Integrating long-acting injectable treatment to improve medication adherence among persons living with HIV and opioid use disorder: study protocol.

IF 3.7 2区 医学 Q1 SUBSTANCE ABUSE Addiction Science & Clinical Practice Pub Date : 2023-10-14 DOI:10.1186/s13722-023-00418-6
Kirsten J Langdon, Anthony E Hitch, Alexandra B Collins, Curt G Beckwith, Sara Becker, Karen Tashima, Josiah D Rich
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Abstract

Background: Oral antiretroviral therapy (ART) has been effective at reducing mortality rates of people with HIV. However, despite its effectiveness, people who use drugs face barriers to maintaining ART adherence. Receipt of opioid agonist treatment, in the context of HIV care, is associated with medication adherence and decreased HIV viral loads. Recent pharmacological advancements have led to the development of novel long-acting, injectable, medications for both HIV (cabotegravir co-administered with rilpivirine) and OUD (extended-release buprenorphine). These therapies have the potential to dramatically improve adherence by eliminating the need for daily pill-taking. Despite the extensive evidence base supporting long-acting injectable medications for both HIV and OUD, and clinical guidelines supporting integrated care provision, currently little is known about how these medications may be optimally delivered to this population. This paper presents the study design for the development of a clinical protocol to guide the delivery of combined treatment for HIV and OUD using long-acting injectable medications.

Methods: The study aims are to: (1) develop a clinical protocol to guide the delivery of combined LAI for HIV and OUD by conducting in-depth interviews with prospective patients, clinical content experts, and other key stakeholders; and (2) conduct This single group, open pilot trial protocol to assess feasibility, acceptability, and safety among patients diagnosed with HIV and OUD. Throughout all phases of the study, information on patient-, provider-, and organizational-level variables will be collected to inform future implementation.

Discussion: Findings from this study will inform the development of a future study to conduct a fully-powered Hybrid Type 1 Effectiveness-Implementation design.

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整合长效注射治疗以提高艾滋病毒和阿片类药物使用障碍患者的药物依从性:研究方案。
背景:口服抗逆转录病毒疗法(ART)在降低艾滋病毒感染者死亡率方面非常有效。然而,尽管它有效,使用药物的人在保持抗逆转录病毒疗法的依从性方面面临障碍。在HIV护理的背景下,接受阿片类激动剂治疗与药物依从性和HIV病毒载量降低有关。最近的药理学进展导致开发了新型长效、可注射的HIV药物(卡博替拉韦与利匹韦林联合给药)和OUD(缓释丁丙诺啡)。这些疗法有可能通过消除每天服药的需要来显著提高依从性。尽管有广泛的证据支持长效注射药物治疗HIV和OUD,以及支持综合护理的临床指南,但目前对如何将这些药物最佳地提供给这一人群知之甚少。本文介绍了开发临床方案的研究设计,以指导使用长效注射药物进行HIV和OUD的联合治疗。方法:本研究旨在:(1)通过对潜在患者、临床内容专家和其他关键利益相关者进行深入访谈,制定一项临床方案,指导联合LAI治疗HIV和OUD;和(2)进行这一单组开放试点试验方案,以评估被诊断为HIV和OUD患者的可行性、可接受性和安全性。在研究的所有阶段,将收集患者、提供者和组织层面变量的信息,为未来的实施提供信息。讨论:这项研究的结果将为未来进行全动力混合动力1型有效性实施设计的研究提供信息。
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来源期刊
Addiction Science & Clinical Practice
Addiction Science & Clinical Practice Psychology-Clinical Psychology
CiteScore
3.90
自引率
10.80%
发文量
64
审稿时长
28 weeks
期刊介绍: Addiction Science & Clinical Practice provides a forum for clinically relevant research and perspectives that contribute to improving the quality of care for people with unhealthy alcohol, tobacco, or other drug use and addictive behaviours across a spectrum of clinical settings. Addiction Science & Clinical Practice accepts articles of clinical relevance related to the prevention and treatment of unhealthy alcohol, tobacco, and other drug use across the spectrum of clinical settings. Topics of interest address issues related to the following: the spectrum of unhealthy use of alcohol, tobacco, and other drugs among the range of affected persons (e.g., not limited by age, race/ethnicity, gender, or sexual orientation); the array of clinical prevention and treatment practices (from health messages, to identification and early intervention, to more extensive interventions including counseling and pharmacotherapy and other management strategies); and identification and management of medical, psychiatric, social, and other health consequences of substance use. Addiction Science & Clinical Practice is particularly interested in articles that address how to improve the quality of care for people with unhealthy substance use and related conditions as described in the (US) Institute of Medicine report, Improving the Quality of Healthcare for Mental Health and Substance Use Conditions (Washington, DC: National Academies Press, 2006). Such articles address the quality of care and of health services. Although the journal also welcomes submissions that address these conditions in addiction speciality-treatment settings, the journal is particularly interested in including articles that address unhealthy use outside these settings, including experience with novel models of care and outcomes, and outcomes of research-practice collaborations. Although Addiction Science & Clinical Practice is generally not an outlet for basic science research, we will accept basic science research manuscripts that have clearly described potential clinical relevance and are accessible to audiences outside a narrow laboratory research field.
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