ACTG DACS 325: Screening and Enrollment by Sex in HIV Clinical Trials in the United States

Clinical Infectious Diseases, September 2019

While women represent about one-quarter of adults living with HIV in the United States, many HIV clinical trials enroll fewer than 25% women. ACTG DACS 325 sought to assess how people living with HIV are recruited into the network’s clinical trials and whether ACTG enrolled proportionally lower percentages of women compared to men from the United States (and if so, why).
This analysis included all ACTG trials recruiting people living with HIV in the United States from 2003 (when the screening database started) through 2013. Data from 31 trials recruiting at 99 clinical research sites across the United States  resulted in information on almost 11,000 persons. About one fifth (19%) of those screened were women living with HIV. Among those assessed, 28% did not enroll, which was only slightly higher than the 27% observed among men. These results did not differ when considering race, ethnicity, or age. Researchers were not able to investigate gender identity as it was not added to the ACTG screening questions until 2017. The most common reasons for people not enrolling were not meeting trial requirements or persons opting-out, and these reasons did not differ by sex. Pregnancy, breastfeeding, and trial contraceptive requirements were rarely reported as reasons to not enroll, though researchers speculate that women for whom these requirements applied may have been excluded (or excluded themselves) from trial consideration prior to screening.
Because the data around some of the factors relevant to participant recruitment (for example, childcare access, transportation, or participant reimbursement) were not available in the database, researchers were not able to address their role in recruitment sex differences in this study. Investigators concluded that efforts to expand screening of women for trial eligibility is needed to improve rates of enrollment.

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