title: Feasibility of Identifying a Female Sex Worker Cohort at High Risk of HIV Infection in the Caribbean for HIV Vaccine Efficacy Trials: Longitudinal Results of HVTN 907.
abstract: BACKGROUND
  Identifying cohorts of Caribbean women with HIV infection rates sufficient for inclusion in HIV vaccine efficacy trials has been challenging. HVTN 907 determined the feasibility of identifying and retaining a cohort of women at high risk for HIV acquisition by focusing recruitment on female sex workers (FSWs).
  
  
  METHODS
  HIV uninfected FSWs, residing in Haiti, Dominican Republic, and Puerto Rico, who reported unprotected sex and met previously described more stringent site-specific eligibility criteria, were eligible. Behavioral risk assessment, HIV counseling and testing, and pregnancy testing were performed at baseline, 6, 12, and 18 months.
  
  
  RESULTS
  Among 799 FSWs (264 from Dominican Republic, 334 from Haiti, and 201 from Puerto Rico), the median age was 26 years, with 54% having less than a high school education and 45% having a monthly household income of less than $US 100. Median number of male partners 6 months before screening was 200. Retention at 18 months was 93%. Twelve women became HIV infected, 9 from Haiti. The annualized HIV incidence was 1.07% (95% confidence interval: 0.55% to 1.87%). Pregnancy incidence was 22.5% (95% confidence interval: 21.9% to 29.5%). Statistically significant declines in risk behaviors occurred between screening and the 18-month visit assessment.
  
  
  CONCLUSIONS
  The HVTN 907 study identified a high-risk cohort of women with excellent retention for all 3 sites, despite major challenges especially in Haiti. These results show that a bridging study of a vaccine shown to be efficacious in other clade settings would be possible among FSWs in the region, particularly in Haiti.
authors.affiliation: *Groupe Haitien d'Etude du Sarcome de Kaposi et des Infections Opportunistes (GHESKIO), Port-au-Prince, Haiti;†Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA;‡Maternal and Infant Studies Center (CEMI), University of Puerto Rico School of Medicine, San Juan, PR;§Unidad de Vacunas IDCP-COIN-DIGECITSS, Santo Domingo, Dominican Republic; and‖Division of AIDS, National Institute of Allergy and Infectious Diseases, NIH, Bethesda, MD.
authors.forename: Marie M
authors.initials: MM
authors.lastname: Deschamps
authors.forename: Barbara
authors.initials: B
authors.lastname: Metch
authors.forename: Cecilia A
authors.initials: CA
authors.lastname: Morgan
authors.forename: Carmen D
authors.initials: CD
authors.lastname: Zorilla
authors.forename: Yeycy
authors.initials: Y
authors.lastname: Donastorg
authors.forename: Edith
authors.initials: E
authors.lastname: Swann
authors.forename: Dadaille
authors.initials: D
authors.lastname: Taina
authors.forename: Joseph
authors.initials: J
authors.lastname: Patrice
authors.forename: William J
authors.initials: WJ
authors.lastname: Pape
mesh_terms: D016915:AIDS Vaccines / Q000627:therapeutic use*; D000328:Adult; D017691:Caribbean Region / Q000453:epidemiology; D002986:Clinical Trials as Topic; D005240:Feasibility Studies; D005260:Female; D015658:HIV Infections / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D006801:Humans; D015994:Incidence; D018579:Patient Selection; D011247:Pregnancy; D018570:Risk Assessment; D012307:Risk Factors; D060386:Sex Workers / Q000706:statistics & numerical data*; D012747:Sexual Partners; D047568:Unsafe Sex / Q000706:statistics & numerical data; D055815:Young Adult
chemical_list: D016915:AIDS Vaccines