Case Investigation and Contact Tracing Efforts From Health Departments in the United States, November 2020 to December 2021.

BACKGROUND: Sixty-four state, local, and territorial health departments (HDs) in the United States report monthly performance metrics on coronavirus disease 2019 (COVID-19) case investigation and contact tracing (CI/CT) activities. We describe national CI/CT efforts from 25 October 2020 through 24 December 2021, which included 3 peaks in COVID-19 case reporting. METHODS: Standardized CI/CT data elements submitted by the 64 HDs were summarized as monthly performance metrics for each HD and the nation. These included measures of CI/CT completeness, timeliness, and workloads. We calculated contact tracing efficacy as the proportion of new cases that occurred in persons identified as contacts within the 14 days before the case was reported. RESULTS: A total of 44 309 796 COVID-19 cases were reported to HDs, with completed HD interviews in 18 153 353 (41%). Less than half of interviews yielded ≥1 contact. A total of 19 939 376 contacts were identified; 11 632 613 were notified (58%), with 3 618 846 undergoing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) testing within 14 days of notification. Of the total reported cases, 2 559 383 occurred in recently identified contacts. CONCLUSIONS: We document the resource-intense nationwide effort by US HDs to mitigate the impact of COVID-19 through CI/CT before and after vaccines became widely available. These results document the coverage and performance of CI/CT despite case surges and fluctuating workforce and workloads.

Estimated COVID-19 Cases and Hospitalizations Averted by Case Investigation and Contact Tracing in the US.

Importance: Evidence of the impact of COVID-19 case investigation and contact tracing (CICT) programs is lacking, but policy makers need this evidence to assess the value of such programs. Objective: To estimate COVID-19 cases and hospitalizations averted nationwide by US states' CICT programs. Design, Setting, and Participants: This decision analytical model study used combined data from US CICT programs (eg, proportion of cases interviewed, contacts notified or monitored, and days to case and contact notification) with incidence data to model outcomes of CICT over a 60-day period (November 25, 2020, to January 23, 2021). The study estimated a range of outcomes by varying assumed compliance with isolation and quarantine recommendations. Fifty-nine state and territorial health departments that received federal funding supporting COVID-19 pandemic response activities were eligible for inclusion. Data analysis was performed from July to September 2021. Exposure: Public health case investigation and contact tracing. Main Outcomes and Measures: The primary outcomes were numbers of cases and hospitalizations averted and the percentage of cases averted among cases not prevented by vaccination and other nonpharmaceutical interventions. Results: In total, 22 states and 1 territory reported all measures necessary for the analysis. These 23 jurisdictions covered 42.5% of the US population (approximately 140 million persons), spanned all 4 US Census regions, and reported data that reflected all 59 federally funded CICT programs. This study estimated that 1.11 million cases and 27 231 hospitalizations were averted by CICT programs under a scenario where 80% of interviewed cases and monitored contacts and 30% of notified contacts fully complied with isolation and quarantine guidance, eliminating their contributions to future transmission. As many as 1.36 million cases and 33 527 hospitalizations could have been prevented if all interviewed cases and monitored contacts had entered into and fully complied with isolation and quarantine guidelines upon being interviewed or notified. Across both scenarios and all jurisdictions, CICT averted an estimated median of 21.2% (range, 1.3%-65.8%) of the cases not prevented by vaccination and other nonpharmaceutical interventions. Conclusions and Relevance: These findings suggest that CICT programs likely had a substantial role in curtailing the pandemic in most jurisdictions during the 2020 to 2021 winter peak. Differences in outcomes across jurisdictions indicate an opportunity to further improve CICT effectiveness. These estimates demonstrate the potential benefits from sustaining and improving these programs.

COVID-19 Case Investigation and Contact Tracing Efforts from Health Departments - United States, June 25-July 24, 2020.

