DiSCIS Clinical Core

DiSCIS 临床核心

• 批准号: 8862378
• 负责人: Nicholas J Van Wagoner
• 金额: $ 47.1万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8862378
• 关键词: Adherence; African American; Alabama; Appointment; Bacterial Vaginosis; Behavior; Behavioral; Biological; Chlamydia trachomatis; Clinic; Clinic Visits; Clinical; Clinical Research; Collection; Communication; Confidentiality; Cost Savings; County; Couples; Data; Diagnosis; Diagnostic; Emotional; Enrollment; Ensure; Ethics; Event; Fatigue; Female; Foundations; Goals; Health; Healthcare; High Prevalence; Home environment; Hour; Intervention; Knowledge; Laboratories; Maintenance; Nylons; Online Systems; Paper; Participant; Patient Care; Patients; Performance; Play; Population Study; Prevention; Printing; Procedures; Protocols documentation; Questionnaires; Recovery; Recruitment Activity; Research; Research Design; Research Infrastructure; Research Personnel; Role; Schedule; Secure; Sex Behavior; Sexual Health; Sexual Partners; Sexually Transmitted Diseases; Specimen; Symptoms; Syndrome; Telephone; Text; Time; Training; Universities; Urethritis; Urine; Vagina; Visit; Woman; abstracting; base; cohort; design; diaries; experience; flexibility; follow-up; high standard; human subject; male; men; payment; programs; prospective; research study; sample collection; screening; sex; success; tool

DiSCIS Clinical Core Abstract The overarching goal of the Clinical Core is to engage, enroll, and retain participants in the Discharge Syndromes: Concordance and Interactions Study (DiSCIS) application. The investigators recognize the central role that human subjects play in this application and also the sensitivity of the information collected from study participants. All researchers will adhere to the highest level of ethical behavior in order to protect the physical and emotional wellbeing of the participants. The Clinical Core will support all projects outlined in the proposal through recruitment and performance of all clinic visits, including screening, initial, and subsequent study visits. Recruitment and all clinic events will be centralized at the Jefferson County Department of Health (JCDH) STD Clinic. In 2012, 16,119 patients (males=7,360 and females=8,759) received sexual health care at the JCDH STD Clinic. High prevalence of discharge syndromes including nongonococcal urethritis (about 25% of men), bacterial vaginosis (about 50% of women), and Chlamydia trachomatis (about 12% overall) are diagnosed and treated in this clinic. The JCDH STD Clinic and the University of Alabama (UAB) STD Program have an enduring partnership in STI research and STI-related patient care and a strong infrastructure already exists in this clinic for STI-related research. To maximize the success of the Clinical Core, we have assembled a clinical team with experience in designing, performing and completing longitudinal STI studies including couples studies. The specific aims for the Clinical Core are: (1) To centralize recruitment of men and women in regular sexual partnerships to create a cohort of participants to support all proposed projects, (2) To retain men and women in regular sexual partnerships for the duration of the study period, and (3) To collect accurate and complete participant information and biologics while protecting participant confidentiality. By supporting Projects 1-3, the Clinical Core will help to create new knowledge, advance diagnostic tools, and optimize therapy related to the most common discharge syndromes. The Clinical Core and its tight linkage to the Laboratory Core will ensure collection of quality specimens, efficiency and cost savings. The collective expertise of the Clinical Core team in clinical research study design, participant recruitment, and participant retention in prospective STI research including sexual dyad studies will provide a strong foundation for the success of all DiSCIS Projects while adhering to the highest standards of clinical research.

DiSCIS临床核心摘要 临床核心的首要目标是吸引、招募和留住出院的参与者 症状：和谐与相互作用研究(DiSCIS)的应用。调查人员认识到 人类受试者在这一应用中扮演的中心角色以及信息的敏感性 收集自研究参与者。所有研究人员都将坚持最高水平的道德行为 以保护参与者的身体和情感健康。临床核心意志 通过招聘和执行所有诊所就诊，支持提案中概述的所有项目， 包括筛查、初步和随后的考察访问。招募和所有诊所活动将 集中在杰斐逊县卫生局(JCDH)性病诊所。2012年，16,119 患者(男性=7,360，女性=8,759)在JCDH性病诊所接受性健康护理。 出院综合征的高流行率，包括非淋菌性尿道炎(约25%的男性)， 细菌性阴道病(约占女性的50%)和沙眼衣原体(约占12%)是 在这个诊所诊断和治疗。JCDH性病诊所和阿拉巴马大学(UAB)性病 计划在性传播感染研究和与性传播感染相关的患者护理方面建立了持久的合作伙伴关系，并拥有强大的 该诊所已经为与性传播感染相关的研究建立了基础设施。要最大限度地提高 临床核心，我们组建了一支具有设计、执行和管理经验的临床团队 完成纵向STI研究，包括夫妻研究。临床核心的具体目标 是：(1)集中招募有固定性伴关系的男女，以创造一个 支持所有拟议项目的参与者队列，(2)保留男性和女性 在研究期内定期发生性关系，以及(3)收集准确的 以及完整的参与者信息和生物制剂，同时保护参与者 保密协议。通过支持项目1-3，临床核心将有助于创造新的知识， 先进的诊断工具，优化与最常见的出院综合征相关的治疗。 临床核心及其与实验室核心的紧密联系将确保收集质量 标本、效率和成本节约。临床核心团队在临床上的集体专长 前瞻性STI研究中的研究设计、参与者招募和参与者保留 包括性二联体研究将为所有DiSCIS项目的成功提供坚实的基础 同时坚持最高标准的临床研究。