HIV self-testing among female sex workers in Zambia: A cluster randomized controlled trial.
HIV self-testing among female sex workers in Zambia: A cluster randomized controlled trial.
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DOI：
10.1371/journal.pmed.1002442
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发表时间：
2017-11
期刊：
影响因子：
15.8
通讯作者：
Oldenburg CE
中科院分区：
文献类型：
--
作者：
Chanda MM;Ortblad KF;Mwale M;Chongo S;Kanchele C;Kamungoma N;Fullem A;Dunn C;Barresi LG;Harling G;Bärnighausen T;Oldenburg CE
艾滋病毒自我检测（HIVST）可能在解决艾滋病毒检测覆盖率差距方面发挥作用，并作为艾滋病毒预防服务的切入点。我们对赞比亚女性性工作者 (FSW) 的两种 HIVST 分配机制与护理标准进行了整群随机试验。在赞比亚的卡皮里姆波希、奇伦杜和利文斯通接受培训的同伴教育者各招募了 6 名 FSW 参与者。同伴教育者-FSW 组被随机分配到 3 个组中的 1 个：(1) 交付（从同伴教育者处直接分发口服 HIVST），(2) 优惠券（用于从健康诊所/药房收集口服 HIVST 的优惠券），或 (3) 标准护理 HIV 检测。 2 个 HIVST 组的参与者收到了 2 个试剂盒：1 个在基线时，1 个在 10 周时。主要结果是过去一个月在 1 个月和 4 个月就诊时自我报告的 HIV 检测，因为 HIVST 可以取代其他类型的 HIV 检测。次要结局包括与护理的联系、HIVST 臂中 HIVST 的使用以及不良事件。参与者在同伴教育干预后 1 个月和 4 个月完成了问卷调查。 2016 年 9 月 16 日至 10 月 12 日期间，共有 965 名参与者入组（分娩，N = 316；优惠券，N = 329；标准护理，N = 320）； 20% 的人从未接受过艾滋病毒检测。 1 个月时的总体 HIV 检测率，分娩组为 94.9%，优惠券组为 84.4%，标准护理组为 88.5%（分娩与标准护理风险比 [RR] = 1.07，95% CI 0.99–1.15，P = 0.10；优惠券与标准护理 RR = 0.95，95% CI 0.86–1.05，P = 0.29；交付与优惠券 RR = 1.13，95% CI 1.04–1.22，P = 0.005）。分娩组的四个月发生率为 84.1%，优惠券组为 79.8%，标准护理组为 75.1%（分娩与标准护理 RR = 1.11，95% CI 0.98–1.27，P = 0.11；优惠券与标准护理 RR = 1.06，95% CI 0.92–1.22，P = 0.42；交付与优惠券 RR = 1.05，95% CI 0.94–1.18，P = 0.40）。 1 个月时，大多数 HIV 检测都是自我检测（88.4%）。 1 个月时，交付组的 HIV 自检使用率高于优惠券组（RR = 1.14，95% CI 1.05–1.23，P = 0.001），但 4 个月时没有差异。在 1 个月 (N = 144) 和 4 个月 (N = 235) 报告 HIV 检测呈阳性的参与者中，与标准护理组相比，2 个 HIVST 组与护理的联系并没有显着降低。有 4 起与参与研究相关的亲密伴侣暴力事件，其中 3 起与 HIV 自检的使用有关。局限性包括研究结果的自我报告性质和艾滋病毒检测的总体高采用率。在这项针对赞比亚 FSW 的研究中，我们发现 HIVST 是可以接受且容易获得的。然而，在总体检测和关联性已经很高的情况下，HIVST 可能不会显着增加 HIV 级联进展。 ClinicalTrials.gov NCT02827240 在赞比亚进行的一项整群随机试验中，Catherine Oldenburg 及其同事研究了女性性工作者的艾滋病毒自我检测。艾滋病毒自我检测可以在没有医疗服务提供者的情况下进行，并可能缩小艾滋病毒治疗和预防级联中的差距。女性性工作者感染艾滋病毒的风险增加，并且可能特别受益于艾滋病毒自我检测，因为它可以解决她们在艾滋病毒检测方面的一些特定障碍，例如医疗服务提供者的耻辱和歧视、医疗机构的工作时间以及距医疗机构的距离。如何向女性性工作者提供艾滋病毒自我检测可能会影响这种艾滋病毒检测干预措施的有效性。我们通过随机抽取赞比亚 3 个中转城镇的 965 名女性性工作者来衡量 2 种艾滋病毒自我检测分发机制的有效性，方法是：(1) 直接提供艾滋病毒自检（递送组），(2) 从健康诊所/药房领取艾滋病毒自检优惠券（优惠券组），以及 (3) 转介接受标准护理艾滋病毒检测和咨询（标准护理组）（全部由同伴教育者提供）。在 1 个月和 4 个月的随访中，前一个月的总体 HIV 检测率很高（1 个月：分娩组 94.9%、优惠券组 84.4%、标准护理组 88.5%），并且各研究组之间几乎没有统计学上的显着差异。在报告艾滋病毒检测结果呈阳性的参与者中，在两个时间点，与标准护理组相比，艾滋病毒自我检测组的参与者与艾滋病毒相关护理和开始抗逆转录病毒治疗的联系并没有显着降低，尽管检测差异的能力有限。在研究期间报告了三起与艾滋病毒自我检测相关的不良事件，所有这些都是亲密伴侣暴力。在赞比亚中转城镇的女性性工作者中，艾滋病毒自我检测似乎是安全、可接受且容易获得的。在总体 HIV 检测较高的情况下，HIV 自我检测，无论采用何种交付模式，都可能无法持续增加 HIV 级联进展。
HIV self-testing (HIVST) may play a role in addressing gaps in HIV testing coverage and as an entry point for HIV prevention services. We conducted a cluster randomized trial of 2 HIVST distribution mechanisms compared to the standard of care among female sex workers (FSWs) in Zambia. Trained peer educators in Kapiri Mposhi, Chirundu, and Livingstone, Zambia, each recruited 6 FSW participants. Peer educator–FSW groups were randomized to 1 of 3 arms: (1) delivery (direct distribution of an oral HIVST from the peer educator), (2) coupon (a coupon for collection of an oral HIVST from a health clinic/pharmacy), or (3) standard-of-care HIV testing. Participants in the 2 HIVST arms received 2 kits: 1 at baseline and 1 at 10 weeks. The primary outcome was any self-reported HIV testing in the past month at the 1- and 4-month visits, as HIVST can replace other types of HIV testing. Secondary outcomes included linkage to care, HIVST use in the HIVST arms, and adverse events. Participants completed questionnaires at 1 and 4 months following peer educator interventions. In all, 965 participants were enrolled between September 16 and October 12, 2016 (delivery, N = 