Assuntos
Tratamento Farmacológico da COVID-19 , Avaliação Pré-Clínica de Medicamentos , África , Amidas , Amodiaquina , Artesunato , Sulfato de Atazanavir , COVID-19/fisiopatologia , COVID-19/prevenção & controle , COVID-19/transmissão , Vacinas contra COVID-19/provisão & distribuição , Carbamatos , Ensaios Clínicos como Assunto/organização & administração , Citidina/análogos & derivados , Citidina/economia , Citidina/uso terapêutico , Aprovação de Drogas , Reposicionamento de Medicamentos , Quimioterapia Combinada , Humanos , Hidroxilaminas/economia , Hidroxilaminas/uso terapêutico , Imidazóis , Ivermectina , Naftiridinas , Nitrocompostos , Pregnenodionas , Pirazinas , Pirrolidinas , Ritonavir , Tamanho da Amostra , Tiazóis , Valina/análogos & derivados , Organização Mundial da SaúdeRESUMO
OBJECTIVES: Pre-exposure prophylaxis (PrEP) is not commissioned within National Health Service (NHS) England. Individuals can access it privately online or by enrolment into a clinical trial. We established a list of individuals not enrolled in trials, awaiting PrEP. In response to the observation that patients awaiting PrEP trials were being referred with newly diagnosed HIV, we aimed to measure attendance, incident HIV, STI acquisition and missed opportunities for prevention. METHODS: The search was conducted for patients on the list from November 2017 to November 2019. We examined the electronic clinical records of those on the list and extracted demographic information, STI and HIV diagnoses. In addition, for those diagnosed with HIV, we reviewed risk factors including chemsex and prior postexposure prophylaxis. RESULTS: There were 1073 patients on list, and 520 (48.6%) were still awaiting recruitment in a PrEP trial. Eight (0.75%) had an enrolment appointment booked while 200 (18.64%) had been contacted and deemed ineligible according to PrEP trial criteria. 45 (32.15%) had not responded to contact. We identified 15 new HIV infections in patients awaiting PrEP. Of these, 9/15 (60.00%) did not meet eligibility criteria at point of contact, though had been eligible at first referral. CONCLUSION: It is unacceptable that 15 patients acquired HIV while waiting. The individual lifetime cost of treating HIV is estimated at £360 800(1). This equals £5 412 000 for these 15 infections notwithstanding the psychological and physical burden. We advocate the immediate role out of universal PrEP for those who need it on the NHS. While this decision is delayed, harm is coming to those waiting. Wider provision of PrEP may encourage increased attendance, but must consider additional resources to accommodate added visits. We are relieved that at the point of final submission (21 March 2020) NHS England have recently announced funding of PrEP for eligible patients from, further details are pending.
Assuntos
Ensaios Clínicos como Assunto/organização & administração , Definição da Elegibilidade/organização & administração , Infecções por HIV/prevenção & controle , Acessibilidade aos Serviços de Saúde , Profilaxia Pré-Exposição , Adolescente , Adulto , Idoso , Inglaterra/epidemiologia , Feminino , Infecções por HIV/economia , Humanos , Masculino , Pessoa de Meia-Idade , Programas Nacionais de Saúde , Seleção de Pacientes , Listas de Espera , Adulto JovemRESUMO
Meeting recruitment targets for clinical trials and health research studies is a notable challenge. Unsuccessful efforts to recruit participants from traditionally underserved populations can limit who benefits from scientific discovery, thus perpetuating inequities in health outcomes and access to care. In this study, we evaluated direct mail and email outreach campaigns designed to recruit women who gave birth in North Carolina for a statewide research study offering expanded newborn screening for a panel of rare health conditions. Of the 54,887 women who gave birth in North Carolina from September 28, 2018, through March 19, 2019, and were eligible to be included on the study's contact lists, we had access to a mailing address for 97.9% and an email address for 6.3%. Rural women were less likely to have sufficient contact information available, but this amounted to less than a one percentage point difference by urbanicity. Native American women were less likely to have an email address on record; however, we did not find a similar disparity when recruitment using direct-mail letters and postcards was concerned. Although we sent letters and emails in roughly equal proportion by urbanicity and race/ethnicity, we found significant differences in enrollment across demographic subgroups. Controlling for race/ethnicity and urbanicity, we found that direct-mail letters and emails were effective recruitment methods. The enrollment rate among women who were sent a recruitment letter was 4.1%, and this rate increased to 5.0% among women who were also sent an email invitation. Study Highlights WHAT IS THE CURRENT KNOWLEDGE ON THE TOPIC? Under-representation by traditionally underserved populations in clinical trials and health research is a challenge that may in part reflect inequitable opportunities to participate. WHAT QUESTION DID THIS STUDY ADDRESS? Are direct-mail and email outreach strategies effective for reaching and recruiting women from traditionally underserved and rural populations to participate in large-scale, population-based research? WHAT DOES THIS STUDY ADD TO OUR KNOWLEDGE? Despite sending recruitment letters and email invitations in roughly equal proportion by urbanicity and race/ethnicity, women living in rural areas were less likely to enroll (2.8%) than women from urban areas (4.2%). Additionally, enrollment rates decreased as the probability that women were members of a racial or ethnic minority group increased. HOW MIGHT THIS CHANGE CLINICAL PHARMACOLOGY OR TRANSLATIONAL SCIENCE? Results from this study might encourage researchers to take a holistic and participant-centered view of barriers to study enrollment that may disproportionately affect underserved communities, including differences in willingness to participate, trust, and access to resources needed for uptake.
