Phase II RCT of Comprehensive Triaged HIV Prevention: Tanzania

描述(由申请人提供)：尽管撒哈拉以南非洲20年来作出了相当大的艾滋病毒预防努力，但这一流行病继续产生破坏性影响。该区域艾滋病治疗和护理的扩大提供了重要的挽救生命的服务，但也增加了预防和护理工作中的协调和服务提供的复杂性。如何最好地结合干预策略(预防、治疗、护理、行为、生物医学)是该领域的一个紧迫问题。我们认为，结合干预措施的最佳方式是基于协同作用，干预措施的组成部分直接相互加强，而不仅仅是方案是否同时进行。此外，需求巨大，服务有限。为了最大限度地减少艾滋病毒发病率，最有可能传播和感染艾滋病毒的人必须得到更密集的干预措施。然而，大多数计划只针对人口层面，按群体进行，并且没有单独对服务进行分类的机制。成功干预的另一个主要障碍是没有注意到高危人群在获得服务方面面临的结构性障碍。我们建议对一项前景看好的艾滋病毒预防战略进行为期3年的严格第二阶段试验，该战略旨在显着减少在艾滋病毒普遍严重流行的农村发展中国家的人口水平艾滋病毒发病率。这项研究设计是一项双臂社区随机对照试验，在坦桑尼亚基萨拉韦地区人口统计学和艾滋病毒风险匹配的两个农村社区进行综合分诊艾滋病毒预防(CTHP)。主要终点是艾滋病毒和性传播感染的发病率。这一干预措施是根据我们过去8年在该地区广泛工作的经验教训而设计的。该干预措施将基于社区的检测和咨询与治疗和护理联系起来，将干预强度与客户的风险进行分类，并解决了使用的关键结构性障碍。内容包括：社区动员、以社区为基础的VCT、加强对高危和艾滋病毒感染者的咨询、鼓励高危和艾滋病毒感染者的性伴侣接受VCT。对于艾滋病毒检测呈阳性的客户，有测试后的心理社会支持、创收活动、协助和积极转介治疗，以及坚持治疗支持。干预措施的设计是全面的，但也是廉价的和可复制的。我们还将仔细评估这项第二阶段试验中干预措施的安全性和可接受性。还将进行详细的调解分析，以确定干预的哪些部分最有效。这项研究将使该项目进入适当动力的第三阶段试验，如果发现令人信服的疗效，并建立安全性和接受性。 公共卫生相关性：为了最大限度地提高撒哈拉以南非洲地区艾滋病毒预防、治疗和护理支出的公共卫生效益，需要制定方案，协同结合干预战略，根据风险对干预措施的强度进行分类，并减轻利用的结构性障碍。这项研究的目的是在坦桑尼亚的基萨拉韦检验一项旨在解决这三个主题的第二阶段试验的干预效果。该干预措施仔细整合了社区动员、VCT和治疗部分，如果发现有效，将提供必要的计划和政策指导，对公共卫生具有非常重要的意义。

DESCRIPTION (provided by applicant): Despite 20 years of considerable HIV prevention efforts in Sub Saharan Africa the epidemic continues to have devastating impacts. The advent of expansion of treatment and care for AIDS in the region has provided important and lifesaving services, but has also added complexity to coordination and service delivery across prevention and care efforts. How to best combine intervention strategies (prevention, treatment, care, behavioral, biomedical) is a pressing question in the field. We believe that the best way to combine interventions is based on synergy, with intervention components directly reinforcing one another, not just whether programs occur simultaneously. In addition, needs are great and services limited. To achieve the maximum population-level reduction in HIV incidence it is important that those at greatest risk of transmitting and acquiring HIV receive more intensive interventions. Yet most programs target only at the population level, by groups, and do not have mechanisms to triage services individually. The other major impediment to successful interventions is the lack of attention to the structural barriers that at-risk populations face in accessing services. We propose to conduct a rigorous 3-year Phase II trial of a promising HIV prevention strategy designed to significantly reduce population-level HIV incidence in rural developing country settings with severe generalized HIV epidemics. The study design is a two-arm community randomized controlled trial of Comprehensive Triaged HIV Prevention (CTHP) in two rural communities matched on demographics and HIV risks in Kisarawe District, Tanzania. The primary endpoint is HIV and STI incidence. The intervention was designed from lessons learned from our extensive work in the area over the past 8 years. The intervention links community-based testing and counseling to treatment and care, triages intervention intensity to risk of clients, and addresses key structural barriers to utilization. Components include: community mobilization, community-based VCT, enhanced counseling for high risk and HIV-infected clients, incentives for uptake of VCT by sex partners of high risk and HIV-infected clients. For clients who test positive for HIV there is posttest psychosocial support, income generation activities, assisted and active referral to treatment, and adherence support for treatment. The intervention was designed to be comprehensive, but also inexpensive and replicable. We will also carefully assess the safety and acceptability of the intervention in this Phase II trial. Detailed mediation analyses will be also conducted to identify which components of the intervention were most effective. The study will position the project to advance to an appropriately powered Phase III trial should compelling efficacy be found, and safety and acceptance be established. PUBLIC HEALTH RELEVANCE: To maximize the public health benefit of expenditures on HIV prevention, treatment and care in Sub Saharan Africa programs are needed that synergistically combine intervention strategies, triage the intensity of interventions to risk, and mitigate structural barrier to utilization. The goal of this study is to examine the efficacy of an intervenion in a Phase II trial designed to address these three themes in Kisarawe, Tanzania. The intervention carefully integrates community mobilization, VCT and treatment components, and if found efficacious would provide needed program and policy guidance highly significant to public health.