Community-Based HIV VCT: Zimbabwe

描述（由申请人提供）：从公共卫生的角度来看，没有比发展中国家的艾滋病毒流行病更紧迫的危机了。这是一项III期社区水平随机对照研究，其中非洲（坦桑尼亚，津巴布韦和南非）的32个社区和泰国的14个社区将随机接受基于社区的艾滋病毒自愿咨询和检测（CBVCT）干预或基于诊所的标准VCT（SVCT）。CBVCT干预措施有三个主要战略：（1）在社区环境中提供更多的VCT;（2）通过外展让社区参与;（3）提供测试后支持。这三项战略旨在改变社区规范，减少所有社区成员感染艾滋病毒的风险，无论他们是否直接参与干预。因此，采用社区一级的抽样方法而不是队列设计来评价结果。 主要目的（目的1）是检验接受2- 1/2年CBVCT的社区相对于接受2-1/2年SVCT的社区近期HIV感染率显著降低的假设。此外，我们提出了以下次要目标（目标2）来检验CBVCT社区相对于SVCT社区在干预期结束时将显著报告的假设：a）更少的HIV风险行为; B）更高的HIV检测率; c）关于HIV检测的更有利的社会规范; d）更频繁地讨论HIV; e）更频繁地披露HIV状态; f）减少与艾滋病毒有关的耻辱感; g）减少与艾滋病毒有关的社会危害。最后，由于成本效益数据对东道国和捐助国的重要性，我们建议评估（目标3）CBVCT与SVCT相比的增量成本效益。 在基线和干预后，将从每个社区随机抽取18至32岁的人群，用于测量主要和次要终点。将通过比较研究两组中所有阳性HIV血液样本的灵敏度/较低灵敏度HIV检测测定的干预后近期感染患病率来评价目标1。目标2将通过比较基线和干预后的各种行为指标进行评估。目标3将根据避免艾滋病毒感染和挽救残疾调整生命年的成本进行评价。

DESCRIPTION (provided by applicant): From a public health perspective, there is no more compelling crisis in the world today than the HIV epidemic in the developing world. This is a Phase III community-level randomized controlled study, in which 32 communities in Africa (Tanzania, Zimbabwe, and South Africa) and 14 communities in Thailand will be randomized to either a community-based HIV voluntary counseling and testing (CBVCT) intervention or clinic-based standard VCT (SVCT). The CBVCT intervention has three major strategies: (1) to make VCT more available in community settings; (2) to engage the community through outreach; and (3) to provide post-test support. These three strategies are designed to change community norms and reduce risk for HIV infection among all community members, irrespective of whether they participated directly in the intervention. Thus, a community-level sampling approach as opposed to a cohort design is used to evaluate outcomes. The primary aim (Aim 1) is to test the hypothesis that communities receiving 2-1/2 years of CBVCT, relative to communities receiving 2-1/2 years of SVCT, will have significantly lower prevalence of recent HIV infection. In addition, we propose the following secondary aim (Aim 2) to test the hypotheses that CBVCT communities, relative to SVCT communities, will at the end of the intervention period report significantly: a) less HIV risk behavior; b) higher rates of HIV testing; c) more favorable social norms regarding HIV testing; d) more frequent discussions about HIV; e) more frequent disclosure of HIV status; f) less HIV-related stigma; and g) less HIV-related social harm. Finally, because of the importance of cost-effectiveness data to host and donor countries, we propose to assess (Aim 3) the incremental cost-effectiveness of CBVCT compared to SVCT. A random sample of persons between the ages of 18 and 32 years of age from each community will be selected at baseline and post-intervention for measuring primary and secondary endpoints. Aim 1 will be evaluated by comparing the post-intervention prevalence of recent infection measured by the sensitive/less sensitive HIV assay on all positive HIV blood samples in the two arms of the study. Aim 2 will be evaluated by comparing a variety of behavioral measures at baseline and post-intervention. Aim 3 will be evaluated in terms of cost per HIV infection averted and disability-adjusted life years saved.