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BACKGROUNDAlthough convalescent plasma has been widely used to treat severe coronavirus disease 2019 (COVID-19), data from randomized controlled trials that support its efficacy are limited.METHODSWe conducted a randomized, double-blind, controlled trial among adults hospitalized with severe and critical COVID-19 at 5 sites in New York City (USA) and Rio de Janeiro (Brazil). Patients were randomized 2:1 to receive a single transfusion of either convalescent plasma or normal control plasma. The primary outcome was clinical status at 28 days following randomization, measured using an ordinal scale and analyzed using a proportional odds model in the intention-to-treat population.RESULTSOf 223 participants enrolled, 150 were randomized to receive convalescent plasma and 73 to receive normal control plasma. At 28 days, no significant improvement in the clinical scale was observed in participants randomized to convalescent plasma (OR 1.50, 95% confidence interval [CI] 0.83-2.68, P = 0.180). However, 28-day mortality was significantly lower in participants randomized to convalescent plasma versus control plasma (19/150 [12.6%] versus 18/73 [24.6%], OR 0.44, 95% CI 0.22-0.91, P = 0.034). The median titer of anti-SARS-CoV-2 neutralizing antibody in infused convalescent plasma units was 1:160 (IQR 1:80-1:320). In a subset of nasopharyngeal swab samples from Brazil that underwent genomic sequencing, no evidence of neutralization-escape mutants was detected.CONCLUSIONIn adults hospitalized with severe COVID-19, use of convalescent plasma was not associated with significant improvement in day 28 clinical status. However, convalescent plasma was associated with significantly improved survival. A possible explanation is that survivors remained hospitalized at their baseline clinical status.TRIAL REGISTRATIONClinicalTrials.gov, NCT04359810.FUNDINGAmazon Foundation, Skoll Foundation.
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COVID-19/terapia , SARS-CoV-2 , Adulto , Idoso , Idoso de 80 Anos ou mais , Brasil/epidemiologia , COVID-19/imunologia , COVID-19/mortalidade , Método Duplo-Cego , Feminino , Humanos , Imunização Passiva , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Cidade de Nova Iorque/epidemiologia , Pandemias , SARS-CoV-2/imunologia , Índice de Gravidade de Doença , Resultado do Tratamento , Soroterapia para COVID-19RESUMO
INTRODUCTION: Adolescents account for over 40% of new HIV infections in Haiti. This analysis compares outcomes among HIV-positive adolescents before and after implementation of an adolescent HIV clinic in Port-au-Prince, Haiti. METHODS: We conducted a cohort study using programmatic data among HIV-positive adolescents aged 13 to 19. Data from 41,218 adolescents who were HIV tested from January 2003 to December 2012 were included. Outcomes across the HIV care cascade were assessed before and after implementation of an adolescent clinic (2009), including HIV testing, enrolment in care, assessment for antiretroviral therapy (ART) eligibility, ART initiation and 12-month retention. Pre-ART outcomes were assessed 12 months after HIV testing. Factors associated with pre-ART and ART attrition were identified through multivariable competing risk and Cox proportional hazards regression modelling. RESULTS: Cumulatively, 1672 (4.1%) adolescents tested HIV positive (80% female, median age 16 years). Retention by cascade step comparing pre- and post-clinic included the following: 86% versus 87% of patients enrolled in care, 61% versus 79% were assessed for ART eligibility, 85% versus 92% initiated ART and 68% versus 66% were retained 12 months after ART initiation. Pre-ART attrition decreased from 61% pre-clinic to 50% post-clinic (p<0.001). Pre-ART attrition was associated with being female (sub-distributional hazard ratio (sHR): 1.59; CI: 1.31-1.93), syphilis diagnosis (sHR: 1.47; CI: 1.16-1.85) and slum residence (sHR: 0.84; CI: 0.72-0.97). ART attrition was associated with syphilis diagnosis (hazard ratio (HR): 2.23; CI: 1.35-3.68) and CD4 <50 cells/µL (HR: 1.88; CI: 1.15-3.06). CONCLUSIONS: Implementation of a youth-friendly adolescent clinic improved retention in HIV care among adolescents, particularly in the assessment of ART eligibility and ART initiation. Additional interventions are needed to improve retention among pre-ART patients and support long-term retention among ART patients.
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Instituições de Assistência Ambulatorial , Fármacos Anti-HIV/uso terapêutico , Infecções por HIV/terapia , Adolescente , Contagem de Linfócito CD4 , Estudos de Coortes , Definição da Elegibilidade , Feminino , Infecções por HIV/diagnóstico , Infecções por HIV/tratamento farmacológico , Haiti , Humanos , Masculino , Modelos de Riscos Proporcionais , Sífilis , Adulto JovemRESUMO
The Caribbean has the highest adult HIV prevalence in the world after sub-Saharan Africa (2011). One sub-population in the Dominican Republic is the migratory Batey community primarily comprised of Haitian immigrants with limited access to healthcare and HIV prevalence rates of between 3.0% and 9.0%, compared to 0.7% nationally. This retrospective cohort study describes the cumulative retention from diagnosis to virological suppression for newly-diagnosed HIV-infected adults presenting to the Clínica de Familia and its Batey programme in La Romana, during 2011. Of the patients diagnosed with HIV, 65% entered into care, 59% completed immunologic testing, 53% were eligible for antiretroviral therapy (ART) initiation, 36% initiated ART within three months of eligibility and 27% were retained in care. Seventeen per cent of those retained on ART with a 12-month viral load measure had undetectable viral load. Attrition primarily occurred before ART initiation. The Batey programme had a first step lost-to-follow-up of 88% compared to 20% at the clinic (p < 0.001). This retrospective study details the continuum of care and indicates where structural changes must occur to increase continuity between steps. The manuscript results are important to help implement programmes to enhance engagement and retention in HIV primary care.