Perceptions of Patients with Inflammatory Bowel Diseases on Biobanking:

Little is known about beliefs, understanding and perceptions of biobanking among patients with inflammatory bowel diseases (IBD). We aimed to further understand perceptions of biobanking in the IBD community

A prospective study of asymptomatic SARS-CoV-2 infection among individuals involved in academic research under limited operations during the COVID-19 pandemic

Background Early in the pandemic, transmission risk from asymptomatic infection was unclear, making it imperative to monitor infection in workplace settings. Further, data on SARS-CoV-2 seroprevalence within university populations has been limited. Methods We performed a longitudinal study of University research employees on campus July-December 2020. We conducted questionnaires on COVID-19 risk factors, RT-PCR testing, and SARS-CoV-2 serology using an in-house spike RBD assay, laboratory-based Spike NTD assay, and standard nucleocapsid platform assay. We estimated prevalence and cumulative incidence of seroconversion with 95% confidence intervals using the inverse of the Kaplan-Meier estimator. Results 910 individuals were included in this analysis. At baseline, 6.2% (95% CI 4.29–8.19) were seropositive using the spike RBD assay; four (0.4%) were seropositive using the nucleocapsid assay, and 44 (4.8%) using the Spike NTD assay. Cumulative incidence was 3.61% (95% CI: 2.04–5.16). Six asymptomatic individuals had positive RT-PCR results. Conclusions Prevalence and incidence of SARS-CoV-2 infections were low; however, differences in target antigens of serological tests provided different estimates. Future research on appropriate methods of serological testing in unvaccinated and vaccinated populations is needed. Frequent RT-PCR testing of asymptomatic individuals is required to detect acute infections, and repeated serosurveys are beneficial for monitoring subclinical infection

HIV remission trial investigators’ attitudes towards risk and risk mitigation in trials that include treatment interruption

Early-phase HIV remission (“cure”) trials aim to test interventions developed to eradicate HIV or to sustainably control HIV without antiretroviral treatment (ART). Many remission trials include analytic treatment interruption (ATI) to evaluate interventions, which increases the risk to participants and their sexual partners. We conducted an online questionnaire of international HIV remission trial investigators and other study team members to assess their expectations regarding the time to achieve long-term control of HIV replication without treatment (functional cure) or complete eradication of replication-competent HIV virus (sterilizing cure); attitudes toward HIV remission research and the feasibility, acceptability, and efficacy of six HIV transmission risk mitigation strategies during trials with ATI of fixed duration.Nearly half of respondents (47%) reported expecting a functional cure for HIV to be achieved in 5–10 years, and one-third (35%) reported 10–20 years for a sterilizing cure to be achieved. On a scale of −3 to 3, mean scores indicated greater respondent concern about the risk of HIV transmission to partners during ATI (Time to rebound Mean: 0.4 and Fixed duration Mean: 11), compared to participant health risks from ATI (Time to Rebound Mean: -.9 and Fixed duration Mean: 0.0). With regard to feasibility, acceptability, and efficacy respectively, mitigation efforts rated positively included: requiring counseling for potential participants (Means: 2.3; 2.1; and 1.1), providing partner referrals for PrEP (Means: 1.3; 1.3; 1.5), providing pre-exposure proxylaxis directly to partners (Means: 1.0; 1.5; 1.6), and monitoring participants for new sexually transmitted disease acquisition (Means: 1.9; 1.4; 1.0). Respondents were less positive about requiring that participants’ sexual partner(s) participate in risk counseling or limiting participation to those who commit to abstaining from sex during the entire ATI period.Our study demonstrates that HIV remission trial investigators and study team members are concerned about the risk of transmission to sexual partners during ATI. Separating the assessment of risk mitigation strategies for transmission risk into feasibility, acceptability, and efficacy allows the discovery of strategies that may best achieve all three outcomes. Additional research is needed to compare these more fine-grained assessments with views held by other investigators, people living with HIV, and trial participants

Perceptions of Patients with Inflammatory Bowel Diseases on Biobanking

BACKGROUND/AIMS: Little is known about beliefs, understanding and perceptions of biobanking among patients with inflammatory bowel diseases (IBD). We aimed to further understand perceptions of biobanking in the IBD community. METHODS: Subjects were recruited to participate in a 1:1 telephone interview on their perceptions of the risks and benefits of contributing specimens for research. These interviews informed a survey instrument evaluating perceptions of biobanking within CCFA Partners cohort. We used descriptive statistics to summarize participant responses, and bivariate statistics to compare willingness to participate in biobanking by disease and demographic factors. RESULTS: A total of 26 interviews were conducted. Various themes emerged from the interviews and aided in the development of the survey instrument. Concerns focused upon storage, loss of confidentiality, outside uses and life insurance discrimination. A total of 1007 individuals completed the survey. In all, 397 (39.4%) reported they would definitely donate samples, 568 (56.4%) would probably donate, 36 (3.6%) probably not, and 6 (0.6%) would definitely not donate. No significant differences in willingness to donate samples were seen for Crohn’s disease (CD) versus ulcerative colitis (UC) (p=0.25) or for remission versus active disease (p=0.14). For sample-type preference, 956 (89.6%) would donate blood, 997 (93.5 %) saliva and 822 (77.1%) stool. CONCLUSIONS: Large majorities of patients with IBD demonstrated a willingness to donate specimens for biobanking, albeit with concerns. Addressing these concerns will enhance participation and engagement and create greater alignment between the desires of research participants and the governance structure and operating policies of biobanks

A prospective study of asymptomatic SARS-CoV-2 infection among individuals involved in academic research under limited operations during the COVID-19 pandemic.

BackgroundEarly in the pandemic, transmission risk from asymptomatic infection was unclear, making it imperative to monitor infection in workplace settings. Further, data on SARS-CoV-2 seroprevalence within university populations has been limited.MethodsWe performed a longitudinal study of University research employees on campus July-December 2020. We conducted questionnaires on COVID-19 risk factors, RT-PCR testing, and SARS-CoV-2 serology using an in-house spike RBD assay, laboratory-based Spike NTD assay, and standard nucleocapsid platform assay. We estimated prevalence and cumulative incidence of seroconversion with 95% confidence intervals using the inverse of the Kaplan-Meier estimator.Results910 individuals were included in this analysis. At baseline, 6.2% (95% CI 4.29-8.19) were seropositive using the spike RBD assay; four (0.4%) were seropositive using the nucleocapsid assay, and 44 (4.8%) using the Spike NTD assay. Cumulative incidence was 3.61% (95% CI: 2.04-5.16). Six asymptomatic individuals had positive RT-PCR results.ConclusionsPrevalence and incidence of SARS-CoV-2 infections were low; however, differences in target antigens of serological tests provided different estimates. Future research on appropriate methods of serological testing in unvaccinated and vaccinated populations is needed. Frequent RT-PCR testing of asymptomatic individuals is required to detect acute infections, and repeated serosurveys are beneficial for monitoring subclinical infection