Community-based accompaniment with supervised antiretrovirals in Lima, Peru

描述（由申请人提供）：我们提出了一项集群随机试验，以评估基于社区的DOT-HAART对秘鲁利马艾滋病毒阳性个体和社区成员的影响。我们将招募因病毒学失败而开始一线高效抗逆转录病毒疗法或补救性治疗的极端贫困人群。居住在干预组的患者将接受12个月的DOT-HAART治疗。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社区成员与对照组社区成员的社会资本；3)评估基于社区的DOT-HAART的成本效益。该建议的创新之处包括：1)针对开始HAART治疗的最脆弱人群（即生活在极端贫困中的人）进行有针对性的干预；2)以社区为基础的DOT-HAART干预，旨在实现长期疗效；3)成本效益分析；4)社区层面社会资本干预效果评价。这些研究内容将为如何在秘鲁和其他资源贫乏的环境中最好地设计和实施dots - haart战略提供信息。通过为资源贫乏的环境提供一种实用、有效和具有成本效益的DOT-HAART模式，本研究的发现可以促进全球努力，在接受HAART治疗的个体中实现良好的长期临床结果。公共卫生相关性：鉴于资源有限和在资源贫乏国家扩大人类免疫缺陷病毒（艾滋病毒）治疗的规模，迫切需要为资源贫乏环境提供具有成本效益和有效的坚持干预措施。尽管越来越多的证据表明直接观察的高效抗逆转录病毒疗法（DOT- HAART）是有效的，但如何在资源贫乏的环境中最好地应用DOT-HAART仍然没有答案。开发具有长期疗效的DOT-HAART干预措施、优化目标人群和评估成本效益都是迫切需要的科学研究重点，以便为在资源有限的环境中实施DOT-HAART提供信息。

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.