Impact and Cost-effectiveness of Safer Conception Strategies for HIV Prevention

描述（由申请人提供）：安全受孕策略对预防艾滋病毒的影响和成本效益本指导研究项目将调查一个在艾滋病毒预防研究中被忽视的紧急公共卫生问题：希望怀孕的艾滋病毒不一致夫妇的生殖需求。在整个撒哈拉以南非洲，绝大多数艾滋病毒感染者是育龄成年人。预防艾滋病毒的文献几乎完全集中在预防性艾滋病毒传播的策略上，在促进100%使用避孕套的背景下，这与怀孕是不相容的，以及在怀孕后预防艾滋病毒的策略，例如在怀孕、分娩和分娩或母乳喂养期间预防母婴传播。虽然已经发表了几篇关于更安全受孕和艾滋病毒预防的评论，最近也制定了临床指南，但还没有系统的研究来审查成本、潜在影响和成本效益，或对不同更安全受孕策略的实际偏好。我提出的指导研究计划将解决艾滋病毒预防研究中的这一关键空白。它由两个阶段组成：第一阶段是一个小型混合方法示范项目，在肯尼亚试点测试更安全的概念准则；第二，研究成本估算和模型的潜在影响和成本效益的指导方针。这些阶段将解决以下目标：(1)开展一个混合方法示范项目，以(i)描述对不同安全概念策略的依从性和偏好，以及（ii）估计在这种情况下对组合安全概念计划的影响建模和设计大规模评估所需的参数。我将与肯尼亚的一个研究小组一起，使用定量和定性的方法来描述不同安全受孕策略的吸收、依从性以及患者和提供者的偏好，并对过程和影响结果以及结果的临床间可变性进行关键的初步估计。这项工作的发现将为目标2和目标3奠定基础；(2)估算成本，并对肯尼亚尼扬扎省艾滋病毒感染不一致夫妇的不同安全受孕策略的影响和成本效益进行建模。我将在实施示范项目期间进行“微观成本计算”以及时间和行动研究，以估计提供更安全的概念方案所需的资源。我将使用来自示范项目的数据和适当的历史队列来模拟在这种情况下，不同的安全受孕干预策略对不和谐夫妇预防艾滋病毒的潜在影响和成本效益；(3)制定一项联合安全受孕干预措施的初步计划，以预防Nyanza地区艾滋病毒不一致夫妇之间的艾滋病毒传播。在与当地利益相关者的参与性研讨会上，我们将批判性地评估研究成果，确定潜在的挑战，确定更安全的受孕干预方案，并制定干预计划。在第4年，我将向NIH提交r系列申请进行大规模研究，以确定干预的影响和估计成本效益。

DESCRIPTION (provided by applicant): Impact and Cost-effectiveness of Safer Conception Strategies for HIV prevention This mentored research project will investigate an urgent public health problem that has been neglected in HIV prevention research: the reproductive needs of HIV-discordant couples who desire pregnancy. Across sub-Saharan Africa, the vast majority of HIV-infected individuals are adults of reproductive age. The HIV prevention literature has almost exclusively focused on strategies to prevent sexual HIV transmission in the context of promoting 100% condom use, which is not compatible with conception, and strategies to prevent HIV after conception has occurred, e.g., prevention of transmission from mother to child during pregnancy, labor and delivery, or breastfeeding. While several reviews on safer conception and HIV prevention have been published and clinical guidelines have recently been developed, there has been no systematic research to examine the costs, potential impact and cost-effectiveness, or actual preferences for different strategies of safer conception. My proposed mentored research plan will address this critical gap in HIV prevention research. It is comprised of two phases: the first phase a small mixed methods demonstration project to pilot test the safer conception guidelines in Kenya; and the second, a study to estimate costs and model the potential impact and cost- effectiveness of the guidelines.These phases will address the following aims: (1) Conduct a mixed-methods demonstration project to (i) characterize adherence to and preferences for different safer conception strategies, and (ii) estimate parameters necessary to model the impact of and design a large-scale evaluation of a combination safer conception program in this setting. I will, with a Kenyan research team, use quantitative and qualitative methodologies to characterize uptake, adherence to, and patient and provider preferences for different safer conception strategies, and generate critical preliminary estimates of process and impact outcomes, and inter-clinic variability in outcomes. The findings from this work will lay the groundwork for Aims 2 and 3; (2) Estimate the cost, and model the impact and cost-effectiveness of different strategies for safer conception for HIV-discordant couples in Nyanza Province, Kenya. I will carry out "micro- costing" and time and motion studies during the implementation of the demonstration project (above) to gather estimates on resources required for providing safer conception options. I will use data from the demonstration project and appropriate historical cohorts to model the potential impact and cost-effectiveness of different strategies of safer conception interventions for HIV prevention among discordant couples in this setting; (3) Develop a preliminary plan for a combination safer conception intervention to prevent HIV transmission among HIV discordant couples in Nyanza. In participatory workshops with local stakeholders, we will critically evaluate the research findings, identify potential challenges, define the safer conception intervention package, and develop an intervention plan. In year 4, I will submit an R-series application to the NIH for a large-scale study to determine the impact and estimate the cost-effectiveness of the intervention.