title: Participation in clinical trials among women living with HIV in Canada. Canadian Women's HIV Study Group.
abstract: 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 community-based clinics at 28 sites in 11 Canadian cities were eligible to participate in the Canadian Women's HIV Study. Baseline and follow-up information was collected for 413 women every 6 months by study nurses using standardized questionnaires. Data included sociodemographic variables, HIV exposure group, CD4 count, disease classification, use of antiretroviral therapies and 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 follow-up of 18 months. Multivariate analysis revealed that the following factors were independently associated with participation in a clinical trial: white race (adjusted odds ratio [OR] 3.38, p = 0.001), current use of antiretroviral therapy (adjusted OR 2.01, p = 0.008), completion of secondary school (adjusted OR 1.97, p = 0.024) and residence in the Prairies or Atlantic provinces (adjusted OR 1.98, p = 0.043).
  
  
  CONCLUSIONS
  Although the overall clinical trial participation rate of 23.5% was relatively high among HIV-positive women, injection drug users were underrepresented in this study population, and non-white women, women who did not complete high school and women not receiving antiretroviral therapy were less likely than white women, women of higher education and women receiving antiretroviral therapy to participate in clinical trials in Canada. Because of the importance of trial participants being representative of the 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 assess factors that act as barriers and motivators to women's participation in HIV clinical trials.
authors.affiliation: Infectious Diseases Unit, Montreal Regional Public Health Department, Que. md77@musica.mcgill.ca
authors.forename: C
authors.initials: C
authors.lastname: Hankins
authors.forename: N
authors.initials: N
authors.lastname: Lapointe
authors.forename: S
authors.initials: S
authors.lastname: Walmsley
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use; D002170:Canada; D002986:Clinical Trials as Topic / Q000523:psychology*; D004522:Educational Status; D005260:Female; D015658:HIV Infections / Q000188:drug therapy / Q000209:etiology / Q000523:psychology*; D006801:Humans; D016015:Logistic Models; D008875:Middle Aged; D015999:Multivariate Analysis; D010342:Patient Acceptance of Health Care / Q000208:ethnology / Q000523:psychology* / Q000706:statistics & numerical data; D018579:Patient Selection; D044469:Racial Groups; D035842:Research Subjects; D012111:Residence Characteristics; D012959:Socioeconomic Factors; D015819:Substance Abuse, Intravenous / Q000150:complications; D014504:Urban Health; D035862:Vulnerable Populations; D014930:Women / Q000523:psychology*
chemical_list: D019380:Anti-HIV Agents