HIV self-testing alone or with additional interventions, including financial incentives, and linkage to care or prevention among male partners of antenatal care clinic attendees in Malawi: An adaptive multi-arm, multi-stage cluster randomised trial
HIV self-testing alone or with additional interventions, including financial incentives, and linkage to care or prevention among male partners of antenatal care clinic attendees in Malawi: An adaptive multi-arm, multi-stage cluster randomised trial
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DOI：
10.1371/journal.pmed.1002719
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发表时间：
2019-01-01
期刊：
影响因子：
15.8
通讯作者：
Fielding, Katherine
中科院分区：
文献类型：
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作者：
Choko, Augustine T.;Corbett, Elizabeth L.;Fielding, Katherine
在全球范围内，传统的艾滋病毒检测服务在覆盖男性方面不如覆盖女性全面，但艾滋病毒自我检测（HIVST）似乎是一种可以接受的替代方法。衡量与艾滋病毒/艾滋病防治后检测服务的联系仍然是最大的挑战，但也是成本效益的最大驱动力。我们在一项新型适应性试验中调查了单独或联合其他干预措施的HIVST对产前护理诊所参加者的男性伴侣接受检测以及与护理或预防联系的影响。方法和结果一项适应性多组、2阶段整群随机试验于2016年8月8日至2017年6月30日期间进行，产前护理诊所（ANC）天数（即，在一天内参加的妇女群）作为随机分组的单位。招募对象来自马拉维布兰太尔市的Ndirande、Bangwe和Zingwangwa初级卫生诊所。对于当前妊娠（不考虑妊娠期）首次参加ANC的女性，18岁及以上，其主要男性伴侣未知是否接受ART，在提供知情同意后入组试验。随机化为标准治疗（SOC;向男性伴侣发出诊所邀请函）或5个干预组之一：第一组为女性伴侣提供2个艾滋病毒/艾滋病防治工具包;第二组和第三组提供2个艾滋病毒/艾滋病防治工具包，沿着3美元或10美元的有条件固定经济奖励;第四组提供2个艾滋病毒/艾滋病治疗包，并有10%的机会在彩票中获得30美元;第五组提供2个艾滋病毒/艾滋病治疗包，并为女性的伴侣提供电话提醒。主要结果是男性伴侣的比例，据报道，他们在28天内进行了艾滋病毒检测并与护理或预防联系起来，并相应地转诊接受抗逆转录病毒治疗或包皮环切术。妇女在28天接受了关于伴侣测试和不良事件的采访。使用合格女性作为分母（意向治疗），比较了每种干预与SOC。根据男性伴侣检测史和招募诊所调整风险比。共有2 349/3 137（74.9%）名女性参与（71个ANC日），平均年龄为24.8岁（SD：5.4）。大多数妇女（2 201/2 233; 98.6%）已婚，254/2 107（12.3%）不会读写，1 505/2 247（67.0%）没有工作。男性伴侣的平均年龄为29.6岁（标准差：7.5），2，200人中只有88人（4.0%）失业，2，210人中有966人（43.7%）以前从未接受过艾滋病毒检测。SOC组中的女性报告说，17.4%（71/408）的伴侣进行了艾滋病毒检测，而在所有干预组中，报告有更高比例的伴侣进行了艾滋病毒检测（所有5个干预组中为87.0%-95.4%，p < 0.001）。与SOC组中接受测试的受试者相比，（几何平均值13.0%），在HIVST + $3中，满足主要终点的伴侣比例更高（几何平均值40.9%，调整后风险比[aRR] 3.01 [95% CI 1.63-5.57]，p < 0.001），HIVST +10美元（51.7%，aRR 3.72 [95% CI 1.85-7.48]，p < 0.001）和电话提醒（22.3%，aRR 1.58 [95% CI 1.07-2.33]，p = 0.021）组。相比之下，在单独HIVST组（几何平均值17.5%，aRR 1.45 [95% CI 0.99-2.13]，p = 0.130）或彩票组（18.6%，aRR 1.43 [95% CI 0.96-2.13]，p = 0.211）中，符合主要终点的伴侣没有显著增加。在中期分析时，彩票组被删除。总体而言，46名男性伴侣被确认为艾滋病毒阳性，其中42人（91.3%）在28天内开始接受抗逆转录病毒治疗; 222人检测为艾滋病毒阴性，尚未接受包皮环切术，其中135人（60.8%）作为试验的一部分接受了包皮环切术。未报告严重不良事件。对于HIVST +3美元和HIVST +10美元两组，每名男性伴侣的费用分别为23.73美元和28.08美元。值得注意的局限性的试验包括相对较少的集群随机分配到每个手臂，代理报告的男性伴侣的测试结果，并无法评估保留在care.ConclusionsIn这项研究中，男性的联系，以照顾或预防的几率大幅增加，使用有条件的固定的财政激励措施加上合作伙伴提供的艾滋病毒感染者;组合是潜在的负担得起的。
BackgroundConventional HIV testing services have been less comprehensive in reaching men than in reaching women globally, but HIV self-testing (HIVST) appears to be an acceptable alternative. Measurement of linkage to post-test services following HIVST remains the biggest challenge, yet is the biggest driver of cost-effectiveness. We investigated the impact of HIVST alone or with additional interventions on the uptake of testing and linkage to care or prevention among male partners of antenatal care clinic attendees in a novel adaptive trial.Methods and findingsAn adaptive multi-arm, 2-stage cluster randomised trial was conducted between 8 August 2016 and 30 June 2017, with antenatal care clinic (ANC) days (i.e., clusters of women attending on a single day) as the unit of randomisation. Recruitment was from Ndirande, Bangwe, and Zingwangwa primary health clinics in