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Helping HIV Infected Patients in South Africa Adhere to Drug Regimens

2015年3月9日 更新者:Dr. Richard Chaisson、Johns Hopkins University

DOT-HAART for HIV-Infected South African Adults

Three or more anti-HIV drugs are taken in combination as part of a treatment regimen. These drug regimens must be closely followed in order to be successful. Having a support person watch a patient take his or her anti-HIV drugs each day may help a patient follow his or her regimen. This study will see if patient-chosen treatment supporters help patients take HIV medicines correctly and improve their health.

Study hypothesis: The mean change in CD4 count at 12 and 24 months will be significantly higher in the directly observed therapy-highly active antiretroviral therapy (DOT-HAART) arm as compared to the self-administered arm.

研究概览

详细说明

South Africa has one of the worst and fastest growing HIV epidemics in the world. Highly active antiretroviral therapy (HAART) has been shown both at the individual and public health levels to reduce morbidity, mortality, and vertical and possibly horizontal HIV transmission. However, expenses, feasibility, long-term adherence, and effective delivery of HAART remain formidable barriers, particularly in developing nations. Recently, international initiatives have provided hope for widespread use of HAART at affordable cost in sub-Saharan Africa. Simplified, once-daily HAART regimens with directly observed therapy (DOT) may help to achieve high levels of treatment adherence, a key component for long-term viral suppression and treatment success. Peer advocates have been used to improve adherence with medical therapies in a variety of settings. This study will evaluate the effectiveness and feasibility of DOT using patient-nominated peer supervisors to improve adherence to HAART in HIV infected adults in South Africa.

Participants will be randomly assigned to either Peer-DOT-HAART or self-administration of a once-daily combination of the Western Cape Province ART program medications for 24 months. Study measures will include CD4 cell count and HIV viral load, adherence questionnaires, genotypic HAART resistance testing, and incidence of new or recurrent opportunistic infections.

研究类型

介入性

注册 (实际的)

274

阶段

  • 阶段2

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。

学习地点

      • Cape Town、南非、7925
        • University of Cape Town

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:

  • HIV infected
  • Viral load greater than 1000 copies/ml
  • CD4 count of 200 cells/mm3 or less, or World Health Organization Stage 4 disease
  • Living in the area of the study site
  • Had a known address for more than 3 months
  • Willing to nominate a treatment supervisor (a close family member, sexual partner, friend, or community volunteer) to observe daily ingestion of tablets
  • Willing to disclose HIV status to a treatment supervisor and ready to commit to long-term antiretroviral therapy
  • Acceptable methods of contraception

Exclusion Criteria:

  • Pregnant

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:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 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:1
Use of a patient nominated peer supporter who will observe the morning dose of ARVs
Use of a patient nominated peer supporter who will observe the morning dose of ARVs
无干预:2
Self administration of ARVs

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
Impact of DOT Compared to Self-administered Treatment as Measured by HIV Viral Load at 12 Months of Treatment
大体时间:at 12 and 24 months of treatment
Proportion of Patients with HIV RNA Levels of <400 at 12 Months - Intention-to-treat
at 12 and 24 months of treatment
Impact of DOT Compared to Self-administered Treatment as Measured by HIV Viral Load at 24 Months of Treatment
大体时间:24 months
Proportion of Patients with HIV RNA Levels of <400 Copies/mL at 24 Months [Intention-to-treat (ITT)
24 months
Immunological Response: Median CD4 (IQR) Cell Count Increase From Baseline at 12 Months by Study Arm
大体时间:12 months
12 months
Immunological Response: Median CD4 (IQR) Cell Count Increase From Baseline at 24 Months by Study Arm
大体时间:24 months
24 months

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。

调查人员

  • 首席研究员:Richard E Chaisson, MD、Johns Hopkins University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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

2005年2月1日

初级完成 (实际的)

2008年9月1日

研究完成 (实际的)

2008年9月1日

研究注册日期

首次提交

2004年2月3日

首先提交符合 QC 标准的

2004年2月5日

首次发布 (估计)

2004年2月6日

研究记录更新

最后更新发布 (估计)

2015年3月27日

上次提交的符合 QC 标准的更新

2015年3月9日

最后验证

2015年3月1日

更多信息

与本研究相关的术语

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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