Optimizing HIV-care-continuum engagement and outcomes among opioid users

优化阿片类药物使用者的艾滋病毒护理持续参与和结果

• 批准号: 10267559
• 负责人: David Epstein
• 金额: $ 148.88万
• 依托单位: NATIONAL INSTITUTE ON DRUG ABUSE
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10267559
• 关键词: Adherence; Appointment; Behavior; Buprenorphine; CD4 Lymphocyte Count; Caring; Continuity of Patient Care; Formulation; HIV; HIV Seropositivity; HIV-1; Heroin; Human; Injections; Lead; Manufacturer Name; Monitor; Opiate Addiction; Opioid; Opioid agonist; Outcome; Persons; Pharmaceutical Preparations; Pilot Projects; Population; RNA; Randomized; Research; Risk Behaviors; Viral; Viral Load result; Withdrawal; antiretroviral therapy; base; buprenorphine treatment; clinical care; collaborative trial; improved; improved outcome; mortality; opioid use disorder; opioid user; patient engagement; prescription opioid; subcutaneous; therapy adherence; transmission process; treatment as usual; vector; virology

People living with HIV (PLWHs) who inject heroin or other opioids are substantially less likely to engage or be retained in HIV care and less likely to achieve virologic suppression. They also have faster rates of HIV viral progression and higher mortality compared to PLWHs who dont inject drugs. Long-acting formulations of medications for opioid-use disorder present an opportunity to increase patients engagement into the HIV care continuum. A recently developed formulation of buprenorphine provides a continuous window of withdrawal suppression and opioid blockade. This may lead to a cycle of stable behavior on multiple fronts, including greater adherence to antiretroviral therapy (ART), greater attendance to appointments for HIV clinical care, more consistent avoidance of transmission-risk behaviors, and more steadily maintained suppression of viral load. In this pilot study, up to 60 PLWHs in HIV treatment who are also seeking treatment for opioid-use disorder will be randomized to subcutaneous long-acting buprenorphine injections or treatment as usual (e.g., referral to standard office-based buprenorphine treatment) while ART is continued. Over 12 months, we will monitor HIV-1 RNA levels, CD4 lymphocyte count, ART adherence, retention in HIV care, and avoidance of transmission-risk behaviors. We hypothesize that long-acting buprenorphine, compared to treatment as usual, will improve engagement into the HIV care continuum, specifically in stability of viral suppression. We have been working with the manufacturer of a long-acting subcutaneous formulation of buprenorphine to obtain materials for initiation of a collaborative trial. We expect progress to continue when we can resume in-person human research.

注射海洛因或其他阿片类药物的艾滋病毒携带者(PLWHs)不太可能参与或保留在艾滋病毒护理中，也不太可能实现病毒学抑制。与不注射毒品的PLWHs相比，他们的HIV病毒进展速度更快，死亡率更高。治疗阿片类药物使用障碍的长效药物配方提供了一个机会，使患者更多地参与艾滋病毒护理。最近开发的丁丙诺啡配方提供了连续的戒断抑制和阿片类药物阻断窗口。这可能会导致多个方面的稳定行为循环，包括更多地坚持抗逆转录病毒治疗(ART)，更多地参加艾滋病毒临床护理的预约，更一致地避免传播危险行为，以及更稳定地保持对病毒载量的抑制。 在这项试点研究中，多达60名同时寻求阿片类药物使用障碍治疗的艾滋病患者将被随机分配到皮下注射长效丁丙诺啡或照常治疗(例如，转介到标准的办公室丁丙诺啡治疗)，同时继续抗逆转录病毒治疗。在12个月的时间里，我们将监测HIV-1RNA水平、CD4淋巴细胞计数、抗逆转录病毒治疗的依从性、在HIV护理中的保留情况以及避免传播危险行为。我们假设，与通常的治疗相比，长效丁丙诺啡将改善对艾滋病毒连续护理的参与度，特别是在病毒抑制的稳定性方面。 我们一直在与丁丙诺啡长效皮下制剂的制造商合作，以获得启动合作试验的材料。我们预计，当我们能够恢复面对面的人类研究时，进展将继续下去。