Using an analogue-digital hybrid clinical data management platform during a two-dose preventive Ebola virus vaccine trial in Goma, the Democratic Republic of the Congo
Clinical trials in settings with intermittent or non-existent internet and power connectivity, for example during humanitarian emergencies, present challenges in the synchronisation of data across different sites, in addition to accessing a centralised database in real-time. To overcome these, we de...
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| Vydáno v: | PLOS global public health Ročník 5; číslo 5; s. e0004487 |
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Public Library of Science
02.05.2025
Public Library of Science (PLoS) |
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| Abstract | Clinical trials in settings with intermittent or non-existent internet and power connectivity, for example during humanitarian emergencies, present challenges in the synchronisation of data across different sites, in addition to accessing a centralised database in real-time. To overcome these, we designed a novel hybrid analogue/digital data management system which was deployed during the rapid implementation of a Phase III evaluation of a two-dose preventative vaccine for Ebola virus disease in Goma, Democratic Republic of the Congo, from 2019 to 2022. We provided study participants with an Enhanced Participant Record Card (EPRC) that served as eligibility for, and confirmation of, vaccination and was used in combination with Open Data Kit (ODK) electronic case report forms to create an off-grid study participant management system. To understand the utility of the EPRC, we analysed data from 15,327 study participants who received both vaccines and various types of prompts or reminders to return for dose 2, including home visits, telephone calls, or short messaging service (SMS). A total of 53% participants referred to the date on the EPRC as a prompt to return for dose 2 and 36.1% mentioned this as the only prompt. A multivariable generalised linear mixed-effects model showed that those who were not working, those aged 45–64 years or who had a chronic medical condition identified prior to receiving dose 2 were more likely to use the date on the EPRC as a prompt. Our findings demonstrate the utility of this system in the facilitation of decentralised data collection in off-grid locations that may be useful for future trials in complex humanitarian settings.
Clinical Trials Registration Number: ClinicalTrials.gov NCT01128790 |
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| AbstractList | Clinical trials in settings with intermittent or non-existent internet and power connectivity, for example during humanitarian emergencies, present challenges in the synchronisation of data across different sites, in addition to accessing a centralised database in real-time. To overcome these, we designed a novel hybrid analogue/digital data management system which was deployed during the rapid implementation of a Phase III evaluation of a two-dose preventative vaccine for Ebola virus disease in Goma, Democratic Republic of the Congo, from 2019 to 2022. We provided study participants with an Enhanced Participant Record Card (EPRC) that served as eligibility for, and confirmation of, vaccination and was used in combination with Open Data Kit (ODK) electronic case report forms to create an off-grid study participant management system. To understand the utility of the EPRC, we analysed data from 15,327 study participants who received both vaccines and various types of prompts or reminders to return for dose 2, including home visits, telephone calls, or short messaging service (SMS). A total of 53% participants referred to the date on the EPRC as a prompt to return for dose 2 and 36.1% mentioned this as the only prompt. A multivariable generalised linear mixed-effects model showed that those who were not working, those aged 45-64 years or who had a chronic medical condition identified prior to receiving dose 2 were more likely to use the date on the EPRC as a prompt. Our findings demonstrate the utility of this system in the facilitation of decentralised data collection in off-grid locations that may be useful for future trials in complex humanitarian settings. Clinical Trials Registration Number: ClinicalTrials.gov NCT01128790. Clinical trials in settings with intermittent or non-existent internet and power connectivity, for example during humanitarian emergencies, present challenges in the synchronisation of data across different sites, in addition to accessing a centralised database in real-time. To overcome these, we designed a novel hybrid analogue/digital data management system which was deployed during the rapid implementation of a Phase III