Case investigation and contact tracing are core public health tools used to interrupt transmission of pathogens, including SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19); timeliness is critical to effectiveness (1,2). In May 2020, CDC funded* 64 state, local, and territorial health departments† to support COVID-19 response activities. As part of the monitoring process, case investigation and contact tracing metrics for June 25-July 24, 2020, were submitted to CDC by 62 health departments. Descriptive analyses of case investigation and contact tracing load, timeliness, and yield (i.e., the number of contacts elicited divided by the number of patients prioritized for interview) were performed. A median of 57% of patients were interviewed within 24 hours of report of the case to a health department (interquartile range [IQR] = 27%-82%); a median of 1.15 contacts were identified per patient prioritized for interview§ (IQR = 0.62-1.76), and a median of 55% of contacts were notified within 24 hours of identification by a patient (IQR = 32%-79%). With higher caseloads, the percentage of patients interviewed within 24 hours of case report was lower (Spearman coefficient = -0.68), and the number of contacts identified per patient prioritized for interview also decreased (Spearman coefficient = -0.60). The capacity to conduct timely contact tracing varied among health departments, largely driven by investigators' caseloads. Incomplete identification of contacts affects the ability to reduce transmission of SARS-CoV-2. Enhanced staffing capacity and ability and improved community engagement could lead to more timely interviews and identification of more contacts.

Mentors' Motivation to Address Race/Ethnicity in Research Mentoring Relationships.

The purpose of this study was to investigate the motivation of research mentors to address race/ethnicity in their research mentoring relationships, using self-determination theory as a conceptual framework. Mentors from STEM fields primarily in the biological sciences (N = 115) were asked to report their level of motivation and the reasons behind their motivation to address the role of race and ethnicity in their mentoring relationships. Mentors' responses were coded using a qualitative approach, and results were examined by mentors' degree of motivation, previous experience with mentoring trainees from different racial/ethnic groups, and mentor race/ethnicity. Extrinsic motivation and amotivation were the most frequently assigned codes to mentors' responses. Implications of these findings for mentor practices, higher education initiatives, and for diversifying the STEM workforce are discussed.

Increasing research mentor training among biomedical researchers at Clinical and Translational Science Award hubs: The impact of the facilitator training initiative.

As part of their mission, Clinical and Translational Science Award (CTSA) hubs are charged with developing, testing, and disseminating evidence-based practices to other CTSA hubs. Over the past 7 years, the University of Wisconsin-Madison has answered this charge by implementing the facilitator training (FT) initiative for research mentors. Three elements to advance training across the CTSA hubs have been critical: (1) using an FT model to empower others to build research mentor training at their local institutions; (2) tracking implementation of training events across the CTSA hubs over time; and (3) partnering with implementation sites to build local capacity and evaluate the effectiveness and quality of training. Here we report that facilitators have been trained at 75% of CTSA hubs. These facilitators report high satisfaction with the training and increased confidence in their ability to implement mentor training, and plan to implement local mentor training. These findings demonstrate that the FT initiative can serve as a model for dissemination and implementation of other workforce development interventions across the CTSA hubs.

Building a Sustainable National Infrastructure to Expand Research Mentor Training.

An evidence-based research mentor training (RMT) curricular series has been shown to improve the knowledge and skills of research mentors across disciplines and career stages. A train-the-trainer model was used in the context of several targeted approaches aimed at sustainability to support national dissemination of RMT and expand the network of facilitators prepared to implement the curricula. These infrastructure elements included 1) an expansion initiative to increase the number of trained facilitators able to deliver train-the-trainer workshops nationwide; 2) adaptation of RMT curricula for multiple audiences and career stages to increase accessibility; 3) implementation resources to support facilitators and help them overcome implementation barriers; and 4) standardized evaluation of training. This approach to dissemination and implementation has resulted in the preparation of nearly 600 trained facilitators, a large percentage of whom have implemented mentor training for more than 4000 graduate student, junior faculty, and senior faculty mentors. Implications for and challenges to building and sustaining the national dissemination of RMT are discussed.

