Phase II RCT of Comprehensive Triaged HIV Prevention: Tanzania

综合分类艾滋病毒预防的 II 期随机对照试验：坦桑尼亚

• 批准号: 8514078
• 负责人: Michael D Sweat
• 金额: $ 53.47万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-07-19 至 2015-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8514078
• 关键词: AIDS prevention; Acquired Immunodeficiency Syndrome; Address; Africa South of the Sahara; Area; Attention; Behavior Control; Behavioral; Caring; Characteristics; Client; Clinical Trials Design; Collaborations; Communities; Community Health Systems; Continuity of Patient Care; Cost Analysis; Counseling; Couples; Data; Developing Countries; Epidemic; Ethics; Expenditure; Face; Funding; Generations; Glean; Goals; HIV; HIV Seropositivity; HIV prevention trial; HIV risk; Health; Health Benefit; Household; Human Herpesvirus 2; Human immunodeficiency virus test; Incentives; Incidence; Income; Intervention; Learning; Link; Maps; Mediation; National Institute of Mental Health; Ownership; Persons; Phase; Phase II Clinical Trials; Phase III Clinical Trials; Policies; Population; Populations at Risk; Positioning Attribute; Prevention; Prevention strategy; Preventive Intervention; Program Effectiveness; Program Efficiency; Psychosocial Assessment and Care; Public Health; Qualitative Research; Randomized; Randomized Controlled Trials; Reporting; Research; Research Design; Research Infrastructure; Risk; Risk Behaviors; Risk Factors; Risk Reduction; Rural; Rural Community; Safety; Services; Sexual Partners; Sexually Transmitted Diseases; Site; Syphilis; Tanzania; Testing; Training; Triage; Universities; Work; arm; base; cost; cost effective; demographics; design; experience; high risk; intervention effect; member; neighborhood safety; nutrition; programs; sex risk; social stigma; successful intervention; treatment adherence; treatment center; uptake

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.

描述（由申请人提供）：尽管 20 年来撒哈拉以南非洲地区做出了大量艾滋病毒预防工作，但该流行病仍然造成破坏性影响。该地区艾滋病治疗和护理范围的扩大提供了重要的救生服务，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进行。此外，需求很大，但服务有限。为了最大限度地降低人口水平的艾滋病毒发病率，重要的是那些传播和感染艾滋病毒风险最大的人接受更强化的干预措施。然而，大多数计划仅针对人口层面的群体，并且没有单独分类服务的机制。成功干预措施的另一个主要障碍是缺乏对高危人群在获得服务时面临的结构性障碍的关注。我们建议对一项有前途的艾滋病毒预防战略进行严格的为期三年的二期试验，该战略旨在显着降低艾滋病毒普遍流行的农村发展中国家的人口艾滋病毒发病率。该研究设计是在坦桑尼亚基萨拉韦区的两个农村社区进行的艾滋病毒综合分类预防 (CTHP) 的双臂社区随机对照试验，与人口统计数据和艾滋病毒风险相匹配。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 年在该领域的广泛工作中吸取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，根据客户的风险对干预强度进行分类，并解决利用的关键结构性障碍。组成部分包括：社区动员、基于社区的 VCT、加强对高风险和 HIV 感染客户的咨询、激励高风险和 HIV 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，我们提供检测后社会心理支持、创收活动、协助和积极转诊治疗以及坚持治疗支持。该干预措施旨在全面、廉价且可复制。我们还将仔细评估本次二期试验干预措施的安全性和可接受性。还将进行详细的中介分析，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功效，并建立安全性和可接受性，该研究将使该项目进入适当动力的 III 期试验。