Clinical

临床

• 批准号: 7114449
• 负责人: DONALD P ORR
• 金额: $ 20.4万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 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/7114449
• 关键词: adolescence (12-20); antiinfective agents; biomedical facility; biopsy; cervical /vaginal smear; clinical research; communicable disease control; communicable disease transmission; cooperative study; disease /disorder etiology; human subject; interview; longitudinal human study; medical outreach /case finding; microorganism disease chemotherapy; personal log /diary; questionnaires; sample collection; sex partner; sexually transmitted diseases; topical drug application; urine; women' s health

The purpose of the Clinical Core is to provide biological specimens and behavioral data to the individual research projects. This core will be located in Indianapolis. Core research personnel will enroll and maintain the cohort of adolescent female research subjects over the five year duration of the center, collect all required biological samples (genitourinary swabs, endocervical swabs, vaginal lavages, urine, cervical biopsies, and blood), behavioral information (self-administered questionnaires and personal interviews), and provide interim reproductive health examinations and data collection to facilitate subject retention. The research staff will also be responsible for locating recruiting, enrolling and providing necessary treatment for STI to partners. Research personnel will include the principal investigator of the core, clinical research coordinator, research nurse practitioner, and one Disease Intervention Speciatist (DIS) from the Marion County Health Department. The research nurse will obtain all biological specimens and provide treatment for STI. DIS will perform two important fieldwork functions: (1) contact partners of subjects to obtain personal information, urine samples, provide appropriate antibiotic treatment when partners of infected women prefer to be treated outside of the Marion County STD Clinic (Bell Flower); (2) weekly contact with all subjects during the three month periods of intense data collection to obtain self-directed vaginal swabs, personal behavioral diaries and interview information. Weekly research meetings to assure sucessful completion of project activities will include all personnel of clinical, laboratory and biostatistics cores and principal investigators.

临床核心的目的是向单个研究项目提供生物标本和行为数据。该核心将位于印第安纳波利斯。核心研究人员将在该中心的五年内招募和维持青春期女性研究对象，收集所有必需的生物样品（泌尿生殖拭子，肠道拭子，阴道灌洗，尿液，宫颈活检和血液），行为信息（行为信息），，行为信息（自我管理的问卷和个人访谈），并提供临时生殖健康检查和数据收集以促进主题保留。研究人员还将负责找到招聘，入学和为STI提供必要的治疗方法。研究人员将包括核心，临床研究的主要研究者 马里恩县卫生部门的协调员，研究护士从业者和一名疾病干预措施（DIS）。研究护士将获得所有生物标本，并为STI提供治疗。 DIS将执行两个重要的现场工作功能：（1）与受试者的接触伙伴获得个人信息，尿液样本，提供适当的抗生素治疗，当受感染妇女的伴侣更喜欢在Marion County STD诊所（Bell Flower）之外接受治疗； （2）在三个月内收集的三个月期间，每周与所有受试者接触，以获得自我指导的阴道拭子，个人行为日记和面试信息。每周的研究会议，以确保成功完成项目活动，包括所有临床，实验室和生物统计学核心的人员和校长 调查人员。