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Titolo:
Who will enroll? Predicting participation in a phase II AIDS vaccine trial
Autore:
Halpern, SD; Metzger, DS; Beslin, JA; Ubel, PA;
Indirizzi:
Univ Penn, Ctr Clin Epidemiol & Biostat, Sch Med, Philadelphia, PA 19104 USA Univ Penn Philadelphia PA USA 19104 , Sch Med, Philadelphia, PA 19104 USA Univ Penn, Ctr Bioeth, Sch Med, Philadelphia, PA 19104 USA Univ Penn Philadelphia PA USA 19104 , Sch Med, Philadelphia, PA 19104 USA Univ Penn, Penn VA Ctr Studies Addict, Sch Med, Philadelphia, PA 19104 USAUniv Penn Philadelphia PA USA 19104 , Sch Med, Philadelphia, PA 19104 USA Ann Arbor Vet Affairs Med Ctr, Ann Arbor, MI USA Ann Arbor Vet Affairs MedCtr Ann Arbor MI USA ed Ctr, Ann Arbor, MI USA Univ Michigan, Sch Med, Dept Med, Ann Arbor, MI 48109 USA Univ Michigan Ann Arbor MI USA 48109 d, Dept Med, Ann Arbor, MI 48109 USA
Titolo Testata:
JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES
fascicolo: 3, volume: 27, anno: 2001,
pagine: 281 - 288
SICI:
1525-4135(20010701)27:3<281:WWEPPI>2.0.ZU;2-7
Fonte:
ISI
Lingua:
ENG
Soggetto:
HIGH-RISK POPULATIONS; CLINICAL-TRIALS; EFFICACY TRIALS; UNITED-STATES; WILLINGNESS; SAMPLE; MEN; PREFERENCES; THAILAND; CONSENT;
Keywords:
vaccine; ethics; informed consent; human experimentation; research design; patient recruitment; human volunteers;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
35
Recensione:
Indirizzi per estratti:
Indirizzo: Halpern, SD Univ Penn, Ctr Clin Epidemiol & Biostat, Sch Med, 108 BlockleyHall,423 Guardian Dr, Philadelphia, PA 19104 USA Univ Penn 108 Blockley Hall,423 Guardian Dr Philadelphia PA USA 19104
Citazione:
S.D. Halpern et al., "Who will enroll? Predicting participation in a phase II AIDS vaccine trial", J ACQ IMM D, 27(3), 2001, pp. 281-288

Abstract

Background: The problems of underenrollment and selective enrollment may undermine AIDS vaccine trials. If prospective study subjects' stated willingness to participate (WTP) in hypothetical vaccine trials predicts future enrollment, then measuring WTP before recruitment may enhance the enrollment in, and ethics of, such trials. Methods: We prospectively studied changes over an 18-month period in the stated WTP in, and knowledge of, a hypothetical AIDS vaccine trial among 610Philadelphia residents at high risk for HIV infection. Of these people, 499 were subsequently recruited to participate in an actual, phase II AIDS vaccine trial. We used multivariable logistic regression and the area under the receiver-operating characteristic (ROC) curve to model predictors of actual enrollment. Results: Actual enrollment rates were 8.3%, 6.8%, 15.8%, and 29.0% among those who had initially said they were "definitely not," "probably not." "probably," and "definitely" willing to participate, respectively (p = .006). The area under the ROC curve was 0.65, indicating a modest ability of stated WTP to differentiate those who enroll from those who do not. Knowledge ofbasic vaccine trial concepts, though unrelated to enrollment, increased over an 18-month period with repeated education sessions (p < .0001), whereasstated WTP declined over this same period (p < .0001). Conclusion: Although other factors not captured by stated WTP may also influence future enrollment, prospectively assessing stated WTP may augment the validity of the informed consent process, help prevent underenrollment, and clarify the population from which the study sample is drawn.

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Documento generato il 30/10/20 alle ore 01:01:53