title: Recruitment and retention of diverse populations in antiretroviral clinical trials: practical applications from the gender, race and clinical experience study.
abstract: BACKGROUND
  Women, particularly women of color, remain underrepresented in antiretroviral (ARV) clinical trials. To evaluate sex-based differences in darunavir/ritonavir-based therapy, the Gender, Race And Clinical Experience (GRACE) study was designed to enroll and retain a high proportion of women representative of the racial/ethnic demographics of women with HIV/AIDS in the United States. The recruitment and retention strategies used in GRACE are described in this article.
  
  
  METHODS
  Recruitment and retention strategies targeting women included selecting study sites that focused on women, involving community consultants, site-specific enrollment plans, access to other ARV drugs, study branding, site and patient toolkits, targeted public relations, site grants for patient support, and subsidized child care and transportation.
  
  
  RESULTS
  The recruitment strategies were successful; 287 (67%) women were enrolled, primarily women of color (black, n=191 [67%], Hispanic, n=60 [21%]). Despite the focus on retention, a greater proportion of women (32.8%) discontinued compared with men (23.2%).
  
  
  CONCLUSIONS
  The successes of GRACE in enrolling a representative population of women were rooted in pretrial preparation, engagement of community advisors, enrollment quotas, choice of study sites and site support. Lessons learned from GRACE may be applied to future study design. Further focus on factors that influence discontinuation is warranted.
authors.affiliation: Tibotec Therapeutics, Titusville, NJ 08560, USA. rfalcon@its.jnj.com
authors.forename: Ron
authors.initials: R
authors.lastname: Falcon
authors.forename: Dawn Averitt
authors.initials: DA
authors.lastname: Bridge
authors.forename: Judith
authors.initials: J
authors.lastname: Currier
authors.forename: Kathleen
authors.initials: K
authors.lastname: Squires
authors.forename: Debbie
authors.initials: D
authors.lastname: Hagins
authors.forename: Deborah
authors.initials: D
authors.lastname: Schaible
authors.forename: Robert
authors.initials: R
authors.lastname: Ryan
authors.forename: Joseph
authors.initials: J
authors.lastname: Mrus
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use; D001294:Attitude to Health / Q000208:ethnology; D002986:Clinical Trials as Topic / Q000379:methods / Q000523:psychology*; D005006:Ethnicity / Q000706:statistics & numerical data*; D005260:Female; D015658:HIV Infections / Q000188:drug therapy / Q000523:psychology*; D006801:Humans; D008875:Middle Aged; D010342:Patient Acceptance of Health Care / Q000208:ethnology / Q000523:psychology*; D018579:Patient Selection; D035842:Research Subjects / Q000523:psychology*; D035862:Vulnerable Populations / Q000706:statistics & numerical data; D055815:Young Adult
chemical_list: D019380:Anti-HIV Agents