Phase II RCT of Comprehensive Triaged HIV Prevention: Tanzania (Supplement)

描述（由申请人提供）：尽管在撒哈拉以南非洲进行了20年相当大的艾滋病毒预防工作，但这一流行病继续产生破坏性影响。本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，但也增加了整个预防和护理工作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，而不仅仅是项目是否同时发生。此外，需求很大，服务有限。为了最大限度地在人口水平上减少艾滋病毒发病率，重要的是，那些最有可能传播和感染艾滋病毒的人得到更密集的干预。然而，大多数项目只针对人口水平，按群体划分，没有单独分类服务的机制。干预措施取得成功的另一个主要障碍是缺乏对高危人群在获得服务方面面临的结构性障碍的关注。我们建议对一项有希望的艾滋病毒预防战略进行一项严格的为期3年的二期试验，该战略旨在显著降低艾滋病毒普遍严重流行的发展中国家农村地区的人口水平的艾滋病毒发病率。研究设计是在坦桑尼亚Kisarawe地区的两个农村社区进行的综合分类艾滋病毒预防（CTHP）的两组社区随机对照试验。主要终点是艾滋病毒和性传播感染的发病率。该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，并解决影响利用的主要结构性障碍。组成部分包括：社区动员、以社区为基础的VCT、加强对高风险和艾滋病毒感染客户的咨询、鼓励高风险和艾滋病毒感染客户的性伴侣接受VCT。对于艾滋病毒检测呈阳性的客户，有测试后的社会心理支持，创收活动，协助和积极转诊治疗，以及坚持治疗的支持。干预措施的设计是全面的，但也不昂贵和可复制。我们还将仔细评估该II期试验干预措施的安全性和可接受性。还将进行详细的调解分析，以确定干预的哪些组成部分是最有效的。如果发现令人信服的疗效，并建立安全性和可接受性，该研究将使该项目进入适当的III期试验。

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.