Screening and Enrollment by Sex in HIV Clinical Trials in the United States

2019 
BACKGROUND: Women 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. METHODS: We 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. RESULTS: Of 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. CONCLUSIONS: In the absence of evidence of significantly higher trial screen out for women, approaching more women to screen may increase female representation in HIV trials.
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