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

长效注射抗逆转录病毒治疗可改善被释放到社区的司法参与人员的艾滋病毒治疗

• 批准号: 10705305
• 负责人: CURT G BECKWITH
• 金额: $ 27.38万
• 依托单位: MIRIAM HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-30 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10705305
• 关键词: Acquired Immunodeficiency Syndrome; Anti-Retroviral Agents; Area; Baltimore; Behavioral Model; Clinical Trials; Collaborations; Communities; Contractor; Creativeness; Data; Development; Disease Progression; Dose; Eligibility Determination; Environment; Epidemic; FDA approved; Federally Qualified Health Center; Funding; Future; Geography; Goals; HIV; HIV Infections; HIV resistance; Health; Healthcare; High Prevalence; Imprisonment; Injectable; Interview; Intramuscular Injections; Jail; Justice; Maryland; Medical; Mental disorders; Methods; Oral; Participant; Patient Recruitments; Persons; Pharmaceutical Preparations; Pilot Projects; Prisons; Procedures; Protocols documentation; Provider; Randomized; Randomized, Controlled Trials; Regimen; Relapse; Research; Risk; Role; Safety; Schedule; Services; Site; Substance Use Disorder; Therapeutic; Time; Treatment Protocols; Treatment outcome; Unemployment; United States; United States National Institutes of Health; Urine; Viral; Viral Load result; Vulnerable Populations; antiretroviral therapy; community reentry; comorbidity; design; drug testing; experience; follow-up; high risk; high risk population; housing instability; improved; innovation; metropolitan; open label; oral HIV; pill; pilot test; poor health outcome; primary outcome; response; secondary outcome; substance use; substance user; transmission process; treatment adherence; viral rebound

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.

在美国经历监禁的人受HIV感染和 药物使用障碍（SUD）的健康状况不佳。释放时间 从Carceral Andings（称为社区重新进入）是艾滋病毒患者的风险特别高的时期 （PWH）。在社区恢复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。抗逆转录病毒治疗（ART）在控制HIV方面非常有效，并且可以显着 减少HIV传播。但是，正义涉及PWH经常在日常艺术依靠期间挣扎 社区重新进入，因此经历了疾病的发展，并导致艾滋病毒传播。长的- 表演可注射（LAI）艺术是一种新的替代方法，可以帮助克服遵守日常药丸的挑战。这 第一个由FDA批准的LAI艺术方案，Cabotegravir（CAB）和Rilpivirine（RPV）由肌内进行管理 每四个星期注射一次。有一个立即调查使用Lai Art的机会 每天口服艺术，在在式环境中发起并继续 社区重新进入，以改善治疗结果。我们提出了一项混合方法研究 开发和试点测试是专门为社区重新进入的LAI艺术协议。这项研究将是 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Total Health Care，是一个联邦资格的健康中心 巴尔的摩大都市地区，结束HIV流行地理热点。由行为模型构建 对于弱势群体，我们的目标包括：1）与正义和治疗的采访经历了PWH （n = 20）以及Carceral and Community主要利益相关者（n = 20），以获取有关开发的指导 实施一项关于口头艺术过渡到监狱中的莱艺术的协议，并在 社区重新进入。 2）制定最初的LAI艺术社区重新进入协议并进行开放标签飞行员 研究将跟随10个被监禁的PWH有资格参加LAI ART的资格，他们将从监狱中释放三个月 为了优化协议程序并进行试验研究保留方法和评估。 3）以下 优化协议，在50个被监禁的PWH中进行试验随机对照试验 艺术并计划从监狱释放；参与者将被随机分配1：1，以转换为可注射的艺术 驾驶室/RPV或释放后六个月的随访期继续每日口腔艺术疗法。在 随访期，我们将评估HIV病毒抑制和次要结果的主要结果 指定的LAI或口腔艺术方案，艺术依从性和药物使用的延续。这项研究会 提供初步数据，以告知未来多站点全功率临床试验的设计，该试验将比较LAI 在社区重新进入监狱后维持艾滋病毒抑制的社区中，每日口腔艺术的艺术。