Peer Leaders as HIV Risk Reduction Change Agents Among IDUs in Ukraine

描述(由申请人提供)：在这项为期5年的前瞻性随机临床试验(RCT)中，将评估两种干预方法在减少乌克兰注射吸毒者中艾滋病毒药物和与性相关的危险行为方面的有效性。使用意向治疗设计，我们建议比较手动驱动的艾滋病毒检测和咨询干预，即在NIDA的合作协议(Coyle 1993)期间开发的咨询和教育(C&E)模式，与咨询和教育加上网络为重点的干预，这也是由拉特金(2003)开发的手动驱动的，他已经同意成为一名顾问。我们对乌克兰的这两种干预措施进行了评估，发现它们在降低艾滋病毒相关风险方面是有效的。然而，它们之间没有相互比较，我们在过去的工作中也没有采用RCT设计。我们之所以提出这项测试，是因为：1.在我们最近完成的为期5年的乌克兰研究中，单独的C&E干预与C&E加更密集的个体模型一样有效；2.这项研究还发现，那些在基线检测时得知自己感染了HIV的人，无论干预任务如何，比起HIV阴性和那些已经知道自己是阳性的人，他们的性行为风险降低得更多，这突显了检测和咨询的伦理必要性以及C&E的优点；3.尽管如此，网络干预措施的优势在于，它们有可能影响更广泛的注入者群体，特别是那些与指数相互作用的人。我们还将评估“第一波”网络成员招募“第二波”网络成员的二次扩散，这是迄今为止还没有做过的事情。评估网络中的两个步骤将允许我们检查扩散、重叠、污染，以及预测扩散和对行为变化的抵抗力的指数和网络特征。这两种干预都是基于理论的、手动的、翻译成俄语的，而且都已在乌克兰成功实施。此外，由于所选地点注射吸毒者中艾滋病毒感染率很高(在我们以前的研究中从20%到65%不等)，我们将伴侣披露作为两种干预措施的一部分，并请来了这一领域的专家Seth Kalichman博士作为顾问。我们将与我们的乌克兰合作伙伴Sergiy Dvoryak，M.D.，Ph.D.合作，从敖德萨、Makeevka/Donetsk和Nikolayev招募2250名IDU，每名750人，他们将接受以网络为重点的网络干预加上C&E或仅接受C&E。参与者将通过街头外展招募，在6个月和12个月时接受面谈、干预和跟踪。除ACASI外，还将对生物样本进行艾滋病毒和药物代谢物的评估。 公共卫生相关性：在一项随机临床试验(RCT)中，我们将使用ACASI和生物标记物，比较两种干预措施在我们之前工作并建立关系的三个地点注射吸毒者中减少艾滋病毒药物和性相关危险行为的有效性。之所以选择这次试验的地点，是因为它们拥有该国四个吸毒者人数和艾滋病毒感染率最高的四个地点中的三个(世界银行，2006年；乌克兰卫生部，2008年)，而且因为它们以前在招募和留住注射吸毒者队列方面表现得很好(Booth等人，2006年b)。

DESCRIPTION (provided by applicant): In this 5-year prospective randomized clinical trial (RCT), the effectiveness of two interventions approaches will be evaluated in their ability to reduce HIV drug and sex-related risk behaviors among IDUs in Ukraine. Using an intent to treat design, we propose to compare a manually-driven HIV testing and counseling intervention, the Counseling and Education (C & E) model developed during NIDA's Cooperative Agreement (Coyle 1993), with the C & E plus a network-focused intervention that is also manually-driven developed by Latkin (2003) who has agreed to be a consultant. We have assessed both interventions in Ukraine and found them to be effective in reducing risks associated with HIV. They have not, however, been compared to one another and we have not employed a RCT design in our past work. We are proposing this test because: 1. in our recently completed 5-year Ukraine study the C & E intervention alone was as effective as the C & E plus a more intensive individual model; 2. this study also found that those who learned they were HIV infected when tested at baseline, regardless of intervention assignment, reduced their sex risks more than HIV negatives and those who already knew they were positive, underscoring the ethical necessity for testing and counseling and the merits of the C & E; 3. nevertheless, network interventions have the advantage over individually-focused interventions, including the C & E, in their potential to affect a much wider group of injectors, specifically, those who interact with indexes. We will also assess secondary diffusion by 'first wave' network members recruiting 'second wave' network members, something that heretofore has not been done. Assessing two steps out in the network will allow us to examine diffusion, overlap, contamination, and index and network characteristics that predict diffusion and resistance to behavioral change. Both interventions are theoretically- based, manually-driven, translated into Russian and both have been implemented successfully in Ukraine. In addition, because of the high HIV prevalence among IDUs in the sites selected (ranging from 20% to 65% in our past studies), we have included partner disclosure as part of both interventions and brought in Dr. Seth Kalichman, an expert in this area, as a consultant. In collaboration with our Ukraine Co-I, Sergiy Dvoryak, M.D., Ph.D., we will recruit 2250 IDUs, 750 each from Odessa, Makeevka/Donetsk and Nikolayev, who will receive either the network-focused network intervention plus C & E or C & E alone. Participants will be recruited through street outreach, interviewed, intervened with and followed at six and 12 months. In addition to the ACASI, biological samples will be taken to be assessed for HIV and the presence of drug metabolites. PUBLIC HEALTH RELEVANCE: In a randomized clinical trial (RCT) and using an ACASI and biological markers, we will compare the effectiveness of two interventions in reducing HIV drug and sex-related risk behaviors among drug injectors at three sites where we have previously worked and have established relationships. The sites included in this trial were selected because they have three of the four highest numbers of drug users and HIV rates in the country (World Bank 2006; Ministry of Health of Ukraine 2008) and because of their prior demonstration in recruiting and retaining cohorts of IDUs (Booth et al., 2006b).