Accuracy of Un-supervised Versus Provider-Supervised Self-administered HIV Testing in Uganda: A Randomized Implementation Trial
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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.
KeywordsUnsupervised HIV self-testing Accuracy Randomized Implementation
We would like to thank our research assistants Orishaba Carol, Tumusiime Obed and Ms Merabu. We received very useful comments from the departmental Epidemiology in Action research group led by Christopher Whalen, as well as Doctors Amara E Ezeamama, Ruanne V Barnabas, Elioda Tumwesigye and Connie Celum. Our gratitude extends to the research staff of Kabwohe Clinical Research Center, Uganda and our study participants in the fishing villages for providing us these data. This study was supported by the NIH Fogarty International Center AIDS International Training and Research Program (TW 000011-24).
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