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的有效性，以降低乌克兰注射吸毒者中HIV药物和性相关风险行为的能力。使用意向治疗设计，我们建议比较人工驱动的艾滋病毒检测和咨询干预，在NIDA合作协议（Coyle 1993）期间开发的咨询和教育（c&e）模型，以及c&e加上由拉特金（2003）开发的以网络为中心的干预，拉特金已同意担任顾问。我们对乌克兰的两项干预措施进行了评估，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，它们没有被相互比较，我们在过去的工作中也没有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加更密集的个人模型一样有效；2. 这项研究还发现，那些在基线检测时得知自己感染了艾滋病毒的人，无论干预任务如何，其性行为风险的降低程度都高于艾滋病毒阴性和已经知道自己呈阳性的人，这强调了检测和咨询的道德必要性以及C和E的优点；3. 然而，网络干预相对于以个人为重点的干预（包括c&e）具有优势，因为它们有可能影响更广泛的注射者群体，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，这是迄今为止尚未做过的事情。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制行为变化的指数和网络特征。这两种干预措施都是基于理论的、人工驱动的、翻译成俄语的，并且都在乌克兰成功实施。此外，由于在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为20%至65%），我们已将伴侣披露作为两项干预措施的一部分，并聘请了该领域的专家Seth Kalichman博士作为顾问。与我们的乌克兰合作伙伴sergey Dvoryak，医学博士，博士合作，我们将招募2250名idu，分别来自敖德萨，makevka /顿涅茨克和尼古拉耶夫750人，他们将接受以网络为中心的网络干预加上c&e或单独的c&e。参与者将在6个月和12个月时通过街头宣传、访谈、干预和跟踪来招募。除了ACASI外，还将采集生物样本以评估HIV和药物代谢物的存在。

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).