| Peer-Reviewed

Rapid Review of COVID-19 Mitigation Within a Clinical Trials Unit: The UZ- CTRC Experience

Received: 11 October 2021     Accepted: 8 November 2021     Published: 17 November 2021
Views:       Downloads:
Abstract

Background and aim: The University of Zimbabwe-Clinical Trials Research Centre (UZ-CTRC) continued to provide essential services while safeguarding the safety of study participants and research staff during the COVID-19 pandemic. A COVID-19 Infection Prevention and Control (IPC) Taskforce formed in March 2020 drafted the institutional IPC Standard Operating Procedures (SOP) to prevent, mitigate, and manage SARS-CoV-2 infections. Identifying staff infected with SARS-CoV-2, isolation of positive cases and promoting risk reduction measures were key strategies to prevent workplace transmission. The SOP included a routine self-completed risk assessment questionnaire for staff prior to entering Clinical Trials Unit (CTU) facilities each day in addition to the recommended non-pharmaceutical preventative measures. Staff reporting a risk factor of greater than zero were assessed by a clinician and offered real time COVID-19 testing. Details of confirmed cases were reported to the IPC Taskforce and documented in the CTU COVID-19 tracker by the Monitoring and Evaluation Department. COVID-19 vaccine uptake was reported weekly by each clinical research site from February 2021. Methods: We conducted a desk review of this operational information, from March 2020 to August 2021, which was recorded as de-identified data in the CTU COVID-19 Tracker from ten active sites and 247 research staff. Data was tabulated in Microsoft Excel and analyzed using Stata 15.0. Results: A total of 753 SARS-CoV-2 tests were conducted (560 PCR tests and 193 Rapid Antigen tests) on CTU staff. Fifty-three SARS-CoV-2 cases were identified; 1 (1.9%) from March-August 2020 (first wave), 15 (28.3%) from September 2020- February 2021 (second wave; 2 deaths) and 37 (69.8%) from March-August 2021 (third wave; 1 death). Vaccination uptake was 84.6% (209/247) among staff between February and August 2021. Of 37 confirmed cases occurring after vaccines became available, 27 (73%) were fully vaccinated, 4 (10.8%) had received 1 vaccine dose and 6 (16.2%) were not vaccinated. Close contact with a known case was reported by 23 (43.4%) of whom 11 (20.7%) was presumed associated with workplace contact, and 10 (18.9%) a family member. Association with positive cases was unknown in 30 (56.6%) cases. Conclusion: We observed a significant rate of breakthrough COVID-19 infections in our Research Unit in the background of 84.6% vaccine uptake. Clinical trial units should consider having mechanisms in place to identify, test and isolate SARS-CoV-2 cases among staff for containment, safety, and continuity of research activities. Our staff remained at risk of acquiring COVID-19 even after vaccination, therefore non-pharmaceutical COVID-19 preventative measures remain critical in preventing SARS-CoV-2 transmission.

Published in International Journal of HIV/AIDS Prevention, Education and Behavioural Science (Volume 7, Issue 2)
DOI 10.11648/j.ijhpebs.20210702.14
Page(s) 75-83
Creative Commons

This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.

