Repeated Assessments of Informed Consent Comprehension among HIV-Infected Participants of a Three-Year Clinical Trial in Botswana 英文参考文献.docVIP

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Repeated Assessments of Informed Consent Comprehension among HIV-Infected Participants of a Three-Year Clinical Trial in Botswana 英文参考文献.doc

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Repeated Assessments of Informed Consent Comprehension among HIV-Infected Participants of a Three-Year Clinical Trial in Botswana 英文参考文献

RepeatedAssessmentsofInformedConsent ComprehensionamongHIV-InfectedParticipantsofa Three-YearClinicalTrialinBotswana LeliaH.Chaisson1,NancyE.Kass1,2*,BafananaChengeta3,UnamiMathebula4,TarazSamandari3,4 1BermanInstituteofBioethics,JohnsHopkinsUniversity,Baltimore,Maryland,UnitedStatesofAmerica,2DepartmentofHealthPolicyandManagement,JohnsHopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America, 3Botswana-USA Partnership, Gaborone and Francistown, Botswana, 4Division of TuberculosisElimination,CentersforDiseaseControlandPrevention,Atlanta,Georgia,UnitedStatesofAmerica Abstract Background:Informedconsent(IC)hasbeenaninternationalstandardfordecadesfortheethicalconductofclinicaltrials. Yetfrequentlystudyparticipantshaveincompleteunderstandingofkeyissues,aproblemexacerbatedbylanguagebarriers orlackoffamiliaritywithresearchconcepts.FewinvestigatorsmeasureparticipantcomprehensionofIC,whileevenfewer conductinterimassessmentsonceatrialisunderway. Methods and Findings: We assessed comprehension of IC using a 20-question true/false quiz administered in 6-month intervals in the context of a placebo-controlled, randomized trial for the prevention of tuberculosis among HIV-infected adultsinBotswana(2004–2009).QuizzeswereofferedinbothSetswanaandEnglish.ToenrollintheTBtrial,participants were required to have $16/20 correct responses. We examined concepts understood and the degree to which understanding changed over three-years. We analyzed 5,555 quizzes from 1,835 participants. The participants’ highest educationlevelswere:28%primary,59%secondary,9%tertiaryand7%noformaleducation.Eightypercentofparticipants passedtheenrollmentquiz(Quiz1)ontheirfirstattemptandtheremainderpassedontheirsecondattempt.Thosehaving higherthanprimaryeducationandthosewhotookthequizinEnglishweremorelikelytoreceiveapassingscoreontheir first attempt (adjusted odds ratios and 95% confidence intervals, 3.1 (2.4–4.0) and 1.5 (1.2, 1.9), respectively). The trial’s purposeorprocedures