title: Efficacy of a Multi-level Intervention to Reduce Injecting and Sexual Risk Behaviors among HIV-Infected People Who Inject Drugs in Vietnam: A Four-Arm Randomized Controlled Trial.
abstract: BACKGROUND
  Injecting drug use is a primary driver of HIV epidemics in many countries. People who inject drugs (PWID) and are HIV infected are often doubly stigmatized and many encounter difficulties reducing risk behaviors. Prevention interventions for HIV-infected PWID that provide enhanced support at the individual, family, and community level to facilitate risk-reduction are needed.
  
  
  METHODS
  455 HIV-infected PWID and 355 of their HIV negative injecting network members living in 32 sub-districts in Thai Nguyen Province were enrolled. We conducted a two-stage randomization: First, sub-districts were randomized to either a community video screening and house-to-house visits or standard of care educational pamphlets. Second, within each sub-district, participants were randomized to receive either enhanced individual level post-test counseling and group support sessions or standard of care HIV testing and counseling. This resulted in four arms: 1) standard of care; 2) community level intervention; 3) individual level intervention; and 4) community plus individual intervention. Follow-up was conducted at 6, 12, 18, and 24 months. Primary outcomes were self-reported HIV injecting and sexual risk behaviors. Secondary outcomes included HIV incidence among HIV negative network members.
  
  
  RESULTS
  Fewer participants reported sharing injecting equipment and unprotected sex from baseline to 24 months in all arms (77% to 4% and 24% to 5% respectively). There were no significant differences at the 24-month visit among the 4 arms (Wald = 3.40 (3 df); p = 0.33; Wald = 6.73 (3 df); p = 0.08). There were a total of 4 HIV seroconversions over 24 months with no significant difference between intervention and control arms.
  
  
  CONCLUSIONS
  Understanding the mechanisms through which all arms, particularly the control arm, demonstrated both low risk behaviors and low HIV incidence has important implications for policy and prevention programming.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01689545.
authors.affiliation: Department of Health Behavior, University of North Carolina Gillings School of Global Public Health, Chapel Hill, North Carolina, United States of America.
authors.forename: Vivian F
authors.initials: VF
authors.lastname: Go
authors.affiliation: Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America.
authors.forename: Constantine
authors.initials: C
authors.lastname: Frangakis
authors.affiliation: Thai Nguyen Center for Preventive Medicine, Thai Nguyen, Vietnam.
authors.forename: Nguyen Le
authors.initials: NL
authors.lastname: Minh
authors.affiliation: Department of Health, Behavior and Society, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America.
authors.forename: Carl
authors.initials: C
authors.lastname: Latkin
authors.affiliation: Department of Health Behavior, University of North Carolina Gillings School of Global Public Health, Chapel Hill, North Carolina, United States of America.
authors.forename: Tran Viet
authors.initials: TV
authors.lastname: Ha
authors.affiliation: Department of Health Behavior, University of North Carolina Gillings School of Global Public Health, Chapel Hill, North Carolina, United States of America.
authors.forename: Tran Thi
authors.initials: TT
authors.lastname: Mo
authors.affiliation: Department of Health Behavior, University of North Carolina Gillings School of Global Public Health, Chapel Hill, North Carolina, United States of America.
authors.forename: Teerada
authors.initials: T
authors.lastname: Sripaipan
authors.affiliation: Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America.
authors.forename: Wendy W
authors.initials: WW
authors.lastname: Davis
authors.affiliation: Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America.
authors.forename: Carla
authors.initials: C
authors.lastname: Zelaya
authors.affiliation: Thai Nguyen Center for Preventive Medicine, Thai Nguyen, Vietnam.
authors.forename: Pham The
authors.initials: PT
authors.lastname: Vu
authors.affiliation: Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America.
authors.forename: David D
authors.initials: DD
authors.lastname: Celentano
authors.affiliation: Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America.
authors.forename: Vu Minh
authors.initials: VM
authors.lastname: Quan
mesh_terms: D000328:Adult; D005260:Female; D015658:HIV Infections / Q000453:epidemiology*; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D012725:Sexual Behavior / Q000706:statistics & numerical data*; D015819:Substance Abuse, Intravenous / Q000453:epidemiology*; D016896:Treatment Outcome; D047568:Unsafe Sex / Q000706:statistics & numerical data; D014744:Vietnam / Q000453:epidemiology; D055815:Young Adult