The primary focus of the study was on injecting drug use, thus each participating site was asked to try to recruit 400 current injectors, with a minimum of 100. The target of 400 was based on experience from WHO Phase I. The locally-adapted structured questionnaire was administered by a trained interviewer to each eligible recruit. Subsequently each subject was asked to provide a blood sample for HIV (and in some cases HBV and HCV) testing.
Although drug treatment programs provide a readily accessible pool of potential recruits for a drug study, the restrictive admittance criteria (e.g., high fees, HIV negative status) employed by some programs limit treatment to specific subgroups of drug users. Moreover, many drug users do not seek treatment. Thus in order to obtain broad coverage of injectors and reduce the bias associated with recruitment from treatment programs only, it was recommended that recruitment be carried out both from treatment program settings and from community or other non-treatment settings. The purpose of including subjects from both treatment and community settings was not to compare drug users entering treatment with those who did not seek, or lacked access to, treatment, but rather to provide findings that were generalizable across a broad range of IDUs. However, it should be noted that although comparison of subjects recruited from each source was not an analytic focus at the global level, such comparisons do provide a methodological check of bias at the city level.
In order to effectively target subsequent interventions, examination of reasons for transition from non-injecting to injecting drug use and understanding of reasons for difference in prevalence levels of drug injecting behavior in similar and geographically close cities was needed. Thus, in geographic areas where injection drug use was on the increase or where use of "injectable" drugs by non-injected modes of administration was widespread, individual sites were encouraged to also recruit persons who had replaced injection drug use with non-injection (former injectors), and/or persons who had never injected (never-injectors) in the study. These persons could be recruited from treatment and/or community settings as desired, however, a minimum of 100 former or 100 never-injectors was recommended.
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