Building national capacity for research mentor training: an evidence-based approach to training the trainers.

Research mentor training (RMT), based on the published Entering Mentoring curricula series, has been shown to improve the knowledge and skills of research mentors across career stages, as self-reported by both the mentors engaged in training and their mentees. To promote widespread dissemination and empower others to implement this evidence-based training at their home institutions, we developed an extensive, interactive, multifaceted train-the-trainer workshop. The specific goals of these workshops are to 1) increase facilitator knowledge of an RMT curriculum, 2) increase facilitator confidence in implementing the curriculum, 3) provide a safe environment to practice facilitation of curricular activities, and 4) review implementation strategies and evaluation tools. Data indicate that our approach results in high satisfaction and significant confidence gains among attendees. Of the 195 diverse attendees trained in our workshops since Fall 2010, 44% report implementation at 39 different institutions, collectively training more than 500 mentors. Further, mentors who participated in the RMT sessions led by our trained facilitators report high facilitator effectiveness in guiding discussion. Implications and challenges to building the national capacity needed for improved research mentoring relationships are discussed.

Training mentors of clinical and translational research scholars: a randomized controlled trial.

PURPOSE: To determine whether a structured mentoring curriculum improves research mentoring skills. METHOD: The authors conducted a randomized controlled trial (RCT) at 16 academic health centers (June 2010 to July 2011). Faculty mentors of trainees who were conducting clinical/translational research ≥50% of the time were eligible. The intervention was an eight-hour, case-based curriculum focused on six mentoring competencies. The primary outcome was the change in mentors' self-reported pretest to posttest composite scores on the Mentoring Competency Assessment (MCA). Secondary outcomes included changes in the following: mentors' awareness as measured by their self-reported retrospective change in MCA scores, mentees' ratings of their mentors' competency as measured by MCA scores, and mentoring behaviors as reported by mentors and their mentees. RESULTS: A total of 283 mentor-mentee pairs were enrolled: 144 mentors were randomized to the intervention; 139 to the control condition. Self-reported pre-/posttest change in MCA composite scores was higher for mentors in the intervention group compared with controls (P < .001). Retrospective changes in MCA composite scores between the two groups were even greater, and extended to all six subscale scores (P < .001). More intervention-group mentors reported changes in their mentoring practices than control mentors (P < .001). Mentees working with intervention-group mentors reported larger changes in retrospective MCA pre-/posttest scores (P = .003) and more changes in their mentors' behavior (P = .002) than those paired with control mentors. CONCLUSIONS: This RCT demonstrates that a competency-based research mentor training program can improve mentors' skills.

A research mentor training curriculum for clinical and translational researchers.

PURPOSE: To design and evaluate a research mentor training curriculum for clinical and translational researchers. The resulting 8-hour curriculum was implemented as part of a national mentor training trial. METHOD: The mentor training curriculum was implemented with 144 mentors at 16 academic institutions. Facilitators of the curriculum participated in a train-the-trainer workshop to ensure uniform delivery. The data used for this report were collected from participants during the training sessions through reflective writing, and following the last training session via confidential survey with a 94% response rate. RESULTS: A total of 88% of respondents reported high levels of satisfaction with the training experience, and 90% noted they would recommend the training to a colleague. Participants also reported significant learning gains across six mentoring competencies as well as specific impacts of the training on their mentoring practice. CONCLUSIONS: The data suggest the described research mentor training curriculum is an effective means of engaging research mentors to reflect upon and improve their research mentoring practices. The training resulted in high satisfaction, self-reported skill gains as well as behavioral changes of clinical and translational research mentors. Given success across 16 diverse sites, this training may serve as a national model.

Operational challenges and solutions with implementation of an adaptive seamless phase 2/3 study.

