直接给予接受抗逆转录病毒治疗的感染艾滋病毒的囚犯以治疗，以使其过渡到社区 - 一种改善艾滋病毒治疗结局的潜在途径：一项随机对照试验的基本原理、研究设计和样本特征。
Rationale, study design and sample characteristics of a randomized controlled trial of directly administered antiretroviral therapy for HIV-infected prisoners transitioning to the community - a potential conduit to improved HIV treatment outcomes.
机构信息
Yale University School of Medicine, Department of Medicine, Section of Infectious Diseases, AIDS Program, United States.
出版信息
Contemp Clin Trials. 2012 Mar;33(2):436-44. doi: 10.1016/j.cct.2011.11.002. Epub 2011 Nov 12.
BACKGROUND
HIV-infected prisoners experience poor HIV treatment outcomes post-release. Directly administered antiretroviral therapy (DAART) is a CDC-designated, evidence-based adherence intervention for drug users, yet untested among released prisoners.
METHODS
Sentenced HIV-infected prisoners on antiretroviral therapy (ART) and returning to New Haven or Hartford, Connecticut were recruited and randomized 2:1 to a prospective controlled trial (RCT) of 6 months of DAART versus self-administered therapy (SAT); all subjects received case management services. Subjects meeting DSM-IV criteria for opioid dependence were offered immediate medication-assisted treatment. Trained outreach workers provided DAART once-daily, seven days per week, including behavioral skills training during the last intervention month. Both study groups were assessed for 6 months after the intervention period. Assessments occurred within 90 days pre-release (baseline), day of release, and then monthly for 12 months. Viral load (VL) and CD4 testing was conducted baseline and quarterly; genotypic resistance testing was conducted at baseline, 6 and 12 months. The primary outcome was pre-defined as viral suppression (VL<400 copies/mL) at 6 months.
RESULTS
Between 2004 and 2009, 279 participants were screened, of which 202 met eligibility criteria and 154 were ultimately enrolled in the study; 103 subjects were randomized to DAART and 51 to SAT. Subjects were mostly male (81.2%), people of color (87.0%), had an alcohol use disorder (39.7%), had underlying depression (54.2%), were virally suppressed (78.8%) and had a mean CD4=390.7 cells/mL.
CONCLUSIONS
Outcomes from this RCT will contribute greatly to HIV treatment outcomes after release from prison, a period associated with adverse HIV and other medical consequences.
背景
感染艾滋病毒的囚犯在获释后艾滋病毒治疗效果不佳。直接给予抗逆转录病毒疗法（DAART）是美国疾病控制与预防中心指定的、针对吸毒者的循证药物依从性干预措施，但尚未在获释囚犯中进行测试。
方法
正在接受抗逆转录病毒疗法（ART）治疗且返回康涅狄格州纽黑文或哈特福德的感染艾滋病毒的已判刑囚犯被招募并以 2:1 的比例随机分配到为期 6 个月的直接给予抗逆转录病毒疗法（DAART）与自我给予治疗（SAT）的前瞻性对照试验（RCT）中；所有参与者均接受病例管理服务。符合 DSM-IV 阿片类药物依赖标准的参与者被提供立即的药物辅助治疗。经过培训的外展工作人员每周 7 天每天提供一次 DAART，包括在最后一个干预月进行行为技能培训。两组参与者在干预期结束后 6 个月进行评估。评估在释放前 90 天内（基线）、释放当天以及随后每月进行一次，共 12 个月。在基线和每季度进行病毒载量（VL）和 CD4 检测；在基线、6 个月和 12 个月进行基因耐药性检测。主要结局是预先定义的在 6 个月时病毒抑制（VL<400 拷贝/ml）。
结果
在 2004 年至 2009 年间，对 279 名参与者进行了筛查，其中 202 名符合入选标准，最终有 154 名参与者入组研究；103 名参与者被随机分配到 DAART 组，51 名参与者被随机分配到 SAT 组。参与者主要为男性（81.2%）、有色人种（87.0%）、有酒精使用障碍（39.7%）、有潜在抑郁症（54.2%）、病毒抑制（78.8%），平均 CD4=390.7 个细胞/ml。
结论
这项 RCT 的结果将对囚犯获释后的艾滋病毒治疗效果产生重大影响，这一时期与艾滋病毒和其他医疗后果不良有关。
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