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）：抗逆转录病毒疗法非常有效地防止HIV疾病的进展和艾滋病相关的发病率和死亡率。大约80％的治疗接受者可以很好地依从性和最佳病毒学抑制作用。在此应用中，我们建议计划一项临床试验，该试验将旨在识别和干预患有抗逆转录病毒治疗的人，并在发生失败之前。最终的试验将利用一种新的测量o药物暴露，头发中的ARV水平，触发对依从性的深入评估，然后使用ARV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，因此不会负担高度压力的临床提供者。此外，尽管报告较高的依从性，但药物水平较低的人仍将接受小型粉刺测试，以确定生物学因素是否在起作用。嵌套的物质将头发的ARV水平与血液中的ARV水平进行比较。由于触发因素和干预都是新颖的，因此最终的试验将包括3个随机组：头发触发组，病毒血症触发组和一个通常的护理组。要求的R-34资金将支持研究站点的选择（包括对现有试验网络的探索），开发干预触发器的标准，改编现有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得科学咨询委员会的意见。然后，我们将在一年内申请资金以支持调查员发动的RCT。公共卫生相关性：本申请要求资助不寻常的临床试验。该试验将比较正在开始新的抗逆转录病毒方案的患者中检测失败风险的方法，然后比较最先进的干预措施，以通过通常的护理来改善治疗效果。实验方法涉及通过测试大约10头头皮头发的样品来测量人体实际上有多少药物。计划过程完成后，我们将提交赠款申请进行审判。如果它很有效，则头发样本方法可以提供一种将药物水平包括在常规艾滋病毒护理中的方法，以改善治疗结果的目的。