Linkage and Retention: A Randomized Trial to Optimize HIV/TB Care in South Africa
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
Assigned a Health System Navigator
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
Ingrid V. Bassett, MD, MPH
Assistant Professor of Medicine
Massachusetts General Hospital
