Involving women in HIV vaccine efficacy trials: lessons learned from a vaccine preparedness study in New York City.

This paper identifies the recruitment strategies and human immunodeficiency virus (HIV) risk behaviors of at-risk women in an HIV vaccine preparedness study in New York City, assesses how these behaviors changed over time, and draws implications for women's involvement in HIV vaccine efficacy trials. Noninjecting HIV-1 negative women (N = 89) were recruited into an HIV vaccine preparedness study. An observational cohort study design was used. Women were recruited from clinics and community-based organizations (40%), through other study participants (24%), through newspaper advertisements (20%), and through street outreach (16%). Most women who refused (72%) also came from clinics and agencies. Retention after 12 months was 67%; after 18 months, it was 62%. The proportion of women reporting unprotected vaginal sex in the previous 3 months was 85% at baseline and declined to 70% after 12 months (P < .05). There have been no seroconversions detected. Recruitment efforts to include at-risk women in HIV vaccine efficacy trials must be diverse and actively involve community agencies. Successfully retaining these cohorts over time and detecting a high enough HIV seroincidence rate present ongoing challenges that will need to be addressed to ensure women's involvement in future trials in the US.