316; coupon, N = 329; standard of care, N = 320); 20% had never tested for HIV. Overall HIV testing at 1 month was 94.9% in the delivery arm, 84.4% in the coupon arm, and 88.5% in the standard-of-care arm (delivery versus standard of care risk ratio [RR] = 1.07, 95% CI 0.99–1.15, P = 0.10; coupon versus standard of care RR = 0.95, 95% CI 0.86–1.05, P = 0.29; delivery versus coupon RR = 1.13, 95% CI 1.04–1.22, P = 0.005). Four-month rates were 84.1% for the delivery arm, 79.8% for the coupon arm, and 75.1% for the standard-of-care arm (delivery versus standard of care RR = 1.11, 95% CI 0.98–1.27, P = 0.11; coupon versus standard of care RR = 1.06, 95% CI 0.92–1.22, P = 0.42; delivery versus coupon RR = 1.05, 95% CI 0.94–1.18, P = 0.40). At 1 month, the majority of HIV tests were self-tests (88.4%). HIV self-test use was higher in the delivery arm compared to the coupon arm (RR = 1.14, 95% CI 1.05–1.23, P = 0.001) at 1 month, but there was no difference at 4 months. Among participants reporting a positive HIV test at 1 (N = 144) and 4 months (N = 235), linkage to care was non-significantly lower in the 2 HIVST arms compared to the standard-of-care arm. There were 4 instances of intimate partner violence related to study participation, 3 of which were related to HIV self-test use. Limitations include the self-reported nature of study outcomes and overall high uptake of HIV testing. In this study among FSWs in Zambia, we found that HIVST was acceptable and accessible. However, HIVST may not substantially increase HIV cascade progression in contexts where overall testing and linkage are already high. ClinicalTrials.gov NCT02827240 In a cluster-randomized trial done in Zambia, Catherine Oldenburg and colleagues study HIV self-testing for female sex workers. HIV self-testing can be done in the absence of a health provider and may close gaps in the HIV treatment and prevention cascades. Female sex workers are at increased risk of HIV acquisition and may particularly benefit from HIV self-testing because it could address some of their specific barriers to HIV testing, e.g., health provider stigma and discrimination, health facility hours, and distance to the health facility. How HIV self-tests are delivered to female sex workers may impact the effectiveness of this HIV testing intervention. We measured the effectiveness of 2 HIV self-testing distribution mechanisms by randomizing 965 female sex workers in 3 Zambian transit towns to (1) direct delivery of an HIV self-test (delivery arm), (2) a coupon for collection of an HIV self-test from a health clinic/pharmacy (coupon arm), and (3) referral to standard-of-care HIV testing and counseling (standard-of-care arm) (all provided by peer educators). At the 1-month and 4-month follow-up, overall HIV testing in the previous month was high (1-month: 94.9% delivery arm, 84.4% coupon arm, 88.5% standard-of-care arm), and there were few statistically significant differences across study arms. Among participants reporting an HIV-positive test result, linkage to HIV-related care and ART initiation were non-significantly lower among those in the HIV self-testing arms compared to the standard-of-care arm at both time points, although there was limited power to detect differences. Three adverse events related to HIV self-testing were reported over the duration of the study, all of which were intimate partner violence. HIV self-testing appears safe, acceptable, and accessible among female sex workers in Zambian transit towns. HIV self-testing, regardless of the delivery model, may not sustainably increase HIV cascade progression in contexts where overall HIV testing is high.
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