...
首页> 外文期刊>JMIR Research Protocols >Triggered Escalating Real-Time Adherence Intervention to Promote Rapid HIV Viral Suppression Among Youth Living With HIV Failing Antiretroviral Therapy: Protocol for a Triggered Escalating Real-Time Adherence Intervention
【24h】

Triggered Escalating Real-Time Adherence Intervention to Promote Rapid HIV Viral Suppression Among Youth Living With HIV Failing Antiretroviral Therapy: Protocol for a Triggered Escalating Real-Time Adherence Intervention

机译:触发逐步升级的实时依从干预,以促进艾滋病毒感染者未通过抗逆转录病毒疗法治疗的年轻人中快速的HIV病毒抑制:触发逐步升级的实时依从干预的协议

获取原文
           

摘要

Background Youth living with HIV (YLWH) are confronted with many self-care challenges that can be experienced as overwhelming in the context of normal developmental processes that characterize adolescence and young adulthood. A sizable minority of YLWH have unsuppressed viral loads in the United States attributable to antiretroviral therapy (ART) nonadherence. Interventions to promote sustained viral suppression in YLWH are needed. Objective The aim of this study is to evaluate the efficacy of the Triggered Escalating Real-Time Adherence (TERA) intervention in comparison with standard of care (SOC) in YLWH (aged 13-24 years) failing ART on (1) primary outcome measures—HIV viral suppression (VLS), defined as both 200 copies/ml and 50 copies/ml at 12 weeks, and (2) secondary outcome measures—VLS rates and rates of ART adherence at 24, 36, and 48 weeks as well as patterns of adherence over time as measured by an electronic dose monitoring (EDM) device. Methods The TERA study is a phase 2, multisite clinical trial conducted with 120 YLWH failing ART (randomized 1:1 to TERA or SOC) at participating clinical sites within the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN). Participants are followed for a total of 48 weeks. For TERA arm participants, the first 12 weeks involve delivery of the intervention. For all participants, clinical outcomes are collected throughout follow-up, and adherence is assessed using EDM over the full 48 weeks. During the 12-week intervention period, TERA arm participants receive 3 remote coaching sessions delivered in clinic via videoconferencing timed to coincide with baseline and follow-up clinical visits, text message reminders when the EDM has not been opened at dose time (which escalate to 2-way theory-informed short message service coaching interactions in response to real-time nonadherence), and review of dosing graphs produced by EDM at follow-up visits. Results Launch dates for enrollment varied by site. Enrollment began in April 2018 and is expected to be completed by August 2019, with results presented by the second quarter of 2021. Conclusions Effective, generalizable, and scalable approaches to rapidly assist YLWH failing to achieve and sustain VLS may have a substantial impact on individual health and efforts to curb transmission. Coaching for a brief but intensive period from remote coaches and using communication channels common to youth may offer multiple unique advantages in promoting self-care.
机译:背景艾滋病毒携带者(YLWH)面临着许多自我保健挑战,在以青春期和成年为特征的正常发育过程中,这些挑战可能是压倒性的。由于抗逆转录病毒疗法(ART)的不坚持,在美国相当大一部分的YLWH的病毒载量未得到抑制。需要采取干预措施来促进YLWH中持续的病毒抑制。目的这项研究的目的是评估在(1)主要结局指标未达到ART的YLWH(13-24岁)中,触发式实时依从性(TERA)干预与护理标准(SOC)的疗效比较-HIV病毒抑制(VLS),定义为12周时<200拷贝/毫升和<50拷贝/毫升,以及(2)次要结局指标-VLS发生率和24、36和48周时ART依从率以及通过电子剂量监测(EDM)设备测得的随时间变化的依从性模式。方法TERA研究是一项2期,多站点临床试验,在HIV / AIDS干预的青少年医学试验网络(ATN)的参与临床站点中,对120例YLWH失败的ART(随机分配至TERA或SOC 1:1)进行。参与者被追踪总共48周。对于TERA小组的参与者,最初的12周需要进行干预。对于所有参与者,在整个随访过程中收集临床结局,并在整个48周内使用EDM评估依从性。在为期12周的干预期间,TERA小组参与者通过视频会议在诊所接受了3次远程指导,这些会议的时间安排与基线和后续临床就诊相吻合,当剂量时EDM未打开时,短信提醒(逐步升级为EDM) 2路理论知识的短消息服务教练互动,以响应实时的不遵守情况),并在后续访问中查看由EDM生成的剂量图表。结果注册的启动日期因站点而异。入学于2018年4月开始,预计将于2019年8月完成,结果将于2021年第二季度提交。结论有效,可推广,可扩展的方法可快速帮助YLWH无法实现和维持VLS可能对个人产生重大影响健康和努力遏制传播。在远程教练的指导下进行短暂但密集的训练,并使用青少年共有的沟通渠道,可以在促进自我保健方面提供多个独特优势。

相似文献

  • 外文文献
  • 中文文献
获取原文

客服邮箱:kefu@zhangqiaokeyan.com

京公网安备:11010802029741号 ICP备案号:京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有
  • 客服微信

  • 服务号