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-Vulindlela 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）干预或标准的基于诊所的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。本研究的主要目的（目的1）是检验以下假设：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感染的患病率显著较低。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将显著报告的假设：更少的HIV风险行为，更高的HIV检测率，更有利的HIV检测社会规范，更频繁地讨论HIV，更频繁地披露HIV状态，更少的HIV相关污名，以及更少的HIV相关负面生活事件。本研究的目的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选择16至32岁的人群，并在干预后选择，用于测量主要和次要终点。目标1将通过比较CBVCT和SVCT社区中近期HIV感染的干预后患病率进行评价，使用包括CD 4 + T细胞计数、HIV-1 BED发病率EIA（Calypte）、亲合力指数（BioRad）和ART残留HPLC（HPTN Core Lab/JHU）的算法方法。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.