Test and Linkage to Care (TLC_IDU) Kenya

描述（由申请人提供）：在撒哈拉以南非洲，艾滋病毒感染越来越多地发生在注射吸毒者（IDUs）中，这是最危险的人群（MARP）。针对注射吸毒者的循证服务，如针头和注射器交换计划（NSPs）、阿片类药物替代治疗（OST）和针对注射吸毒者的抗逆转录病毒治疗（ART）依从性支持，在该地区一直不存在。肯尼亚正在对注射吸毒者的规模进行估计，并准备启动有史以来第一个国家战略计划。我们的肯尼亚政策领导人、成瘾/行为科学家和建模人员团队将利用肯尼亚新的marp /NSP平台寻找注射吸毒者，提供快速艾滋病毒检测、护理点CD4计数和与ART的联系，并评估内罗毕和蒙巴萨沿海地区的社区病毒载量，肯尼亚大多数注射吸毒者居住在那里。目的1：使用阶梯楔形聚类随机设计评估寻求检测治疗保留-“检测与idu护理联系”（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），覆盖内罗毕和蒙巴萨的注射吸毒者，以确定HIV-1的基线流行率，然后在服务站点推出时收集七波研究数据，包括pda的行为数据。各小组将进行快速艾滋病毒检测，并转诊成瘾/心理健康和性病。艾滋病毒阳性者将接受阳性预防（PwP）咨询和护理点CD4计数。那些CD4 <350/<L的患者将被指派一名同伴病例管理人员，在参与研究的艾滋病毒诊所将其与抗逆转录病毒疗法联系起来，支持抗逆转录病毒疗法和PwP的依从性和护理保留。同伴病例管理人员和受试者都将获得小额有条件现金转移，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开始前后成功连接到护理的时间、抗逆转录病毒治疗的时间和社区病毒载量。“社区病毒载量”将通过从n=25个站点中的每个站点随机选择的n=10个艾滋病毒阳性者收集标本来确定。该采样将在一段时间内分八波进行，以记录传染性（中位病毒载量）的变化。在使用线性混合效应分析比较干预前后期间时，每个位点每个时间步长有7个单独的病毒载量（n=1400），我们将有很好的能力检测到0.23的log10病毒载量变化和~1.5的风险比。目的2：通过数学建模来估计IDU注射网络和性网络中的社区病毒载量，并评估TLC-IDU干预对Ro、避免感染数量和质量调整预期寿命的潜在人群水平影响。目标3：使用国家付款人的视角，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对注射吸毒者实施寻找、检测、治疗和保留模式的数据。它将展示结构、生物医学和行为干预相结合可以降低传染性的程度。与肯尼亚国家艾滋病毒方案建立伙伴关系将使从这项研究中吸取的经验教训为其他国家提供参考，以考虑如何最好地解决在这一艾滋病毒高负担地区日益严重的注射吸毒者对艾滋病毒流行的影响。

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. PUBLIC HEALTH RELEVANCE: Interventions for injecting drug users (IDUs) in sub-Saharan African have been almost entirely absent, despite the fact that in countries like Kenya they contribute a growing proportion of incident HIV infections. This study will leverage a historic needle exchange program (NSP) for this most-at-risk population (MARP) in Kenya to seek out IDUs, deliver rapid HIV testing, point of care CD4 count and link to ART using peer case managers and evaluate community viral load impact using a stepped wedge cluster-randomized design. Lessons learned will have important applicability throughout sub-Saharan African.