evaluation of a two-dose preventative vaccine for Ebola virus disease in Goma, Democratic Republic of the Congo, from 2019 to 2022. We provided study participants with an Enhanced Participant Record Card (EPRC) that served as eligibility for, and confirmation of, vaccination and was used in combination with Open Data Kit (ODK) electronic case report forms to create an off-grid study participant management system. To understand the utility of the EPRC, we analysed data from 15,327 study participants who received both vaccines and various types of prompts or reminders to return for dose 2, including home visits, telephone calls, or short messaging service (SMS). A total of 53% participants referred to the date on the EPRC as a prompt to return for dose 2 and 36.1% mentioned this as the only prompt. A multivariable generalised linear mixed-effects model showed that those who were not working, those aged 45–64 years or who had a chronic medical condition identified prior to receiving dose 2 were more likely to use the date on the EPRC as a prompt. Our findings demonstrate the utility of this system in the facilitation of decentralised data collection in off-grid locations that may be useful for future trials in complex humanitarian settings. Clinical Trials Registration Number: ClinicalTrials.gov NCT01128790 Clinical trials in settings with intermittent or non-existent internet and power connectivity, for example during humanitarian emergencies, present challenges in the synchronisation of data across different sites, in addition to accessing a centralised database in real-time. To overcome these, we designed a novel hybrid analogue/digital data management system which was deployed during the rapid implementation of a Phase III evaluation of a two-dose preventative vaccine for Ebola virus disease in Goma, Democratic Republic of the Congo, from 2019 to 2022. We provided study participants with an Enhanced Participant Record Card (EPRC) that served as eligibility for, and confirmation of, vaccination and was used in combination with Open Data Kit (ODK) electronic case report forms to create an off-grid study participant management system. To understand the utility of the EPRC, we analysed data from 15,327 study participants who received both vaccines and various types of prompts or reminders to return for dose 2, including home visits, telephone calls, or short messaging service (SMS). A total of 53% participants referred to the date on the EPRC as a prompt to return for dose 2 and 36.1% mentioned this as the only prompt. A multivariable generalised linear mixed-effects model showed that those who were not working, those aged 45-64 years or who had a chronic medical condition identified prior to receiving dose 2 were more likely to use the date on the EPRC as a prompt. Our findings demonstrate the utility of this system in the facilitation of decentralised data collection in off-grid locations that may be useful for future trials in complex humanitarian settings. Clinical Trials Registration Number: ClinicalTrials.gov NCT01128790.Clinical trials in settings with intermittent or non-existent internet and power connectivity, for example during humanitarian emergencies, present challenges in the synchronisation of data across different sites, in addition to accessing a centralised database in real-time. To overcome these, we designed a novel hybrid analogue/digital data management system which was deployed during the rapid implementation of a Phase III evaluation of a two-dose preventative vaccine for Ebola virus disease in Goma, Democratic Republic of the Congo, from 2019 to 2022. We provided study participants with an Enhanced Participant Record Card (EPRC) that served as eligibility for, and confirmation of, vaccination and was used in combination with Open Data Kit (ODK) electronic case report forms to create an off-grid study participant management system. To understand the utility of the EPRC, we analysed data from 15,327 study participants who received both vaccines and various types of prompts or reminders to return for dose 2, including home visits, telephone calls, or short messaging service (SMS). A total of 53% participants referred to the date on the EPRC as a prompt to return for dose 2 and 36.1% mentioned this as the only prompt. A multivariable generalised linear mixed-effects model showed that those who were not working, those aged 45-64 years or who had a chronic medical condition identified prior to receiving dose 2 were more likely to use the date on the EPRC as a prompt. Our findings demonstrate the utility of this system in the facilitation of decentralised data collection in off-grid locations that may be useful for future trials in complex humanitarian settings. Clinical Trials Registration Number: