Recruitment, screening and characteristics of injection drug users participating in the AIDSVAX B/E HIV vaccine trial, Bangkok, Thailand

ENGLISH :
Objectives : To describe recruitment, screening and baseline characteristics of injection drug users (IDU) participating in a phase III HIV vaccine (AIDSVAX B/E ; VaxGen, USA) trial and to compare enrollment characteristics between trial participants and 1209 IDU from a 1995-1998 vaccine trial preparatory cohort for changes that might impact trial design assumptions. Methods : Enrollment for both studies was conducted at Bangkok narcotic treatment clinics, where a standardized questionnaire was administered on demographics, risk behavior and incarceration history over the previous 6 months. Results : During 1999-2000, 4943 IDU were screened for enrollment; successful sources of recruitment included clinic attendees (43.4%), an IDU referral program (20.4%) and preparatory cohort participants (14.7%). Of those screened, 1689 (34%) were HIV seropositive (HIV subtype B 23.6% ; subtype E 76.4%). Of the 2545 enrolled, 93.4% were male. Compared with cohort IDU, trial IDU were younger (mean age : 28.8 versus 31.3 years), better educated (secondary level or higher : 67.2% versus 58.7%), and less likely to inject drugs daily (39.4% versus 90.4%) ; they were more likely to have been incarcerated (78.4% versus 65.7%), have recently injected stimulants (14.8% versus 5.8%) and tranquilizers (11.5% versus 2.3%), and obtained needles/syringes from a source other than a pharmacist (7.2% versus 3.9%) (all P ~ 0.003). Conclusions : IDU at high risk for HIV have been successfully enrolled in the AIDSVAX B/E efficacy trial. Only minor epidemiologic differences were found at enrollment between trial and preparatory cohort IDU. The latter has proven critical in guiding trial design ; results are expected in late 2003. (Author' s abstract)