Division of Infectious Diseases, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA; Department of Global Health, University of Washington, Seattle, WA, USA; Division of Allergy and Infectious Diseases, University of Washington, Seattle, WA, USA.
Department of Biostatistics, University of Washington, Seattle, WA, USA.
Lancet HIV. 2022 Dec;9(12):e848-e856. doi: 10.1016/S2352-3018(22)00254-5. Epub 2022 Nov 3.
Home delivery and monitoring of antiretroviral therapy (ART) is convenient, overcomes logistical barriers, and could increase individual ART adherence and viral suppression. With client payment and sufficient health benefits, this strategy could be scalable. The aim of the Deliver Health Study was to test the acceptability and efficacy of a user fee for home ART monitoring and delivery.
We conducted a randomised trial, the Deliver Health Study, of a fee for home delivery of ART compared with free clinic ART delivery in South Africa. People with HIV who were 18 years or older and clinically stable (including CD4 count >100 cells per μL and WHO HIV stage 1-3) were randomly assigned to: (1) fee for home delivery and monitoring of ART, including community ART initiation if needed; or (2) clinic-based ART (standard of care). The one-time fee for home delivery (ZAR 30, 60, and 90; equivalent to US$2, 4, 6) was tiered on the basis of participant income. The primary outcomes were recorded fee payment and acceptability assessed via questionnaire. The key virological secondary outcome was viral suppression with the difference between study groups assessed through robust Poisson regression including participants with viral load measured at exit (modified intention-to-treat analysis). This trial is registered on ClinicalTrials.gov (NCT04027153) and is complete, with analyses ongoing.
From Oct 7, 2019, to Jan 30, 2020, 162 participants were enrolled; 82 were randomly assigned to the fee for home delivery group and 80 to the clinic-based group, with similar characteristics at baseline. Overall, 87 (54%) participants were men, 101 (62%) were on ART, and 98 (60%) were unemployed. In the home delivery group, 40 (49%), 33 (40%), and nine (11%) participants qualified for the ZAR 30, 60, and 90 fee, respectively. Median follow-up was 47 weeks (IQR 43-50) with 96% retention. 80 (98%) participants paid the user fee, with high acceptability and willingness to pay. In the modified intention-to-treat analysis of 155 (96%) participants who completed follow-up, fee for home delivery and monitoring statistically significantly increased viral suppression from 74% to 88% overall (RR 1·21, 95% CI 1·02-1·42); and from 64% to 84% among men (1·31, 1·01-1·71).
Among South African adults with HIV, a fee for home delivery and monitoring of ART significantly increased viral suppression compared with clinic-based ART. Clients' paying a fee for home delivery and monitoring of ART was highly acceptable in the context of low income and high unemployment, and improved health outcomes as a result. Home ART delivery and monitoring, potentially with a user fee to offset costs, should be evaluated as a differentiated service delivery strategy to increase access to care.
National Institutes of Mental Health.
在家中提供并监测抗逆转录病毒疗法（ART）既方便，又克服了后勤方面的障碍，还可能提高个体接受 ART 的依从性和病毒抑制率。如果有客户付费和足够的健康福利，那么这种策略就具有可扩展性。“Deliver Health 研究”旨在测试收取家庭 ART 监测和交付费用的可接受性和疗效。
我们开展了一项随机试验，即“Deliver Health 研究”，比较了向南非提供家庭 ART 与在诊所提供 ART 的情况。年龄在 18 岁或以上且临床稳定（包括 CD4 计数>每微升 100 个细胞和世卫组织 HIV 分期 1-3）的 HIV 感染者被随机分配到以下两组：（1）支付费用后提供家庭 ART 并进行监测，包括根据需要在社区开展 ART；或（2）在诊所接受 ART（标准护理）。家庭交付的一次性费用（ZAR 30、60 和 90；相当于 2、4、6 美元）根据参与者的收入分为三个档次。主要结局是记录费用支付情况，通过问卷调查评估可接受性。关键病毒学次要结局是通过稳健泊松回归评估研究组之间的病毒抑制率，包括在退出时测量病毒载量的参与者（改良意向治疗分析）。该试验在 ClinicalTrials.gov（NCT04027153）上注册，现已完成，正在进行分析。
从 2019 年 10 月 7 日至 2020 年 1 月 30 日，共纳入 162 名参与者；82 名随机分配到家庭交付组，80 名随机分配到诊所组，两组基线特征相似。总体而言，87 名（54%）参与者为男性，101 名（62%）正在接受 ART，98 名（60%）失业。在家庭交付组中，分别有 40 名（49%）、33 名（40%）和 9 名（11%）参与者有资格支付 ZAR 30、60 和 90 的费用。中位随访时间为 47 周（IQR 43-50），96%的参与者保留。80 名（98%）参与者支付了用户费用，具有很高的可接受性和支付意愿。在 155 名（96%）完成随访的参与者的改良意向治疗分析中，家庭交付和监测的费用使病毒抑制率从总体的 74%显著提高到 88%（RR 1.21，95%CI 1.02-1.42）；在男性中从 64%提高到 84%（1.31，1.01-1.71）。
在南非的 HIV 成年感染者中，与在诊所接受 ART 相比，家庭交付和监测 ART 使病毒抑制率显著提高。在收入低、失业率高的情况下，客户为家庭 ART 交付和监测付费的意愿很高，并且这种付费意愿提高了健康结果。应评估家庭 ART 交付和监测（可能需要支付用户费用以抵消成本）作为一种差异化的服务提供策略，以增加获得护理的机会。
美国国立精神卫生研究所。
