Experiences and lessons learned from a patient-engagement service established by a national research consortium in the U.S. Veterans Health Administration.

Introduction: Meaningful engagement of patients in the research process has increased over the past 20 years. Few accounts are available of engagement infrastructure and processes used by large research organizations. The Pain/Opioid Consortium of Research (Consortium) is a U.S. Department of Veterans Affairs (VA) research network that provides infrastructure to accelerate health research and implementation of evidence-based health care. The Consortium's key activities include facilitating Veteran-engaged research and building community between Veterans and VA researchers. This report sought to describe experiences and lessons learned from the first 3 years of a national research engagement service, featuring a Veteran Engagement (VE) Panel, established by the Consortium. Methods: We gathered authors' experiences to describe development and operation of the Consortium's VE Panel. Engagement staff collected program evaluation data about partners (Veterans and researchers), projects about which the VE Panel consulted, and meeting attendance during operation of the engagement service. Results: We created a 12-member VE Panel; all of whom had lived experience with chronic pain, prescription opioid medication use, or opioid use disorder. Engagement staff and VE Panel members implemented an engagement service operational model designed to continuously learn and adapt. The panel consulted on 48 projects spanning the research process. Seventy-eight percent of panel members, on average, attended each monthly meeting. VE Panel members and participating researchers reported high satisfaction with the quality, ease, and outcomes of their engagement service experiences. Conclusions: This work provides an illustrative example of how a national research consortium facilitated Veteran-engaged research and built community between Veterans and VA researchers by developing and operating an ongoing engagement consulting service, featuring a VE Panel. The service, designed as a learning community, relied on skilled engagement staff to cultivate high quality experiences and outcomes for all partners.

Investigation of false positive results with an oral fluid rapid HIV-1/2 antibody test.

BACKGROUND: In March 2004, the OraQuick rapid HIV antibody test became the first rapid HIV test approved by the US Food and Drug Administration for use on oral fluid specimens. Test results are available in 20 minutes, and the oral fluid test is non-invasive. From August 2004-June 2005, we investigated a sudden increase in false-positive results occurring in a performance study of OraQuick oral-fluid rapid HIV tests in Minnesota. METHODOLOGY/PRINCIPAL FINDINGS: In a field investigation, we reviewed performance study data on oral-fluid and whole-blood OraQuick rapid HIV test device lots and expiration dates and assessed test performance and interpretation with oral-fluid and whole-blood specimens by operators who reported false-positive results. We used multivariate logistic regression to evaluate client demographic and risk characteristics associated with false-positive results. Next, we conducted an incidence study of false-positive OraQuick rapid HIV tests in nine US cities and tested both oral-fluid and finger-stick whole-blood specimens from clients; reactive tests were confirmed with Western blot. Sixteen (4.1%) false-positive oral-fluid results occurred in the performance study from April 15, 2004 through August 31, 2004 with unexpired devices from six test lots among 388 HIV-uninfected clients (specificity, 95.9%; 95% CI: 93.4-97.6). Three test operators who had reported false-positive results performed and interpreted the test according to package-insert instructions. In multivariate analysis, only older age was significantly associated with false-positive results (adjusted odds ratio = 4.5, 95% CI: 1.2-25.7). In the incidence study, all valid oral-fluid and whole-blood results from 2,268 clients were concordant and no false-positive results occurred (100% specificity). CONCLUSIONS/SIGNIFICANCE: The field investigation did not identify a cause for the increase in false-positive oral-fluid results, and the incidence study detected no false-positive results. The findings suggest this was an isolated cluster; the test's overall performance was as specified by the manufacturer.

HIV-1 subtype diversity in Minnesota.

BACKGROUND: Genetic variation in human immunodeficiency virus (HIV)-1 poses significant public-health and clinical challenges. In North America, subtype B is most prevalent. HIV-1 subtyping is not integrated into routine HIV/acquired immunodeficiency syndrome surveillance in the United States. In 2003, the Minnesota Department of Health piloted HIV-1 subtyping with routine surveillance to describe the existence and variety of non-subtype B strains. METHODS: Targeted HIV-1 subtype surveillance was conducted on 98 African-born HIV-infected patients. Sentinel subtype surveillance was conducted in a Minneapolis sexually transmitted disease clinic on 28 newly diagnosed non-African HIV-positive patients. Subtype determination was based on a partial sequence of the gp41 region of the HIV-1 env gene. RESULTS: Subtyping was successful for 87 of 98 samples from African-born HIV-infected patients; 95% were non-B subtypes. The 7 subtypes observed were consistent with strains endemic in patients' birth regions. Subtyping was also completed for samples from 25 of 28 non-African-born patients; all were subtype B. CONCLUSIONS: Multiple HIV-1 subtypes are present in Minnesota. Our data suggest that most of the HIV cases in Minnesota among African-born patients are non-B subtypes. Population-based surveillance inclusive of groups at high risk for variant strains is needed to monitor the prevalence and variety of HIV subtypes in the United States.

An epidemiologic update on the HIV/AIDS epidemic in Minnesota.

Since 1982 a cumulative total of 7,073 Minnesotans have been diagnosed with HIV or AIDS and reported to the Minnesota Department of Health. The annual number of new infections has been relatively stable at just under 300 per year since 1996. Due in large part to advances in antiretroviral medications, more Minnesotans were known to be living with HIV/AIDS at the end of 2002 (4,598 people) than ever before. Men who have sex with men, racial/ethnic minorities (particularly, African Americans and Hispanic men), and individuals in urban areas continue to be disproportionately affected by HIV/AIDS. The proportion of cases attributable to heterosexual contact has gradually increased over the past 20 years. Marked increases over the past several years in the number of new HIV infections diagnosed among African-born persons is a trend of concern in the evolving HIV/AIDS epidemic in Minnesota.