Promoting Adherence to TB Regimens in High-Risk Youth

描述（由申请人提供）： 结核病（TB）在20世纪造成了近10亿人死亡。它在发展中国家流行，移民将结核病带到发达国家。结核病控制需要治疗LTBI和活动性疾病，以及坚持药物治疗方案。我们建议在高危青少年中确定LTBI控制的公共卫生模式的有效性。行为科学、医疗服务、家长指导、学校和诊所的帮助，都由县卫生部门协调，是根据疾病预防控制中心的建议进行的。该系统的有效性部分取决于患者的依从性。这项拟议的研究将证明PPD+青少年结核病控制的公共卫生计划，并进行一项同伴咨询加家长教育的对照试验，以坚持使用INH。我们将在拉丁美洲、亚洲和外国出生的高危青少年中测试这些程序，对他们来说，潜伏性结核病是流行病。将对高中生进行筛查，并对300名PPD+男女青年（13-18岁）进行筛查。将被随机分配到常规医疗护理加非定向（注意力控制）咨询，或常规医疗护理加同伴依从性咨询和父母指导以支持依从性。将向符合条件的青少年的父母提供有关结核病、其子女的风险和预防性治疗的指导。被分配到同伴咨询条件的青少年的父母将获得额外的指导，使用应急管理，以支持他们的孩子坚持INH。诊所工作人员将接受与结核病有关的继续医学教育。主要的具体目标是：1）确定同伴咨询是否增加了相对于对照组的处方INH药物的依从性; 2）确定干预的成本和成本效益。我们将确定培训是否增加了家长和专业人员对结核病控制的知识，我们将探索坚持使用异烟肼的可能决定因素。将通过每月一次的临时尿液分析来验证报告的依从性（服用药丸数量/月）、药丸计数和电子分配器测量值。将使用多变量统计检验确定12个月内依从性的可能中介/调节因子和其他预测因子。对结果和相对成本的评估将为圣地亚哥和结核病流行的其他地区的高危青年更大规模的结核病预防计划的有效性和实用性提供信息。

DESCRIPTION (provided by applicant): Tuberculosis (TB) was responsible for almost one billion deaths in the 20th century. It is epidemic in the developing world and immigrants introduce TB to developed nations. TB control requires treatment for LTBI and active disease, as well as adherence to medical regimens. We propose to determine the effectiveness of a public health model of LTBI control among high-risk adolescents. The integration of behavioral science, medical services, parent instruction, assistance from schools and clinics, all coordinated by the County Health Department, is based on recommendations from CDC. The effectiveness of this system is dependent, in part, on patients' adherence. The proposed study will demonstrate a public health program for TB control among PPD+ adolescents and conduct a controlled trial of peer counseling plus parent education for adherence to INH. We will test these procedures with high-risk adolescents, from Latino, Asian, and foreign-born populations, for whom latent TB is epidemic. High school students will be screened and 300 PPD+ male and female youth (13-18 yrs.) will be assigned at random to either usual medical care plus non-directed (attention control) counseling, or to usual medical care plus peer adherence counseling and parent instructions to support adherence. Parents of eligible youth will be provided instruction about TB, their child's risk, and preventive treatment. Parents of youth assigned to the peer counseling condition will obtain additional instruction to use contingency management to support their child's adherence to INH. Clinic personnel will receive continuing medical education (CME) related to TB. The primary specific aims are: 1) to determine whether peer counseling increases adherence to prescribed INH medication relative to controls and 2) to determine the cost and cost effectiveness of the intervention. We will determine if training increases parents' and professionals' knowledge of TB control and we will explore possible determinants of adherence to INH. Reported adherence (number of pills taken/month), pill counts and electronic dispenser measures will be verified by monthly impromptu urine assays. Multivariate statistical tests will be used to determine possible mediators/moderators and other predictors of adherence over 12 months. The assessment of both outcomes and relative costs will inform the effectiveness and practicality of a larger scale TB prevention program for high-risk youth in San Diego and other regions where TB is epidemic.