Participation in clinical trials among women living with HIV in Canada

Background: To describe participation in clinical trials among HIV-positive women enrolled since 1993 in the Canadian Women's HIV Study, a prospective open cohort study. Methods: All HIV-positive women being followed at hospital-based or communi ty-based clinics at 28 sites in 11 Canadian cities were eligible to partici pate in the Canadian Women's HIV Study. Baseline and follow-up information was collected for 413 women every 6 months by study nurses using standardiz ed questionnaires. Data included sociodemographic variables, HIV exposure g roup, CD4 count, disease classification, use of antiretroviral therapies an d participation in clinical trials. Results: At study intake 15.0% (62/413) of the women had participated in a clinical trial; an additional 8.5% (35/413) participated during a median fo llow-up of 18 months. Multivariate analysis revealed that the following fac tors were independently associated with participation in a clinical trial: white race (adjusted odds ratio [OR] 3.38, p = 0.001), current use of antir etroviral therapy (adjusted OR 2.01, p = 0.008), completion of secondary sc hool (adjusted OR 1.97, p = 0.024) and residence in the Prairies or Atlanti c provinces (adjusted OR 1.98, p = 0.043). Interpretation: Although the overall clinical trial participation rate of 2 3.5% was relatively high among HIV-positive women, injection drug users wer e underrepresented in this study population, and non-white women, women who did not complete high school and women not receiving antiretroviral therap y were less likely than white women, women of higher education and women re ceiving antiretroviral therapy to participate in clinical trials in Canada. Because of the importance of trial participants being representative of th e population for which therapeutic agents are intended, HIV clinical trials must recruit women with lower literacy levels, non-white women, women not receiving antiretroviral therapy and women who are injection drug users to ensure generalizability of research findings. Further study is needed to as sess factors that act as barriers and motivators to women's participation i n HIV clinical trials.