• Ron Falcon, Dawn Averitt Bridge, Judith Currier, Kathleen Squires, Debbie Hagins, Deborah Schaible, Robert Ryan, Joseph Mrus, and GRACE Study Group.
• Tibotec Therapeutics, Titusville, NJ 08560, USA. rfalcon@its.jnj.com
• J Womens Health (Larchmt). 2011 Jul 1; 20 (7): 104310501043-50.

BackgroundWomen, 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.MethodsRecruitment 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.ResultsThe 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%).ConclusionsThe 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.

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