Assuntos
Ensaios Clínicos como Assunto/organização & administração , Correio Eletrônico/estatística & dados numéricos , Triagem Neonatal/organização & administração , Seleção de Pacientes , Serviços Postais/estatística & dados numéricos , Ensaios Clínicos como Assunto/estatística & dados numéricos , Feminino , Humanos , Recém-Nascido , Mães/estatística & dados numéricos , North Carolina , População Rural/estatística & dados numéricos , Populações Vulneráveis/estatística & dados numéricosAssuntos
Pesquisa Biomédica/organização & administração , COVID-19/terapia , Ensaios Clínicos como Assunto , Pandemias , Pesquisa Biomédica/história , Pesquisa Biomédica/normas , COVID-19/diagnóstico , COVID-19/epidemiologia , Canadá/epidemiologia , Ensaios Clínicos como Assunto/métodos , Ensaios Clínicos como Assunto/organização & administração , Ensaios Clínicos como Assunto/normas , Redes Comunitárias/organização & administração , Redes Comunitárias/normas , Avaliação Pré-Clínica de Medicamentos/métodos , Avaliação Pré-Clínica de Medicamentos/normas , Europa (Continente)/epidemiologia , História do Século XXI , Humanos , Cooperação Internacional , Aprendizagem , Redes Neurais de Computação , Inovação Organizacional , Pandemias/história , Seleção de Pacientes , Ensaios Clínicos Pragmáticos como Assunto/métodos , Ensaios Clínicos Pragmáticos como Assunto/normas , Projetos de Pesquisa , Países Escandinavos e Nórdicos/epidemiologia , Reino Unido/epidemiologia , Organização Mundial da Saúde/organização & administraçãoAssuntos
Ensaios Clínicos como Assunto/organização & administração , Infecções por Coronavirus , Prestação Integrada de Cuidados de Saúde/organização & administração , Controle de Infecções/organização & administração , Pandemias , Pneumonia Viral , Projetos de Pesquisa , Pesquisadores/organização & administração , COVID-19 , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/terapia , Infecções por Coronavirus/transmissão , Humanos , Transmissão de Doença Infecciosa do Paciente para o Profissional/prevenção & controle , Transmissão de Doença Infecciosa do Profissional para o Paciente/prevenção & controle , Saúde Ocupacional , Segurança do Paciente , Pneumonia Viral/diagnóstico , Pneumonia Viral/epidemiologia , Pneumonia Viral/terapia , Pneumonia Viral/transmissão , Distância Psicológica , Fatores de RiscoAssuntos
Ensaios Clínicos como Assunto/organização & administração , Ensaios Clínicos como Assunto/normas , Infecções por Coronavirus/terapia , Pneumonia Viral/terapia , Organização Mundial da Saúde/organização & administração , Monofosfato de Adenosina/análogos & derivados , Monofosfato de Adenosina/uso terapêutico , Alanina/análogos & derivados , Alanina/uso terapêutico , Animais , Fármacos Anti-HIV/uso terapêutico , Betacoronavirus/efeitos dos fármacos , COVID-19 , China/epidemiologia , Cloroquina/uso terapêutico , Infecções por Coronavirus/tratamento farmacológico , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/virologia , Dioxanos/uso terapêutico , Modelos Animais de Doenças , Combinação de Medicamentos , Humanos , Imunização Passiva , Lopinavir/uso terapêutico , Medicina Tradicional Chinesa , Monossacarídeos/uso terapêutico , Pandemias , Pneumonia Viral/tratamento farmacológico , Pneumonia Viral/epidemiologia , Pneumonia Viral/virologia , Sistema de Registros , Ritonavir/uso terapêutico , SARS-CoV-2 , Síndrome Respiratória Aguda Grave/tratamento farmacológico , Transplante de Células-Tronco , Esteroides/uso terapêutico , Fatores de Tempo , Resultado do Tratamento , Soroterapia para COVID-19RESUMO
BACKGROUND: Low cancer clinical trial (CCT) enrollment may contribute to survival disparities affecting adolescents and young adults (AYAs) (ages 15-39 years). The objective of this study was to evaluate whether differences in CCT availability related to treatment site could explain the low CCT enrollment. METHODS: This prospective, observational cohort study was conducted at an academic children's hospital and its affiliated but geographically separated adult cancer hospital within a National Cancer Institute-designated Comprehensive Cancer Center. For consecutive, newly diagnosed AYA patients, it was determined whether an appropriate CCT existed nationally, was available at the treatment site, and was used for enrollment. Proportions of AYAs in these categories were compared between sites using the chi-square test. RESULTS: One hundred fifty-two consecutive AYA patients were included from the children's hospital (n = 68; ages 15-20 years) and the adult cancer hospital (n = 84; ages 18-39 years). Although there was no difference in CCT existence for individual AYA patients by site (children's hospital [36 of 68 patients; 52.9%] vs adult cancer hospital [45 of 84 patients; 53.6%]; P = .938), CCT availability was significantly lower at the adult cancer hospital (14 of 84 patients [16.7%] vs 30 of 68 [44.1%] at the children's hospital; P < .001). The proportion of AYAs enrolled was low at both sites (8 of 68 patients [11.8%] vs 6 of 84 patients [7.1%], respectively; P = .327). Fewer existing CCTs were available at the adult cancer hospital (4 of 27 patients [14.8%] vs 8 of 14 patients [57.1%], respectively), and those were directed toward solid tumors and new agents. CONCLUSIONS: Efforts to improve low CCT enrollment among AYAs should be differentiated by treatment site. In the adult setting, these efforts should be aimed at improving CCT availability by overcoming site-level barriers to opening existing CCTs.