Community-Based HIV VCT: South Africa

基于社区的 HIV VCT：南非

• 批准号: 7880741
• 负责人: Thomas J. Coates
• 金额: $ 274.72万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-30 至 2013-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7880741
• 关键词: AIDS prevention; African; Avidity; Awareness; Beds; Behavioral; Biological Assay; Blood specimen; Budgets; CD4 Positive T Lymphocytes; Cancer Center; Cell Count; Clinic; Collaborations; Communication; Communities; Counseling; Country; Czech Republic; Data; Discipline; Disclosure; End Point Assay; Ensure; Ethics; Ethnography; Event; Frequencies; Funding; Goals; HIV; HIV Infections; HIV prevention trials network; HIV-1; Health; High Pressure Liquid Chromatography; Household; Human immunodeficiency virus test; Incidence; Institution; International; Intervention; Interview; Laboratories; Learning; Life; Low Prevalence; Maps; Measures; Mediation; Methodology; Methods; Modeling; Monitor; National Institute of Mental Health; Outcome; Persons; Phase; Phase III Clinical Trials; Population; Preparation; Prevalence; Preventive Intervention; Procedures; Process; Protocols documentation; Public Health; Qualifying; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Readiness; Relative (related person); Reporting; Research Ethics Committees; Research Personnel; Resources; Risk; Sampling; Schedule; Science; Scientist; Secure; Services; Site; South Africa; Stigmata; Surveys; System; Tanzania; Testing; Thailand; Time; TimeLine; Training; Treatment Efficacy; Universities; Work; Zimbabwe; aged; authority; base; behavior measurement; cohort; community intervention; community setting; cost; cost effectiveness; data management; design; disability-adjusted life years; experience; falls; high risk; high risk behavior; indexing; member; multidisciplinary; outreach; post intervention; programs; social; social stigma; uptake

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.

描述（由申请人提供）：这是一项 III 期、社区层面的随机对照研究，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、14 个）泰国）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 干预有三大策略：(1) 使 VCT 在社区环境中更容易获得； (2) 通过外展活动吸引社区参与； (3) 提供测试后支持。这三项策略旨在改变社区规范并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。本研究的主要目标（目标 1）是检验以下假设：相对于接受 2-1/2 年 SVCT 的社区，接受 2-1/2 年 CBVCT 的社区近期 HIV 感染率将显着降低。第二个目标（目标 2）是检验以下假设：相对于 SVCT 社区，CBVCT 社区在干预期结束时将显着报告：HIV 危险行为更少、HIV 检测率更高、有关 HIV 检测的社会规范更有利，更频繁地讨论艾滋病毒，更频繁地披露艾滋病毒状况，减少与艾滋病毒相关的耻辱，以及减少与艾滋病毒相关的负面生活事件。该研究的目标 3 将是评估 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 岁的人样本，并将在干预后进行选择，用于测量主要和次要终点。将使用由 CD4+ T 细胞计数、HIV-1 BED 发生率 EIA (Calypte)、Avidity Index (BioRad) 组成的算法方法，通过比较 CBVCT 和 SVCT 社区中近期 HIV 感染的干预后患病率来评估目标 1和 ART 残留物的 HPLC（HPTN 核心实验室/JHU）。将通过比较基线和干预后的各种行为测量来评估目标 2。目标 3 将根据避免每次 HIV 感染的成本和节省的伤残调整生命年 (DALY) 进行评估。