Accuracy of un-supervised versus provider-supervised self-administered HIV testing in Uganda: A randomized implementation trial.

Accuracy of un-supervised versus provider-supervised self-administered HIV testing in Uganda: A randomized implementation trial.
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DOI:
10.1007/s10461-014-0765-4
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发表时间:
2014-12
期刊:
影响因子:
4.4
通讯作者:
Whalen, Christopher C.
Whalen, Christopher C.
中科院分区:
医学2区
文献类型:
--
作者:
Asiimwe, Stephen;Oloya, James;Song, Xiao;Whalen, Christopher C.

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无人监督的艾滋病毒自我检测(HST)有可能增加对艾滋病毒状况的了解;然而,其准确性尚不清楚。为了估计乌干达野外环境中无监督HST的准确性,我们在2013年7月至9月期间在乌干达的三个渔村中选择的高HIV风险人群(22.1% HIV流行率)中进行了一项无监督HST与有监督HST相比的非盲、随机对照、非劣效性试验。该研究招募了246名参与者,并将他们以1:1的比例随机分配到无监督HST或提供者监督的HST。在意向治疗分析中,无监督组的HST敏感性为90%,提供者监督组为100%,差异为0 f-10%(90%CI-21,1%);未显示非劣效性。在符合方案分析中,灵敏度差异为-5.6%(90%CI-14.4,3.3%),显示出非劣效性。我们的结论是,无人监督的HST在非洲农村是可行的,可能是不劣于供应商监督的HST。
Unsupervised HIV self-testing (HST) has potential to increase knowledge of HIV status; however, its accuracy is unknown. To estimate the accuracy of unsupervised HST in field settings in Uganda, we performed a non-blinded, randomized controlled, non-inferiority trial of unsupervised compared with supervised HST among selected high HIV risk fisherfolk (22.1 % HIV Prevalence) in three fishing villages in Uganda between July and September 2013. The study enrolled 246 participants and randomized them in a 1:1 ratio to unsupervised HST or provider-supervised HST. In an intent-to-treat analysis, the HST sensitivity was 90 % in the unsupervised arm and 100 % among the provider-supervised, yielding a difference 0f −10 % (90 % CI −21, 1 %); non-inferiority was not shown. In a per protocol analysis, the difference in sensitivity was −5.6 % (90 % CI −14.4, 3.3 %) and did show non-inferiority. We conclude that unsupervised HST is feasible in rural Africa and may be non-inferior to provider-supervised HST.
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