HIV self-testing to improve the efficiency of PrEP delivery

HIV 自检可提高 PrEP 交付效率

• 批准号: 10053732
• 负责人: Nelly Rwamba Mugo
• 金额: $ 48.73万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-01-20 至 2022-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10053732
• 关键词: Address; Adherence; Africa; Behavioral Sciences; Blood; Blood specimen; Clinic; Clinic Visits; Clinical; Clinical Trials; Cost Analysis; Country; Couples; Data; Detection; Diagnostic Reagent Kits; Enrollment; Fingers; Frequencies; Gender; Guidelines; HIV; HIV-1; Health; Health system; Healthcare Systems; Heterosexuals; Home; Human immunodeficiency virus test; Individual; Infrastructure; Intervention; Interview; Kenya; Liquid substance; Measures; Methods; Modality; Modeling; Nature; Oral; Outcome; Patient Care; Patients; Persons; Population; Prevention; Provider; Public Health; Randomized; Research; Resources; Risk; Safety; Savings; Self Efficacy; Services; Social Sciences; Spottings; Subgroup; Surveys; Testing; Time; Travel; Visit; Whole Blood; Woman; Work; Workload; arm; base; care providers; cost; cost effective; cost effectiveness; cost efficient; design; effectiveness evaluation; experience; follow-up; implementation science; impression; improved; innovation; intervention participants; mathematical model; men; microcosting; multidisciplinary; opportunity cost; pre-exposure prophylaxis; preference; programs; randomized trial; scale up; self testing; side effect; social; standard of care; structured data; tool

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.

抽象的 最大化访问权限并最大程度地降低交付成本是优化公共卫生影响的关键挑战 预防前预防前预防HIV-1的预防。在非洲，将添加预备 卫生基础设施和公共卫生系统负担准备的能力将有必要交付 具有成本效益和时间效益。准备递送计划将对人员配备需求敏感（例如，频率 诊所就诊），如果机会费用（例如，前往诊所旅行并等待），患者可能不会继续准备 很高。 HIV-1测试是准备交付的核心：高危人的测试是准备启动的第一步， 持续的HIV-1测试对于准备交付至关重要。像PREP一样，HIV-1自我测试是一种新的创新，它的创新 改善HIV-1预防的机会尚未完全实现。我们假设HIV-1自我 测试可用于简化PREP交付 - 特别是通过降低PrEP的频率 - 通过在家中进行自我测试来替代基于诊所的测试，以提高诊所的访问。新的全血基HIV-1自我 测试套件可能比口服流体测试更实惠，并且可能导致更大的患者和提供者 信心。与一个多学科合作团队一起，我们建议解决关键访问和交付成本 通过使用HIV-1自我测试的新模式来进行准备的挑战。我们将进行单独的 在肯尼亚的495名男性和男性之间使用非效率设计的试验开始了Prep，他们将随机进行 分配给：季度诊所就诊，基于临床血液的HIV-1测试（护理臂标准）或六 每月在家里进行HIV-1自我测试的诊所就诊，以在诊所就诊之间进行宿舍（自测臂）；那些 分配给自我测试将分配给基于口服流体或基于血液的测试。人口将 包括异性恋HIV-1 SerioDiscordant夫妇（n = 165，HIV-1未感染的男性，n = 165，用HIV-1 n = 165 未感染的妇女）和HIV-1未感染的妇女有危险（n = 165）。 6个月和12个月的结果将是 准备依从性（在血液样本中检测和获得补金的持久性），HIV-1的完成 测试和安全性（包括副作用和社会伤害）。我们将整合混合方法以了解 用户体验，偏好，提供者选项，障碍和与HIV-1自我测试有关的促进者 准备上下文，探索两种自我测试方式的印象（血液和口服流体），并考虑 性别和夫妇身份对我们的发现的影响。最后，我们还将使用微固定和数学 建模以评估HIV-1自测的成本和成本效益，以优化PREP交付。结合 自我测试和准备汇集了两种尖端的干预措施，以及简单的HIV-1自我测试策略 在此应用程序中，可以改善PREP的成本效益，触及和影响，而无需牺牲HIV-1保护 和安全。考虑到这个问题的时间敏感性，并利用我们的经验，我们建议 在3。5年内进行这项工作。

项目成果

Using routine programmatic data to measure HIV incidence among pregnant women in Botswana.

• DOI: 10.1186/s12963-022-00287-2
• 发表时间: 2022-03-04
• 期刊: Population health metrics
• 影响因子: 3.3
• 作者: Ortblad KF;Mawandia S;Bakae O;Tau L;Grande M;Mogomotsi GP;Mmatli E;Ngombo M;Seckel L;Heffron R;Pintye J;Ledikwe J
• 通讯作者: Ledikwe J

Assessing young Kenyan women's willingness to engage in a peer-delivered HIV self-testing and referral model for PrEP initiation: A qualitative formative research study.

• DOI: 10.3389/fpubh.2022.932948
• 发表时间: 2022
• 期刊: FRONTIERS IN PUBLIC HEALTH
• 影响因子: 5.2
• 作者: McGowan, Maureen;Casmir, Edinah;Wairimu, Njeri;Mogere, Peter;Jahn, Albrecht;Ngure, Kenneth;Ortblad, Katrina F. F.;Roche, Stephanie D. D.
• 通讯作者: Roche, Stephanie D. D.

Predictors of male circumcision incidence in a traditionally non-circumcising South African population-based cohort.

传统非包皮环切南非人群中男性包皮环切发生率的预测因子。

• DOI: 10.1371/journal.pone.0209172
• 发表时间: 2018
• 期刊: PloS one
• 影响因子: 3.7
• 作者: Ortblad,KatrinaF;Bärnighausen,Till;Chimbindi,Natsayi;Masters,SamuelH;Salomon,JoshuaA;Harling,Guy
• 通讯作者: Harling,Guy