Rogers A S, Futterman D K, Moscicki A B, Wilson C M, Ellenberg J, Vermund S H
Pediatric, Adolescent, and Maternal AIDS Branch, National Institute of Child Health and Human Development, Bethesda, Maryland 20892-7510, USA.
J Adolesc Health. 1998 Apr;22(4):300-11. doi: 10.1016/s1054-139x(97)00279-6.
To describe the Reaching for Excellence in Adolescent Care and Health (REACH) Project of the Adolescent Medicine Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS) Research Network, a unique collaborative effort to conceive and implement a research design intended to examine HIV pathogenesis, pubertal hormonal variation, and the effects of sexually transmitted disease comorbidity in HIV-infected youth to improve their health care.
This multidisciplinary team has drawn on basic science and clinical experience to produce a study design with relevant and feasible study aims and testable hypotheses. Particular attention has been paid to centralized training and quality control practices. Standardized measurements include direct and computer interviews, physical examination, laboratory analysis, and medical chart abstraction. The protocol has been approved by local institutional review boards.
A highly standardized and quality control monitored protocol has been implemented at 16 sites throughout the United States collecting historical, observational, and laboratory data in a group of HIV-infected adolescents and HIV-negative controls. Preliminary data collected on subjects are consistent with published reports of the sociodemographic and clinical characteristics of the HIV epidemic in sexually active youth, thus supporting the integrity of the protocol development process. The study population is, for the most part, in older adolescence, predominantly minority and female, and with publicly financed or no health insurance.
The REACH Project is positioned to address questions about the clinical course, immunologic profile, and viral dynamics in HIV-positive youth, and thus is able to inform drug development and management strategies for this understudied population.
描述青少年医学人类免疫缺陷病毒/获得性免疫缺陷综合征（HIV/AIDS）研究网络的青少年护理与健康卓越计划（REACH）项目，这是一项独特的合作努力，旨在构思并实施一项研究设计，以研究HIV发病机制、青春期激素变化以及性传播疾病合并症对HIV感染青少年健康的影响，从而改善他们的医疗保健。
这个多学科团队借鉴了基础科学和临床经验，制定了一个具有相关且可行研究目标和可检验假设的研究设计。特别关注了集中培训和质量控制措施。标准化测量包括直接和计算机访谈、体格检查、实验室分析以及病历摘要。该方案已获得当地机构审查委员会的批准。
一项高度标准化且受质量控制监测的方案已在美国的16个地点实施，在一组HIV感染青少年和HIV阴性对照中收集历史、观察和实验室数据。收集到的受试者初步数据与已发表的关于性活跃青少年中HIV流行的社会人口统计学和临床特征的报告一致，从而支持了方案制定过程的完整性。研究人群大多处于青少年后期，主要为少数族裔和女性，且有公共资助或无医疗保险。
REACH项目旨在解决有关HIV阳性青少年临床病程、免疫特征和病毒动态的问题，因此能够为这一研究不足人群的药物研发和管理策略提供信息。
