HIV self-testing to improve the efficiency of PrEP delivery

摘要 最大限度地获得机会和最大限度地减少交付成本是优化公共卫生影响的关键挑战 暴露前预防(PrEP)预防艾滋病毒-1。在非洲，PrEP将增加到已经负担沉重的 卫生基础设施和公共卫生系统负担得起预防接种计划的能力将需要交付 具有成本效益和时间效益。预科交付计划将对人员需求(例如，频繁的 就诊)，如果机会成本(例如，前往诊所和在诊所等待)，患者可能不会继续进行PrEP 都很高。HIV-1检测是PrEP交付的核心：检测高危人群是PrEP启动和 正在进行的HIV-1检测对PrEP的交付至关重要。与PrEP一样，HIV-1自我检测是一项新的创新，其 改善艾滋病毒-1预防的机会尚未完全实现。我们假设HIV-1自身 可以使用测试来简化PrEP的交付-特别是通过减少PrEP跟踪的频率- 通过在家中进行自我测试来取代基于诊所的测试，从而增加诊所就诊次数。新型全血HIV-1自体 检测试剂盒可能比口服液测试更实惠，可能会带来更多的患者和提供者 自信。通过一个多学科协作团队，我们建议解决关键访问和交付成本问题 使用HIV-1自我检测的新方式对PrEP的挑战。我们将进行一项单独随机的 在肯尼亚495名启动PrEP的男女中使用非自卑设计的试验，这些人将是随机的 分配给：每季度就诊一次，进行门诊血液HIV-1检测(标准护理部门)或六次- 每月就诊艾滋病毒-1自我检测在家中的季度(自测组)； 被分配到自我检测的人将被分配到基于口服液或血液的检测。人口将会 包括艾滋病毒-1血清不一致异性夫妇(165名未感染艾滋病毒的男性和165名艾滋病毒-1感染者 未感染的妇女(n=165)和未感染艾滋病毒的妇女(n=165)。6个月和12个月的结果将是 Prep依从性(血液样本中PrEP检测和持续获得补充物)，完成HIV-1 检测和安全性(包括副作用和社会危害)。我们将整合混合方法的工作来理解 与HIV-1自检相关的用户体验、偏好、提供商选项、障碍和促进者 准备背景，以探索两种自检方式(血液和口腔液体)的印象，并考虑 性别和夫妻身份对我们的研究结果的影响。最后，我们还将使用微观成本计算和数学 建模以评估HIV-1自我检测的成本和成本效益，以优化PrEP交付。组合 自我检测和PrEP结合了两种尖端干预措施，以及简单的艾滋病毒-1自我检测战略 这一应用可以提高PrEP的成本效益、覆盖范围和影响，而不会牺牲对HIV-1的保护 和安全。鉴于这一问题具有时间敏感性，并利用我们的经验，我们建议 用三年半的时间做好这项工作。

ABSTRACT Maximizing access and minimizing costs of delivery are key challenges for optimizing the public health impact of pre-exposure prophylaxis (PrEP) for HIV-1 prevention. In Africa, PrEP will be added to an already-burdened health infrastructure and the ability of public health systems to afford PrEP will necessitate making its delivery cost-effective and time-efficient. PrEP delivery programs will be cost-sensitive to staffing needs (e.g., frequent clinic visits), and patients may not continue PrEP if the opportunity costs (e.g., travel to and waiting in clinics) are high. HIV-1 testing is central to PrEP delivery: testing at-risk persons is the first step for PrEP initiation and ongoing HIV-1 testing is essential for PrEP delivery. Like PrEP, HIV-1 self-testing is a new innovation and its opportunities to improve HIV-1 prevention have not yet been fully realized. We hypothesize that HIV-1 self- testing could be used to streamline PrEP delivery – specifically through decreasing the frequency of PrEP follow- up clinic visits by having self-tests at home replace clinic-based testing. New whole blood-based HIV-1 self- testing kits are potentially more affordable than oral fluid tests and may result in greater patient and provider confidence. With a multidisciplinary collaborative team, we propose to address key access and cost of delivery challenges for PrEP by using the new modality of HIV-1 self-testing. We will conduct an individually-randomized trial using a non-inferiority design among 495 women and men in Kenya initiating PrEP who will be randomly assigned to either: quarterly clinic visits with in-clinic blood-based HIV-1 testing (standard of care arm) or six- monthly clinic visits with HIV-1 self-testing at home for quarters between clinic visits (self-testing arm); those assigned to self-testing will be assigned to either oral fluid-based or blood-based testing. The population will include heterosexual HIV-1 serodiscordant couples (n=165 with HIV-1 uninfected men and n=165 with HIV-1 uninfected women) and HIV-1 uninfected women at risk (n=165). The outcomes at 6 and 12 months will be PrEP adherence (PrEP detection in blood samples and persistence in obtaining refills), completion of HIV-1 testing, and safety (including side effects and social harm). We will integrate mixed-methods work to understand user experiences, preferences, provider options, barriers, and facilitators related to HIV-1 self-testing within the PrEP context, to explore impressions of the two self-testing modalities (blood and oral fluid), and to consider the effect of gender and couple status on our findings. Finally, we will also use microcosting and mathematical modeling to assess the cost and cost-effectiveness of HIV-1 self-testing to optimize PrEP delivery. Combining self-testing and PrEP brings together two cutting-edge interventions, and the simple HIV-1 self-testing strategy in this application could improve PrEP’s cost-effectiveness, reach, and impact without sacrificing HIV-1 protection and safety. Given the time-sensitive nature of this question, and leveraging our experience, we propose to conduct this work in 3.5 years.