title: Feasibility and initial efficacy of a culturally sensitive women-centered substance use intervention in Georgia: Sex risk outcomes.
abstract: BACKGROUND
  This paper reports on the feasibility and initial efficacy of a culturally sensitive, comprehensive women-centered substance use intervention for women who inject drugs in Georgia in terms of the primary and secondary sex risk outcomes. The hypothesis under examination was that, relative to case management participants, participants in a culturally sensitive, comprehensive women-specific and -centered intervention would, on average, show significant decreases in past-30-day frequency of unprotected sex, unprotected sex at the last sexual encounter, and increases in condom use and safer sex actions.
  
  
  METHODS
  The study was a two-arm randomized trial, in which 173 potentially eligible women were screened, and those 128 women determined to be eligible were assigned at random to either Reinforcement-based Treatment plus Women's Co-Op (RBT + WC) or case management (CM). RBT + WC participants received 12 sessions of a structured intervention with the goal of reducing risky sex and substance use and improving physical and mental health. CM participants received 12 sessions of case management and informational brochures that focused on the same issues on which RBT + WC focused. Participants were assessed at baseline, post-treatment, and 3 months following treatment enrollment.
  
  
  RESULTS
  Analyses revealed case management having significantly overall higher Safer Sex action scores than RBT + WC, and a significant decrease over time for past 30-day number of unprotected sex acts. Unprotected sex at the last encounter and Condom Use action scores were nonsignificant.
  
  
  CONCLUSIONS
  Women who inject drugs in Georgia are engaging in risky sexual practices, and are in need of an intervention that addresses these risky behaviors. Reasons for the failure to find differences between a culturally sensitive, comprehensive women-centered intervention and case management tailored to the needs of women who inject drugs in Georgia may have been the result of inadequate power to detect an effect in a sample whose drug use was not as serious as warranted by the intervention. (ClinicalTrials.gov Identifier: NCT01331460 ).
authors.affiliation: UNC Horizons, Department of Obstetrics and Gynecology, School of Medicine, University of North Carolina at Chapel Hill, 127 Kingston Drive, Chapel Hill, NC, 27514, USA. Hendree_Jones@med.unc.edu.|Departments of Psychiatry and Behavioral Sciences and Obstetrics and Gynecology, School of Medicine, Johns Hopkins University, Baltimore, MD, 21224, USA. Hendree_Jones@med.unc.edu.
authors.forename: Hendrée E
authors.initials: HE
authors.lastname: Jones
authors.affiliation: Addiction Research Center, Alternative Georgia, Tbilisi, 0177, Georgia. irma@altgeorgia.ge.|Ilia State University, Business School, Tbilisi, 0162, Georgia. irma@altgeorgia.ge.
authors.forename: Irma
authors.initials: I
authors.lastname: Kirtadze
authors.affiliation: Addiction Research Center, Alternative Georgia, Tbilisi, 0177, Georgia. dato@altgeorgia.ge.
authors.forename: David
authors.initials: D
authors.lastname: Otiashvili
authors.affiliation: UNC Horizons, Department of Obstetrics and Gynecology, School of Medicine, University of North Carolina at Chapel Hill, 127 Kingston Drive, Chapel Hill, NC, 27514, USA. kerynmurphy@gmail.com.
authors.forename: Keryn
authors.initials: K
authors.lastname: Murphy
authors.affiliation: Department of Psychology, University of Maryland, College Park, College Park, MD, 20742, USA. ogrady@umd.edu.
authors.forename: Kevin E
authors.initials: KE
authors.lastname: O'Grady
authors.affiliation: Substance Abuse Treatment Evaluations and Interventions Research Program, RTI International, Research Triangle Park, ᅟ, NC, 27709, USA. zule@rti.org.
authors.forename: William
authors.initials: W
authors.lastname: Zule
authors.affiliation: Department of Addictions, Bekhterev Research Psychoneurological Institute, St. Petersburg, 192019, Russia. kruenator@gmail.com.
authors.forename: Evgeny
authors.initials: E
authors.lastname: Krupitsky
authors.affiliation: Substance Abuse Treatment Evaluations and Interventions Research Program, RTI International, Research Triangle Park, ᅟ, NC, 27709, USA. wmw@rti.org.
authors.forename: Wendee M
authors.initials: WM
authors.lastname: Wechsberg
mesh_terms: D000328:Adult; D001521:Behavior Therapy; D019090:Case Management; D017280:Condoms / Q000706:statistics & numerical data*; D065246:Culturally Competent Care / Q000379:methods*; D005240:Feasibility Studies; D005260:Female; D005846:Georgia (Republic); D006801:Humans; D015819:Substance Abuse, Intravenous / Q000628:therapy*; D019966:Substance-Related Disorders / Q000628:therapy*; D047568:Unsafe Sex / Q000517:prevention & control*; D055815:Young Adult