Effect of door-to-door distribution of HIV self-testing kits on HIV testing and antiretroviral therapy initiation: a cluster randomised trial in Malawi.
Effect of door-to-door distribution of HIV self-testing kits on HIV testing and antiretroviral therapy initiation: a cluster randomised trial in Malawi.
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DOI：
10.1136/bmjgh-2020-004269
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发表时间：
2021-07
影响因子：
8.1
通讯作者：
Corbett EL
中科院分区：
文献类型：
--
作者：
Indravudh PP;Fielding K;Chilongosi R;Nzawa R;Neuman M;Kumwenda MK;Nyirenda R;Johnson CC;Taegtmeyer M;Desmond N;Hatzold K;Corbett EL
实现艾滋病毒检测的高覆盖率对于艾滋病毒的诊断、治疗和预防仍然至关重要。我们评估了在马拉维农村挨家挨户分发艾滋病毒自我检测（HIVST）试剂盒的有效性和安全性。这项在2016年9月至2018年1月期间进行的群集随机试验使用限制性1：1随机分配，将22家卫生机构及其指定区域分配给挨家挨户的HIVST以及标准治疗（SOC）或仅SOC。研究人群包括居民（≥16岁）。艾滋病毒/艾滋病防治工具包由社区分发机构挨家挨户提供，至少持续12个月。主要结果是最近的艾滋病毒检测（在过去12个月内）通过终点调查测量。次要结果是终身艾滋病毒检测和累积16个月的抗逆转录病毒治疗（ART）启动，这是在卫生设施捕获。社会危害通过社区报告系统报告。总体而言，203个CBDA分发了273729个HIVST试剂盒。终点调查包括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）的近期检测率高于SOC组（48.9%，1422/2908），调整后风险差异（RD）为16.1%（95% CI 6.5%-25.7%）。HIVST组（86.9%，2243/2582）的寿命测试也高于SOC组（78.5%，2283/2908;调整后的RD 6.3%，95% CI 2.3%-10.3%）。16-19岁青少年（校正后RD 18.6%，95% CI 7.3%-29.9%）和男性（校正后RD 10.2%，95% CI 3.1%-17.2%）的差异最明显。在HIVST和SOC组中，ART启动的累积发生率分别为1187.2/100 000和909.0/100 000人群（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。挨家挨户的艾滋病毒/艾滋病检测增加了人口一级的近期和终生检测，显示出高度的安全性，强调了艾滋病毒/艾滋病检测在优先环境中促进消除艾滋病毒目标的潜力。NCT 02718274。
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. 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. 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. 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. NCT02718274.
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