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

项目摘要/摘要 HIV暴露前预防(PrEP)已经在有效性和有效性试验中被证明达到高水平 保护，在那些具有可测量的药物水平的人中具有超过95%的保护，表明 坚持不懈。这提供了一个巨大的公共卫生机会，与美国疾病控制和预防中心 预防(CDC)估计约有120万美国成年人有资格获得预防接种计划，其中包括492,000人 MSM。预科处方呈指数级增长，2012至2015年间处方数量超过79,000张 美国。疾控中心和世卫组织发布的指导意见要求对接受预防接种计划的人进行季度后续检查，包括 进行行为和实验室评估，并根据需要进行治疗或咨询。目前，那些服用PrEP的人 必须亲自拜访他们的医疗提供者以获得此类服务，这一系统给 无论是提供者还是患者。如果将PrEP扩大到覆盖美国合格的高危男男性接触者， 我们估计每年将需要超过150万人次的患者就诊，这对寻求 使PrEP规模化。将PrEP规模化的一个相关问题是，患者可能不会坚持PrEP护理 随着时间的推移。这一点特别令人担忧，因为那些在人口统计中感染艾滋病毒风险最高的患者 据观察，随着时间的推移，年轻和黑人MSM更有可能不会坚持PrEP护理。 拟议的研究旨在使PrEP扩大规模更可行，并增加PrEP护理的持久性， 通过开发基于家庭的监控和支持系统，将减少对季度、在- 人员提供者访问。我们建议进行一项随机对照试验，以确定参与者 (一半是黑人，一半是18-34岁)随机进入家庭护理PrEP系统的人在 由生物标记物和自我报告确定的相对于护理控制参与者标准的准备护理。这个 试验将在佐治亚州亚特兰大、马萨诸塞州波士顿、密苏里州杰克逊和密苏里州圣路易斯进行。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.