title: The feasibility of HIV-1 vaccine efficacy trials among gay/bisexual men in New York City: Project ACHIEVE. AIDS Community Health Initiative Enroute to the Vaccine EFfort.
abstract: OBJECTIVE
  Candidate populations for HIV-1 vaccine efficacy trials need to be at high risk of infection, adhere to study protocols and be willing to participate. The goal of Project ACHIEVE is to collect baseline data needed in order to prepare for vaccine efficacy trials among gay/bisexual men in New York City.
  
  
  METHODS
  HIV-1 antibody-negative men were recruited into a cohort study with follow-up visits every 3 months (n = 622). Frequency of high-risk behaviors and incidence of HIV-1 seroconversion were measured.
  
  
  RESULTS
  Of 544 men reporting having had at least one partner in the previous 3 months who was HIV-1 antibody-positive or of unknown status at baseline, 49% reported receptive anal sex encounters. Thirty-two per cent of these men reported the highest risk behavior, unprotected receptive anal sex. The follow-up rate at 12 months was 81%. The incidence rate of infection was 2.9 per 100 person-years (95% confidence interval: 1.7, 4.9). During follow-up, declines were observed in the proportion of men with an HIV-1 antibody-positive partner and the proportion reporting unprotected receptive or insertive anal sex. HIV-1 infection rates declined from 4.3 per 100 person-years in the first 6 months to 1.6 per 100 person-years by the 12-month visit.
  
  
  CONCLUSIONS
  Gay/bisexual men in New York City are still placing themselves at risk of HIV-1 infection and may be a suitable population for future vaccine trials. Continued follow-up is needed to further define the incidence over time, especially for the period after the initial 3 to 6 months when vaccines are most likely to be effective. Immediate prevention efforts need to target this population more effectively.
authors.affiliation: Wolf Szmuness Laboratory of Epidemiology, New York Blood Center, New York 10021, USA.
authors.forename: B A
authors.initials: BA
authors.lastname: Koblin
authors.forename: P E
authors.initials: PE
authors.lastname: Taylor
authors.forename: S
authors.initials: S
authors.lastname: Avrett
authors.forename: C E
authors.initials: CE
authors.lastname: Stevens
mesh_terms: D016915:AIDS Vaccines; D001727:Bisexuality; D002986:Clinical Trials as Topic; D005240:Feasibility Studies; D005500:Follow-Up Studies; D015658:HIV Infections / Q000453:epidemiology / Q000276:immunology / Q000517:prevention & control*; D015497:HIV-1 / Q000276:immunology*; D018451:Homosexuality, Male; D006801:Humans; D015994:Incidence; D008297:Male; D008403:Mass Screening; D009519:New York City / Q000453:epidemiology; D012153:Retention, Psychology; D012309:Risk-Taking
chemical_list: D016915:AIDS Vaccines