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1996-01-30
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Document 0601
DOCN M9610601
TI Medical eligibility, comprehension of the consent process, and retention
of injection drug users recruited for an HIV vaccine trial.
DT 9601
AU Harrison K; Vlahov D; Jones K; Charron K; Clements ML; Department of
International Health, Johns Hopkins School of; Hygiene and Public
Health, Baltimore, MD, USA.
SO J Acquir Immune Defic Syndr Hum Retrovirol. 1995 Nov 1;10(3):386-90.
Unique Identifier : AIDSLINE MED/96027808
AB 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.
DE Adolescence Adult *AIDS Vaccines Clinical Trials Double-Blind Method
Educational Status Eligibility Determination/*STATISTICS & NUMER DATA
Female Human HIV Infections/*PREVENTION & CONTROL Informed
Consent/*STATISTICS & NUMER DATA Male Middle Age *Patient Selection
Questionnaires Research Design Substance Abuse,
Intravenous/*COMPLICATIONS Support, U.S. Gov't, P.H.S. CLINICAL TRIAL
CLINICAL TRIAL, PHASE II JOURNAL ARTICLE MULTICENTER STUDY RANDOMIZED
CONTROLLED TRIAL
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).