跳至主要内容
临床试验/NCT01188941
NCT01188941已完成不适用

Linkage and Retention: A Randomized Trial to Optimize HIV/TB Care in South Africa

Massachusetts General Hospital4 个研究点 分布在 1 个国家目标入组 1,899 人开始时间: 2010年8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
入组人数
1,899
试验地点
4
主要终点
Linkage and Retention in Care: TB Patients

研究概览

简要总结

The purpose of this study is to test the effects of a health system navigator intervention on rates of linkage to human immunodeficiency virus (HIV) and tuberculosis (TB) care among newly diagnosed HIV-infected outpatients in Durban, South Africa. Subjects will be approached in the outpatient department and enrolled prior to an HIV test. Subjects will then be randomized to the navigator arm or the standard of care arm. Subjects in the navigator arm will receive scheduled phone and short message service (SMS) contacts throughout the follow-up period to help guide them through the HIV and TB care pathways. The navigator will provide personalized support to help subjects overcome barriers they may face along the way.

详细描述

This project is a randomized controlled trial of an intervention to improve linkage to HIV and TB care for South Africans undergoing HIV testing. Subjects undergoing HIV testing will be enrolled at three sites in the greater Durban area. These sites comprise two hospital-affiliated outpatient departments and primary health clinics served by a mobile health van. Routine TB screening, regardless of signs or symptoms, will be offered to all HIV-infected participants. HIV-infected participants will be randomized to determine whether they will be assigned to a health system navigator or will receive the current standard of care in Durban. Block randomization will be stratified by site and gender, with blocks of varying length.

The health system navigator will help patients identify barriers to entering care and devise solutions, optimize use of available resources, and serve as a trusted social supporter who is knowledgeable about the health care system but remains outside of it. The health system navigator will help subjects engage the HIV and TB care system through face-to-face contact, telephone conversations, and short messaging service SMS text reminders which are free for patients to receive. These phone contacts and SMS will follow a standardized protocol. We will evaluate the efficacy of the intervention, as measured by increased rates of antiretroviral therapy (ART) initiation and, for those with TB co-infection, TB treatment completion. We will also evaluate the cost and cost-effectiveness of this intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

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

入选标准

  • •English or Zulu speaking
  • •Presenting for outpatient care
  • •Voluntarily undergoing an HIV test
  • •Able to give informed consent
  • •Report no prior HIV test
  • •Willing to share HIV and TB test results with research staff

排除标准

  • •Lying in a stretcher
  • •Not oriented to person, place and time

研究组 & 干预措施

Standard of Care

No Intervention

Assigned a Health System Navigator

Experimental

干预措施: Health System Navigator (Behavioral)

结局指标

主要结局

Linkage and Retention in Care: TB Patients

时间窗: 9 Months after Enrollment

For patients co-infected with TB, 6 months of TB treatment as documented by a written discharge of treatment outcome from a TB clinic.

Linkage and Retention in Care: ART-eligible Patients

时间窗: 9 Months after Enrollment

For ART-eligible HIV-infected patients, 3 months on ART as documented by ART initiation date in the electronic medical record.

Linkage and Retention in Care: ART-eligible HIV/TB Co-infected Patients

时间窗: 9 Months after Enrollment

For HIV and TB co-infected patients who are ART-eligible, completion of either the ART or TB treatment outcome will be considered successful completion of the Primary Outcome Measure.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ingrid V. Bassett, MD, MPH

Assistant Professor of Medicine

Massachusetts General Hospital

研究点 (4)

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