Division of Infectious Diseases, University of California Los Angeles, Los Angeles, CA, USA; Partners in Hope, Lilongwe, Malawi.
Partners in Hope, Lilongwe, Malawi.
Lancet Glob Health. 2020 Feb;8(2):e276-e287. doi: 10.1016/S2214-109X(19)30534-0.
HIV self-testing increases testing uptake in sub-Saharan Africa but scale-up is challenging because of resource constraints. We evaluated an HIV self-testing intervention integrated into high-burden outpatient departments in Malawi.
In this cluster-randomised trial, we recruited participants aged 15 years or older from 15 outpatient departments at high-burden health facilities (including health centres, mission hospitals, and district hospitals) in central and southern Malawi. The trial was clustered at the health facility level. We used constrained randomisation to allocate each cluster (1:1:1) to one of the following groups: standard provider-initiated testing and counselling with no intervention (provider offered during consultations), optimised provider-initiated testing and counselling (with additional provider training and morning HIV testing), and facility-based HIV self-testing (Oraquick HIV self-test, group demonstration and distribution, and private spaces for interpretation and counselling). The primary outcome was the proportion of outpatients tested for HIV on the day of enrolment, measured through exit surveys with a sample of outpatients. Analyses were on an intention-to-treat basis. The trial is registered with ClinicalTrials.gov, NCT03271307, and Pan African Clinical Trials, PACTR201711002697316.
Between Sept 12, 2017, and Feb 23, 2018, 5885 outpatients completed an exit survey-2097 in the HIV self-testing group, 1951 in the standard provider-initiated testing and counselling group, and 1837 in the optimised provider-initiated testing and counselling group. 1063 (51%) of 2097 patients in the HIV self-testing group had HIV testing on the same day as enrolment, compared with 248 (13%) of 1951 in the standard provider-initiated testing and counselling group and 261 (14%) of 1837 in the optimised provider-initiated testing and counselling group. The odds of same-day HIV testing were significantly higher in the facility-based HIV self-testing group compared with either standard provider-initiated testing and counselling (adjusted odds ratio 8·52, 95% CI 3·98-18·24) or optimised provider-initiated testing and counselling (6·29, 2·96-13·38). Around 4% of those tested in the standard provider-initiated testing and counselling and optimised provider-initiated testing and counselling groups felt coerced to test, and around 1% felt coerced to share test results. No coercion was reported in the facility-based HIV self-testing group.
Facility-based HIV self-testing increased HIV testing among outpatients in Malawi, with a minimal risk of adverse events. Facility-based HIV self-testing should be considered for scale-up in settings with a high unmet need for HIV testing.
United States Agency for International Development.
艾滋病毒自检在撒哈拉以南非洲增加了检测量，但由于资源限制，扩大规模具有挑战性。我们评估了一种将艾滋病毒自检整合到马拉维高负担门诊部门的干预措施。
在这项整群随机试验中，我们从马拉维中部和南部高负担卫生设施（包括卫生中心、传教医院和地区医院）的 15 个门诊部门招募了 15 岁及以上的参与者。试验按卫生设施进行整群随机分组。我们使用约束随机化将每个集群（1:1:1）分配到以下组之一：标准提供者发起的测试和咨询（不干预，即咨询期间提供）、优化的提供者发起的测试和咨询（提供额外的提供者培训和早上艾滋病毒测试）和基于设施的艾滋病毒自检（Oraquick HIV 自检、小组演示和分发以及解释和咨询的私人空间）。主要结局是在登记当天接受艾滋病毒检测的门诊患者比例，通过对门诊患者的抽样进行退出调查来衡量。分析采用意向治疗。该试验在 ClinicalTrials.gov、NCT03271307 和泛非临床试验注册处（PACTR201711002697316）进行注册。
2017 年 9 月 12 日至 2018 年 2 月 23 日，5885 名门诊患者完成了退出调查，其中 2097 名患者在艾滋病毒自检组，1951 名患者在标准提供者发起的测试和咨询组，1837 名患者在优化提供者发起的测试和咨询组。在艾滋病毒自检组中，有 1063 名（51%）患者在登记当天接受了艾滋病毒检测，而在标准提供者发起的测试和咨询组中，有 248 名（13%）患者接受了检测，在优化提供者发起的测试和咨询组中，有 261 名（14%）患者接受了检测。与标准提供者发起的测试和咨询（调整后的优势比 8.52，95%CI 3.98-18.24）或优化提供者发起的测试和咨询（6.29，2.96-13.38）相比，基于设施的艾滋病毒自检组患者当天进行艾滋病毒检测的可能性显著更高。在标准提供者发起的测试和咨询以及优化提供者发起的测试和咨询组中，约有 4%的接受测试的人感到被迫接受检测，约有 1%的人感到被迫分享检测结果。在基于设施的艾滋病毒自检组中没有报告强制情况。
基于设施的艾滋病毒自检增加了马拉维门诊患者的艾滋病毒检测量，且不良事件的风险极小。在艾滋病毒检测需求未得到满足的高风险地区，应考虑扩大基于设施的艾滋病毒自检。
美国国际开发署。