Copyright

Copyright © The Author(s), 2021. Published by Science Publishing Group

Keywords

COVID-19, Workplace Infection Prevention and Control, Clinical Research Staff

References
[1] Shi Y, Wang G, Cai X peng, Deng J wen, Zheng L, Zhu H hong, et al. An overview of COVID-19. J Zhejiang Univ Sci B. 2020; 21 (5): 343–60.
[2] Khan M, Adil SF, Alkhathlan HZ, Tahir MN, Saif S, Khan M, et al. COVID-19: A Global Challenge with Old History, Epidemiology and Progress So Far. Molecules. 2020 Dec 23; 26 (1).
[3] Karia R, Gupta I, Khandait H, Yadav A, Yadav A. COVID-19 and its Modes of Transmission. SN Compr Clin Med. 2020; 2 (10): 1798–801.
[4] WHO Coronavirus (COVID-19) Dashboard | WHO Coronavirus (COVID-19) Dashboard with Vaccination Data [Internet]. [cited 2021 Sep 9] Available from: https://COVID19.who.int/
[5] Ministry of Health and Child Care - Daily Updates - COVID 19 Daily Updates [Internet]. [cited 2021 Sep 9]. Available from: http://www.mohcc.gov.zw/index.php?option=com_phocadownload&view=category&id=15&Itemid=742
[6] Gómez-Ochoa SA, Franco OH, Rojas LZ, Raguindin PF, Roa-Díaz ZM, Wyssmann BM, et al. COVID-19 in Health-Care Workers: A Living Systematic Review and Meta-Analysis of Prevalence, Risk Factors, Clinical Characteristics, and Outcomes. Am J Epidemiol. 2021; 190 (1): 161–75.
[7] World Health Organization and International Labour Organization. COVID-19: Occupational health and safety for health workers. COVID-19 Occup Heal Saf Heal Work [Internet]. 2021; (February):1–16. Available from: https://www.who.int/publications/i/item/WHO-2019-nCoV-HCW_advice-2021.1
[8] Karlsson U, Fraenkel C-J. COVID-19: risks to healthcare workers and their families. BMJ [Internet]. 2020 Oct 28 [cited 2021 Sep 9]; 371. Available from: https://www.bmj.com/content/371/bmj.m3944
[9] Sim MR. The COVID-19 pandemic: major risks to healthcare and other workers on the front line. Occup Environ Med [Internet]. 2020 May 1; 77 (5): 281 LP – 282. Available from: http://oem.bmj.com/content/77/5/281.abstract
[10] Xiang B, Li P, Yang X, Zhong S, Manyande A, Feng M. The impact of novel coronavirus SARS-CoV-2 among healthcare workers in hospitals: An aerial overview. Am J Infect Control [Internet]. 2020 Aug 1 [cited 2021 Sep 9]; 48 (8): 915–7. Available from: http://www.ajicjournal.org/article/S0196655320303163/
[11] When You’ve Been Fully Vaccinated | CDC [Internet]. [cited 2021 Oct 4]. Available from: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated.html
[12] Ministry of Publicity Information. Post Cabinet Meeting Briefings. Veritas Website. 2021.
[13] Rushton AG. Risk assessment and management of health-care workers in the context of COVID-19. World Heal Organ [Internet]. 2020; 6 (September): 5. Available from: http://www.sciencedirect.com/science/article/pii/S0921911098800098
[14] Benenson S, Oster Y, Cohen MJ, Nir-Paz R. BNT162b2 mRNA COVID-19 Vaccine Effectiveness among Health Care Workers. N Engl J Med. 2021; 384 (18): 1775–7.
[15] Bergwerk M, Gonen T, Lustig Y, Amit S, Lipsitch M, Cohen C, et al. COVID-19 Breakthrough Infections in Vaccinated Health Care Workers. https://doi.org/101056/NEJMoa2109072 [Internet]. 2021 Jul 28 [cited 2021 Oct 4]; Available from: https://www.nejm.org/doi/full/10.1056/NEJMoa2109072
[16] Niyas VKM, Arjun R. Breakthrough COVID-19 infections among health care workers after two doses of ChAdOx1 nCoV-19 vaccine. QJM An Int J Med [Internet]. 2021 Jun 12 [cited 2021 Oct 4]; Available from: https://academic.oup.com/qjmed/advance-article/doi/10.1093/qjmed/hcab167/6297399
[17] Correlation of SARS-CoV-2 Breakthrough Infections to Time-from-vaccine; Preliminary Study [Internet]. [cited 2021 Oct 4]. Available from: https://www.researchgate.net/publication/353609975_Correlation_of_SARS-CoV-2_Breakthrough_Infections_to_Time-from-vaccine_Preliminary_Study
[18] Goldberg Y, Mandel M, Bar-On YM, Bodenheimer O, Freedman L, Haas EJ, et al. Waning immunity of the BNT162b2 vaccine: A nationwide study from Israel. medRxiv. 2021.
[19] Waning of BNT162b2 vaccine protection against SARS-CoV-2 infection in Qatar [Internet]. [cited 2021 Oct 4]. Available from: https://www.researchgate.net/publication/354173407_Waning_of_BNT162b2_vaccine_protection_against_SARS-CoV-2_infection_in_Qatar
[20] Bar-On YM, Goldberg Y, Mandel M, Bodenheimer O, Freedman L, Kalkstein N, et al. Protection of BNT162b2 Vaccine Booster against COVID-19 in Israel. https://doi.org/101056/NEJMoa2114255 [Internet]. 2021 Sep 15 [cited 2021 Oct 4]; Available from: https://www.nejm.org/doi/full/10.1056/NEJMoa2114255
Cite This Article
  • APA Style

    Mhembere Tsungai Patience, Mutambanengwe-Jacob Mercy, Vhembo Tichaona, Nicodimus Nicol, Kokera Sandra Betty, et al. (2021). Rapid Review of COVID-19 Mitigation Within a Clinical Trials Unit: The UZ- CTRC Experience. International Journal of HIV/AIDS Prevention, Education and Behavioural Science, 7(2), 75-83. https://doi.org/10.11648/j.ijhpebs.20210702.14

