title: Medical eligibility, comprehension of the consent process, and retention of injection drug users recruited for an HIV vaccine trial.
abstract: Injection drug users (IDUs) at high risk for human immunodeficiency virus (HIV) infection are being identified as a population for HIV vaccine trials. We studied willingness of drug users to enroll and their comprehension of consent procedures in the context of a Phase II trial at one site. Of 175 people screened for enrollment and whose data sets were complete, 119 (68%) were IDUs. Of the 71 who were eligible, 39 (55%) were IDUs. Exclusion of IDUs was usually for medical reasons. Using a 17-item true/false test, comprehension of the informed consent procedure was high (median score, 16 of 17 for IDUs and non-IDUs); only three subjects (all of whom were IDUs) were excluded from enrollment due to lack of comprehension. Follow-up rates were similar for IDUs and non-IDUs. These data suggest that recruitment of IDUs into HIV vaccine trials is feasible, that IDUs can comprehend and complete the informed consent procedures, and that they return for follow-up visits.
authors.affiliation: Department of International Health, Johns Hopkins School of Hygiene and Public Health, Baltimore, MD, USA.
authors.forename: K
authors.initials: K
authors.lastname: Harrison
authors.forename: D
authors.initials: D
authors.lastname: Vlahov
authors.forename: K
authors.initials: K
authors.lastname: Jones
authors.forename: K
authors.initials: K
authors.lastname: Charron
authors.forename: M L
authors.initials: ML
authors.lastname: Clements
mesh_terms: D016915:AIDS Vaccines; D000293:Adolescent; D000328:Adult; D002986:Clinical Trials as Topic; D032882:Comprehension; D032962:Consent Forms; D004311:Double-Blind Method; D004522:Educational Status; D004608:Eligibility Determination / Q000706:statistics & numerical data*; D005260:Female; D015658:HIV Infections / Q000517:prevention & control*; D006801:Humans; D007258:Informed Consent / Q000706:statistics & numerical data*; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D012107:Research Design; D035842:Research Subjects; D015819:Substance Abuse, Intravenous / Q000150:complications*; D011795:Surveys and Questionnaires
chemical_list: D016915:AIDS Vaccines