A wide variety of operational issues were encountered with the planning and implementation of an adaptive, dose-finding, seamless phase 2/3 trial for a diabetes therapeutic. Compared with a conventional design, significant upfront planning was required, as well as earlier, more integrated cross-functional coordination. The existing infrastructure necessitated greater flexibility to meet the needs of the adaptive design. Rapid data acquisition, analysis, and reporting were essential to support the successful implementation of the adaptive algorithm. Drug supply for nine treatment arms had to be carefully managed across many sites worldwide. Details regarding these key operational challenges and others will be discussed along with resolutions taken to enable successful implementation of this adaptive, seamless trial.

A randomized, double-blind comparison of duloxetine and venlafaxine in the treatment of patients with major depressive disorder.

BACKGROUND: Clinical trials assessing antidepressant therapies typically include separate assessments of efficacy (benefit) and adverse events (risk). Global benefit-risk (GBR) assessment allows the simultaneous evaluation of both efficacy and adverse events. The objective was to compare the serotonin and norepinephrine reuptake inhibitors (SNRIs) duloxetine and venlafaxine using GBR assessment. METHODS: Data were combined from two similarly designed, multicenter, randomized, double-blind, parallel group studies in which patients with major depressive disorder were randomized to either duloxetine 60 mg/day or venlafaxine extended release (XR) 150 mg/day (75 mg/day for the first 2 weeks) for a 6-week fixed dosing period followed by an additional 6 weeks of treatment in which the dose could be increased up to 120 mg/day for duloxetine and 225 mg/day for venlafaxine. Patients completing the study (or receiving study drug for 2 weeks or more) were eligible to enter a taper period where the dose of study drug was gradually reduced over 1-2 weeks prior to drug discontinuation. The primary outcome measure (defined a priori) was the GBR comparison of duloxetine 60 mg/day and venlafaxine XR 150 mg/day after 6 weeks of treatment. In the GBR analysis, benefit was defined as remission at endpoint [17-item Hamilton Depression Rating Scale (HAMD17) 7]. Risk was defined by four categories: patients having either no adverse events (AEs), AEs with no severity rating greater than moderate, AEs with at least one severity rating of severe, or having discontinued with a reason of self-reported adverse event (regardless of any AE severity). Additional efficacy measures included HAMD17 total score and subscales, HAMA, CGI-S, and PGI-I. Safety and tolerability were assessed via analysis of reasons for discontinuation, treatment-emergent adverse events (TEAEs), discontinuation-emergent adverse events, and changes in vital signs, weight, and laboratory analytes. RESULTS: There were no significant differences between duloxetine 60 mg/day and venlafaxine 150 mg/day as measured by GBR assessment at the end of 6 weeks (-1.418 vs. -1.079, P = 0.217) or 12 weeks (-0.349 vs. -0.121, P = 0.440), nor were there significant differences between treatment groups on the majority of efficacy measures. Significantly more venlafaxine-treated patients (74.5%) completed 12 weeks of treatment compared with duloxetine-treated patients (64.8%, P =.006). Nausea was the most common treatment-emergent adverse event (TEAE) for both drugs, and was significantly higher with duloxetine 60 mg/day compared to venlafaxine 150 mg/day during the first 6 weeks of treatment (43.6% vs. 35.0%, P0.05). During the taper period, significantly more venlafaxine-treated patients reported discontinuation-emergent adverse events (DEAEs) than duloxetine-treated patients. From a safety perspective, significantly more venlafaxine-treated patients (n = 4) than duloxetine-treated patients (n=0, P =.047) experienced sustained elevations of systolic blood pressure during the fixed dosing period. Otherwise, there were few significant differences in safety measures found between treatment groups during 6 and 12 weeks of therapy. CONCLUSIONS: Duloxetine 60 mg/day and venlafaxine XR 150 mg/day have similar benefit-risk profiles on the basis of a comparison utilizing GBR assessment. The implications of the more subtle differences between these drugs, as well as for interpreting the GBR assessment, are discussed.