Background

Despite the global scale-up of antiretroviral therapy (ART), incarcerated people have not benefited equally from test-and-treat recommendations for HIV. To improve access to ART for incarcerated people with HIV, we introduced a universal test-and-treat (UTT) intervention in correctional facilities in South Africa and Zambia, and aimed to assess UTT feasibility and clinical outcomes.

Methods

Treatment as Prevention (TasP) was a multisite, mixed methods, implementation research study done at three correctional complexes in South Africa (Johnannesburg and Breede River) and Zambia (Lusaka). Here, we report the clinical outcomes for a prospective cohort of incarcerated individuals who were offered the TasP UTT intervention. Incarcerated individuals were eligible for inclusion if they were aged 18 years or older, with new or previously diagnosed HIV, not yet on ART, and were expected to remain incarcerated for 30 days or longer. To enable the implementation of UTT at the included correctional facilities, we first strengthened on-site HIV service delivery. All participants were offered same-day ART initiation, and had two study-specific follow-up visits scheduled to coincide with routine clinic visits at 6 and 12 months. The main outcomes were ART uptake, time from cohort enrolment to ART initiation, and retention in care and viral suppression at 6 and 12 months. We estimated the association between baseline demographic characteristics and time to ART initiation using Cox proportional hazard models, and, in a post-hoc analysis, we used logistic regression models to assess the association between demographic and clinical variables, including time to ART initiation, and the proportion of participants with a composite poor outcome (defined as viral load >50 copies per mL, or for participants with a missing viral load, lack of retention in care in the on-site ART programme) at 6 months. This study is registered at ClinicalTrials.gov, NCT02946762.

Findings

Between June 23, 2016, and Dec 31, 2017, we identified 1562 incarcerated people with HIV, of whom 1389 (89%) were screened, 1021 (74%) met eligibility criteria, and 975 (95%) were enrolled and followed up to March 31, 2018. At the end of follow-up, 835 (86%) of 975 participants had started ART. Median time from enrolment to ART initiation was 0 days (IQR 0–8). Of 346 participants who remained incarcerated at 6 months, 327 (95%) were retained in care and 269 (78%) had a documented viral load, of whom 262 (97%) achieved viral suppression (<1000 copies per mL). The mortality rate among the 835 participants who had initiated ART was 1·9 per 100 person-years (95% CI 0·9–3·9). No statistically significant associations were identified between any baseline characteristics and time to ART initiation or composite poor outcome.

Interpretation

UTT implementation is feasible in correctional settings, and can achieve levels of same-day ART uptake, retention in care, and viral suppression among incarcerated people with HIV that are comparable to those observed in community settings.

Funding

UK Department for International Development, Swedish International Development Cooperation Agency, Norwegian Agency for Development Cooperation.

中文翻译：

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赞比亚和南非教养所的通用试验与治疗：一项多地点前瞻性队列研究。

背景

尽管全球已经扩大了抗逆转录病毒疗法（ART）的规模，但被监禁的人们并未从艾滋病毒的治疗建议中同样受益。为了增加被艾滋病毒监禁者获得抗逆转录病毒疗法的机会，我们在南非和赞比亚的惩教设施中引入了通用测试治疗（UTT）干预措施，旨在评估UTT的可行性和临床结果。

方法

作为预防的治疗（TasP）是一项在南非（Johnannesburg和Breede River）和赞比亚（卢萨卡）的三个惩教综合体进行的多地点，混合方法，实施研究研究。在这里，我们报告了接受TasP UTT干预的被监禁个体的前瞻性队列研究的临床结果。如果被监禁的个人年龄在18岁或18岁以上，且患有新的或先前被诊断出的HIV，但尚未接受抗逆转录病毒治疗，并且有望继续被监禁30天或更长时间。为了在包括的教养设施中实施UTT，我们首先加强了现场HIV服务的提供。为所有参与者提供当日抗病毒治疗起始服务，并安排了两次针对特定研究的随访，以配合6和12个月的常规门诊随访。主要结局是吸收ART，从队列入组到开始ART的时间，以及在6和12个月时仍保持护理和病毒抑制。我们使用Cox比例风险模型估算了基线人口统计学特征与抗病毒治疗开始时间之间的关联，在事后分析中，我们使用了逻辑回归模型评估了人口统计学与临床变量之间的关联，包括抗病毒治疗开始时间，以及6个月时复合不良结果（定义为病毒载量> 50拷贝/ mL，或病毒载量缺失，现场ART计划缺乏护理保留）的参与者比例。该研究已在ClinicalTrials.gov上注册，NCT02946762。并在6和12个月时保持护理和病毒抑制。我们使用Cox比例风险模型估算了基线人口统计学特征与抗病毒治疗开始时间之间的关联，在事后分析中，我们使用了逻辑回归模型评估了人口统计学与临床变量之间的关联，包括抗病毒治疗开始时间，以及6个月时复合不良结果（定义为病毒载量> 50拷贝/ mL，或病毒载量缺失，现场ART计划缺乏护理保留）的参与者比例。该研究已在ClinicalTrials.gov上注册，NCT02946762。并在6和12个月时保持护理和病毒抑制。我们使用Cox比例风险模型估算了基线人口统计学特征与抗病毒治疗开始时间之间的关联，在事后分析中，我们使用了逻辑回归模型评估了人口统计学与临床变量之间的关联，包括抗病毒治疗开始时间，以及6个月时复合结果差（定义为病毒载量> 50拷贝/ mL，或病毒载量缺失，现场ART计划缺乏护理保留）的参与者比例。该研究已在ClinicalTrials.gov上注册，NCT02946762。我们使用逻辑回归模型评估人口统计学和临床​​变量之间的关联，包括开始抗病毒治疗的时间以及复合不良结果（定义为病毒载量> 50拷贝/ mL，或缺少病毒载量的参与者）的比例，在6个月时没有进行现场ART计划的护理。该研究已在ClinicalTrials.gov上注册，NCT02946762。我们使用逻辑回归模型评估人口统计学和临床​​变量之间的关联，包括开始抗病毒治疗的时间以及复合不良结果（定义为病毒载量> 50拷贝/ mL，或缺少病毒载量的参与者）的比例，在6个月时没有进行现场ART计划的护理。该研究已在ClinicalTrials.gov上注册，NCT02946762。

发现

在2016年6月23日至2017年12月31日期间，我们确定了1562名被监禁的HIV感染者，其中筛查了1389名（89％），符合资格标准的1021名（74％），并且招募了975名（95％）并对其进行了随访截止到2018年3月31日。在随访结束时，有975名参与者中的835名（86％）开始了抗逆转录病毒疗法。从注册到开始抗病毒治疗的中位时间为0天（IQR 0-8）。在6个月后仍被监禁的346名参与者中，有327名（95％）被留在护理中，有269名（78％）的病毒载量已记录在案，其中262名（97％）达到了病毒抑制（每毫升<1000份）。发起抗病毒治疗的835名参与者的死亡率为每100人年1·9（95％CI 0·9-3·9）。在任何基线特征和ART开始时间或复合不良预后之间均未发现统计学上的显着关联。

解释

在矫正环境中实施UTT是可行的，与在社区环境中观察到的情况相比，被监禁的HIV感染者在同一天接受ART的水平，护理的保持率和病毒抑制水平都可以达到。

资金

英国国际发展部，瑞典国际发展合作署，挪威发展合作署。