title: Recruitment and ethical considerations in HIV cure trials requiring treatment interruption.
abstract: BACKGROUND
  Relative to antiretroviral treatment (ART), early HIV cure-related trials (HCRTs) carry limited therapeutic benefits and unknown risks. In HCRTs requiring treatment interruption (TI) the health risks and burdens may create a barrier to study enrolment and increase the possibility for unintentional ethical violations in recruitment.
  
  
  METHODS
  An online survey was administered to over 2,000 HIV-positive ART users in the US. Using multivariable ordinal regression we assessed effects of research participation attitudes, health and demographic traits on willingness to participate in treatment interruption studies (WtP-TI).
  
  
  RESULTS
  WtP-TI was greatest among those who were highly motivated to participate in research studies for the benefit of science, society and, to a lesser extent, personal benefit. Personal benefit was less of an influence on WtP-TI among persons with higher viral loads or a history of multiple ART regimens. WtP-TI was greater among respondents who were more likely to consider personal health in making decisions about trial participation. WtP-TI had no association with perceptions of the importance of compensation to research participation. After accounting for attitudes, health status and demographic traits were generally not significantly related to WtP-TI. Notable exceptions included viral suppression status and race/ethnicity.
  
  
  CONCLUSIONS
  Recruitment strategies in TI studies can benefit from a focus on the long-term scientific and social benefits of study participation. Strategies targeted to particular demographic groups may have little impact on accrual, and in some cases will need to be accompanied by strategies to improve the quality of researcher-community relationships. Findings also suggest that informing communities about the health impacts of trial participation may positively impact participation decisions. However, more research is needed to interpret the impact of health messaging on recruitment and therapeutic expectations. Future work should explore the implications of altruism-based expectations on the strategic and ethical appropriateness of TI study recruitment efforts.
authors.affiliation: Department of Health Behavior and Health Education, University of Michigan School of Public Health, Ann Arbor, MI, USA; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
authors.forename: Michael P
authors.initials: MP
authors.lastname: Arnold
authors.affiliation: Research Advocacy, Project Inform , San Francisco , CA , USA .
authors.forename: David
authors.initials: D
authors.lastname: Evans
authors.affiliation: Program for Wellness Restoration , Houston , TX , USA.
authors.forename: Nelson
authors.initials: N
authors.lastname: Vergel
keywords: HIV cure; altruism; clinical research; patient attitudes; treatment interruption; willingness to participate