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: 10547852
• 负责人: CURT G BECKWITH
• 金额: $ 21.24万
• 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/10547852
• 关键词: Acquired Immunodeficiency Syndrome; Anti-Retroviral Agents; Area; Baltimore; Behavioral Model; Clinical Trials; Collaborations; Communities; Contractor; Data; Development; Disease Progression; Dose; 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; Outcome; Participant; Patient Recruitments; Persons; Pharmaceutical Preparations; Pilot Projects; Prisons; Procedures; Protocols documentation; Provider; Randomized; Randomized Controlled Trials; Regimen; Relapse; Research; Risk; Role; Safety; 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; base; community reentry; comorbidity; design; drug testing; experience; follow-up; high risk; housing instability; improved; innovation; metropolitan; open label; oral HIV; pill; pilot test; 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.

在美国经历过监禁的人受到艾滋病毒感染和感染的影响尤为严重 物质使用障碍 (SUD)，并且健康状况不佳的风险增加。发布时间 从监狱环境中出来，即所谓的重返社区，对于艾滋病毒感染者来说是一个特别高风险的时期 （艾滋病毒）。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 迫切需要入境。抗逆转录病毒治疗（ART）对于控制艾滋病毒非常有效，并且可以显着 减少艾滋病毒传播。然而，涉及正义的 PWH 经常在日常 ART 坚持方面遇到困难。 重新进入社区并因此经历疾病进展并促进艾滋病毒传播。长的- 作用注射 (LAI) ART 是一种新的替代方案，有助于克服坚持每日服药的挑战。这 第一个 FDA 批准的 LAI ART 方案是卡博特韦 (CAB) 和利匹韦林 (RPV)，通过肌肉注射给药 每四个星期注射一次。现在有机会调查是否使用 LAI ART，而不是 每日口服抗逆转录病毒疗法在监狱环境中启动并在监狱期间持续时具有独特而重要的作用 以改善治疗结果为目标的重返社区。我们提出了一项混合方法研究 开发并试点测试专为社区重新进入而设计的 LAI ART 协议。这项研究将 与马里兰州公共安全和惩教部 Corizo​​n 合作进行 Health（州监狱医疗承包商）和 Total Health Care（位于该州的联邦合格健康中心） 巴尔的摩都会区是终结艾滋病毒流行的地理热点地区。以行为模型为框架 对于弱势群体，我们的目标包括： 1) 对有司法和治疗经验的感染者进行访谈 (n=20) 以及监狱和社区主要利益相关者 (n=20)，以获得有关发展和 实施一项协议，将监狱中接受口服抗逆转录病毒疗法的感染者从口服抗逆转录病毒治疗过渡到 LAI ART，并在 重新进入社区。 2) 制定初始 LAI ART 社区重新进入协议并进行开放标签试点 这项研究将跟踪 10 名符合 LAI ART 条件、即将出狱三个月的被监禁 PWH 以优化方案程序并试点研究保留方法和评估。 3）关注 优化方案，在 50 名符合 LAI 条件的被监禁 PWH 中进行试点随机对照试验 ART 并计划出狱；参与者将以 1:1 的比例随机分配，以将 ART 过渡到注射剂 CAB/RPV 或在出院后六个月的随访期内继续每日口服 ART 治疗方案。期间 随访期间，我们将评估 HIV 病毒抑制的主要结果和次要结果，包括 继续指定的 LAI 或口服 ART 治疗方案、ART 依从性和物质使用。这项研究将 提供初步数据，为未来多中心全功能临床试验的设计提供信息，该试验将比较 LAI 出狱后重返社区期间从 ART 到每日口服 ART，以维持 HIV 病毒抑制。