Biondi Breanne E, Mohanty Subhasis, Wyk Brent Vander, Montgomery Ruth R, Shaw Albert C, Springer Sandra A
Department of Internal Medicine, Section of Infectious Diseases, AIDS Program, Yale School of Medicine, New Haven, CT, USA.
Department of Internal Medicine, Section of Geriatrics, Yale School of Medicine, New Haven, CT, USA.
Contemp Clin Trials Commun. 2021 Jan 6;21:100704. doi: 10.1016/j.conctc.2021.100704. eCollection 2021 Mar.
Opioid use disorder (OUD) negatively impacts the HIV continuum of care for persons living with HIV. Medication treatment for OUD (MOUD) may have differential biological effects in individuals with HIV and OUD. To address the question of modulation of immune responses by MOUDs, we describe state of the art systems biology approaches to carry out the first prospective, longitudinal study of persons with and without HIV infection with OUD initiating MOUD.
A prospective cohort study of persons with DSM-5 diagnosed OUD who are living with and without HIV infection and initiating treatment with methadone or buprenorphine is underway to assess biological effects of these medications on immunobiological outcomes.
We describe the recruitment, laboratory, and statistical methods of this study as well as the protocol details. Of those screened for enrollment into the study, 468 (36%) were eligible and 135 were enrolled thus far. Retention through month 6 has been high at 80%.
This study will use state of the art systems biology approaches to carry out the first prospective, longitudinal studies of persons living with and without HIV with DSM-5 OUD initiating treatment with MOUD.
阿片类物质使用障碍(OUD)对HIV感染者的HIV连续护理产生负面影响。OUD的药物治疗(MOUD)可能对HIV和OUD患者产生不同的生物学效应。为了解决MOUD对免疫反应的调节问题,我们描述了最先进的系统生物学方法,以对患有和未患有OUD且开始使用MOUD的HIV感染者进行首次前瞻性纵向研究。
一项针对被诊断为患有OUD且感染或未感染HIV并开始接受美沙酮或丁丙诺啡治疗的人群的前瞻性队列研究正在进行,以评估这些药物对免疫生物学结果的生物学效应。
我们描述了本研究的招募、实验室和统计方法以及方案细节。在筛选纳入研究的人群中,468人(36%)符合条件,迄今为止有135人入组。到第6个月时的保留率很高,为80%。
本研究将采用最先进的系统生物学方法,对患有和未患有HIV且被诊断为患有DSM-5 OUD并开始接受MOUD治疗的人群进行首次前瞻性纵向研究。