ClinicalTrials.gov NCT01128790. Clinical trials in settings with intermittent or non-existent internet and power connectivity, for example during humanitarian emergencies, present challenges in the synchronisation of data across different sites, in addition to accessing a centralised database in real-time. To overcome these, we designed a novel hybrid analogue/digital data management system which was deployed during the rapid implementation of a Phase III evaluation of a two-dose preventative vaccine for Ebola virus disease in Goma, Democratic Republic of the Congo, from 2019 to 2022. We provided study participants with an Enhanced Participant Record Card (EPRC) that served as eligibility for, and confirmation of, vaccination and was used in combination with Open Data Kit (ODK) electronic case report forms to create an off-grid study participant management system. To understand the utility of the EPRC, we analysed data from 15,327 study participants who received both vaccines and various types of prompts or reminders to return for dose 2, including home visits, telephone calls, or short messaging service (SMS). A total of 53% participants referred to the date on the EPRC as a prompt to return for dose 2 and 36.1% mentioned this as the only prompt. A multivariable generalised linear mixed-effects model showed that those who were not working, those aged 45–64 years or who had a chronic medical condition identified prior to receiving dose 2 were more likely to use the date on the EPRC as a prompt. Our findings demonstrate the utility of this system in the facilitation of decentralised data collection in off-grid locations that may be useful for future trials in complex humanitarian settings. Clinical Trials Registration Number: ClinicalTrials.gov NCT01128790 |
| Author | Johnson, John Aboubacar, Soumah Kavunga-Membo, Hugo Choi, Edward Man-Lik Watson-Jones, Deborah Tetsa-Tata, Darius Kasonia, Kambale Mambula, Grace Roberts, Chrissy H. Bausch, Daniel G. Ama, Ibrahim Seyni Lees, Shelley Muyembe-Tamfum, Jean-Jacques Edwards, Tansy Grais, Rebecca Camacho, Anton Brindle, Hannah E. |
| AuthorAffiliation | 2 Epicentre, Paris, France 5 FIND, Geneva, Switzerland 1 London School of Hygiene & Tropical Medicine (LSHTM), London, United Kingdom 3 Institut National pour la Recherche Biomédicale (INRB), Kinshasa, DR Congo 6 Mwanza Intervention Trials Unit, National Institute for Medical Research, Mwanza, Tanzania Fundacao Oswaldo Cruz, BRAZIL 4 Médecins sans Frontières, Paris, France |
| AuthorAffiliation_xml | – name: 2 Epicentre, Paris, France – name: 1 London School of Hygiene & Tropical Medicine (LSHTM), London, United Kingdom – name: 3 Institut National pour la Recherche Biomédicale (INRB), Kinshasa, DR Congo – name: 6 Mwanza Intervention Trials Unit, National Institute for Medical Research, Mwanza, Tanzania – name: 5 FIND, Geneva, Switzerland – name: 4 Médecins sans Frontières, Paris, France – name: Fundacao Oswaldo Cruz, BRAZIL |
| Author_xml | – sequence: 1 givenname: Hannah E. orcidid: 0000-0003-1684-5801 surname: Brindle fullname: Brindle, Hannah E. – sequence: 2 givenname: Darius surname: Tetsa-Tata fullname: Tetsa-Tata, Darius – sequence: 3 givenname: Tansy surname: Edwards fullname: Edwards, Tansy – sequence: 4 givenname: Edward Man-Lik orcidid: 0000-0002-8148-120X surname: Choi fullname: Choi, Edward Man-Lik – sequence: 5 givenname: Kambale orcidid: 0000-0001-5340-7048 surname: Kasonia fullname: Kasonia, Kambale – sequence: 6 givenname: Soumah surname: Aboubacar fullname: Aboubacar, Soumah – sequence: 7 givenname: Grace orcidid: 0000-0001-6284-7838 surname: Mambula fullname: Mambula, Grace – sequence: 8 givenname: Hugo surname: Kavunga-Membo fullname: Kavunga-Membo, Hugo – sequence: 9 givenname: Rebecca orcidid: 0000-0002-5037-8218 surname: Grais fullname: Grais, Rebecca – sequence: 10 givenname: John surname: Johnson fullname: Johnson, John – sequence: 11 givenname: Daniel G. orcidid: 0000-0002-7209-6983 surname: Bausch fullname: Bausch, Daniel G. – sequence: 12 givenname: Jean-Jacques surname: Muyembe-Tamfum fullname: Muyembe-Tamfum, Jean-Jacques – sequence: 13 givenname: Ibrahim Seyni surname: Ama fullname: Ama, Ibrahim Seyni – sequence: 14 givenname: Shelley surname: Lees fullname: Lees, Shelley – sequence: 15 givenname: Deborah surname: Watson-Jones fullname: Watson-Jones, Deborah – sequence: 16 givenname: Anton surname: Camacho fullname: Camacho, Anton – sequence: 17 givenname: Chrissy H. surname: Roberts fullname: Roberts, Chrissy H. |
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| Title | Using an analogue-digital hybrid clinical data management platform during a two-dose preventive Ebola virus vaccine trial in Goma, the Democratic Republic of the Congo |
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