The Zambian Peer Educators for HIV Self-Testing (ZEST) Study: A randomized controlled trial of HIV self-test provision for female sex workers in Zambia

Background: HIV testing is the critical first step for realization of the 90-90-90 targets, which aim to have 90% of people living with HIV aware of their status, 90% of those linked to care, and 90% of those virally suppressed. However, HIV testing among female sex workers (FSWs) in sub-Saharan Africa remains below the 90% target. The objective of this study was thus to evaluate 1) the effectiveness of HIV self-test provision compared to standard of care HIV testing for increasing HIV testing coverage among FSW and 2) the effectiveness of two delivery models for HIV self-test provision. Methods: This study was a cluster randomized trial conducted in three transit towns in Zambia: Livingstone, Chirundu, and Kapiri Mposhi. FSWs were recruited by a peer educator. FSW-peer educator groups were randomized in a 1:1:1 ratio to one of three groups: 1) standard-of-care, which consisted of referral to existing HIV testing facilities 2) direct delivery of an HIV self-test kit from the peer educator to the participant or 3) distribution of a coupon from the peer educator, which could be used to collect an HIV self-test kit at a participating distribution point. Results: At one month, 94.9% and 84.4% of participants in the delivery and coupon arms reported testing for the past month, compared to 88.5% in the standard-of-care arm. Participants in the delivery arm were significantly more likely to report testing for HIV in the past month compared to the coupon arm but not compared with standard of care (Direct vs SOC: RR 1.07, P=0.29, Coupon vs SOC: RR 1.05 P=0.10, Direct vs Coupon RR 1.13, P=0.005). At four months, 84.1%, 79.8%, and 75.1% of participants reported testing for HIV in the past month in the delivery, coupon, and standard-of-care arms. There were no statistically significant differences in HIV testing at four months. Conclusion: Although HIV self-testing did not increase HIV testing, high reported use of HIV self-tests indicate that it is acceptable to FSWs in Zambia. Although directly providing the HIV self-test may increase use in the short-term, delivery models utilizing distribution via existing distribution points (e.g., clinics or pharmacies) will likely be successful in distributing kits.

背景：实现90-90-90目标的关键第一步是人类免疫缺陷病毒（Human Immunodeficiency Virus, HIV）检测，该目标旨在让90%的艾滋病病毒感染者知晓自身感染状况，其中90%的感染者可获得规范医疗护理，且90%的感染者实现病毒抑制。然而，撒哈拉以南非洲地区的女性性工作者（Female Sex Workers, FSWs）的HIV检测率仍未达到90%的既定目标。本研究旨在评估两项核心内容：1）对比HIV自我检测服务与标准HIV检测服务在提升女性性工作者HIV检测覆盖率方面的有效性；2）评估两种HIV自我检测服务递送模式的有效性。
方法：本研究为整群随机对照试验，在赞比亚的三座过境城镇开展，分别为利文斯顿（Livingstone）、奇龙杜（Chirundu）与卡皮里姆波希（Kapiri Mposhi）。研究通过同伴教育者招募女性性工作者，将女性性工作者-同伴教育者小组以1:1:1的比例随机分配至三个组别：1）标准护理组：为参与者提供转诊至现有HIV检测机构的服务；2）直接递送组：由同伴教育者向参与者直接发放HIV自我检测试剂盒；3）优惠券发放组：由同伴教育者发放兑换券，参与者可凭券在合作分发点领取HIV自我检测试剂盒。
结果：干预后1个月，直接递送组与优惠券发放组的参与者中，报告过去1个月内接受过HIV检测的比例分别为94.9%与84.4%，而标准护理组的该比例为88.5%。直接递送组的参与者在过去1个月内报告接受HIV检测的概率显著高于优惠券发放组，但与标准护理组无统计学差异（直接组vs标准护理组：相对风险RR=1.07，P=0.29；优惠券组vs标准护理组：RR=1.05，P=0.10；直接组vs优惠券组：RR=1.13，P=0.005）。干预后4个月，直接递送组、优惠券发放组与标准护理组的参与者中，报告过去1个月内接受过HIV检测的比例分别为84.1%、79.8%与75.1%，三组在4个月时的HIV检测率均无统计学显著差异。
结论：尽管HIV自我检测未能整体提升HIV检测覆盖率，但参与者对HIV自我检测的高报告使用率表明，该检测方式在赞比亚女性性工作者中具备良好的可接受性。虽然直接递送HIV自我检测试剂盒可在短期内提升检测使用率，但依托现有分发点（如诊所或药房）的递送模式，或可更高效地推广HIV自我检测试剂盒的分发。