    Copy | Download

    ACS Style

    Mhembere Tsungai Patience; Mutambanengwe-Jacob Mercy; Vhembo Tichaona; Nicodimus Nicol; Kokera Sandra Betty, et al. Rapid Review of COVID-19 Mitigation Within a Clinical Trials Unit: The UZ- CTRC Experience. Int. J. HIV/AIDS Prev. Educ. Behav. Sci. 2021, 7(2), 75-83. doi: 10.11648/j.ijhpebs.20210702.14

    Copy | Download

    AMA Style

    Mhembere Tsungai Patience, Mutambanengwe-Jacob Mercy, Vhembo Tichaona, Nicodimus Nicol, Kokera Sandra Betty, et al. Rapid Review of COVID-19 Mitigation Within a Clinical Trials Unit: The UZ- CTRC Experience. Int J HIV/AIDS Prev Educ Behav Sci. 2021;7(2):75-83. doi: 10.11648/j.ijhpebs.20210702.14

    Copy | Download

  • @article{10.11648/j.ijhpebs.20210702.14,
      author = {Mhembere Tsungai Patience and Mutambanengwe-Jacob Mercy and Vhembo Tichaona and Nicodimus Nicol and Kokera Sandra Betty and Bwakura-Dangarembizi Mutsa and Chirenje Zvavahera Mike},
      title = {Rapid Review of COVID-19 Mitigation Within a Clinical Trials Unit: The UZ- CTRC Experience},
      journal = {International Journal of HIV/AIDS Prevention, Education and Behavioural Science},
      volume = {7},
      number = {2},
      pages = {75-83},
      doi = {10.11648/j.ijhpebs.20210702.14},
      url = {https://doi.org/10.11648/j.ijhpebs.20210702.14},
      eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ijhpebs.20210702.14},
      abstract = {Background and aim: The University of Zimbabwe-Clinical Trials Research Centre (UZ-CTRC) continued to provide essential services while safeguarding the safety of study participants and research staff during the COVID-19 pandemic. A COVID-19 Infection Prevention and Control (IPC) Taskforce formed in March 2020 drafted the institutional IPC Standard Operating Procedures (SOP) to prevent, mitigate, and manage SARS-CoV-2 infections. Identifying staff infected with SARS-CoV-2, isolation of positive cases and promoting risk reduction measures were key strategies to prevent workplace transmission. The SOP included a routine self-completed risk assessment questionnaire for staff prior to entering Clinical Trials Unit (CTU) facilities each day in addition to the recommended non-pharmaceutical preventative measures. Staff reporting a risk factor of greater than zero were assessed by a clinician and offered real time COVID-19 testing. Details of confirmed cases were reported to the IPC Taskforce and documented in the CTU COVID-19 tracker by the Monitoring and Evaluation Department. COVID-19 vaccine uptake was reported weekly by each clinical research site from February 2021. Methods: We conducted a desk review of this operational information, from March 2020 to August 2021, which was recorded as de-identified data in the CTU COVID-19 Tracker from ten active sites and 247 research staff. Data was tabulated in Microsoft Excel and analyzed using Stata 15.0. Results: A total of 753 SARS-CoV-2 tests were conducted (560 PCR tests and 193 Rapid Antigen tests) on CTU staff. Fifty-three SARS-CoV-2 cases were identified; 1 (1.9%) from March-August 2020 (first wave), 15 (28.3%) from September 2020- February 2021 (second wave; 2 deaths) and 37 (69.8%) from March-August 2021 (third wave; 1 death). Vaccination uptake was 84.6% (209/247) among staff between February and August 2021. Of 37 confirmed cases occurring after vaccines became available, 27 (73%) were fully vaccinated, 4 (10.8%) had received 1 vaccine dose and 6 (16.2%) were not vaccinated. Close contact with a known case was reported by 23 (43.4%) of whom 11 (20.7%) was presumed associated with workplace contact, and 10 (18.9%) a family member. Association with positive cases was unknown in 30 (56.6%) cases. Conclusion: We observed a significant rate of breakthrough COVID-19 infections in our Research Unit in the background of 84.6% vaccine uptake. Clinical trial units should consider having mechanisms in place to identify, test and isolate SARS-CoV-2 cases among staff for containment, safety, and continuity of research activities. Our staff remained at risk of acquiring COVID-19 even after vaccination, therefore non-pharmaceutical COVID-19 preventative measures remain critical in preventing SARS-CoV-2 transmission.},
     year = {2021}
    }
    

