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

Mhembere Tsungai Patience; Mutambanengwe-Jacob Mercy; Vhembo Tichaona; Nicodimus Nicol; Kokera Sandra Betty; Bwakura-Dangarembizi Mutsa; Chirenje Zvavahera Mike

doi:doi:10.11648/j.ijhpebs.20210702.14

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

Mhembere Tsungai Patience, Mutambanengwe-Jacob Mercy, Vhembo Tichaona, Nicodimus Nicol, Kokera Sandra Betty, Bwakura-Dangarembizi Mutsa, Chirenje Zvavahera Mike

Published in International Journal of HIV/AIDS Prevention, Education and Behavioural Science (Volume 7, Issue 2)

Received: 11 October 2021 Accepted: 8 November 2021 Published: 17 November 2021

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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

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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

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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

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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

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@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}
}

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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  -

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Author Information

Mhembere Tsungai Patience

University of Zimbabwe, Clinical Trials Research Centre, Harare, Zimbabwe
Mutambanengwe-Jacob Mercy

University of Zimbabwe, Clinical Trials Research Centre, Harare, Zimbabwe
Vhembo Tichaona

University of Zimbabwe, Clinical Trials Research Centre, Harare, Zimbabwe
Nicodimus Nicol

University of Zimbabwe, Clinical Trials Research Centre, Harare, Zimbabwe
Kokera Sandra Betty

University of Zimbabwe, Clinical Trials Research Centre, Harare, Zimbabwe
Bwakura-Dangarembizi Mutsa

Child and Adolescent Health Unit, Faculty of Medicine and Health Sciences, University of Zimbabwe, Harare, Zimbabwe
Chirenje Zvavahera Mike

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

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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

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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

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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}
}

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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  -

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