Division of Infectious Diseases, David Geffen School of Medicine, University of California, Los Angeles, California, United States of America.
Partners in Hope, Lilongwe, Malawi.
PLoS Med. 2023 Aug 4;20(8):e1004270. doi: 10.1371/journal.pmed.1004270. eCollection 2023 Aug.
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.
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.
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.
ClinicalTrials.gov, NCT03271307, and Pan African Clinical Trials, PACTR201711002697316.
在南部和东部非洲，对 HIV 阳性患者的性伴侣进行 HIV 检测对于病例识别和减少传播至关重要。HIV 自我检测（HIVST）可能会提高接受抗逆转录病毒治疗（ART）患者性伴侣的 HIV 服务利用率，但 HIVST 对伴侣检测和随后的 ART 启动的影响仍不清楚。
我们进行了一项个体随机、非盲法试验，以评估针对 ART 患者性伴侣的 HIV 自我检测干预措施是否能提高马拉维的检测和治疗服务利用率。该试验在马拉维中部和南部的 3 个高负担设施中进行。接受 HIV 治疗诊所的 ART 患者采用简单随机化以 1:2.5 的比例随机分配至：（1）标准伴侣转诊单（PRS），即 ART 患者获得转介给其主要性伴侣的机构转诊单；或（2）HIV 自我检测索引，即 ART 患者获得 HIV 自我检测试剂盒+HIV 自我检测说明和机构转诊单以分发给其主要性伴侣。ART 患者的纳入标准为：≥15 岁，主要伴侣的 HIV 状况未知，没有与伴侣发生人际暴力（IPV）的历史，并且伴侣居住在机构的覆盖范围内。主要结局是在招募后 4 周时，由 ART 患者通过终线调查报告的伴侣检测情况。通过与 HIV 检测呈阳性的伴侣进行医疗图表审查和追踪活动，衡量在 12 个月时开始接受 ART 的情况。分析基于改良意向治疗原则进行，其中排除了没有完整终线数据的个体（即从研究中失去随访的个体）。调整后的模型控制了年龄和婚姻状况的影响。共筛查了 4237 名 ART 患者，有 484 名符合条件并登记（77%为女性），登记时间为 2018 年 3 月 28 日至 2020 年 1 月 5 日。共有 365 名参与者完成了终线调查（257 名/34 名 HIV 自我检测组；107 名/13 名 PRS 组），并纳入最终分析（78%为女性）。HIV 自我检测组中性伴侣的检测覆盖率为 71%（257 名中的 183 名），PRS 组为 25%（107 名中的 27 名）（ARR：2.77，95%CI [2.56 至 3.00]，p ≤ 0.001）。报告的 HIV 阳性率在两组之间没有显著差异（HIV 自我检测组为 16%（30/183），PRS 组为 15%（4/27）；p = 0.99）。12 个月时开始接受 ART 的比例在 HIV 自我检测组为 47%（30 名中的 14 名），PRS 组为 75%（4 名中的 3 名）；然而，HIV 自我检测组仍因更高的 HIV 检测率而导致所有开始接受 ART 的伴侣比例增加了 94%（HIV 自我检测组中有 5%的伴侣开始接受 ART，PRS 组中有 3%的伴侣开始接受 ART）。包括 IPV 和终止关系在内的不良事件在两组之间没有差异（IPV：HIV 自我检测组 3 名/257 名，PRS 组 4 名/107 名；p = 0.57）。局限性包括依赖 ART 患者的二级报告、潜在的社会期望偏差以及没有对性别进行分析。
HIV 自我检测显著提高了马拉维的 HIV 检测率和开始接受 ART 的伴侣绝对数量，且没有增加不良事件的风险。需要进一步研究来改善 HIVST 使用后与 HIV 治疗服务的联系。
ClinicalTrials.gov，NCT03271307，和泛非临床研究（PACTR），PACTR201711002697316。
