The Hair Trigger Study

一触即发研究

基本信息

批准号：
8331729
负责人：
RUTH Martha GREENBLATT
金额：
$ 18.83万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-05-01 至 2014-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8331729
关键词：
Acquired Immunodeficiency Syndrome Adherence Advisory Committees Anti-Retroviral Agents Applications Grants Behavioral Biological Factors Blood Caring Chronic Disease Clinic Clinical Clinical Trials Clinical trial protocol document Collection Controlled Clinical Trials Data Quality Development Dose Drug Delivery Systems Drug Exposure Drug Kinetics Drug Monitoring Electronics Enrollment Exposure to Failure Funding Goals HIV Hair Incentives Individual Internet Intervention Measurement Measures Medicine Methods Modification Morbidity - disease rate Outcome Participant Patients Persons Pharmaceutical Preparations Play Preparation Process Protocols documentation Provider Randomized Randomized Clinical Trials Regimen Reporting Request for Applications Research Contracts Research Personnel Resources Risk Sample Size Sampling Scalp structure Scheme Scientist Series Services Site Stress System Telephone Testing Therapeutic Time Treatment outcome Viral Load result Viremia Work antiretroviral therapy base biobank comparison group design effective intervention follow-up high risk improved innovation instrument meetings mortality novel operation prevent response sample collection tool treatment as usual treatment effect

项目摘要

DESCRIPTION (provided by applicant): Antiretroviral therapies are highly effective at preventing the progression of HIV illness and AIDS related morbidity and mortality. Approximately 80% of treatment recipients do well with adequate adherence and optimal virologic suppression. In this application, we propose to plan a clinical trial that would be directed at identifying and intervening with individuals who are at risk for the failure of antiretroviral treatment before failure occurs. The eventual trial would utilize a novel measure o drug exposure, ARV levels in hair, to trigger an in-depth assessment of adherence, and then intervene to increase adherence using the ARV levels as a tool. The assessment and intervention would be provided centrally via telephone and electronic means, and thus not burden highly stressed clinical providers. Additionally persons who have low drug levels despite reporting high adherence would undergo miniPK testing to determine if biologic factors are at play. A nested substudy would compare the ARV levels in hair to those in blood. Because both the trigger and the intervention are novel, the eventual trial would include 3 randomized groups: a hair level triggered group, a viremia triggered group and a usual care group. The requested R-34 funding would support selection of study sites (including exploration of existing trials networks), development of criteria for intervention triggers, adaptation of existing adherence and pharmacologic assessments, selection of a contract research organization, development of study materials. Web video conferencing would be used to obtain input from a scientific advisory committee. Provided these resources, we would then apply for funding to support an investigator-initiated RCT within one year. PUBLIC HEALTH RELEVANCE: This application requests funding for planning of an unusual clinical trial. The trial would compare methods for detecting risk of failure among patients who are starting a new antiretroviral regimen and then compare a state of the art intervention to improve treatment effects with usual care. The experimental method involves measuring how much medication is actually in the body by testing samples of about 10 scalp hairs. Once the planning process is complete, we will submit a grant application to conduct the trial. If it is fond effective, the hair sample approach could provide a means to include drug levels in routine HIV care with the goal of improving treatment outcomes.

描述（由申请人提供）：抗逆转录病毒疗法对于预防艾滋病毒疾病的进展以及艾滋病相关的发病率和死亡率非常有效。大约 80% 的治疗接受者表现良好，具有足够的依从性和最佳的病毒学抑制。在本申请中，我们建议计划一项临床试验，旨在在抗逆转录病毒治疗失败之前识别和干预有抗逆转录病毒治疗失败风险的个体。最终的试验将利用一种新的药物暴露测量方法，即头发中的抗逆转录病毒药物水平，来引发对依从性的深入评估，然后使用抗逆转录病毒药物水平作为工具进行干预以提高依从性。评估和干预将通过电话和电子方式集中提供，因此不会给压力很大的临床提供者带来负担。此外，尽管报告依从性较高，但药物水平较低的人将接受 miniPK 测试，以确定是否有生物因素在起作用。嵌套子研究将比较头发中的抗逆转录病毒药物与血液中的抗逆转录病毒药物水平。由于触发因素和干预措施都是新颖的，最终的试验将包括 3 个随机组：头发水平触发组、病毒血症触发组和常规护理组。请求的 R-34 资金将支持研究地点的选择（包括探索现有的试验网络）、制定干预触发标准、调整现有的依从性和药理学评估、选择合同研究组织、开发研究材料。网络视频会议将用于获取科学咨询委员会的意见。提供这些资源后，我们将申请资金以支持研究者在一年内发起的随机对照试验。公共卫生相关性：本申请要求为规划一项不寻常的临床试验提供资金。该试验将比较检测开始新的抗逆转录病毒治疗方案的患者失败风险的方法，然后将改善治疗效果的最先进的干预措施与常规护理进行比较。实验方法包括通过测试约 10 根头皮毛发的样本来测量体内实际有多少药物。规划过程完成后，我们将提交拨款申请以进行试验。如果效果良好，头发样本方法可以提供一种将药物水平纳入常规艾滋病毒护理中的方法，以改善治疗结果。