title: Accuracy of un-supervised versus provider-supervised self-administered HIV testing in Uganda: A randomized implementation trial.
abstract: 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.
authors.affiliation: Department of Epidemiology and Biostatistics, College of Public Health, University of Georgia, Health Sciences Campus, 101 Buck Road, Miller Hall, Athens, GA, 30602, USA, asiimwes@uga.edu.
authors.forename: Stephen
authors.initials: S
authors.lastname: Asiimwe
authors.forename: James
authors.initials: J
authors.lastname: Oloya
authors.forename: Xiao
authors.initials: X
authors.lastname: Song
authors.forename: Christopher C
authors.initials: CC
authors.lastname: Whalen
mesh_terms: D000328:Adult; D037001:Directive Counseling; D005240:Feasibility Studies; D005260:Female; D006679:HIV Seropositivity / Q000175:diagnosis* / Q000453:epidemiology; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D008297:Male; D008403:Mass Screening; D010342:Patient Acceptance of Health Care; D010353:Patient Education as Topic; D015995:Prevalence; D011933:Reagent Kits, Diagnostic / Q000592:standards; D015203:Reproducibility of Results; D012648:Self Care; D012747:Sexual Partners; D011795:Surveys and Questionnaires; D014454:Uganda / Q000453:epidemiology
chemical_list: D011933:Reagent Kits, Diagnostic