GH16-002, Botswana: Impact Evaluation of Combination HIV Prevention Interventions

 描述（由申请人提供） 几项新的艾滋病毒预防干预措施已证明在减少艾滋病毒传播方面非常有效，并为遏制和可能扭转撒哈拉以南非洲的流行病带来了希望。模式研究表明，投资于迅速、协调地扩大艾滋病毒循证预防干预措施的组合，包括艾滋病毒检测和咨询、男性包皮环切术、抗逆转录病毒疗法和预防母婴传播，可以显著降低人口一级的艾滋病毒发病率，并可能具有成本效益。如果国家和国际机构要证明进一步投资于综合预防战略是合理的，就需要有严格的循证结果来支持对人口影响的这些预测。 这笔资金的主要目的是完成一项正在进行的关于综合预防一揽子计划对博茨瓦纳人口艾滋病毒发病率的影响的评价，并估计每避免一次艾滋病毒感染的费用。过度干预研究设计是一项配对的社区随机试验，干预组接受联合预防包，对照组接受标准治疗，加强临床、实验室和数据管理。对每个社区随机选择的大约20%的家庭进行基线家庭调查，以（1）建立艾滋病毒发病率队列，（2）估计综合预防一揽子计划的基线和年度覆盖率。每年对参加基线家庭调查的个人进行随访，以评估两个研究组对研究服务的接受情况，并描述主要结局。每年对HIV发病率队列进行随访，以评估36个月内的累积HIV发病率，这是主要的研究结果。 将使用针对4个社区对（4个综合预防社区和4个强化护理社区）中100%家庭的研究结束调查来估计和比较两组之间的综合预防包摄取情况。此外，实验室研究活动将用于绘制研究期间确定的HIV感染者的基因型，以告知加强护理社区和联合预防社区分支的病毒基因型图谱。 如果观察到艾滋病毒感染率下降，关于综合预防干预措施降低艾滋病毒感染率的幅度以及干预措施的成本和成本效益的数据将为政策和方案设计提供关键信息，说明如何最有效地分配有限的资源，以消除艾滋病毒传播。该研究还将提供宝贵的数据，说明将生物有效干预措施的组合扩大到具有影响力的水平的可行性和可接受性。最后，这项研究的数据将提供有关性网络和风险群体的信息，以及在不同环境中实施的最有效方法，从而可以设计更有针对性的艾滋病毒治疗和预防干预措施。

 DESCRIPTION (provided by applicant) Several new HIV prevention interventions have proven to be highly effective at reducing transmission of HIV and have offered hope for containing and possibly reversing epidemics in sub-Saharan Africa. Modeling studies suggest that investment in rapid, coordinated scale-up of a combination of evidence-based HIV prevention interventions, including HIV testing and counseling (HTC), male circumcision (MC), antiretroviral therapy (ART) and prevention of mother-to-child transmission (PMTCT), can significantly reduce population-level HIV incidence and may be cost-effective. Rigorous evidence-based outcomes to support these projections of population-level impact are needed if national and international bodies are to justify further investment in combination prevention strategies. The primary objective of this funding is to complete an ongoing evaluation of the impact of a combination prevention package on population-level HIV incidence in Botswana and estimate the cost per HIV infection averted. The over-arching study design is a pair-matched Community Randomized Trial with an intervention arm that receives the combination prevention package and a control arm that receives standard of care with clinical, laboratory, and data management strengthening. A baseline household survey of approximately 20% of randomly selected households in each community is implemented to (1) establish an HIV incidence cohort and (2) estimate baseline and annual coverage of the combination prevention package. Individuals who enroll in the baseline household survey are followed annually to assess uptake of study services in both study arms and describe major outcomes. The HIV incidence cohort is followed annually to assess cumulative HIV incidence over 36 months, which is the primary study outcome of interest. An end-of-study survey targeting 100% of households in four community pairs (4 combination prevention communities and 4 enhanced care communities) will be used to estimate and compare combination prevention package uptake between arms. Additionally, laboratory research activities will be used to map genotypes from HIV-infected individuals identified during the study to inform viral genotype maps of enhanced care community and combination prevention community arms. Data regarding the magnitude of reduction in HIV incidence with the combination prevention intervention, if a reduction is observed, and the cost and cost-effectiveness of the intervention will provide key information for policy and program design about how to most effectively allocate limited resources to eliminate HIV transmission. The study will also provide valuable data about the feasibility and acceptability of scaling up a combination of biologically efficacious interventions to a level that will have impact. Finally, data from this study will be informative o sexual networks and risk groups and the most effective approaches to implementation in different settings, allowing for the design of more targeted treatment and prevention interventions for HIV.