BACKGROUND HIV testing among the sexual partners of HIV-positive clients is critical for case identification and reduced transmission in southern and eastern Africa. HIV self-testing (HIVST) may improve uptake of HIV services among sexual partners of antiretroviral therapy (ART) clients, but the impact of HIVST on partner testing and subsequent ART initiation remains unclear. METHODS AND FINDINGS We conducted an individually randomized, unblinded trial to assess if an index HIVST intervention targeting the partners of ART clients improves uptake of testing and treatment services in Malawi. The trial was conducted at 3 high-burden facilities in central and southern Malawi. ART clients attending HIV treatment clinics were randomized using simple randomization 1:2·5 to: (1) standard partner referral slip (PRS) whereby ART clients were given facility referral slips to distribute to their primary sexual partners; or (2) index HIVST whereby ART clients were given HIVST kits + HIVST instructions and facility referral slips to distribute to their primary sexual partners. Inclusion criteria for ART clients were: ≥15 years of age, primary partner with unknown HIV status, no history of interpersonal violence (IPV) with partner, and partner lives in facility catchment area. The primary outcome was partner testing 4-weeks after enrollment, reported by ART clients using endline surveys. Medical chart reviews and tracing activities with partners with a reactive HIV test measured ART initiation at 12 months. Analyses were conducted based on modified intention-to-treat principles, whereby we excluded individuals who did not have complete endline data (i.e., were loss to follow up from the study). Adjusted models controlled for the effects of age and marital status. A total of 4,237 ART clients were screened and 484 were eligible and enrolled (77% female) between March 28, 2018 and January 5, 2020. A total of 365 participants completed an endline survey (257/34 index HIVST arm; 107/13 PRS arm) and were included in the final analysis (78% female). Testing coverage among sexual partners was 71% (183/257) in the index HIVST arm and 25% (27/107) in the PRS arm (aRR: 2·77, 95% CI [2·56 to 3·00], p ≤ 0.001). Reported HIV positivity rates did not significantly differ by arm (16% (30/183) in HIVST versus 15% (4/27) in PRS; p = 0.99). ART initiation at 12 months was 47% (14/30) in HIVST versus 75% (3/4) in PRS arms; however, index HIVST still resulted in a 94% increase in the proportion of all partners initiating ART due to higher HIV testing rates in the HIVST arm (5% partners initiated ART in HVIST versus 3% in PRS). Adverse events including IPV and termination of the relationship did not vary by arm (IPV: 3/257 index HIVST versus 4/10 PRS; p = 0.57). Limitations include reliance on secondary report by ART clients, potential social desirability bias, and not powered for sex disaggregated analyses. CONCLUSIONS Index HIVST significantly increased HIV testing and the absolute number of partners initiating ART in Malawi, without increased risk of adverse events. Additional research is needed to improve linkage to HIV treatment services after HIVST use. TRIAL REGISTRATION ClinicalTrials.gov, NCT03271307, and Pan African Clinical Trials, PACTR201711002697316.

中文翻译：

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马拉维参加抗逆转录病毒治疗 (ART) 项目的客户性伴侣的 HIV 指数自我检测的效果：一项随机对照试验。

背景 在南部非洲和东部非洲，艾滋病毒阳性客户的性伴侣中的艾滋病毒检测对于病例识别和减少传播至关重要。HIV 自我检测 (HIVST) 可能会提高抗逆转录病毒治疗 (ART) 客户的性伴侣对 HIV 服务的接受度，但 HIVST 对伴侣检测和随后 ART 启动的影响仍不清楚。方法和结果 我们进行了一项单独随机、非盲试验，以评估针对 ART 客户伴侣的 HIVST 指数干预措施是否可以提高马拉维对检测和治疗服务的接受度。该试验在马拉维中部和南部的 3 个高负荷设施进行。参加 HIV 治疗诊所的 ART 客户使用简单随机 1:2·5 进行随机分配： (1) 标准伴侣转介单 (PRS)，其中 ART 客户获得机构转介单以分发给其主要性伴侣；(2) 索引 HIVST，从而向 ART 客户提供 HIVST 套件 + HIVST 说明和设施转介单以分发给其主要性伴侣。ART 客户的纳入标准为：年龄≥15 岁、主要伴侣 HIV 状况未知、与伴侣无人际暴力 (IPV) 史、且伴侣居住在设施服务区域。主要结果是 ART 客户使用终端调查报告的入组后 4 周的伴侣测试。医疗图表审查和与合作伙伴的追踪活动通过反应性 HIV 测试测量了 12 个月时 ART 的启动情况。分析是根据修改后的意向治疗原则进行的，我们排除了没有完整终点数据的个体（即在研究中失访）。调整后的模型控制了年龄和婚姻状况的影响。2018 年 3 月 28 日至 2020 年 1 月 5 日期间，共有 4,237 名 ART 客户接受了筛查，其中 484 名符合资格并入组（77% 为女性）。共有 365 名参与者完成了最终调查（257/34 指数 HIVST 臂；107/13 PRS 组）并被纳入最终分析（78% 为女性）。HIVST 组中性伴侣的检测覆盖率为 71% (183/257)，PRS 组中为 25% (27/107)（aRR：2·77，95% CI [2·56 至 3·00]， p ≤ 0.001）。各组报告的 HIV 阳性率没有显着差异（HIVST 为 16% (30/183)，PRS 为 15% (4/27)；p = 0.99）。HIVST 组在 12 个月时开始 ART 的比例为 47% (14/30)，而 PRS 组为 75% (3/4)；然而，由于 HIVST 组中 HIV 检测率较高，指数 HIVST 仍然导致所有伴侣开始 ART 的比例增加了 94%（HVIST 中 5% 的伴侣开始了 ART，而 PRS 中为 3%）。包括 IPV 和关系终止在内的不良事件并没有因组而异（IPV：3/257 指数 HIVST 与 4/10 PRS；p = 0.57）。局限性包括依赖 ART 客户的二次报告、潜在的社会期望偏差以及不支持按性别分类分析。结论 HIVST 指数显着增加了马拉维的 HIV 检测和开始 ART 的性伴侣的绝对数量，且没有增加不良事件的风险。需要开展更多研究来改善使用 HIVST 后与 HIV 治疗服务的联系。试验注册 ClinicalTrials.gov，NCT03271307 和泛非临床试验，PACTR201711002697316。