urban Blantyre, Malawi. Women attending an ANC for the first time for their current pregnancy (regardless of trimester), 18 years and older, with a primary male partner not known to be on ART were enrolled in the trial after giving consent. Randomisation was to either the standard of care (SOC; with a clinic invitation letter to the male partner) or 1 of 5 intervention arms: the first arm provided women with 2 HIVST kits for their partners; the second and third arms provided 2 HIVST kits along with a conditional fixed financial incentive of $3 or $10; the fourth arm provided 2 HIVST kits and a 10% chance of receiving $30 in a lottery; and the fifth arm provided 2 HIVST kits and a phone call reminder for the women's partners. The primary outcome was the proportion of male partners who were reported to have tested for HIV and linked into care or prevention within 28 days, with referral for antiretroviral therapy (ART) or circumcision accordingly. Women were interviewed at 28 days about partner testing and adverse events. Cluster-level summaries compared each intervention versus SOC using eligible women as the denominator (intention-to-treat). Risk ratios were adjusted for male partner testing history and recruitment clinic. A total of 2,349/3,137 (74.9%) women participated (71 ANC days), with a mean age of 24.8 years (SD: 5.4). The majority (2,201/2,233; 98.6%) of women were married, 254/2,107 (12.3%) were unable to read and write, and 1,505/2,247 (67.0%) were not employed. The mean age for male partners was 29.6 years (SD: 7.5), only 88/2,200 (4.0%) were unemployed, and 966/2,210 (43.7%) had never tested for HIV before. Women in the SOC arm reported that 17.4% (71/408) of their partners tested for HIV, whereas a much higher proportion of partners were reported to have tested for HIV in all intervention arms (87.0%-95.4%, p < 0.001 in all 5 intervention arms). As compared with those who tested in the SOC arm (geometric mean 13.0%), higher proportions of partners met the primary endpoint in the HIVST + $3 (geometric mean 40.9%, adjusted risk ratio [aRR] 3.01 [95% CI 1.63-5.57], p < 0.001), HIVST + $10 (51.7%, aRR 3.72 [95% CI 1.85-7.48], p < 0.001), and phone reminder (22.3%, aRR 1.58 [95% CI 1.07-2.33], p = 0.021) arms. In contrast, there was no significant increase in partners meeting the primary endpoint in the HIVST alone (geometric mean 17.5%, aRR 1.45 [95% CI 0.99-2.13], p = 0.130) or lottery (18.6%, aRR 1.43 [95% CI 0.96-2.13], p = 0.211) arms. The lottery arm was dropped at interim analysis. Overall, 46 male partners were confirmed to be HIV positive, 42 (91.3%) of whom initiated ART within 28 days; 222 tested HIV negative and were not already circumcised, of whom 135 (60.8%) were circumcised as part of the trial. No serious adverse events were reported. Costs per male partner who attended the clinic with a confirmed HIV test result were $23.73 and $28.08 for the HIVST + $3 and HIVST + $10 arms, respectively. Notable limitations of the trial included the relatively small number of clusters randomised to each arm, proxy reporting of the male partner testing outcome, and being unable to evaluate retention in care.ConclusionsIn this study, the odds of men's linkage to care or prevention increased substantially using conditional fixed financial incentives plus partner-delivered HIVST; combinations were potentially affordable.