Test and Linkage to Care (TLC_IDU) Kenya

描述(由申请人提供)：撒哈拉以南非洲的艾滋病毒感染越来越多地发生在注射吸毒者(IDU)中，这是一个最危险的人群(MARP)。为注射成瘾者提供的循证服务，如针头和注射器交换计划(NSP)、阿片类药物替代疗法(OST)和IDU特异性抗逆转录病毒疗法(ART)依从性支持，在该地区一直不存在。肯尼亚正在进行注射吸毒者的规模估计，并准备推出有史以来第一个国家战略规划。我们的肯尼亚政策领导人、成瘾/行为科学家和模型师团队将利用肯尼亚新的MARPS/NSP平台来寻找注射吸毒者，提供快速艾滋病毒检测、护理点CD4计数和与抗逆转录病毒治疗的链接，并评估肯尼亚大多数注射吸毒者居住的内罗毕和沿海蒙巴萨的社区病毒载量。目的1：采用阶梯式楔形整群随机设计，评估Seek测试治疗保留-‘Testing&Linkage to Care for IDUs’(TLC-IDU肯尼亚)。集群将是规划的n=20个MARP服务站点和n=5个NSP。我们将启动受访者驱动抽样(RDS)，以接触内罗毕和蒙巴萨的注射吸毒者，以确定HIV-1的基线流行率，然后随着服务站点的推出收集七波研究数据，包括PDA的行为数据。团队将进行快速艾滋病毒检测，并转介成瘾/精神健康和OST。HIV阳性患者将接受阳性预防(PWP)咨询和护理点CD4计数。那些患有CD4350/&lt；L的患者将被指派一名同行病例经理，在参与研究的艾滋病毒诊所将此人与抗逆转录病毒治疗联系起来，支持抗逆转录病毒治疗和PWP的坚持和护理保留。同行病例经理和受试者都将收到小额有条件的现金转移，以奖励受试者坚持艾滋病毒护理访问。主要研究结果将包括TLC-IDU启动前后成功关联护理的时间、抗逆转录病毒治疗的时间以及社区病毒载量。“社区病毒载量”将通过在n=25个地点中的每个地点从n=10个随机选择的艾滋病毒阳性者中收集样本来确定。这一抽样将在一段时间内分八波进行，以记录传染性(病毒载量中值)的变化。每个时间点(n=1400)有7个病毒载量，采用线性混合效应分析比较干预前后，我们将有很好的能力检测log10病毒载量0.23的变化和~1.5的风险比。目的2：进行数学建模以估计注射注射和性行为网络中的社区病毒载量，并评估TLC-IDU干预对Ro、避免的感染数量和经质量调整的预期寿命的潜在人口水平影响。目的3：从国家支付者的角度评估TLC-IDU模式的增量成本效益比。这项研究将提供世界上第一批关于在撒哈拉以南非洲实施注射吸毒者的寻找、测试、治疗和保留范例的数据。它将展示结构、生物医学和行为干预的组合可以在多大程度上降低传染性。与肯尼亚国家艾滋病毒方案的伙伴关系将使从这项研究中吸取的经验教训能够为其他国家提供参考，这些国家正在考虑如何最好地应对注射吸毒者对这个艾滋病毒负担高的地区艾滋病毒流行病日益增长的贡献。

DESCRIPTION (provided by applicant): HIV infections in sub-Saharan Africa increasingly occur among injecting drug users (IDUs), a most-at-risk population (MARP). Evidence-based services for IDUs such as needle and syringe exchange programs (NSPs), opioid substitution therapy (OST), and IDU-specific antiretroviral therapy (ART) adherence support have been non-existent in this region. Kenya is conducting size estimations of IDUs and is preparing to launch first-ever NSPs. Our team of Kenyan policy leaders, addiction/behavioral scientists and modelers will leverage Kenya's new MARPs/NSP platform to seek out IDUs, deliver rapid HIV testing, point of care CD4 count and link to ART, and evaluate community viral load in Nairobi and coastal Mombasa, where most IDUs in Kenya reside. Aim 1: Evaluate seek test treat retain - 'Testing & Linkage to Care for IDUs' (TLC-IDU Kenya) - using a stepped wedge cluster-randomized design. Clusters will be the planned n=20 MARP service sites and n=5 NSPs. We will initiate respondent-driven sampling (RDS) to reach IDUs in Nairobi and Mombasa for baseline HIV-1 prevalence determination, and then collect seven waves of study data as service sites roll out, including behavioral data on PDAs. Teams will do rapid HIV testing and refer for addiction/mental health and OST. HIV-positives will receive prevention with positives (PwP) counseling and point of care CD4 counts. Those with CD4 <350/<L will be assigned a peer case manager to link the person to ART at study-participating HIV clinics, support ART and PwP adherence and care retention. Both peer case managers and subjects will receive small conditional cash transfers for subject's adherence to HIV care visits. Primary study outcomes will include time to successful linkage to care, time to ART, and community viral load before and after the TLC-IDU initiation. 'Community viral load' will be ascertained by collecting specimens from n=10 randomly-selected HIV-positives at each of n=25 sites. This sampling will be done in eight waves over time, to document changes in infectivity (median viral load). With seven individual viral loads per site per time step (n=1400) we will have good power to detect log10 viral load changes of 0.23 and hazard ratios of ~1.5 when comparing pre- and post-intervention period using linear mixed effects analysis. Aim 2: Conduct mathematical modeling to estimate community viral load in IDU injecting and sexual networks, and to assess potential population-level impact of the TLC-IDU intervention on Ro, numbers of infections averted, and quality-adjusted life expectancy. Aim 3: Assess the incremental cost-effectiveness ratio of the TLC-IDU model, using a national payer perspective. This study will provide among the world's first data regarding implementation of the seek, test, treat and retain paradigm with IDUs in sub-Saharan Africa. It will demonstrate the degree to which a combination of structural, biomedical and behavioral interventions can reduce infectivity. Partnership with Kenya's national HIV program will allow lessons learned from this study to inform other countries considering how best to address the growing IDU contribution to the HIV epidemic in this high-HIV-burden region.