and gender minority youths (SGMY), especially males at risk for HIV. A cross-sectional comparison of sociodemographic and risk histories of HPV vaccinated/unvaccinated youths was conducted using both univariate and multivariate regressions. RESULTS: About half (51.9%) of youth were vaccinated, with similar percentages across states and across genders. Sexual and gender minority youths (SGMY, i.e., gay, bisexual, transgender, and non-heterosexual; 68.8%) and their heterosexual peers (15%) were equally likely to be vaccinated (54%), even though their risk for HPV-related cancers is very different. Vaccinations were higher among younger youth, those not using condoms, youth with greater education, that possessed a primary health care provider, and youth diagnosed with HIV. Vaccinations were lower among youth that were out-of-home due to mental health inpatient hospitalization, drug treatment, homelessness, or incarceration. CONCLUSIONS: Special programs are required to target youth experiencing multiple life stressors, especially out-of-home experiences, those with less education, and without the safety net of health insurance or a provider.
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Sexual and gender minority (SGM) and racial or ethnic minority youth at-risk for or living with HIV may have higher risk of SARS-CoV-2 infection. However, there are few data on vaccine hesitancy/acceptance and COVID-19 self-protective behaviors among this population. Youth aged 15-24 years (n = 440), predominantly African American and Latine (73%, n = 320) SGM, from Los Angeles and New Orleans reported their vaccine attitudes and COVID-19 and HIV preventive behaviors in October 2020. Latent class analyses categorized individuals into groups based on their vaccine attitudes and preventive behaviors. Relationships between these groups and other factors were analyzed using Fisher's exact tests, ANOVA, and logistic regression. Most youth had accepting vaccine attitudes (70.2%, n = 309), with 20.7% hesitant (n = 91), and 9.1% resistant (n = 40). SGM and African Americans were significantly less accepting than their cis-gender and heterosexual peers. About two-thirds (63.2%, n = 278) of the respondents reported consistent COVID-19 self-protective behaviors. Youth with pro-vaccine attitudes were most consistently self-protective; however, only 54.4% (n= 168/309) intended to take a COVID-19 vaccine. Homelessness history, race, and sexual orientation were associated with vaccine attitudes. Accepting vaccine attitudes and consistent COVID-19 self-protective behaviors were closely related. COVID-19 attitudes/behaviors were not associated with HIV risk and only loosely associated with SARS-CoV-2 vaccine intentions.