跳至主要内容
临床试验/NCT03508310
NCT03508310已完成不适用

A Waiting Room-Delivered Video to Enhance Antiretroviral Therapy Readiness, Adherence, and Retention in Care for Minority Persons Living With HIV Infection

Centers for Disease Control and Prevention0 个研究点目标入组 4,003 人开始时间: 2016年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
4,003
主要终点
Antiretroviral therapy (ART) medication adherence (suppression level)

研究概览

简要总结

The purpose of this project is to beta-test a brief waiting room video intervention that promotes early initiation of antiretroviral treatment among treatment-naïve HIV-positive patients, adherence to antiretroviral treatment and retention in care among HIV-positive patients currently on therapy, sexual risk reduction tailored to HIV-positive persons, and patient-initiated discussion of these topics with their health providers. The video is currently being created, and will be ready for beta-testing by June 1, 2016. Results of the beta-testing will be used to refine and improve the video before dissemination to HIV/AIDS treatment facilities nationally. This video project is being funded by the Centers for Disease Control and Prevention, Division of HIV/AIDS Prevention (DHAP).

详细描述

The overall goal of this study is to beta-test the waiting room video in three HIV/AIDS treatment facilities in different US jurisdictions with high AIDS prevalence. These results will be used to refine the video and to increase its effectiveness among minority persons living with HIV infection. The beta-testing will consist of: 1) unobtrusive observations of waiting room patients for one day at each facility and 2) de-identified, existing patient medical data abstracted from each facility's electronic medical record (EMR) system to investigate outcomes relevant to HIV medication adherence and retention in care.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 87 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •HIV/AIDS treatment facility inclusion: The participating treatment facilities will have a combined total of at least 2,700 monthly patient visits during the study period. Each of the HIV/AIDS treatment facilities meets the following inclusion criteria:
  • •located in a jurisdiction with high AIDS prevalence;
  • •managing more than 500 unique HIV-positive patients annually;
  • •serving minority persons such that minimally 55% of the clinic population is African-American and Hispanic/Latino;
  • •at least 163 patients have unsuppressed viral load;
  • •utilizing an electronic medical record (EMR) system; and
  • •not participating in another behavioral intervention research project during the historical comparison data period (August 2015 through May 2016) or during the 10-month intervention period (June 2016 through March 2017).

排除标准

  • 未提供

研究组 & 干预措施

Intervention

Experimental

29-minute clinic waiting room video intervention that includes three vignettes and a 2-part animation sequence about main characters who model overcoming challenges to optimal HIV care. The video was played on continuous loop in recognition of typically short patient wait times. Waiting room posters used images from the video to direct patients' attention to the video and reinforce prevention messages.

干预措施: Taking Care of Me Video (Other)

Comparison

No Intervention

Historical comparison condition. Patients were exposed to standard waiting room environment (absent of intervention video and posters).

结局指标

主要结局

Antiretroviral therapy (ART) medication adherence (suppression level)

时间窗: By 6 months (183 days) after the patient's index (first) visit to the clinic

Adherence was measured by whether viral load suppression (\<200 RNA copies/mL) was achieved

Antiretroviral therapy (ART) medication adherence (undetectable level)

时间窗: By 6 months (183 days) after the patient's index (first) visit to the clinic

Adherence was measured by whether viral load suppression (\<50 RNA copies/mL) was achieved

次要结局

  • Treatment initiation(on, before, or within 7 days after, their index visit, as documented by OAMC visits in patient EMRs.)
  • Retention in HIV medical care(2 or more clinic visits for any reason at least 90 days apart in the past year divided by all active clients who had had at least one such visit in the past year)

研究者

发起方
Centers for Disease Control and Prevention
申办方类型
Fed
责任方
Sponsor

相似试验

A Waiting Room-Delivered Video to Enhance Clinical... | 临床试验