Overcoming Barriers to HIV/AIDS Care and ART Initiation (LINC)
2019年3月12日 更新者：Brandon Guthrie、University of Washington
The study will evaluate interventions to improve engagement in HIV care following HIV diagnosis through a voluntary counseling and testing program.
The specific aims are to (1) determine if a VCT-based intervention of CD4 count testing, alone or in combination with peer counseling, improves linkage to HIV/AIDS care; (2) assess the impact of the intervention on ART initiation.
The study will recruit 450 HIV-positive individuals from VCTs and randomize a third to standard counseling and referral, a third to receive CD4 testing at the VCT with results return by phone after 1 weeks, and a third to receive the same CD4 testing combined with peer counseling.
These combined investigations will create a comprehensive understanding of obstacles to appropriate HIV/AIDS care and result in new interventions to achieve measurable outcomes in applied settings.
研究概览
研究类型
介入性
注册 (实际的)
315
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
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Nairobi、肯尼亚
- Karen Health Center
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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:
- At least 18 years or older and
- Testing HIV-positive for the first time at a voluntary counseling and testing (VCT) center.
- Willing to receive counseling to encourage linkage to care at a comprehensive care center (CCC).
- Willing to have a CD4 count test conducted at the enrollment visit.
- Willing to have a telephone follow-up where they may receive additional counseling and/or have their CD4 count results returned to them.
- Willing to be contacted over 1 year to determine if they linked to care.
Exclusion Criteria:
- Previous positive HIV test.
- Currently taking antiretroviral medications.
- Currently pregnant (females only).
- Currently participating in another research study or trial.
- Not planning to remain in Nairobi for the next 12 months (not including short trips out of Nairobi).
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：卫生服务研究
- 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 |
|---|---|
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无干预：Standard of care
Standard HIV counseling and referral to care
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实验性的：CD4 testing
Standard HIV counseling and testing plus blood drawn for CD4 testing at time of HIV diagnosis.
CD4 results are reported to participants via telephone within 1 week.
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实验性的：CD4 testing plus peer counseling
Standard HIV counseling and testing plus blood drawn for CD4 testing at time of HIV diagnosis.
CD4 results are reported to participants via telephone within 1 week.
Additionally, a trained peer counselor provides supplemental counseling at the time of diagnosis and at the 1 week telephone follow-up.
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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 |
|---|---|---|
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Number of days from study enrollment until first visit to a comprehensive care center for HIV care.
大体时间：1 year
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An interviewer administered questionnaire will be used to determine if each participant visited a comprehensive care center.
Is so, the date of the first visit will be recorded.
From this, the time from enrollment until first visit to a comprehensive care center will be calculated.
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1 year
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Number of days from study enrollment until initiation of antiretroviral therapy.
大体时间：1 year
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An interviewer administered questionnaire will be used to determine if each participant started antiretroviral therapy.
Is so, the date of treatment initiation will be recorded.
From this, the time from enrollment until treatment initiation will be calculated.
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1 year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Interviewer-administered questionnaire to determine the number of visits made to a comprehensive care center for HIV care.
大体时间：1 year
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Measurement of the number of visits to a comprehensive care center will be made questionnaire administered in an in-person interview at 12 months after enrollment.
The total number of visits will be recorded.
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1 year
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Measurement of CD4+ T-cell count.
大体时间：1 year
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Each participant's CD4 count will be measure at 1 year after enrollment.
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1 year
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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：Brandon L Guthrie, PhD、University of Washington
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
2013年8月1日
初级完成 (实际的)
2017年12月22日
研究完成 (实际的)
2017年12月22日
研究注册日期
首次提交
2016年3月11日
首先提交符合 QC 标准的
2016年3月23日
首次发布 (估计)
2016年3月24日
研究记录更新
最后更新发布 (实际的)
2019年3月13日
上次提交的符合 QC 标准的更新
2019年3月12日
最后验证
2019年3月1日
更多信息
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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