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受到艾滋病毒感染的影响不成比例， 物质使用障碍（SUD），并在具有不良健康结果的风险增加。放行时 从监狱环境中出来，即重返社区，是艾滋病毒感染者面临特别高风险的时期。 （威尔斯亲王医院）。在社区重建期间持续艾滋病毒治疗和病毒抑制的新的创造性方法 入口是迫切需要的。抗逆转录病毒治疗（ART）在控制艾滋病毒方面非常有效， 减少艾滋病毒传播。然而，涉及正义的PWH经常与日常ART坚持斗争， 重新进入社区，从而经历疾病进展并促进艾滋病毒传播。长- 抗逆转录病毒疗法是一种新的替代疗法，有助于克服坚持每日服用药片的挑战。的 第一个FDA批准的LAI ART方案，卡替拉韦（CAB）和利匹韦林（RPV），通过肌内给药， 每四周注射一次。有一个直接的机会，以调查是否使用赖艺术，而不是 每日口服抗逆转录病毒治疗，具有独特的和重要的作用时，开始在监狱设置和持续期间， 重返社区，以改善治疗结果。我们提出了一个混合方法的研究，将 制定并试点测试一项专门为重返社区设计的LAI ART方案。本研究将 与马里兰州公共安全和惩教服务部合作进行， 健康（州监狱医疗承包商）和全面保健，一个联邦合格的健康中心， 巴尔的摩大都会区，一个结束艾滋病毒流行的地理热点。由行为模型构建 对于弱势群体，我们的目标包括：1）与具有司法和治疗经验的威尔斯亲王医院进行访谈 （n=20），以及社区和社区主要利益相关者（n=20），以获得关于开发和 实施一项议定书，将威尔斯亲王医院的口服抗逆转录病毒疗法过渡到在监狱进行的非传染性抗逆转录病毒疗法，并在 社区重返。2)制定初步的LAI ART社区重返协议并进行开放标签试点 这项研究将跟踪10名符合赖抗逆转录病毒疗法资格的被监禁的威尔斯亲王，他们即将从监狱释放三个月 以优化方案程序并试点研究保留方法和评估。3)以下 优化方案，在50名符合LAI条件的嵌顿PWH中进行初步随机对照试验 ART并计划从监狱释放;参与者将以1：1随机分配，将ART过渡到注射 CAB/RPV或在释放后的6个月随访期内继续每日口服ART方案。期间 随访期间，我们将评估HIV病毒抑制的主要结局和次要结局，包括 继续分配的LAI或口服ART方案，ART依从性和物质使用。本研究将 提供初步数据，为未来多中心充分把握度临床试验的设计提供信息，该试验将比较LAI 在从监狱释放后重返社区维持艾滋病毒抑制期间，将抗逆转录病毒疗法改为每日口服抗逆转录病毒疗法。

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.