Comparison of Door-to-door Versus Community Gathering to Provide HIV Counseling and Testing Services in Rural Lesotho (DoDoPi)
2012年2月8日 更新者：Niklaus Labhardt、SolidarMed
Comparing Door-to-door Versus Community Gathering in Providing HIV Counseling and Testing Within an Integrated Primary Health Care Package: a Cluster Randomized Trial in Rural Lesotho
The purpose of this trial is to determine if door-to-door is more effective than community gathering in providing voluntary HIV counseling and testing (VCT) in communities in rural Lesotho.
The voluntary HIV counseling and testing will be proposed as an integrated part of a package of proposed services.
The package consists of: Blood-pressure measurement, blood-glucose measurement, Body-mass-index (adults), weight for height (children), catch-up vaccinations, deworming (children) Vitamin A (children & young women), family planning for eligible women, Tuberculosis screening and HIV counseling and testing.
研究概览
详细说明
12 health centers (clusters) in rural Lesotho are matched according to their routine performance in VCT and enrollment into chronic HIV/AIDS care (average numbers tested positive and enrolled into HIV/AIDS care per month per facility). After matching, 6 health centers are randomly assigned to perform door-to-door VCT, whereas the others perform the traditional community gathering approach (called "pitso" in Sesotho). Within the catchment area of each health center five campaigns in five different, randomly selected villages, are held (one day VCT campaign per village). Within each cluster another five villages are randomly selected who do not get a particular campaign and serve as a control for each cluster. In each matched cluster-pair, both health centers conduct the five campaigns during the same week (one conducting it as door-to-door, the other one conducting it through "pitsos" (community gathering)).
Both approaches receive the same resources in terms of finances, time spending doing the VCT-campaign and human resources.
研究类型
介入性
注册 (预期的)
1800
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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Thaba-Tseka、莱索托
- Paray Hospital
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Botha-Bothe
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Seboche、Botha-Bothe、莱索托、P.O. 304
- Seboche Hospital
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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
- 孩子
- 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:
- Not already known to be HIV-positive
- Resident in the catchment area of the health center where the campaign is conducted
- Provision of written informed consent to participate (signed by writing or fingerprint)
- In case of children: Provision of written informed consent by an adult care-taker
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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实验性的：Door-to-Door
Health care workers propose the integrated service package including VCT at the peoples' homes.
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Health workers propose the integrated service package including VCT at the peoples' homes (home-based testing).
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有源比较器：Pitso
Health care workers propose the integrated service package including VCT through community gatherings ("pitso").
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Health care workers propose the integrated service package including VCT through community gatherings ("Pitso").
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无干预：control
Within each cluster (catchment area of a health center), five villages are randomly chosen as comparators on cluster level.
These villages get no particular intervention (VCT-campaign).
However, routine services continue to be provided.
These villages serve as a control for the third primary outcome that assesses the overall numbers newly enrolled into chronic HIV/AIDS care at facility-level.
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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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Proportion of newly tested HIV-positive clients over all clients tested for HIV during the campaigns
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Proportion refers to the proportion of newly tested HIV-positive clients among all clients tested for HIV during the voluntary counselling and testing campaigns in each arm.
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Proportion of clients newly tested HIV-positive who enrolled into HIV/AIDS care within one month over all clients newly tested HIV-positive during the campaigns
大体时间：4 weeks after tested positive
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One month after the campaigns, enrollment of clients who newly tested HIV-positive at the campaign is assessed at the facilities based on the clinics' registers.
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4 weeks after tested positive
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Overall number newly tested HIV-positive and enrolled into chronic HIV/AIDS-care at each facility
大体时间：4 weeks after campaign
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Between the two study-arms, the overall numbers will be compared in two ways:
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4 weeks after campaign
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Absolute number of newly tested HIV-positive clients
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Refers to the overall number newly tested HIV-positive during the campaigns in both arms
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Absolute number of clients newly tested HIV-positive who enrolled into HIV/AIDS care
大体时间：4 weeks after tested HIV-positive
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This refers to the absolute number newly tested HIV-positive during the campaigns who enrolled thereafter into chronic HIV/AIDS care within one month
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4 weeks after tested HIV-positive
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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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CD4-count among clients newly tested HIV-positive
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CD4-counts will be measured on site using a Point-of-care machine.
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Clinical WHO-stage among clients newly tested HIV-positive
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Proportion of clients screened positive for Tuberculosis during the campaigns
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All clients accessing services (irrespective of HIV-status) will be screened for TB by a nurse.
Clients with a positive screening are provided sputum bottles and are entered in the Tuberculosis-suspect register.
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Proportion of first-time HIV-testers among all clients accessing the testing services
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Proportion of clients with positive tuberculosis screening who return 3 sputum-bottles within ≤ 5 days to the facility
大体时间：5 days after the campaign was held
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Tuberculosis-suspect registers and tuberculosis registers at the facility are used for verification
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5 days after the campaign was held
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Proportion of clients with a positive Tuberculosis-screening who return their sputum-bottles and who have at least one AFB-positive smear.
大体时间：5 days after the campaign was held
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Tuberculosis suspect registers and Tuberculosis registers at the facility are used for verification.
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5 days after the campaign was held
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Demographic characteristics of clients accessing the voluntary counseling and testing services
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Absolute number of clients accessing the services at the campaigns who have a positive screening for Tuberculosis
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Absolute number of clients with positive tuberculosis screening who return 3 sputum-bottles within ≤ 5 days to the facility
大体时间：≤ 5 days after the campaigns
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≤ 5 days after the campaigns
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Absolute number of clients with a positive Tuberculosis-screening who return their sputum-bottles and who have at least one AFB-positive smear.
大体时间：≤ 5 days after the campaign
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≤ 5 days after the campaign
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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。
赞助
调查人员
- 首席研究员：Motlomelo Masetsibi、SolidarMed
- 研究主任：Niklaus Labhardt, MD, MIH、SolidarMed
- 学习椅：Karolin Pfeiffer, MD, McommH、SolidarMed
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
2011年10月1日
初级完成 (实际的)
2012年2月1日
研究完成 (实际的)
2012年2月1日
研究注册日期
首次提交
2011年10月18日
首先提交符合 QC 标准的
2011年10月21日
首次发布 (估计)
2011年10月25日
研究记录更新
最后更新发布 (估计)
2012年2月9日
上次提交的符合 QC 标准的更新
2012年2月8日
最后验证
2012年2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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