INTRODUCTION Reaching high coverage of HIV testing remains essential for HIV diagnosis, treatment and prevention. We evaluated the effectiveness and safety of door-to-door distribution of HIV self-testing (HIVST) kits in rural Malawi. METHODS This cluster randomised trial, conducted between September 2016 and January 2018, used restricted 1:1 randomisation to allocate 22 health facilities and their defined areas to door-to-door HIVST alongside the standard of care (SOC) or the SOC alone. The study population included residents (≥16 years). HIVST kits were provided door-to-door by community-based distribution agents (CBDAs) for at least 12 months. The primary outcome was recent HIV testing (in the last 12 months) measured through an endline survey. Secondary outcomes were lifetime HIV testing and cumulative 16-month antiretroviral therapy (ART) initiations, which were captured at health facilities. Social harms were reported through community reporting systems. Analysis compared cluster-level outcomes by arm. RESULTS Overall, 203 CBDAs distributed 273 729 HIVST kits. The endline survey included 2582 participants in 11 HIVST clusters and 2908 participants in 11 SOC clusters. Recent testing was higher in the HIVST arm (68.5%, 1768/2582) than the SOC arm (48.9%, 1422/2908), with adjusted risk difference (RD) of 16.1% (95% CI 6.5% to 25.7%). Lifetime testing was also higher in the HIVST arm (86.9%, 2243/2582) compared with the SOC arm (78.5%, 2283/2908; adjusted RD 6.3%, 95% CI 2.3% to 10.3%). Differences were most pronounced for adolescents aged 16-19 years (adjusted RD 18.6%, 95% CI 7.3% to 29.9%) and men (adjusted RD 10.2%, 95% CI 3.1% to 17.2%). Cumulative incidence of ART initiation was 1187.2 and 909.0 per 100 000 population in the HIVST and SOC arms, respectively (adjusted RD 309.1, 95% CI -95.5 to 713.7). Self-reported HIVST use was 42.5% (1097/2582), with minimal social harms reported. CONCLUSION Door-to-door HIVST increased recent and lifetime testing at population level and showed high safety, underscoring potential for HIVST to contribute to HIV elimination goals in priority settings. TRIAL REGISTRATION NUMBER NCT02718274.

中文翻译：

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挨家挨户分发 HIV 自检试剂盒对 HIV 检测和抗逆转录病毒治疗启动的影响：马拉维的一项整群随机试验。

引言 实现 HIV 检测的高覆盖率对于 HIV 诊断、治疗和预防仍然至关重要。我们评估了在马拉维农村地区挨家挨户分发 HIV 自我检测 (HIVST) 试剂盒的有效性和安全性。方法 该整群随机试验于 2016 年 9 月至 2018 年 1 月期间进行，使用限制性 1:1 随机分配将 22 家医疗机构及其指定区域与护理标准 (SOC) 或单独的 SOC 一起分配到门到门 HIVST。研究人群包括居民（≥16 岁）。HIVST 试剂盒由社区分销代理 (CBDA) 挨家挨户提供至少 12 个月。主要结果是最近的 HIV 检测（在过去 12 个月内），通过最终调查测量。次要结果是终生 HIV 检测和累计 16 个月的抗逆转录病毒治疗 (ART) 启动，这些是在医疗机构获得的。通过社区报告系统报告社会危害。分析按手臂比较了集群级别的结果。结果 总体而言，203 个 CBDA 分发了 273 729 个 HIVST 试剂盒。最终调查包括 11 个 HIVST 集群的 2582 名参与者和 11 个 SOC 集群的 2908 名参与者。HIVST 组（68.5%，1768/2582）的近期检测高于 SOC 组（48.9%，1422/2908），调整后的风险差异 (RD) 为 16.1%（95% CI 6.5% 至 25.7%）。与 SOC 臂（78.5%、2283/2908；调整后的 RD 6.3%、95% CI 2.3% 至 10.3%）相比，HIVST 臂的终生测试也更高（86.9%，2243/2582）。差异在 16-19 岁的青少年中最为明显（调整后的 RD 18.6%，95% CI 7. 3% 至 29.9%）和男性（调整后的 RD 10.2%，95% CI 3.1% 至 17.2%）。HIVST 和 SOC 组开始 ART 的累积发生率分别为每 100 000 人 1187.2 人和 909.0 人（调整后的 RD 309.1，95% CI -95.5 至 713.7）。自我报告的 HIVST 使用率为 42.5% (1097/2582)，报告的社会危害最小。结论 挨家挨户的 HIVST 增加了人群水平的近期和终生检测，并显示出高安全性，强调了 HIVST 有助于在优先环境中实现 HIV 消除目标的潜力。试用注册号 NCT02718274。报告的社会危害最小。结论 挨家挨户的 HIVST 增加了人群水平的近期和终生检测，并显示出高安全性，强调了 HIVST 有助于在优先环境中实现 HIV 消除目标的潜力。试用注册号 NCT02718274。报告的社会危害最小。结论 挨家挨户的 HIVST 增加了人群水平的近期和终生检测，并显示出高安全性，强调了 HIVST 有助于在优先环境中实现 HIV 消除目标的潜力。试用注册号 NCT02718274。