HIV self-testing among young women in rural South Africa: A randomized controlled trial comparing clinic-based HIV testing to the choice of either clinic testing or HIV self-testing with secondary distribution to peers and partners
HIV self-testing among young women in rural South Africa: A randomized controlled trial comparing clinic-based HIV testing to the choice of either clinic testing or HIV self-testing with secondary distribution to peers and partners
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DOI：
10.1016/j.eclinm.2020.100327
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发表时间：
2020-04-01
影响因子：
15.1
通讯作者：
Kahn, Kathleen
中科院分区：
文献类型：
--
作者：
Pettifor, Audrey;Lippman, Sheri A.;Kahn, Kathleen
背景：许多高流行地区的艾滋病毒检测率低于遏制艾滋病毒流行所需的水平。需要新的艾滋病毒检测战略，以克服传统临床检测的障碍；HIV自我检测是一种有希望接触到遇到诊所检测障碍的个人的方式。方法：我们在南非姆普马兰加农村18-26岁的年轻女性中进行了一项随机对照试验，她们按1：1随机分配到：(1)HIV咨询和检测(HCT)ARM：邀请在9家提供免费HCT且是标准护理(SOC)的地方政府诊所之一进行检测，或(2)选择ARM：选择基于诊所的HCT邀请或口服HIV自我检测(HIVST)试剂盒。根据ARM的情况，还向参与者提供：(1)4份Ha邀请，供同行/伙伴在当地9家诊所之一进行艾滋病毒检测，或(2)4份艾滋病毒自检试剂盒，供同行/伙伴提供(因此，总共5份HIVST试剂盒或HCT邀请)。年轻女性被要求在注册后3个月和9个月返回，以评估检测、吸收和邀请或向同行和合作伙伴分发试剂盒以及检测经验。被指数参与者报告在后续访问期间收到工具包邀请的同行和合作伙伴也被邀请参加考察访问，以评估他们的测试经验。这项试验在临床试验网站上注册。政府NCT03162965。结果：287名年轻女性参加了随机试验，其中146人被随机分配到Ha组，141人被随机分配到CHOICE(HCT或HIVST)组。在随机选择的ARM组中，超过95%(n=135)的人选择了HIV自我检测试剂盒，只有6人选择了HCT。在3个月的随访中，选择组中92%的指数参与者报告过艾滋病毒检测，而HCT组中43%的参与者报告过艾滋病毒检测，结果风险差异显著，为49%(95%可信区间40%，58%)。到9个月时，这一差异减少到两组间的风险差异25%(95%可信区间17%，33%)(选择组96%，Ha组72%)。与HCT组相比，Choose组的参与者也更有可能邀请同行和合作伙伴进行测试(94%比76%，或平均4.97vs.2.79次测试)。很少有男性伴侣被指数参与者邀请进行测试；然而，选择组的指数参与者比Ha组的指数参与者更有可能让他们的男性伴侣进行测试(RR 2.99，95%CI 1.45，6.16)。解释：当让绝大多数年轻女性在基于临床的HIV检测和HIV口头自我检测之间进行选择时，绝大多数年轻女性选择了HIVST。此外，与HCT ARM相比，那些提供艾滋病毒检测方式选择的人更有可能进行检测，向同行和合作伙伴分发检测试剂盒，并有报告检测的同行和合作伙伴。与以诊所为基础的HCT相比，自我检测提供了一个重要的机会，可以显著提高年轻女性及其同龄人和伴侣的检测率。还需要采取其他策略来帮助男性进行检测。(C)2020年提交人(S)。爱思唯尔有限公司出版。
Background: HIV testing rates in many hyper-endemic areas are lower than needed to curtail the HIV epidemic. New HIV testing strategies are needed to overcome barriers to traditional clinic based testing; HIV self-testing is one modality that offers promise in reaching individuals who experience barriers to clinic-based testing.Methods: We conducted a randomized control trial among young women ages 18-26 living in rural Mpumalanga, South Africa where they were randomized in a 1:1 allocation to either the: (1) HIV Counseling and Testing (HCT) arm: an invitation to test at one of the 9 local government clinics where free HCT is provided and is standard of care (SOC), or (2) choice arm: choice of either a clinic-based HCT invitation or oral HIV Self-Testing (HIVST) kits. Depending on the arm, participants were also provided either: (1) 4 Ha invitations to provide to peers/partners for HIV testing at one of the 9 local clinics, or (2) 4 HIV self-test kits to provide to peers/partners (thus 5 total HIVST kits or HCT invitations). Young women were asked to return 3 months and 9 months after enrollment to assess testing uptake and invitation or kit distribution to peers and partners and experiences with testing. Peers and partners who were reported by index participants to have received kits invitations during follow-up visits were also invited to attend a study visit to assess their testing experiences. The trial is registered at clinical trials.gov NCT03162965.Findings: 287 young women were enrolled and randomized, with 146 randomized to the Ha arm and 141 to the choice (HCT or HIVST) arm. Of those randomized to the choice arm, over 95% (n=135) chose the HIV self-testing kit and only 6 individuals chose HCT. At the 3-month follow-up visit, 92% of index participants in the choice arm reported having tested for HIV compared to 43% of participants in the HCT arm, resulting in a significant risk difference of 49% (95% CI 40%, 58%). By 9 months, this difference decreased to a risk difference of 25% (95% CI 17%, 33%) between arms (96% in the choice arm and 72% in the Ha arm). Participants in the choice arm were also more likely to invite peers and partners to test compared to the HCT arm (94% vs. 76% or an average of 4.97 vs 2.79 tests). Few male partners were invited to test by index participants; however, index participants in the choice arm were more likely to have their male partners test than index participants in the Ha arm (RR 2.99, 95% CI 1.45, 6.16).Interpretation: When given a choice between clinic-based HIV testing and HIV oral self-testing, the overwhelming majority of young women chose HIVST. In addition, those offered a choice of HIV testing modality were much more likely to test, distribute test kits to peers and partners, and to have peers and partners who reported testing compared to the HCT arm. Self-testing offers an important opportunity to significantly increase testing rates among young women and their peers and partners compared to clinic-based HCT. Other strategies to reach men with testing are needed. (C) 2020 The Author(s). Published by Elsevier Ltd.