Phase II RCT of Comprehensive Triaged HIV Prevention: Tanzania

描述（由申请人提供）：尽管在撒哈拉以南非洲地区进行了20年的大量艾滋病毒预防工作，但该流行病继续产生破坏性影响。本区域艾滋病治疗和护理范围的扩大提供了重要的救命服务，但也增加了预防和护理工作的协调和服务提供的复杂性。如何最好地结合联合收割机干预策略（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，联合收割机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发生。此外，需求巨大，服务有限。为了最大限度地减少人口中的艾滋病毒发病率，必须对那些最有可能传播和感染艾滋病毒的人采取更密集的干预措施。然而，大多数方案只针对人群，按群体分类，没有机制对个别服务进行分类。干预措施取得成功的另一个主要障碍是对高危人群在获得服务方面面临的结构性障碍缺乏关注。我们建议对一项有希望的艾滋病毒预防战略进行为期3年的严格的第二阶段试验，该战略旨在显著降低艾滋病毒流行严重的农村发展中国家人口艾滋病毒发病率。该研究设计是在坦桑尼亚Kisarawe区的两个人口统计学和艾滋病毒风险相匹配的农村社区进行的综合分类艾滋病毒预防（CTHP）的双臂社区随机对照试验。主要终点是艾滋病毒和性传播感染发病率。干预措施是根据我们过去8年在该领域广泛工作中吸取的经验教训设计的。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，根据客户的风险对干预措施的强度进行分类，并解决利用的关键结构性障碍。组件包括：社区动员、以社区为基础的自愿咨询和检验、加强对高风险和艾滋病毒感染者的咨询、鼓励高风险和艾滋病毒感染者的性伴侣接受自愿咨询和检验。对于艾滋病毒检测呈阳性的客户，提供检测后心理社会支助、创收活动、协助和积极转诊治疗以及坚持治疗支助。干预措施的设计是全面的，但也是廉价和可复制的。我们还将仔细评估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，以确定干预措施的哪些组成部分最有效。如果发现令人信服的疗效，并确定安全性和可接受性，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.