Publications

With successful antiretroviral therapy, HIV-1-infected subjects can achieve undetectable peripheral viral loads and immune homeostasis. However, in a subset of individuals on therapy, peripheral monocytes have a gene expression profile characteristic of a type 1 interferon α (IFN) response. This type 1 IFN response correlates with a number of pathogenic conditions including neural cell injury and in combination with HCV infection, cognitive impairment. Lessons from the non-human primate models of pathogenic and nonpathogenic SIV suggest that returning the initial IFN spike in acute SIV infection to normal allows the immune system to control infection and return to homeostasis. An IFN "alarm" signature, defined as monocyte activation with overexpression of the type1 IFN genes IFI27 and CD169, would be useful for identifying a subset of subjects with HIV-1 infection that could progress to a number of pathologies associated with immune activation including cognitive dysfunction. This strategy is being actively pursued for autoimmune diseases that are characterized by an IFN signature. Therapies to block the IFN signature are under investigation as a means to reset the immune system and in a subset of HIV-1-infected subjects may be an adjuvant to standard antiviral therapy to return cognitive function.

BACKGROUND

Racial/ethnic minority patients are less likely than non-Latino white patients to participate in cancer clinical trials. A key barrier to participation is limited health literacy which is more common among minorities. At the organizational level, it is important that clinical trials sites become better equipped to recruit minority patients by expanding their organizational health literacy including language competency and outreach efforts. We explored the characteristics of clinical trial sites that are associated with these health literate behaviors.

METHODS

We identified 353 breast clinical trials recruiting participants in 2006 from four states (California, Florida, Illinois, and New York) through the National Cancer Institute Physician Data Query system. From October 2008 to November 2009, we contacted one research team member (RTM) from each site for a telephone survey to assess the site's health literate characteristics.

RESULTS

Of 233 RTMs who responded, 93% were female and 89% were US-born. Overall, 48% of sites offered supplementary trial information, 80% offered materials to assist with patient navigation and 45% reported outreach efforts. Lower percentages offered information in other languages while 65% offered professional interpretation services. Sites with >10% limited English proficiency (LEP) patients were more likely than their counterparts to offer consent forms (OR=3.13, 1.36-7.19) and supplementary information about trials in other languages (OR=2.52, 1.15-5.52). Sites with diverse patient populations (>10% Latino) were also more likely than less diverse sites to engage in outreach (OR=1.97, 1.07-3.60), to offer consent forms (OR=2.72, 1.38-5.36), supplementary information about trials (OR=2.58, 1.24-5.36), and materials to improve patient navigation (OR=2.50, 1.22-5.13) in other languages.

CONCLUSIONS

Efforts to recruit diverse participants were limited. Practice type and diversity of patient population were associated with sites' efforts to accommodate these characteristics, suggesting that sites were responsive to the needs of their patients when diversity was prevalent.