Background

People released from correctional facilities face multifactorial barriers to continuing HIV treatment. We hypothesised that barriers faced in the first 6 months of community re-entry would be decreased by a multilevel group-based and peer-led intervention, the Transitional Community Adherence Club (TCAC).

Methods

We did a pragmatic, open-label, individually randomised controlled trial in five correctional facilities in Gauteng, South Africa. Participants aged 18 years and older and receiving antiretroviral therapy (ART) in correctional facilities were enrolled before release and randomly assigned (1:2) to either passive referral (usual care) or TCACs. TCACs followed a 12-session curriculum over 6 months and were facilitated by trained peer and social workers. Participants were followed up by telephone and in person to assess the primary outcome: post-release enrolment in HIV treatment services at 6 months from the date of release. We did an intention-to-treat analysis to determine the effectiveness of TCACs compared with usual care. The trial was registered with the South African National Clinical Trials Register (DOH-27–0419–605) and ClinicalTrials.gov (NCT03340428). This study is completed and is listed as such on ClinicalTrials.gov.

Findings

From March 1, to Dec 13, 2019, we screened 222 individuals and enrolled 176 participants who were randomly assigned 1:2 to the usual care group (n=59) or TCACs (n=117). 175 participants were included in the final analysis. In the usual care group, 21 (36%) of 59 participants had enrolled in HIV treatment services at 6 months, compared with 71 (61%) of 116 in the TCAC group (risk ratio 1·7, 95% CI 1·2–2·5; p=0·0010). No adverse events were reported.

Interpretation

We found strong evidence that a differentiated service delivery model with curriculum and peer support designed specifically to address the needs of people with HIV returning from incarceration improved the primary outcome of enrolment in HIV treatment services. Our approach is a reasonable model to build further HIV treatment continuity interventions for individuals in the criminal justice system in South Africa and elsewhere.

Funding

National Institute of Mental Health.

中文翻译：

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为南非出狱人员提供过渡性社区依从性支持：一项务实、开放标签、随机对照试验

背景

从惩教所释放的人在继续接受艾滋病毒治疗方面面临着多因素的障碍。我们假设，通过基于团体和同伴主导的多层次干预措施，即过渡社区依从俱乐部 (TCAC)，重新进入社区的前 6 个月所面临的障碍将会减少。

方法

我们在南非豪登省的五个惩教设施中进行了一项务实、开放、单独随机对照试验。年龄在 18 岁及以上并在惩教机构接受抗逆转录病毒治疗 (ART) 的参与者在释放前进行登记，并随机分配 (1:2) 到被动转诊（常规护理）或 TCAC。TCAC 遵循为期 6 个月的 12 节课程，并由经过培训的同伴和社会工作者提供协助。通过电话和亲自对参与者进行随访，以评估主要结果：出院后 6 个月后参加艾滋病毒治疗服务。我们进行了意向治疗分析，以确定 TCAC 与常规护理相比的有效性。该试验已在南非国家临床试验注册处 (DOH-27-0419-605) 和ClinicalTrials.gov ( NCT03340428 ) 注册。该研究已完成并在ClinicalTrials.gov上列出。

发现

从2019年3月1日到2019年12月13日，我们筛查了222人并招募了176名参与者，他们被随机分配到常规护理组（n=59）或TCAC组（n=117）。最终分析纳入 175 名参与者。在常规护理组中，59 名参与者中有 21 名 (36%) 在 6 个月时参加了 HIV 治疗服务，而 TCAC 组 116 名参与者中有 71 名 (61%) 参加了治疗服务（风险比 1·7，95% CI 1·2） –2·5；p=0·0010）。没有不良事件的报告。

解释

我们发现强有力的证据表明，专门为满足从监狱返回的艾滋病毒感染者的需求而设计的差异化服务提供模式（包括课程和同伴支持）改善了艾滋病毒治疗服务注册的主要结果。我们的方法是一个合理的模型，可以为南非和其他地方刑事司法系统中的个人建立进一步的艾滋病毒治疗连续性干预措施。

资金

国家心理健康研究所。