title: A randomized noninferiority trial of standard versus enhanced risk reduction and adherence counseling for individuals receiving post-exposure prophylaxis following sexual exposures to HIV.
abstract: BACKGROUND
  The National HIV/AIDS Strategy proposes to scale-up post-exposure prophylaxis (PEP). Intensive risk reduction and adherence counseling appear to be effective but are resource intensive. Identifying simpler interventions that maximize the HIV prevention potential of PEP is critical.
  
  
  METHODS
  A randomized noninferiority study comparing 2 (standard) or 5 (enhanced) risk reduction counseling sessions was performed. Adherence counseling was provided in the enhanced arm. We measured changes in unprotected sexual intercourse acts at 12 months, compared with baseline; HIV acquisition; and PEP adherence. Outcomes were stratified by degree of baseline risk.
  
  
  RESULTS
  We enrolled 457 individuals reporting unprotected intercourse within 72 h with an HIV-infected or at-risk partner. Participants were 96% male and 71% white. There were 1.8 and 2.3 fewer unprotected sex acts in the standard and enhanced groups. The maximum potential risk difference, reflected by the upper bound of the 95% confidence interval, was 3.9 acts. The difference in the riskier subset may have been as many as 19.6 acts. The incidence of HIV seroconversion was 2.9% and 2.6% among persons randomized to standard and enhanced counseling, respectively, with a maximum potential difference of 3.4%. The absolute and maximal HIV seroconversion incidence was 9.9% and 20.4% greater in the riskier group randomized to standard, compared with enhanced, counseling. Adherence outcomes were similar, with noninferiority in the lower risk group and concerning differences among the higher-risk group.
  
  
  CONCLUSIONS
  Risk assessment is critical at PEP initiation. Standard counseling is only noninferior for individuals with lower baseline risk; thus, enhanced counseling should be targeted to individuals at higher risk.
authors.affiliation: Positive Health Program, Department of Internal Medicine, San Francisco General Hospital, San Francisco, California, USA. michelle.roland@cdph.ca.gov
authors.forename: Michelle E
authors.initials: ME
authors.lastname: Roland
authors.forename: Torsten B
authors.initials: TB
authors.lastname: Neilands
authors.forename: Melissa R
authors.initials: MR
authors.lastname: Krone
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Coates
authors.forename: Karena
authors.initials: K
authors.lastname: Franses
authors.forename: Margaret A
authors.initials: MA
authors.lastname: Chesney
authors.forename: James S
authors.initials: JS
authors.lastname: Kahn
authors.forename: Jeffrey N
authors.initials: JN
authors.lastname: Martin
mesh_terms: D000328:Adult; D037001:Directive Counseling / Q000379:methods*; D005260:Female; D015658:HIV Infections / Q000517:prevention & control* / Q000523:psychology / Q000628:therapy*; D006801:Humans; D008297:Male; D010349:Patient Compliance; D056990:Post-Exposure Prophylaxis / Q000379:methods*; D040242:Risk Reduction Behavior; D047568:Unsafe Sex