Background

Gaps in the HIV care continuum contribute to poor health outcomes and increase HIV transmission. A combination of interventions targeting multiple steps in the continuum is needed to achieve the full beneficial impact of HIV treatment.

Methods and findings

Link4Health, a cluster-randomized controlled trial, evaluated the effectiveness of a combination intervention strategy (CIS) versus the standard of care (SOC) on the primary outcome of linkage to care within 1 month plus retention in care at 12 months after HIV-positive testing. Ten clusters of HIV clinics in Swaziland were randomized 1:1 to CIS versus SOC. The CIS included point-of-care CD4+ testing at the time of an HIV-positive test, accelerated antiretroviral therapy (ART) initiation for treatment-eligible participants, mobile phone appointment reminders, health educational packages, and noncash financial incentives. Secondary outcomes included each component of the primary outcome, mean time to linkage, assessment for ART eligibility, ART initiation and time to ART initiation, viral suppression defined as HIV-1 RNA < 1,000 copies/mL at 12 months after HIV testing among patients on ART ≥6 months, and loss to follow-up and death at 12 months after HIV testing. A total of 2,197 adults aged ≥18 years, newly tested HIV positive, were enrolled from 19 August 2013 to 21 November 2014 (1,096 CIS arm; 1,101 SOC arm) and followed for 12 months. The median participant age was 31 years (IQR 26–39), and 59% were women. In an intention-to-treat analysis, 64% (705/1,096) of participants at the CIS sites achieved the primary outcome versus 43% (477/1,101) at the SOC sites (adjusted relative risk [RR] 1.52, 95% CI 1.19–1.96, p = 0.002). Participants in the CIS arm versus the SOC arm had the following secondary outcomes: linkage to care regardless of retention at 12 months (RR 1.08, 95% CI 0.97–1.21, p = 0.13), mean time to linkage (2.5 days versus 7.5 days, p = 0.189), retention in care at 12 months regardless of time to linkage (RR 1.48, 95% CI 1.18–1.86, p = 0.002), assessment for ART eligibility (RR 1.20, 95% CI 1.07–1.34, p = 0.004), ART initiation (RR 1.16, 95% CI 0.96–1.40, p = 0.12), mean time to ART initiation from time of HIV testing (7 days versus 14 days, p < 0.001), viral suppression among those on ART for ≥6 months (RR 0.97, 95% CI 0.88–1.07, p = 0.55), loss to follow-up at 12 months after HIV testing (RR 0.56, 95% CI 0.40–0.79, p = 0.002), and death (N = 78) within 12 months of HIV testing (RR 0.80, 95% CI 0.46–1.35, p = 0.41). Limitations of this study include a small number of clusters and the inability to evaluate the incremental effectiveness of individual components of the combination strategy.

Conclusions

A combination strategy inclusive of 5 evidence-based interventions aimed at multiple steps in the HIV care continuum was associated with significant increase in linkage to care plus 12-month retention. This strategy offers promise of enhanced outcomes for HIV-positive patients.

Trial registration

ClinicalTrials.gov NCT01904994.

中文翻译：

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链接和保留联合疗法在斯威士兰成人HIV护理中的有效性：Link4Health集群随机试验

背景

艾滋病毒保健连续体中的空白会导致不良的健康状况并增加艾滋病毒的传播。需要采取针对连续步骤中多个步骤的干预措施，以实现HIV治疗的充分有益效果。

方法和发现

Link4Health是一项整群随机对照试验，评估了联合干预策略（CIS）与护理标准（SOC）在1个月内与护理相关联的主要结局以及HIV阳性后12个月仍保持护理的有效性测试。斯威士兰的十个HIV诊所按1：1的比例随机分配给CIS和SOC。CIS包括HIV阳性检测时的即时CD4 +检测，针对符合治疗条件的参与者的加速抗逆转录病毒疗法（ART）启动，手机预约提醒，健康教育套餐以及非现金财务激励措施。次要结局包括主要结局的各个组成部分，平均联动时间，ART资格评估，ART发起和ART发起时间，病毒抑制定义为HIV-1 RNA <1 ≥6个月ART的患者在接受HIV检测后12个月时000拷贝/ mL，在接受HIV检测后12个月时失去随访并死亡。2013年8月19日至2014年11月21日，共有2197名年龄≥18岁的成年人（新检测出HIV阳性）入组（独联体部门1,096名； SOC部门1,101名），并随访了12个月。参与者的中位年龄为31岁（IQR 26-39），女性为59％。在意向性分析中，独联体站点的参与者达到了主要结果的比例为64％（705 / 1,096），而SOC站点的参与者为43％（477 / 1,101）（校正后相对风险[RR] 1.52，95％CI 1.19–1.96，1,101 SOC臂），然后跟踪12个月。参与者的中位年龄为31岁（IQR 26-39），女性为59％。在意向性分析中，独联体站点的参与者达到了主要结果的比例为64％（705 / 1,096），而SOC站点的参与者为43％（477 / 1,101）（校正后相对风险[RR] 1.52，95％CI 1.19–1.96，1,101 SOC臂），然后跟踪12个月。参与者的中位年龄为31岁（IQR 26-39），女性为59％。在意向性分析中，独联体站点的参与者达到了主要结果的比例为64％（705 / 1,096），而SOC站点的参与者为43％（477 / 1,101）（校正后相对风险[RR] 1.52，95％CI 1.19–1.96，p = 0.002）。CIS组和SOC组的参与者具有以下次要结局：12个月时无论是否保留，都可以进行护理联动（RR 1.08，95％CI 0.97-1.21，p = 0.13），平均联动时间（2.5天比7.5天） ，p = 0.189），在12个月内仍保持护理（无论何时建立联系）（RR 1.48，95％CI 1.18–1.86，p = 0.002），ART资格评估（RR 1.20，95％CI 1.07-1.34，p = 0.004），抗病毒治疗的起始时间（RR 1.16，95％CI 0.96-1.40，p = 0.12），从HIV检测开始至抗病毒治疗的平均时间（7天对14天，p <0.001），抗病毒治疗的抗病毒药≥6个月（RR 0.97，95％CI 0.88–1.07，p= 0.55），HIV检测后12个月随访失败（RR 0.56，95％CI 0.40-0.79，p = 0.002），HIV检测12个月内死亡（N = 78）（RR 0.80，95％） CI 0.46-1.35，p = 0.41）。该研究的局限性包括少数几个集群以及无法评估组合策略中各个组成部分的增量有效性。

结论

旨在针对艾滋病毒护理连续性中多个步骤的包括5种基于证据的干预措施的联合策略与护理联系的显着增加以及12个月的保留时间有关。该策略有望为HIV阳性患者带来更好的治疗效果。

试用注册

ClinicalTrials.gov NCT01904994。