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在临床试验中招募和纳入感染 HIV 且有阿片类药物使用障碍的个体的障碍和促进因素。

Barriers and facilitators to recruitment and enrollment of HIV-infected individuals with opioid use disorder in a clinical trial.

机构信息

Oregon Health and Science University- Portland State University, School of Public Health, 3181 SW Sam Jackson Park Rd., CB669, Portland, OR, 97239-3088, USA.

Department of Medicine, University of California-San Francisco, San Francisco, CA, USA.

出版信息

BMC Health Serv Res. 2019 Nov 21;19(1):862. doi: 10.1186/s12913-019-4721-x.

Abstract

BACKGROUND

The CTN-0067 CHOICES trial tests implementation of extended-release naltrexone (XR-NTX) versus treatment-as-usual (TAU) for opioid use disorders (OUD) in HIV clinics to improve HIV viral suppression. The study team investigated recruitment strategies to elucidate the barriers and facilitators to recruitment and enrollment in the study.

MAIN TEXT

Methods: Semi-structured, in-depth, digitally recorded interviews were completed with study recruitment-related staff and medical providers (n = 26) from six participating HIV clinics in the fall of 2018. Interviews probed 1) factors that might prevent prospective participants from engaging in study recruitment and enrollment procedures and 2) strategies used by study staff that encourage eligible patient participation. Interviews were transcribed and thematically analyzed using a content analysis approach.

RESULTS

All respondents reported that barriers to recruitment and enrollment included challenging patient social and structural factors (e.g., homelessness or living environments with high substance use, criminal justice involvement), difficulty locating patients with unsuppressed HIV viral load and OUD within the HIV clinic, time-consuming study enrollment processes, and stigma around HIV and OUD which inhibited treatment seeking. Some respondents observed that distrust of research and researchers impeded recruitment activities in the community. A specific medication-related barrier was patient fear of opioid abstinence required prior to XR-NTX induction. Facilitators of recruitment included use of trusted peer outreach/recruitment workers in the community, hospitalizations that offered windows of opportunities for screening and XR-NTX induction, providing participant transportation, and partnerships with harm reduction organizations for referrals.

CONCLUSIONS

Though study personnel encountered barriers to recruitment in the CHOICES study, persons with untreated HIV and OUD can be enrolled in multisite clinical trials by using enhanced recruitment strategies that extend outside of the HIV clinic. Employing peer outreach workers and collaborating with syringe service programs may be especially helpful in facilitating recruitment and merit inclusion in similar study protocols.

摘要

背景

CTN-0067 CHOICES 试验测试了在 HIV 诊所中为阿片类药物使用障碍(OUD)患者实施长效纳曲酮(XR-NTX)与常规治疗(TAU)的实施情况,以改善 HIV 病毒抑制。研究小组研究了招募策略,以阐明招募和入组研究的障碍和促进因素。

主要文本

方法:2018 年秋季,对来自参与研究的六个 HIV 诊所的与研究招募相关的工作人员和医务人员(n=26)进行了半结构化、深入的、数字记录访谈。访谈探讨了 1)可能阻止潜在参与者参与研究招募和入组程序的因素,以及 2)研究人员鼓励符合条件的患者参与的策略。访谈记录被转录,并使用内容分析方法进行主题分析。

结果

所有受访者均表示,招募和入组的障碍包括具有挑战性的患者社会和结构因素(例如,无家可归或生活环境中存在大量药物使用、刑事司法介入)、在 HIV 诊所中难以找到 HIV 病毒载量未得到抑制且存在 OUD 的患者、耗时的研究入组流程以及对 HIV 和 OUD 的污名化,这抑制了对治疗的寻求。一些受访者观察到,对研究和研究人员的不信任阻碍了社区的招募活动。一个特定的与药物相关的障碍是患者对 XR-NTX 诱导前需要阿片类药物戒断的恐惧。招募的促进因素包括在社区中使用受信任的同伴外展/招募工作人员、提供筛查和 XR-NTX 诱导机会的住院治疗、为参与者提供交通、以及与减少伤害组织建立伙伴关系以进行转介。

结论

尽管 CHOICES 研究中的研究人员遇到了招募方面的障碍,但通过使用超越 HIV 诊所的强化招募策略,仍可招募未经治疗的 HIV 和 OUD 患者参加多地点临床试验。雇用同伴外展工作者并与注射器服务项目合作可能特别有助于促进招募,并值得在类似的研究方案中纳入。

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