Building Capacity for Cancer Research in the Era of COVID-19: Implementation and Results From an International Virtual Clinical Research Training Program in Zambia.

PURPOSE: The incidence of cancer in sub-Saharan Africa is increasing rapidly, yet cancer research in the region continues to lag. One contributing factor is limited exposure to clinical research among trainees. We describe implementation and results of a virtual clinical research training program for Zambian clinical oncology fellows developed jointly by the Cancer Diseases Hospital in Zambia and the MD Anderson Cancer Center to address this need. METHODS: The clinical research training program consisted of 14 weekly virtual lectures, development of research questions by Zambian clinical oncology fellows, assignment of faculty and peer mentors, longitudinal mentorship of research protocols, and anonymous precourse and postcourse surveys. The paired t-test was used to analyze the change in academic self-efficacy scores. RESULTS: Fourteen Zambian clinical oncology fellows participated. Senior fellows were paired with research mentors, leading to the development of eight research protocols. A total of 70 meetings and 126 hours of mentorship occurred with a median of seven meetings and 15 hours per pairing. The precourse and postcourse survey response rates were 86% and 79%, respectively. There were statistically significant increases in nine of 12 academic self-efficacy domains. The largest gains were in ability to independently perform research (P < .001) and research mentorship (P = .02) with an average increase of 1.5 points on a five-point scale in both domains. CONCLUSION: The Cancer Diseases Hospital MD Anderson Cancer Center clinical research training program for Zambian clinical oncology fellows led to increases in multiple academic self-efficacy domains among participants, formation of longitudinal mentorship groups with both faculty and peer mentors, and development of Zambian-led research protocols, demonstrating the feasibility of implementing a virtual model. This may be especially relevant because of shifting international collaboration paradigms after the COVID-19 pandemic.

Rationale and design of the Prevent Anal Cancer Self-Swab Study: a protocol for a randomised clinical trial of home-based self-collection of cells for anal cancer screening.

INTRODUCTION: Squamous cell carcinoma of the anus is a common cancer among sexual minority men, especially HIV-positive sexual minority men; however, there is no evidenced-based national screening protocol for detection of anal precancers. Our objective is to determine compliance with annual anal canal self-sampling or clinician-sampling for human papillomavirus (HPV) DNA. METHODS AND ANALYSIS: This is a prospective, randomised, two-arm clinical study to evaluate compliance with annual home-based versus clinic-based HPV DNA screening of anal canal exfoliated cells. The setting is primary care community-based clinics. Recruitment is ongoing for 400 HIV-positive and HIV-negative sexual minority men and transgender persons, aged >25 years, English or Spanish speaking, no current use of anticoagulants other than nonsteroidal anti-inflammatory drugs and no prior diagnosis of anal cancer. Participants are randomised to either receive a swab in the mail for home-based collection of an anal canal specimen at 0 and 12 months (arm 1) or attend a clinic for clinician collection of an anal canal specimen at 0 and 12 months (arm 2). Persons will receive clinic-based Digital Anal Rectal Examinations and high-resolution anoscopy-directed biopsy to assess precancerous lesions, stratified by study arm. Anal exfoliated cells collected in the study are assessed for high-risk HPV persistence and host/viral methylation. The primary analysis will use the intention-to-treat principle to compare the proportion of those who comply with 0-month and 12-month sampling in the home-based and clinic-based arms. The a priori hypothesis is that a majority of persons will comply with annual screening with increased compliance among persons in the home-based arm versus clinic-based arm. ETHICS AND DISSEMINATION: The study has been approved by the Medical College of Wisconsin Human Protections Committee. Results will be disseminated to communities where recruitment occurred and through peer-reviewed literature and conferences. TRIAL REGISTRATION NUMBER: NCT03489707.

Why Contact Tracing Efforts Have Failed to Curb Coronavirus Disease 2019 (COVID-19) Transmission in Much of the United States.

By late April 2020, public discourse in the United States had shifted toward the idea of using more targeted case-based mitigation tactics (eg, contact tracing) to combat coronavirus disease 2019 (COVID-19) transmission while allowing for the safe "reopening" of society, in an effort to reduce the social, economic, and political ramifications associated with stricter approaches. Expanded tracing-testing efforts were touted as a key solution that would allow for a precision approach, thus preventing economies from having to shut down again. However, it is now clear that many regions of the United States were unable to mount robust enough testing-tracing programs to prevent major resurgences of disease. This viewpoint offers a discussion of why testing-tracing efforts failed to sufficiently mitigate COVID-19 across much of the nation, with the hope that such deliberation will help the US public health community better plan for the future.

The estimation of diagnostic accuracy of tests for COVID-19: A scoping review.

OBJECTIVES: To assess the methodologies used in the estimation of diagnostic accuracy of SARS-CoV-2 real-time reverse transcription polymerase chain reaction (rRT-PCR) and other nucleic acid amplification tests (NAATs) and to evaluate the quality and reliability of the studies employing those methods. METHODS: We conducted a systematic search of English-language articles published December 31, 2019-June 19, 2020. Studies of any design that performed tests on ≥10 patients and reported or inferred correlative statistics were included. Studies were evaluated using elements of the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) guidelines. RESULTS: We conducted a narrative and tabular synthesis of studies organized by their reference standard strategy or comparative agreement method, resulting in six categorizations. Critical study details were frequently unreported, including the mechanism for patient/sample selection and researcher blinding to results, which lead to concern for bias. CONCLUSIONS: Current studies estimating test performance characteristics have imperfect study design and statistical methods for the estimation of test performance characteristics of SARS-CoV-2 tests. The included studies employ heterogeneous methods and overall have an increased risk of bias. Employing standardized guidelines for study designs and statistical methods will improve the process for developing and validating rRT-PCR and NAAT for the diagnosis of COVID-19.