Community-Based VCT: Zimbabwe

描述(申请人提供)：这是一项第三阶段，社区水平的随机对照研究，其中48个社区(坦桑尼亚10个，津巴布韦8个，南非索韦托8个，南非Vulindlela 8个，泰国14个)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干预有三个主要战略：(1)使VCT在社区环境中更容易获得；(2)通过外展使社区参与；(3)提供测试后支持。这三项战略旨在改变社区规范，降低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。这项研究的主要目标(目标1)是检验这样一种假设，即接受CBVCT两年半的社区与接受两年半SVCT的社区相比，近期HIV感染的患病率将显著降低。第二个目标(目标2)是检验以下假设：与SVCT社区相比，CBVCT社区将在干预期结束时显著报告：更少的艾滋病毒风险行为，更高的艾滋病毒检测率，更有利的关于艾滋病毒检测的社会规范，更频繁的关于艾滋病毒的讨论，更频繁地披露艾滋病毒状况，更少的与艾滋病毒相关的耻辱，以及更少的与艾滋病毒相关的负面生活事件。这项研究的目标3将评估CBVCT与SVCT相比是否具有成本效益。从每个研究社区中随机抽取年龄在16岁至32岁之间的人作为基线样本，并在干预后选择，用于测量主要和次要终点。目的1通过比较CBVCT和SVCT社区近期HIV感染的患病率，使用由CD4+T细胞计数、HIV-1床位率EIA(Calypte)、亲和力指数(BioRad)和反转录病毒治疗残留高效液相色谱(HPTN Core Lab/JHU)组成的算法方法进行评估。目标2将通过比较基线和干预后的各种行为测量来进行评估。目标3将根据避免的艾滋病毒感染和节省的残疾调整生命年(DALY)的单位成本进行评估。

DESCRIPTION (provided by applicant): This is a Phase III, community-level, randomized controlled study, in which 48 communities (10 in Tanzania, 8 in Zimbabwe, 8 in South Africa-Soweto, 8 in South Africa-Vulindlela, and 14 in Thailand) were randomized to receive either a community-based HIV voluntary counseling and testing (CBVCT) intervention or standard clinic-based 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. The primary objective (Aim 1) of this study 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. The secondary objective (Aim 2) is to test the hypotheses that CBVCT communities, relative to SVCT communities, will at the end of the intervention period report significantly: less HIV risk behavior, higher rates of HIV testing, more favorable social norms regarding HIV testing, more frequent discussions about HIV, more frequent disclosure of HIV status, less HIV-related stigma, and fewer HIV- related negative life events. Aim 3 of the study will be to assess whether CBVCT is cost-effective compared to SVCT. A random sample of persons aged 16 to 32 from each study community was selected at baseline, and will be selected post intervention, for measuring primary and secondary endpoints. Aim 1 will be evaluated by comparing the post-intervention prevalence of recent HIV infection in CBVCT and SVCT communities, using an algorithmic approach comprised of CD4+ T-cell counts, the HIV-1 BED Incidence EIA (Calypte), Avidity Index (BioRad), and HPLC for ART residues (HPTN Core Lab/JHU). 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 (DALYs) saved.