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, an d draws implications for women's involvement in HIV vaccine efficacy trials . Noninjecting HIV-1 negative women (N = 89) were recruited into an HIV vac cine preparedness study. An observational cohort study design was used. Wom en were recruited from clinics and community-based organizations (40%), thr ough 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 mon ths, 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 m onths (P < .05). There have been no seroconversions detected. Recruitment e fforts to include at-risk women in HIV vaccine efficacy trials must be dive rse and actively involve community agencies. Successfully retaining these c ohorts over time and detecting a high enough HIV seroincidence rate present ongoing challenges that will need to be addressed to ensure women's involv ement in future trials in the US.