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临床试验/NCT02545673
NCT02545673已完成不适用

Enhanced Linkage to HIV Care Following Home-Based HIV Testing in Rural Uganda

Susan M Kiene1 个研究点 分布在 1 个国家目标入组 567 人开始时间: 2015年11月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
567
试验地点
1
主要终点
Undetectable HIV Viral load

研究概览

简要总结

The purpose of this study is to evaluate the effectiveness of a linkage to care intervention at achieving HIV viral suppression and intermediate outcomes of linkage/time to care, time to /receipt of opportunistic infection prophylaxis, and antiretroviral therapy (ART) among people testing HIV positive during home-based HIV counseling and testing (HBHCT) in rural Uganda.

详细描述

Throughout sub-Saharan Africa there is a pressing need to facilitate early and easier entry into HIV care and treatment; up to two-thirds of patients are lost to follow up between testing HIV positive and initiation of antiretroviral (ARV) treatment. Home-based HIV testing and counseling (HBHCT), which identifies those who are HIV positive at earlier disease stages than other testing approaches, is becoming a large component of many sub-Saharan African countries' HIV prevention programs, including Uganda's. Paper-based referral to care, sometimes adding follow-up home visits, is the most common linkage-to-care approach with HBHCT. Linkage to care may be challenging with HBHCT since the testing occurs in the home at a distance from a health facility. The investigators propose to test an intervention which enhances a linkage to care intervention tested in an urban Ugandan provider-initiated HIV testing setting and found to improve linkage to care. The aims of the project are: (1) In a cluster randomized trial compare the effectiveness of the enhanced linkage to care intervention vs. standard-of-care (paper based referrals) at achieving HIV viral suppression and intermediate outcomes of linkage to care, receipt of opportunistic infection prophylaxis, and ART initiation among those eligible for antiretroviral therapy (ART). (2) Using the standard-of-care group as a natural history control, collect longitudinal data on barriers to and facilitators of linkage to and retention in care and treatment and HIV viral suppression. (3) Estimate the cost-effectiveness of the intervention, as compared to standard-of-care, in terms of major study outcomes.

Participation in the full study will last 12 months. All participants will first undergo HBHCT, viral load and CD4 testing, and complete a brief questionnaire. Participants will then be randomly assigned to one of two study arms: the enhanced linkage to care intervention arm or the standard-of-care control arm. Participants in both study arms will participate in interviewer administered questionnaires at 6 months and 12 months follow-up, viral load and CD4 testing at 12 month follow-up, and will permit the research team to access their medical records to extract information about their health status and linkage to care. Participants in the intervention arm will also receive a series of counseling sessions with an HIV counselor taking place at the participant's home, clinic, and over the phone. These sessions will last approximately 30 minutes, and consist of counseling to help clients identify and reduce barriers to engagement in care, assistance disclosing and identifying a treatment supporter, and stigma reduction through increasing social support.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 18-59 years of age or an emancipated minor

排除标准

  • not a resident of the household
  • Does not speak Luganda or English
  • Inclusion/Exclusion for the Intervention Study:
  • Inclusion criteria:
  • participated in the baseline interview and home-based HIV counseling and testing,
  • newly diagnosed HIV positive in the home-based HIV counseling and testing or previously diagnosed but never linked to HIV care
  • Exclusion criteria:
  • Other household members also newly diagnosed as HIV positive/previously diagnosed but never linked to care. Only one person per household will be eligible to enroll

结局指标

主要结局

Undetectable HIV Viral load

时间窗: 12 months follow up

defined as HIV RNA \<20 cells/ml collected via venous blood draw

次要结局

  • Short-term retention in care: Missed visits(6 and 12 months follow up)
  • HIV Viral load Suppression(12 months follow up)
  • Initiating ART(6 and 12 months follow up)
  • Short-term retention on treatment(6 and 12 months follow up)
  • Time to HIV care(6 and 12 months follow up)
  • Time to receipt of ART(6 and 12 months follow up)
  • Short-term retention in care: Proportion of kept visits/scheduled visits(6 and 12 months follow up)
  • Short-term retention in care: 4 month visit constancy(6 and 12 months follow up)
  • Linkage to HIV care(6 and 12 months follow up)

研究者

发起方
Susan M Kiene
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Susan M Kiene

Professor

San Diego State University

研究点 (1)

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