Community-based accompaniment with supervised antiretrovirals in Lima, Peru

描述（由申请人提供）：我们提出了一个集群随机试验，以评估社区为基础的DOT-HAART对艾滋病毒阳性的个人和社区成员在利马，秘鲁的影响。我们将招募生活在极端贫困中的个体，他们因病毒学失败而开始一线HAART或挽救治疗。那些居住在干预集群将接受12个月的DOT-HAART。我们的目标是：1）评估在开始HAART治疗后18个月和24个月，接受社区DOT-HAART治疗的患者与对照组相比，HIV病毒载量受到抑制的比例; 2）比较DOT-HAART社区成员与对照社区的社会资本; 3）评估社区DOT-HAART的成本效益。这项建议的创新方面包括：（1）对开始HAART治疗的最脆弱人群（即生活在赤贫中的人）进行有针对性的干预;（2）专门为实现长期疗效而设计的基于社区的DOT-HAART干预;（3）成本效益分析;（4）评估干预对社区一级社会资本的影响。这些研究内容将为如何在秘鲁和其他资源贫乏的地区最好地设计和执行DOT-HAART战略提供信息。通过为资源匮乏的环境提供一个实用，有效和具有成本效益的DOT-HAART模型，这项研究的结果可以改善全球努力，在HAART患者中实现良好的长期临床结局。公共卫生相关性：鉴于资源匮乏国家的资源有限，而且扩大人类免疫缺陷病毒（艾滋病毒）治疗的规模很大，因此迫切需要为资源匮乏环境采取具有成本效益和有效的依从性干预措施。尽管越来越多的证据表明，直接观察治疗的高效抗逆转录病毒疗法（DOT-HAART）是有效的，如何最好地应用DOT-HAART在资源匮乏的环境仍然没有答案。开发具有长期疗效的DOT-HAART干预措施，改善目标人群，以及评估成本效益都是迫切需要的科学研究优先事项，以告知在资源有限的情况下实施DOT-HAART的努力。

DESCRIPTION (provided by applicant): We propose a cluster-randomized trial to assess the impact of community-based DOT-HAART on HIV-positive individuals and community members in Lima, Peru. We will enroll individuals living in extreme poverty who are starting either first-line HAART or salvage therapy due to virologic failure. Those residing in intervention clusters will receive 12 months of DOT-HAART. We aim to 1) assess the proportion with suppressed HIV viral load at 18 and 24 months after starting HAART among those receiving community-based DOT-HAART versus the control group; 2) compare social capital among community members in DOT-HAART versus control communities; and 3) assess the cost-effectiveness of community-based DOT-HAART. Innovative aspects of this proposal include 1) a targeted intervention for the most vulnerable subgroup of individuals starting HAART (i.e. those living in extreme poverty); 2) a community- based DOT-HAART intervention designed specifically to achieve long-term efficacy; 3) cost- effectiveness analysis; and 4) assessment of the intervention effect on community-level social capital. These study components will inform how best to design and implement DOT-HAART strategies in Peru and other resource-poor settings. By offering a practical, efficacious and cost-effective model of DOT-HAART for resource-poor settings, the findings of this study could improve global efforts to achieve excellent long-term clinical outcomes among individuals on HAART. PUBLIC HEALTH RELEVANCE: Given the limited resources and magnitude of human immunodeficiency virus (HIV) treatment scale-up in resource-poor countries, cost-effective, efficacious adherence interventions for resource-poor settings are urgently needed. Despite accumulating evidence that directly observed therapy of highly active antiretroviral therapy (DOT- HAART) is effective, how best to apply DOT-HAART in resource-poor settings remains unanswered. Development of DOT-HAART interventions with long-term efficacy, refinement of target populations, and evaluation of cost-effectiveness are all scientific research priorities that are urgently needed to inform efforts to implement DOT-HAART in settings with limited resources.