Making it last: A randomized, controlled trial of a home care system to promote persistence in PrEP care

项目总结/摘要 艾滋病毒暴露前预防（PrEP）已在疗效和有效性试验中显示， 保护，其中超过95%的保护与可测量的药物水平，表明 坚持。这提供了一个巨大的公共卫生机会，美国疾病控制中心和 美国疾病预防控制中心（CDC）估计，大约有120万美国成年人有资格接受PrEP，其中包括492，000人 男男性接触者PrEP处方呈指数级增长，2012年至2015年期间， 美方疾病预防控制中心和世卫组织发布的指南要求对PrEP患者进行季度随访，包括 行为和实验室评估，以及根据需要进行治疗或咨询。目前，那些在PrEP 必须亲自与他们的医疗提供者进行这种服务，这一系统给他们带来了很大的负担。 提供者和患者。如果要扩大PrEP的规模，以覆盖美国符合条件的高风险MSM， 我们估计每年需要超过150万人次的病人就诊，这对寻求 将PrEP推向规模。将PrEP规模化的一个相关问题是，患者可能无法坚持PrEP护理 随着时间这一点尤其令人担忧，因为那些艾滋病毒感染风险最高的患者 已经观察到，随着时间的推移，年轻和黑人MSM更有可能不坚持PrEP护理。 拟议的研究旨在使PrEP规模扩大更加可行，并增加PrEP护理的持久性， 开发一个以家庭为基础的监测和支持系统，以减轻对季度， 提供者访问。我们建议进行随机对照试验，以确定参与者是否 (half黑人，一半年龄在18-34岁之间）随机分配到家庭护理PrEP系统， 根据生物标志物和自我报告确定的相对于标准护理对照参与者的PrEP护理。的 试验将在佐治亚州亚特兰大、马萨诸塞州波士顿、密西西比州杰克逊和密苏里州圣路易斯的研究中心进行。我们还将 对试验结果进行混合方法评估，并评估家庭护理的成本效益 系统

PROJECT SUMMARY/ABSTRACT HIV pre-exposure prophylaxis (PrEP) has been shown in efficacy and effectiveness trials to achieve high levels of protection, with over 95% protection among those with measurable levels of medication that indicate adherence. This provides a substantial public health opportunity, with the US Centers for Disease Control and Prevention (CDC) estimating that approximately 1.2 million US adults are eligible for PrEP, including 492,000 MSM. PrEP prescriptions are growing exponentially, with over 79,000 prescriptions between 2012 and 2015 in the US. Guidance issued by CDC and by WHO calls for quarterly follow-up visits for those on PrEP, to include behavioral and laboratory assessments, and treatment or counseling as needed. Currently, those on PrEP must have in-person visits with their medical provider for such services, a system that places a large burden on both providers and patients. If PrEP were to be scaled up to cover eligible, high-risk MSM in the United States, we estimate over 1.5 million yearly patient visits would be required, a substantial burden on clinics seeking to bring PrEP to scale. A related problem with bringing PrEP to scale is that patients may not persist in PrEP care over time. This is particularly concerning because those patients in demographics with highest risk for HIV acquisition, young and Black MSM, have been observed to be more likely to not persist in PrEP care over time. The proposed research seeks to make PrEP scale-up more feasible and to increase persistence in PrEP care, by developing a home-based monitoring and support system that would alleviate the need for quarterly, in- person provider visits. We propose to conduct a randomized, controlled trial to determine whether participants (half Black, half aged 18-34) randomized to the home care PrEP system have higher levels of retention in PrEP care relative to standard of care control participants, as determined by biomarker and self-report. The trial will be conducted at sites in Atlanta, GA, Boston, MA, Jackson, MS, and St. Louis, MO. We will also conduct a mixed-methods assessment of trial results, and assess the cost-effectiveness of the home care system.