Clinical infectious diseases : an official publication of the Infectious Diseases Society of America | 2019
Screening and Enrollment by Sex in HIV Clinical Trials in the United States.
Abstract
BACKGROUND\nWomen are underrepresented in HIV research in the United States. To determine if women screening for HIV clinical trials enrolled at lower rates than men, we performed a retrospective, cross-trial analysis.\n\n\nMETHODS\nWe conducted an analysis of screening and enrollment during 2003-2013 to 31 clinical trials at 99 AIDS Clinical Trials Group network research sites in the United States. Random-effects meta regression estimated whether sex differences in not enrolling ( screen out ) varied by various individual, trial or site characteristics.\n\n\nRESULTS\nOf 10,744 persons screened, 18.9% were women. The percentage of women and men who screened out was 27.9% and 26.5%, respectively (p-value = 0.19); this small difference did not significantly vary by race, ethnicity or age group. Most common reasons for screening out were not meeting eligibility criteria (30-35%) and opting-out (23%), and these did not differ by sex. Trial and research site characteristics associated with variable screen-out by sex included HIV research domain and type of hemoglobin eligibility criterion, but individual associations did not persist after adjustment for multiple testing.\n\n\nCONCLUSIONS\nIn the absence of evidence of significantly higher trial screen out for women, approaching more women to screen may increase female representation in HIV trials.