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An Enhanced Package of Care to Reduce Reduce Mortality in Advanced HIV Disease (ENCORE)

2022年7月9日 更新者：Makerere University

A Community-based Phase III, Cluster Randomized Trial of Point-of-care CD4 Testing and Enhanced Screening and Prophylaxis in Advanced HIV Disease

A community-based Phase III, cluster randomized trial that seeks to determine the 24 week survival with retention in care of point of care CD4 testing with visitect and an enhanced package of screening and prophylaxis for opportunistic infections among patients with advanced HIV disease.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

The study will be carried out in a population of HIV-infected adults with advanced HIV disease (CD4 <200 cells/µL) in Uganda. It will be a Randomized controlled trial, Phase III in Uganda over a duration of 5 years assessing 24 weeks survival with retention in care. @4 clinic will be randomized to either receive the enhanced package or standard of care.

Description of Intervention Arm

  1. Point-of-care CD4 testing via Visitect (point of care semi Quantitaive CD4 LFA) lateral flow assay (LFA)

  2. Enhanced package of opportunistic infection screening and prophylaxis for CD4<200, including:

    • FujiFilm SILVAMP TB LAM (FujiLAM)
    • Isoniazid (INH) + rifapentine: 1 month of therapy for latent TB(Tuberculosis) infection
    • Cryptococcal Antigen semi-quantitative (CrAg-SQ) LFA (Immy)
    • Treatment for disseminated CNS cryptococcal infection if high blood CrAg titer (>3+ CrAg SQ)

Description of Standard of Care Arm

  1. CD4 testing by flow cytometry

  2. WHO recommended package of OI screening and prophylaxis, including:

    • Urine TB LAM
    • INH ( isoniazid 6 months)
    • CrAg LFA
    • Fluconazole for asymptomatic CrAg+ o 800mg daily x 2 weeks, then 400mg daily x 8 weeks, then 200mg daily.

Problem statement: Current lab-based CD4 testing results in a delay to either start ART(Antiretroviral therapy) or a delay in screening persons with low CD4s for OIs. At present, prioritization has been on ART initiation without systematic OI screening. Those with subclinical OIs started on ART unmask their OIs, with hospitalization / deaths for OIs such as cryptococcosis and TB.

We hypothesize that with point of care CD4 testing, same-day OI screening can occur, yet not interrupt prompt ART initiation for those at low risk (FujiLAM and CrAg-SQ negative) of unmasking immune reconstitution syndrome.

We hypothesize that point-of-care CD4 testing will improve 6-month survival by reducing lag time in CD4 results, thereby facilitating ART initiation, retention-in-care, and OI screening and prophylaxis.

We hypothesize that enhanced screening with the point-of-care FujiLAM, CrAg-SQ LFA, with enhanced prophylaxis for TB (1 month of INH and rifapentine) and with treatment for disseminated CNS cryptococcal infection in those CrAg+ with high titers (>3+) will improve 6-month survival compared to current WHO-recommended standard practice in persons with advanced HIV disease.

研究类型

介入性

注册 (预期的)

2400

阶段

  • 第三阶段

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。

学习联系方式

  • 姓名：Radha Rajasingham, MD
  • 电话号码：612 626-8171
  • 邮箱：radha@umn.edu

研究联系人备份

学习地点

  • 乌干达
      • Kampala、乌干达
        • 招聘中
        • kisugu health center IV
        • 接触：
          • Teopista Namuli

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:

  • Age >18 years
  • CD4<200 cells/µL
  • Ability and willingness to give informed consent for the enhanced package of care arm.

Exclusion Criteria:

  • Known virologic suppression (viral load <1000 copies/mL) within prior 3 months
  • Cannot or unlikely to attend regular clinic 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：阶乘赋值
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：intervention(Enhanced package of care) Arm
The patients with advanced HIV disease that receive HIV care at the intervention clinics will receive the enhanced intervention package which will include: point of care CD4 testing with visitect, screening for TB and cryptococcal meningitis using Fujifilm LAM and semiquantitative crAg LFA respectively and pre-emptive treatment with isoniazid and rifapentine for one month. Those with a high crAg titers will receive treatment for CNS cryptococcal disease.
其他：Enhanced care package
The intervention is an improved package of care for patients with advanced HIV disease with point of care CD4 testing, more sensitive screening tests for opportunistic infections and more intensive pre-emptive treatment for opportunistic infections
无干预：Standard of care Arm
The patients with advanced HIV disease that receive HIV care at the standard of care clinics will receive the usual routine HIV care as per the Uganda national guidelines. That is CD4 testing with flowcytometry or other CD4 testing modalities available, screening for TB and cryptococcal meningitis using Alere LAM and crAg LFA respectively and pre-emptive treatment with isoniazid and rifapentine for 3-6 month. Treatment of all asymptomatic crAG positives with fluconazole as per guidelines.

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
24-week survival with retention in care
大体时间：24 weeks
Comparison will be made between study arms of those who receive POC CD4 testing vs. those who receive standard flow cytometry, and those who receive the enhanced package of OI screening and prophylaxis, vs. those who receive the current WHO standard.
24 weeks

次要结果测量

结果测量
措施说明
大体时间
Evaluate sensitivity and specificity of the different TB point of care tests.
大体时间：24 weeks
After a positive FujiFilm TB LAM test, incidence of Xpert-positive or culture positive TB, and clinical outcomes to distinguish between false positive vs. true positive urine tests
24 weeks
Incidence of OIs and associated hospitalization and mortality
大体时间：Six months
Incidence of active TB within 6 months, Incidence of cryptococcal meningitis and associated mortality.
Six months
Tolerability and adherence to prophylaxis regimen and associated grade 3 to 5 adverse events
大体时间：24 weeks
percentage completion of regimen and proportions that get grade 3 and above AEs.
24 weeks

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。

赞助

Makerere University

合作者

University of Minnesota

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 (实际的)

2022年5月4日

初级完成 (预期的)

2027年3月1日

研究完成 (预期的)

2027年9月1日

研究注册日期

首次提交

2021年10月8日

首先提交符合 QC 标准的

2021年10月8日

首次发布 (实际的)

2021年10月20日

研究记录更新

最后更新发布 (实际的)

2022年7月12日

上次提交的符合 QC 标准的更新

2022年7月9日

最后验证

2022年7月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • IDIREC REF 007/2021

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Aggregated patient data will be summarized and disseminated.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

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