Community-based accompaniment with supervised antiretrovirals in Lima, Peru

描述(由申请人提供)：我们建议进行一项整群随机试验，以评估秘鲁利马基于社区的DOT-HAART对艾滋病毒阳性个人和社区成员的影响。我们将招收因病毒学失败而开始一线HAART或抢救治疗的极端贫困个人。那些居住在干预组的人将获得12个月的DOT-HAART。我们的目标是1)评估接受基于社区的DOT-HAART的患者和对照组在开始HAART后18个月和24个月HIV病毒载量被抑制的比例；2)比较DOT-HAART和对照社区社区成员的社会资本；以及3)评估基于社区的DOT-HAART的成本效益。这一建议的创新之处包括：1)对开始接受HAART治疗的最脆弱的个人群体(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干预措施，专门为实现长期疗效而设计；3)成本效益分析；以及4)对社区一级社会资本的干预效果进行评估。这些研究内容将介绍如何在秘鲁和其他资源匮乏的环境中最好地设计和实施DOT-HAART战略。通过为资源匮乏的环境提供实用、有效和成本效益高的DOT-HAART模式，这项研究的结果可以促进全球努力，在接受HAART的个体中实现出色的长期临床结果。与公共卫生的相关性：鉴于资源贫乏的国家扩大人类免疫缺陷病毒(艾滋病毒)治疗的资源和规模有限，迫切需要针对资源贫乏的环境采取具有成本效益和有效遵守的干预措施。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，但如何在资源匮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，细化目标人群，评估成本效益，都是迫切需要的科学研究优先事项，以便在资源有限的情况下为实施DOT-HAART的努力提供信息。

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.