Recruitment, screening and characteristics of injection drug users participating in the AIDSVAX®B/E HIV vaccine trial, Bangkok, Thailand
Recruitment, screening and characteristics of injection drug users participating in the AIDSVAX®B/E HIV vaccine trial, Bangkok, Thailand
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DOI：
10.1097/00002030-200401230-00022
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发表时间：
2004-01-23
期刊：
影响因子：
3.8
通讯作者：
Choopanya, K
中科院分区：
文献类型：
--
作者：
Vanichseni, S;Tappero, JW;Choopanya, K
Objectives: To describe recruitment, screening and baseline characteristics of injection drug users (IDU) participating in a phase III HIV vaccine (AIDSVAX(R) 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 less than or equal to 0.003).Conclusions: IDU at high risk for HIV have been successfully enrolled in the AIDSVAX(R)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. (C) 2004 Lippincott Williams Wilkins.
