Community-Based VCT: Zimbabwe

描述（由申请人提供）：这是一项III期，社区水平，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，南非伍林代拉8个，泰国14个）被随机分配接受基于社区的艾滋病毒自愿咨询和检测（CBVCT）干预或标准的基于临床的VCT （SVCT）。CBVCT干预有三个主要策略：(1)在社区环境中提供更多的VCT；(2)透过外展活动与社区互动；(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。本研究的主要目的（目的1）是检验接受2-1/2年CBVCT治疗的社区与接受2-1/2年SVCT治疗的社区相比，近期HIV感染率显著降低的假设。次要目标（目标2）是检验CBVCT社区相对于SVCT社区在干预期结束时显著报告的假设：更少的艾滋病毒风险行为，更高的艾滋病毒检测率，关于艾滋病毒检测的更有利的社会规范，更频繁地讨论艾滋病毒，更频繁地披露艾滋病毒状况，更少与艾滋病毒相关的污名化，以及更少与艾滋病毒相关的负面生活事件。该研究的目的3是评估CBVCT与SVCT相比是否具有成本效益。在基线时从每个研究社区随机抽取16至32岁的人群，并在干预后抽取，以测量主要和次要终点。目的1将通过比较干预后CBVCT和SVCT社区近期HIV感染的流行情况来进行评估，使用由CD4+ t细胞计数、HIV-1 BED发生率EIA （Calypte）、发病率指数（BioRad）和ART残留物HPLC （HPTN核心实验室/JHU）组成的算法方法。目的2将通过比较基线和干预后的各种行为测量来评估。目标3将根据避免每次艾滋病毒感染的成本和节省的残疾调整生命年（DALYs）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.