    Copy | Download

  • TY  - JOUR
    T1  - Rapid Review of COVID-19 Mitigation Within a Clinical Trials Unit: The UZ- CTRC Experience
    AU  - Mhembere Tsungai Patience
    AU  - Mutambanengwe-Jacob Mercy
    AU  - Vhembo Tichaona
    AU  - Nicodimus Nicol
    AU  - Kokera Sandra Betty
    AU  - Bwakura-Dangarembizi Mutsa
    AU  - Chirenje Zvavahera Mike
    Y1  - 2021/11/17
    PY  - 2021
    N1  - https://doi.org/10.11648/j.ijhpebs.20210702.14
    DO  - 10.11648/j.ijhpebs.20210702.14
    T2  - International Journal of HIV/AIDS Prevention, Education and Behavioural Science
    JF  - International Journal of HIV/AIDS Prevention, Education and Behavioural Science
    JO  - International Journal of HIV/AIDS Prevention, Education and Behavioural Science
    SP  - 75
    EP  - 83
    PB  - Science Publishing Group
    SN  - 2575-5765
    UR  - https://doi.org/10.11648/j.ijhpebs.20210702.14
    AB  - Background and aim: The University of Zimbabwe-Clinical Trials Research Centre (UZ-CTRC) continued to provide essential services while safeguarding the safety of study participants and research staff during the COVID-19 pandemic. A COVID-19 Infection Prevention and Control (IPC) Taskforce formed in March 2020 drafted the institutional IPC Standard Operating Procedures (SOP) to prevent, mitigate, and manage SARS-CoV-2 infections. Identifying staff infected with SARS-CoV-2, isolation of positive cases and promoting risk reduction measures were key strategies to prevent workplace transmission. The SOP included a routine self-completed risk assessment questionnaire for staff prior to entering Clinical Trials Unit (CTU) facilities each day in addition to the recommended non-pharmaceutical preventative measures. Staff reporting a risk factor of greater than zero were assessed by a clinician and offered real time COVID-19 testing. Details of confirmed cases were reported to the IPC Taskforce and documented in the CTU COVID-19 tracker by the Monitoring and Evaluation Department. COVID-19 vaccine uptake was reported weekly by each clinical research site from February 2021. Methods: We conducted a desk review of this operational information, from March 2020 to August 2021, which was recorded as de-identified data in the CTU COVID-19 Tracker from ten active sites and 247 research staff. Data was tabulated in Microsoft Excel and analyzed using Stata 15.0. Results: A total of 753 SARS-CoV-2 tests were conducted (560 PCR tests and 193 Rapid Antigen tests) on CTU staff. Fifty-three SARS-CoV-2 cases were identified; 1 (1.9%) from March-August 2020 (first wave), 15 (28.3%) from September 2020- February 2021 (second wave; 2 deaths) and 37 (69.8%) from March-August 2021 (third wave; 1 death). Vaccination uptake was 84.6% (209/247) among staff between February and August 2021. Of 37 confirmed cases occurring after vaccines became available, 27 (73%) were fully vaccinated, 4 (10.8%) had received 1 vaccine dose and 6 (16.2%) were not vaccinated. Close contact with a known case was reported by 23 (43.4%) of whom 11 (20.7%) was presumed associated with workplace contact, and 10 (18.9%) a family member. Association with positive cases was unknown in 30 (56.6%) cases. Conclusion: We observed a significant rate of breakthrough COVID-19 infections in our Research Unit in the background of 84.6% vaccine uptake. Clinical trial units should consider having mechanisms in place to identify, test and isolate SARS-CoV-2 cases among staff for containment, safety, and continuity of research activities. Our staff remained at risk of acquiring COVID-19 even after vaccination, therefore non-pharmaceutical COVID-19 preventative measures remain critical in preventing SARS-CoV-2 transmission.
    VL  - 7
    IS  - 2
    ER  - 

    Copy | Download

Author Information
  • University of Zimbabwe, Clinical Trials Research Centre, Harare, Zimbabwe

  • University of Zimbabwe, Clinical Trials Research Centre, Harare, Zimbabwe

  • University of Zimbabwe, Clinical Trials Research Centre, Harare, Zimbabwe

  • University of Zimbabwe, Clinical Trials Research Centre, Harare, Zimbabwe

  • University of Zimbabwe, Clinical Trials Research Centre, Harare, Zimbabwe

  • Child and Adolescent Health Unit, Faculty of Medicine and Health Sciences, University of Zimbabwe, Harare, Zimbabwe

  • Obstetrics and Gynaecology Unit, Faculty of Medicine and Health Sciences, University of Zimbabwe, Harare, Zimbabwe

  • Sections