title: Recruitment of HIV/AIDS treatment-naïve patients to clinical trials in the highly active antiretroviral therapy era: influence of gender, sexual orientation and race.
abstract: BACKGROUND
  In the USA, women, racial/ethnic minorities and persons who acquire HIV infection through heterosexual intercourse represent an increasing proportion of HIV-infected persons, and yet are frequently underrepresented in clinical trials. We assessed the demographic predictors of trial participation in antiretroviral-naïve patients.
  
  
  METHODS
  Patients were characterized as trial participants if highly active antiretroviral therapy (HAART) was initiated within a clinical trial. Prevalence ratios (PRs) were obtained using binomial regression.
  
  
  RESULTS
  Between 1996 and 2006, 30% of 738 treatment-naïve patients initiated HAART in a clinical trial. Trial participation rates for men who have sex with men (MSM), heterosexual men, and women were respectively 36.5, 29.6 and 24.3%. After adjustment for other factors, heterosexual men appeared less likely to participate in trials compared with MSM [PR 0.79, 95% confidence interval (CI) 0.57, 1.11], while women were as likely to participate as MSM (PR 0.97, 95% CI 0.68, 1.39). The participation rate in Black patients (25.9%) was lower compared with non-Black patients (37.5%) (adjusted PR 0.80, 95% CI 0.60, 1.06).
  
  
  CONCLUSIONS
  In our clinical setting, gender did not appear to impact participation in HIV treatment trials, but Black patients were slightly less likely to participate in these trials. Considering the substantial proportion of HIV-infected patients who are Black, future trials need to consider strategies to incorporate such underrepresented populations.
authors.affiliation: Division of Infectious Diseases, School of Medicine, University of North Carolina, Chapel Hill, NC 27599, USA. menez001@med.unc.edu
authors.forename: P
authors.initials: P
authors.lastname: Menezes
authors.forename: J J
authors.initials: JJ
authors.lastname: Eron
authors.forename: P A
authors.initials: PA
authors.lastname: Leone
authors.forename: A A
authors.initials: AA
authors.lastname: Adimora
authors.forename: D A
authors.initials: DA
authors.lastname: Wohl
authors.forename: W C
authors.initials: WC
authors.lastname: Miller
mesh_terms: D000328:Adult; D023241:Antiretroviral Therapy, Highly Active; D002986:Clinical Trials as Topic / Q000379:methods*; D003430:Cross-Sectional Studies; D005260:Female; D005783:Gender Identity; D015658:HIV Infections / Q000188:drug therapy* / Q000208:ethnology / Q000523:psychology; D006801:Humans; D008297:Male; D018579:Patient Selection; D044469:Racial Groups; D012725:Sexual Behavior
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