title: Feasibility of identifying a cohort of US women at high risk for HIV infection for HIV vaccine efficacy trials: longitudinal results of HVTN 906.
abstract: BACKGROUND
  Identifying cohorts of US women with HIV infection rates sufficient for inclusion in vaccine efficacy trials has been challenging. Using geography and sexual network characteristics to inform recruitment strategies, HVTN 906 determined the feasibility of recruiting a cohort of women at high risk for HIV acquisition.
  
  
  METHODS
  HIV uninfected women who reported unprotected sex in the prior 6 months, resided or engaged in risk behavior in local geographical high-risk pockets and/or had a male partner who had been incarcerated, injected drugs, or had concurrent partners were eligible. Behavioral risk assessment, HIV counseling and testing, and pregnancy testing were done at baseline, 6, 12, and 18 months.
  
  
  RESULTS
  Among 799 women, 71% were from local high-risk pockets and had high-risk male partners. Median age was 37 years; 79% were Black; and 15% Latina. Over half (55%) reported a new partner in the prior 6 months, 57% reported a male partner who had concurrent female sexual partners, and 37% reported a male partner who had been incarcerated. Retention at 18 months was 79.5%. Annual pregnancy incidence was 12%. Annual HIV incidence was 0.31% (95% confidence interval: 0.06% to 0.91%). Risk behaviors decreased between screening and 6 months with smaller changes thereafter.
  
  
  CONCLUSIONS
  This cohort of women recruited using new strategies based on geography and sexual network characteristics did not have an HIV incidence high enough for HIV vaccine efficacy trials, despite high baseline levels of risk and a high pregnancy rate. New strategies to identify cohorts of US women for efficacy trials are needed.
authors: Laboratory of Infectious Disease Prevention, New York Blood Center, New York, NY 10065, USA. bkoblin@nybloodcenter.org
authors: Beryl A
authors: BA
authors: Koblin
authors: Barbara
authors: B
authors: Metch
authors: Richard M
authors: RM
authors: Novak
authors: Cecilia
authors: C
authors: Morgan
authors: Debbie
authors: D
authors: Lucy
authors: Debora
authors: D
authors: Dunbar
authors: Parrie
authors: P
authors: Graham
authors: Edith
authors: E
authors: Swann
authors: Tamra
authors: T
authors: Madenwald
authors: Gina
authors: G
authors: Escamilia
authors: Ian
authors: I
authors: Frank
mesh_terms: D016915:AIDS Vaccines / Q000627:therapeutic use*; D000328:Adult; D002986:Clinical Trials as Topic; D015331:Cohort Studies; D005240:Feasibility Studies; D005260:Female; D015658:HIV Infections / Q000453:epidemiology / Q000517:prevention & control*; D006801:Humans; D018579:Patient Selection; D011247:Pregnancy; D012309:Risk-Taking; D012747:Sexual Partners; D011795:Surveys and Questionnaires; D014481:United States / Q000453:epidemiology; D047568:Unsafe Sex; D055815:Young Adult
chemical_list: D016915:AIDS Vaccines