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性相关风险行为的能力方面的有效性。使用意向治疗设计，我们建议比较手动驱动的HIV检测和咨询干预，咨询和教育（C & E）模式在NIDA的合作协议（Coyle 1993），与C & E加上网络为重点的干预，也是手动驱动的Latkin（2003）开发的，他已经同意成为一名顾问。我们评估了乌克兰的这两种干预措施，发现它们在减少与艾滋病毒有关的风险方面是有效的。然而，他们没有相互比较，我们也没有在过去的工作中采用随机对照试验设计。我们提出这个测试是因为：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加上更密集的个人模式一样有效; 2.这项研究还发现，那些在基线检测时知道自己感染了艾滋病毒的人，无论干预分配如何，都比艾滋病毒阴性者和那些已经知道自己是阳性的人减少了更多的性风险，强调了检测和咨询的道德必要性以及C & E的优点;然而，网络干预措施的优势在于其可能影响更广泛的注射者群体，特别是那些与指数互动的人，而不是以个人为重点的干预措施，包括C & E。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。评估网络中的两个步骤将使我们能够检查扩散，重叠，污染以及预测扩散和抵抗行为变化的指数和网络特征。这两种干预措施都是以理论为基础，以人为驱动，并已译成俄文，在乌克兰都得到了成功实施。此外，由于所选地点的注射吸毒者中艾滋病毒流行率很高（在我们过去的研究中从20%到65%不等），我们将伴侣披露作为两种干预措施的一部分，并聘请了该领域的专家Seth Kalichman博士担任顾问。与我们的乌克兰Co-I，Sergiy Dvoryak，M.D.合作，哲学博士、我们将从敖德萨、马基耶夫卡/顿涅茨克和尼古拉耶夫招募2250名注射吸毒者，他们将接受以网络为中心的网络干预加C & E或仅接受C & E。参与者将通过街头宣传招募，在6个月和12个月时进行访谈、干预和随访。除ACASI外，还将采集生物样本以评估HIV和药物代谢产物的存在。 公共卫生相关性：在一项随机临床试验（RCT）中，使用ACASI和生物标志物，我们将比较两种干预措施在减少我们以前工作并建立关系的三个地点的药物注射者中与艾滋病毒药物和性相关的风险行为方面的有效性。选择本试验中包括的研究中心是因为它们拥有该国吸毒者人数和艾滋病毒感染率最高的四个研究中心中的三个（世界银行，2006年;乌克兰卫生部，2008年），并且因为它们先前在招募和保留注射吸毒者队列方面的表现（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).