by Jeffrey T. Kirchner, DO, AAHIVS, AAHIVM Chief Medical Officer
September 29, 2020
Smeaton LM et al. Screening and Enrollment by Sex in Human Immunodeficiency Virus Clinical Trials in the United States. Clin Infect Dis 2020;71(5):1300–5. DOI: 10.1093/cid/ciz959.
Approximately 25% of adults and adolescents with HIV in the U.S. are women but they have been underrepresented in HIV research studies. Key reasons may be ineligibility due to pregnancy or breastfeeding potential or refusal to participate after screening. This study was a retrospective, cross-trial analysis to determine if women screened for HIV clinical trials ultimately enrolled at lower rates than men. The authors looked at screening and subsequent enrollment in 31 clinical trials conducted at 99 ACTG sites from 2003 -2012. The primary outcome measured was “screen-out” defined as an individual who was formally screened for a trial but subsequently did NOT enroll. There were 10,744 persons with HIV screened of whom 18.9% were women. The percentage of women screened out was 27.9% compared to 26.5% of men (P = .19). The difference did not significantly vary by age, ethnicity, or race. The two most common reasons for screening out were not meeting eligibility criteria (30–35%) and subject opting out (23%), and these did not differ by sex. Some individual-level factors not addressed regarding trial participation were socioeconomic and employment status, caregiving status of dependents, and level of education. The authors believe approaching a greater number of women to screen for HIV clinical trials may be one approach to increasing participation in these studies
The underrepresentation of women in HIV research has resulted in significant knowledge gaps regarding differences in ART responses, adverse drug reactions, and other important clinical outcomes. A prior study published in AIDS found the median proportion of women was 19.2% in 395 treatment trials and only 9.9% in “cure” trials. The Women’s Interagency HIV Study (WIHS), a prospective, observational cohort started in 1993 has produced invaluable data but as the authors of this study note, greater outreach efforts are needed to screen and enroll women in clinical trials. One recent example from the ACTG – “Follow Your Heart,” was a campaign to increase enrollment of women into the REPRIEVE trial of statin therapy. A recent paper in JID reported an enrollment of 31% female.
The author has no conflicts of interest to disclose.
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