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).