title: Effect of risk-reduction counseling with rapid HIV testing on risk of acquiring sexually transmitted infections: the AWARE randomized clinical trial.
abstract: OBJECTIVE
  To increase human immunodeficiency virus (HIV) testing rates, many institutions and jurisdictions have revised policies to make the testing process rapid, simple, and routine. A major issue for testing scale-up efforts is the effectiveness of HIV risk-reduction counseling, which has historically been an integral part of the HIV testing process.
  
  
  OBJECTIVE
  To assess the effect of brief patient-centered risk-reduction counseling at the time of a rapid HIV test on the subsequent acquisition of sexually transmitted infections (STIs).
  
  
  METHODS
  From April to December 2010, Project AWARE randomized 5012 patients from 9 sexually transmitted disease (STD) clinics in the United States to receive either brief patient-centered HIV risk-reduction counseling with a rapid HIV test or the rapid HIV test with information only. Participants were assessed for multiple STIs at both baseline and 6-month follow-up.
  
  
  METHODS
  Participants randomized to counseling received individual patient-centered risk-reduction counseling based on an evidence-based model. The core elements included a focus on the patient's specific HIV/STI risk behavior and negotiation of realistic and achievable risk-reduction steps. All participants received a rapid HIV test.
  
  
  METHODS
  The prespecified outcome was a composite end point of cumulative incidence of any of the measured STIs over 6 months. All participants were tested for Neisseria gonorrhoeae, Chlamydia trachomatis, Treponema pallidum (syphilis), herpes simplex virus 2, and HIV. Women were also tested for Trichomonas vaginalis.
  
  
  RESULTS
  There was no significant difference in 6-month composite STI incidence by study group (adjusted risk ratio, 1.12; 95% CI, 0.94-1.33). There were 250 of 2039 incident cases (12.3%) in the counseling group and 226 of 2032 (11.1%) in the information-only group.
  
  
  CONCLUSIONS
  Risk-reduction counseling in conjunction with a rapid HIV test did not significantly affect STI acquisition among STD clinic patients, suggesting no added benefit from brief patient-centered risk-reduction counseling.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT01154296.
authors.affiliation: Department of Sociomedical Sciences, Mailman School of Public Health, Columbia University, New York, New York2Department of Public Health Sciences, Miller School of Medicine, University of Miami, Miami, Florida.
authors.forename: Lisa R
authors.initials: LR
authors.lastname: Metsch
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Feaster
authors.forename: Lauren
authors.initials: L
authors.lastname: Gooden
authors.forename: Bruce R
authors.initials: BR
authors.lastname: Schackman
authors.forename: Tim
authors.initials: T
authors.lastname: Matheson
authors.forename: Moupali
authors.initials: M
authors.lastname: Das
authors.forename: Matthew R
authors.initials: MR
authors.lastname: Golden
authors.forename: Shannon
authors.initials: S
authors.lastname: Huffaker
authors.forename: Louise F
authors.initials: LF
authors.lastname: Haynes
authors.forename: Susan
authors.initials: S
authors.lastname: Tross
authors.forename: C Kevin
authors.initials: CK
authors.lastname: Malotte
authors.forename: Antoine
authors.initials: A
authors.lastname: Douaihy
authors.forename: P Todd
authors.initials: PT
authors.lastname: Korthuis
authors.forename: Wayne A
authors.initials: WA
authors.lastname: Duffus
authors.forename: Sarah
authors.initials: S
authors.lastname: Henn
authors.forename: Robert
authors.initials: R
authors.lastname: Bolan
authors.forename: Susan S
authors.initials: SS
authors.lastname: Philip
authors.forename: Jose G
authors.initials: JG
authors.lastname: Castro
authors.forename: Pedro C
authors.initials: PC
authors.lastname: Castellon
authors.forename: Gayle
authors.initials: G
authors.lastname: McLaughlin
authors.forename: Raul N
authors.initials: RN
authors.lastname: Mandler
authors.forename: Bernard
authors.initials: B
authors.lastname: Branson
authors.forename: Grant N
authors.initials: GN
authors.lastname: Colfax
mesh_terms: D015492:AIDS Serodiagnosis / Q000379:methods; D000328:Adult; D003376:Counseling; D005260:Female; D015658:HIV Infections / Q000175:diagnosis*; D006801:Humans; D008297:Male; D018802:Patient-Centered Care; D012306:Risk; D040242:Risk Reduction Behavior; D012749:Sexually Transmitted Diseases / Q000453:epidemiology* / Q000517:prevention & control*; D013997:Time Factors; D014481:United States / Q000453:epidemiology; D055815:Young Adult