title: A randomized trial of enhanced HIV risk-reduction and vaccine trial education interventions among HIV-negative, high-risk women who use noninjection drugs: the UNITY study.
abstract: BACKGROUND
  Limited data are available on interventions to reduce sexual risk behaviors and increase knowledge of HIV vaccine trial concepts in high-risk populations eligible to participate in HIV vaccine efficacy trials.
  
  
  METHODS
  The UNITY Study was a 2-arm randomized trial to determine the efficacy of enhanced HIV risk-reduction and vaccine trial education interventions to reduce the occurrence of unprotected vaginal sex acts and increase HIV vaccine trial knowledge among 311 HIV-negative noninjection drug using women. The enhanced vaccine education intervention using pictures along with application vignettes and enhanced risk-reduction counseling consisting of 3 one-on-one counseling sessions were compared with standard conditions. Follow-up visits at 1 week and 1, 6, and 12 months after randomization included HIV testing and assessment of outcomes.
  
  
  RESULTS
  During follow-up, the percent of women reporting sexual risk behaviors declined significantly but did not differ significantly by study arm. Knowledge of HIV vaccine trial concepts significantly increased but did not significantly differ by study arm. Concepts about HIV vaccine trials not adequately addressed by either condition included those related to testing a vaccine for both efficacy and safety, guarantees about participation in future vaccine trials, assurances of safety, medical care, and assumptions about any protective effect of a test vaccine.
  
  
  CONCLUSIONS
  Further research is needed to boost educational efforts and strengthen risk-reduction counseling among high-risk noninjection drug using women.
authors.affiliation: Laboratory of Infectious Disease Prevention, New York Blood Center, 310 E.67th Street, New York, NY 10065, USA. bkoblin@nybloodcenter.org
authors.forename: Beryl A
authors.initials: BA
authors.lastname: Koblin
authors.forename: Sebastian
authors.initials: S
authors.lastname: Bonner
authors.forename: Donald R
authors.initials: DR
authors.lastname: Hoover
authors.forename: Guozhen
authors.initials: G
authors.lastname: Xu
authors.forename: Debbie
authors.initials: D
authors.lastname: Lucy
authors.forename: Princess
authors.initials: P
authors.lastname: Fortin
authors.forename: Sara
authors.initials: S
authors.lastname: Putnam
authors.forename: Mary H
authors.initials: MH
authors.lastname: Latka
mesh_terms: D016915:AIDS Vaccines; D000293:Adolescent; D000328:Adult; D032763:Behavior Control / Q000379:methods*; D018562:Disease Transmission, Infectious / Q000517:prevention & control*; D055030:Drug Users; D005260:Female; D015658:HIV Infections / Q000635:transmission*; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D008875:Middle Aged; D040242:Risk Reduction Behavior; D047568:Unsafe Sex / Q000706:statistics & numerical data*; D055815:Young Adult
chemical_list: D016915:AIDS Vaccines