Long-acting injectable antiretroviral treatment to improve HIV treatment among justice-involved persons being released to the community

在美国经历监禁的人不成比例地受到艾滋病毒感染和 物质使用障碍(SUD)，并有更高的风险，有不良的健康结果。释放的时间 对于艾滋病毒携带者来说，离开监狱环境，即所谓的重返社区，是一个特别危险的时期 (威尔斯亲王医院)。在社区重建期间维持艾滋病毒治疗和病毒抑制的新的和创造性的方法 迫切需要进入。抗逆转录病毒疗法(ART)在控制艾滋病毒方面非常有效，可以显著 减少艾滋病毒的传播。然而，涉及正义的威尔斯亲王经常与日常的艺术坚持作斗争 重新进入社区，从而经历疾病的发展，并促进艾滋病毒的传播。长- 行为可注射(LAI)ART是一种新的替代方案，有助于克服坚持服用每日服药的挑战。这个 第一个FDA批准的LAI ART方案，卡替格韦(CAB)和利培韦林(RPV)，是通过肌肉注射给药的 每四周注射一次。现在就有机会调查是否使用LAI ART，而不是 对于日常的口述艺术，具有独特而重要的作用，当在殡仪馆开始并在 社区重新进入，目标是改善治疗结果。我们提出了一项混合方法研究，将 开发和试运行专门为社区重新进入而设计的LAI ART协议。这项研究将是 与科里松马里兰州公共安全和惩教服务部合作进行 Health(州立监狱医疗承包商)和Total Health Care，这是一家联邦合格的健康中心 巴尔的摩大都会地区，一个结束艾滋病毒流行的地理热点。以行为模型为框架 对于弱势人群，我们的目标包括：1)与有司法和治疗经验的威尔斯亲王医院进行访谈 (n=20)，以及监狱和社区关键利益攸关方(n=20)，以获得关于发展和 执行一项议定书，将口腔艺术的威尼斯人医院过渡到监狱中的赖氏艺术，并在#年继续 社区重新进入。2)制定初步的LAI艺术社区重返协议，并进行开放标签试点 研究将跟踪10名符合莱阿特治疗资格的被监禁的威尔斯亲王医院，他们即将从监狱获释三个月 以优化方案程序，并试行研究保留方法和评估。3)以下 方案优化，在50例符合LAI条件的监禁重症监护病房中进行试点随机对照试验 ART并计划从监狱释放；参与者将以1：1的随机比例将ART过渡到可注射 CAB/RPV或在释放后六个月内继续每日口腔ART养生法。在.期间 在随访期内，我们将评估抑制艾滋病毒的主要结果和次要结果，包括 继续进行指定的LAI或口腔艺术养生，坚持艺术，并使用物质。这项研究将 提供初步数据，为未来多点全功率临床试验的设计提供参考，该试验将比较LAI 在重新进入社区期间，从艺术到日常口腔艺术，讲述出狱后维持艾滋病毒病毒抑制的能力。

Persons who experience incarceration in the United States are disproportionately impacted by HIV infection and substance use disorders (SUD) and are at increased risk of having poor health outcomes. The time of release from carceral settings, known as community re-entry, is a period of particularly high risk for persons with HIV (PWH). New and creative approaches to sustaining HIV treatment and viral suppression during community re- entry are urgently needed. Antiretroviral treatment (ART) is highly effective in controlling HIV and can significantly reduce HIV transmission. However, justice involved PWH often struggle with daily ART adherence during community re-entry and consequently experience disease progression and contribute to HIV transmission. Long- acting injectable (LAI) ART is a new alternative to help overcome the challenges of adhering to daily pills. The first FDA-approved LAI ART regimen, cabotegravir (CAB) and rilpivirine (RPV), is administered by intramuscular injection every four weeks. There is an immediate opportunity to investigate whether using LAI ART, as opposed to daily oral ART, has a unique and important role when initiated in carceral settings and continued during community re-entry with the goal of improving treatment outcomes. We propose a mixed methods study that will develop and pilot test an LAI ART protocol designed specifically for community re-entry. This study will be conducted in collaboration with the Maryland Department of Public Safety and Correctional Services, Corizon Health (state prison medical contractor), and Total Health Care, a Federally Qualified Health Center in the Baltimore Metropolitan area, an Ending the HIV Epidemic geographic hotspot. Framed by the Behavioral Model for Vulnerable Populations, our aims include: 1) Conduct interviews with justice and treatment experienced PWH (n=20), and carceral and community key stakeholders (n=20), to obtain guidance on the development and implementation of a protocol to transition PWH on oral ART to LAI ART in prison with continuation during community re-entry. 2) Develop an initial LAI ART community re-entry protocol and conduct an open label pilot study that will follow 10 incarcerated PWH eligible for LAI ART who are near release from prison for three months in order to optimize protocol procedures and to pilot study retention methods and assessments. 3) Following optimization of protocol, conduct a pilot randomized controlled trial among 50 incarcerated PWH eligible for LAI ART and scheduled to be released from prison; participants will be randomized 1:1 to transition ART to injectable CAB/RPV or continue daily oral ART regimen through a six-month follow-up period after release. During the follow-up period, we will assess the primary outcome of HIV viral suppression and secondary outcomes including continuance of the assigned LAI or oral ART regimen, ART adherence, and substance use. This study will provide preliminary data to inform the design of a future multi-site fully powered clinical trial that will compare LAI ART to daily oral ART during community re-entry on sustaining HIV viral suppression after release from prison.