此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Integrating ENGagement and Adherence Goals Upon Entry iENGAGE to Control HIV (iENGAGE)

2019年2月13日 更新者:Michael J Mugavero, MD、University of Alabama at Birmingham
iENGAGE is a 4 session, in-clinic behavioral intervention that is delivered to new clinic patients during the first year of HIV care on a flexible delivery schedule, with intervention visits scheduled to coincide with HIV medical care visits. Interventionists from each participating collaborating site will be trained centrally to implement the iENGAGE protocol. Following study enrollment and baseline assessment, participants will be randomized to treatment as usual and intervention groups. For intervention-arm participants, each iENGAGE intervention session includes: interventionist-delivered educational content for managing HIV medical care appointment-keeping and information sessions for learning to manage HIV medications. The intervention will have a tailored, interactive agenda for each of the 4 sessions based on behavioral motivational interviewing (MI) techniques. The goal of this intervention is for the participant to establish early behaviors that help him/her to arrive at scheduled medical appointments and learn to take medications as prescribed during the initial year of HIV care in order to improve overall health.

研究概览

详细说明

The Centers for Disease Control's Retention In Care (CDC RIC) and the Participating and Communicating Together (PACT) antiretroviral therapy (ART) adherence interventions have shown success in the literature, and they are well suited to target the two essential HIV adherence behaviors needed to achieve better overall health: HIV medical visit adherence and ART adherence. While these original interventions target each of these behaviors separately, the comprehensive iENGAGE intervention combines these two approaches to address the experience of an individual who is initiating HIV care. Upon entry to care, knowledge, motivation, and skills for adherence to HIV medical visits and ART must be learned rapidly. Jointly targeting these behaviors offers a distinct advantage over addressing them separately.

iENGAGE integrates CDC RIC and PACT through their common intervention targets with the assistance of trained interventionists, who will maintain contact with the new patient to educate and assist with reinforcing the importance of adherence to care. While the actions required to attend HIV medical care appointments and take medications properly are distinct, each is influenced by an individual's personal motivation and skills for self-management of HIV infection and overall health; these principles are the focus of the intervention sessions for this protocol .

During this intervention, our team will make every effort to protect all participants' confidential and private information in order to minimize possible study-associated risks. In addition, the follow up measurement plan for this study is unique, as it aims to utilize the X060831001: Unsolicited R24 for the Centers for AIDS Research (CFAR) Network of Integrated Clinical Sciences, (CNICS), PI Michael Saag) secure electronic data infrastructure, which has existing defined protocols for the protection of human subjects data, including a data management core that is housed at the collaborating site at the University of Washington.

Stigma Supplement (Michael J. Mugavero, Janet M. Turan, Bulent Turan)

As part of this supplement, the research team has incorporated multi-item questionnaire measures of stigma into baseline and final data collection for the iENGAGE trial. The goal of Aim 1 is to examine the longitudinal associations and potential causal mechanisms in the relationships between dimensions of HIV-related stigma and HIV visit adherence, antiretroviral therapy (ART) adherence, and viral load suppression, among control participants in the study. In addition, in Aim 2, we will examine the effects of the iENGAGE intervention on dimensions of stigma, by comparing changes in stigma in the two arms of the Randomized Controlled Trial (RCT).

For Aim 3, after participants have completed the 48-week iENGAGE intervention, we will conduct up to 40 individual in-depth face-to-face qualitative interviews with selected participants using a separate informed consent process. Topics to be explored in these interviews include qualitative exploration of how HIV-related stigma and other intersectional stigmas affect engagement in HIV care, as wells as exploring how participation in the iENGAGE intervention may have influenced the participant's experiences of anticipated, internalized, and experienced stigma; as well as disclosure concerns and actual disclosure behavior.

研究类型

介入性

注册 (实际的)

371

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Alabama
      • Birmingham、Alabama、美国、35294
        • University of Alabama at Birmingham
    • Maryland
      • Baltimore、Maryland、美国、21205
        • The Johns Hopkins HIV Care Program
    • North Carolina
      • Chapel Hill、North Carolina、美国、27599
        • UNC Infectious Diseases Clinic
    • Washington
      • Seattle、Washington、美国、98104
        • University of Washington

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Documented HIV infection
  • Newly establishing HIV care at study site
  • Age 18 years or older
  • English speaking

Exclusion Criteria:

  • Not willing or able to provide informed consent
  • Received prior outpatient HIV care
  • Completed >1 primary care visits

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:随机化
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
无干预:Control
Control arm participants will receive standard clinical care (i.e. receive usual clinic treatment)
实验性的:Motivation Behavioral Technique
Behavioral: 4 sessions of tailored, interactive agenda based on behavioral motivational interviewing (MI) techniques. Each iENGAGE intervention session includes: interventionist-delivered educational content for managing HIV medical care appointment-keeping and information sessions for learning to manage HIV medications. The goal of this intervention is for the participant to establish early behaviors that help him/her to arrive at scheduled medical appointments and learn to take medications as prescribed during the initial year of HIV care in order in order to achieve viral suppression and improve overall health.
In addition to receiving standard clinic care, the intervention will have a tailored, interactive agenda for each of the 4 sessions based on behavioral motivational interviewing (MI) technique. The goal of this intervention is for the participant to establish early behaviors that help him/her to arrive at scheduled medical appointments and learn to take medications as prescribed during the initial year of HIV care in order to in order to achieve viral suppression and improve overall health.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Viral load (VL) suppression (<200c/ml) among patients newly initiating outpatient HIV medical care
大体时间:48 weeks
VL suppression is defined as <200 copies/ml of blood
48 weeks

次要结果测量

结果测量
措施说明
大体时间
Viremia Copy Years (VCY)
大体时间:96 weeks
VCY is the area under the curve estimate of cumulative VL burden
96 weeks
Visit adherence
大体时间:First provider visit to 48 weeks and 96 weeks
We will calculate visit adherence as a proportion that captures the number of "attended" visits in the numerator and the number of total scheduled visits ("attended" plus "no show") in the denominator during study period.
First provider visit to 48 weeks and 96 weeks
4 month visit constancy
大体时间:First provider visit to 48 weeks and 96 weeks
We will evaluate visit constancy as the proportion of pre-specified time intervals with at least 1 attended clinic visit during the study period. We will use 4 month time interval
First provider visit to 48 weeks and 96 weeks
Time to viral load (VL) suppression
大体时间:First provider visit to first VL suppression with administrative censoring at 12 months
We will calculate time to VL suppression (defined as <200 copies/ml) as the time in days from the first medical provider visit to the first date with VL suppression. Kaplan-Meier analyses and Cox proportional hazards analyses will be used to generate survival curves and to estimate the median time to VL suppression.
First provider visit to first VL suppression with administrative censoring at 12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Michael J Mugavero, MD、University of Alabama at Birmingham

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年12月1日

初级完成 (实际的)

2017年6月30日

研究完成 (实际的)

2018年12月1日

研究注册日期

首次提交

2013年7月2日

首先提交符合 QC 标准的

2013年7月15日

首次发布 (估计)

2013年7月16日

研究记录更新

最后更新发布 (实际的)

2019年2月15日

上次提交的符合 QC 标准的更新

2019年2月13日

最后验证

2019年2月1日

更多信息

与本研究相关的术语

其他研究编号

  • 1R01AI103661 (美国 NIH 拨款/合同)

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