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The Effectiveness of a Counselling Intervention on the Uptake of HIV Care Services Among HIV Infected Patients in Uganda

2016年3月22日 更新者:MRC/UVRI and LSHTM Uganda Research Unit
The purpose of this study is to evaluate the impact of follow-up counselling after HIV diagnosis through home-based HIV counselling and testing (HBHCT), on linkage to pre-antiretroviral therapy (pre-ART) care in Uganda.

研究概览

地位

完全的

详细说明

Data on linkage to pre-antiretroviral therapy (pre-ART) care after HIV diagnosis through home-based HIV counselling and testing (HBHCT) in sub-Saharan Africa (SSA) are scarce. The few existing data suggest that only 13% to 54% of HIV-infected persons identified through HBHCT enter pre-ART care. No studies have rigorously evaluated interventions aimed at improving linkage to pre-ART care following HBHCT in SSA. This study will evaluate the effect of follow-up counselling after HIV diagnosis through HBHCT on linkage to pre-ART care in Masaka, south-western Uganda.

The study is a cluster randomised trial of the effectiveness of referral to pre-ART care and follow-up counselling (intervention) compared to referral to pre-ART care only (control), for individuals diagnosed with HIV through HBHCT. The intervention will be administered at months 1 and 2, and linkage to care assessed at month 6 post-HBHCT. Data will be collected on socio-demographic characteristics, sexual risk profile, HIV testing history, HIV status disclosure, linkage to care, CD4 count testing and results, cotrimoxazole prophylaxis, and ART initiation. At least 224 HIV-infected participants will be enrolled from 28 clusters (14/study arm). Approximately 84 HIV-uninfected individuals will also be recruited into the study to reduce the possibility of revealing the sero-status of the HIV-infected participants.

研究类型

介入性

注册 (实际的)

338

阶段

  • 不适用

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

      • Masaka、乌干达
        • MRC/UVRI Uganda Research Unit on AIDS

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

是的

有资格学习的性别

全部

描述

HIV-infected participants

Inclusion Criteria:

  1. HIV-infected adult (≥18 years)
  2. Willing to provide informed consent
  3. Willing to receive follow-up counselling at home

Exclusion Criteria:

  1. Previous or current receipt of HIV care from an ART provider
  2. On-going participation in other health-related research
  3. Intending to change residence in the next 6 months
  4. Conditions that may make it difficult to provide informed consent e.g. reported (by the individual, relatives or other community members) on-going psychiatric illness

HIV-uninfected participants

Inclusion criteria:

  1. HIV negative adult (≥18 years)
  2. Willing to provide informed consent
  3. Willing to receive follow-up counselling at home

Exclusion criteria:

  1. Intending to change residence in the next 6 months
  2. Conditions that may make it difficult to provide informed consent e.g. reported (by the individual, relatives or other community members) on-going psychiatric illness

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

  • 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:Follow-up counselling
Participants in the experimental arm will receive home-based HIV counselling and testing and referral for HIV care if found to have HIV infection. Additionally, participants will receive home-based follow-up counselling at 1 and 2 months after HIV diagnosis.
无干预:Standard of care
Participants in this arm will receive only home-based HIV counselling and testing and referral for HIV care if found to have HIV infection.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
The proportion of HIV-infected participants that register with an anti-retroviral therapy (ART) care provider within 3 and 6 months of HIV diagnosis and referral.
大体时间:6 months
6 months
The time between HIV diagnosis and linkage to pre-ART care.
大体时间:6 months
6 months

次要结果测量

结果测量
大体时间
Time between blood draw for CD4 cell count testing and attending clinic to receive the results among participants that link to pre-ART care
大体时间:6 months
6 months
The time between learning that a participant is eligible for ART and ART initiation
大体时间:6 months
6 months
The proportion of participants who report adherence to daily cotrimoxazole prophylaxis at 3 and 6 months after HIV diagnosis through HBHCT among those that link to pre-ART care.
大体时间:6 months
6 months

其他结果措施

结果测量
大体时间
The proportion of individuals who undergo repeat HIV testing within 6 months of testing HIV negative through HBHCT.
大体时间:6 months
6 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:Eugene Ruzagira、MRC/UVRI and LSHTM Uganda Research Unit

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

2015年3月1日

初级完成 (实际的)

2016年3月1日

研究完成 (实际的)

2016年3月1日

研究注册日期

首次提交

2015年7月6日

首先提交符合 QC 标准的

2015年7月10日

首次发布 (估计)

2015年7月14日

研究记录更新

最后更新发布 (估计)

2016年3月23日

上次提交的符合 QC 标准的更新

2016年3月22日

最后验证

2016年3月1日

更多信息

与本研究相关的术语

其他研究编号

  • Linkage to pre-ART care

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

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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