Understanding Differences in Enrollment Outcomes among Diverse, High-Risk Populations Recruited to a Phase IIb HIV Vaccine Trial
Journal of Acquired Immune Deficiency Syndromes
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Background The Step Study, a Phase IIb HIV vaccine proof of concept study, enrolled approximately 3,000 persons in Clade B regions. The Atlanta site sought to enroll a diverse population. This prospective cohort study examined key factors associated with participant enrollment. Methods We obtained participant information (e.g., sociodemographic, medical) and followed outcomes from 2005 to 2007. Of the 810 potential “Step Study” participants, 340 cases were analyzed. Results The recruitment strategy generated strong interest among minorities with 37% eligible following prescreening, yet 25% of the minorities enrolled. However, the percentage of whites increased from 62% eligible (prescreened sample) to 75% enrolled. The regression model was significant with educational level being an enrollment predictor (p = 0.0023). … See full text for complete abstract.
HIV vaccine; Willingness-to-participate; Recruitment; Retentionl; Women; Minorities
Clinical Trials | Immunology and Infectious Disease | Virology
Frew, P. M.,
del Rio, C.,
Mulligan, M. J.
Understanding Differences in Enrollment Outcomes among Diverse, High-Risk Populations Recruited to a Phase IIb HIV Vaccine Trial.
Journal of Acquired Immune Deficiency Syndromes, 50(3),