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.
INTRODUCTION
Since November 2019, Medecins Sans Frontieres (MSF) and the Malawian Ministry of Health have provided a comprehensive range of cervical cancer care services. Initially, all consultations, pathological diagnoses, chemotherapy, surgery, and patient support activities were centralized at the tertiary hospital. To address the overwhelming surge in demand for these services, an innovative decentralisation approach was introduced to alleviate the workload and enhance patient care quality.
METHODS
The decentralization strategy involves triaging patients at the district level and categorizing them by type of lesion (Fig 1). Patients with early or locally advanced cancer, as well as those in need of palliative chemotherapy, are referred to the tertiary hospital for further evaluation and treatment. Those with premalignant lesions or advanced cancer are treated at the district level by trained surgical and palliative care teams. Quality is ensured through provision of medications, equipment and allowances, as well as monthly mentoring sessions for about 120 providers.
RESULTS
During the first months of comprehensive care provision, the number of palliative consultations at the tertiary hospital increased way above the threshold of 150 manageable consultations. Using the new decentralized system from August 2021, 818 palliative patients were referred to 45 palliative sites at district level, leading to a reduction in monthly consultations at central level from a high of 226 (2021) to a high of only 134 (2023) (Fig 2). Among the new patients presenting at the tertiary hospital, an average of 45% presented with benign or pre-malignant lesions. Therefore, from July 2023, 561 women started to be biopsied and managed at their district hospitals instead of the tertiary level.
CONCLUSIONS
It is feasible to provide a comprehensive package of cervical cancer care in low resource settings without overburdening services when a decentralization strategy is used to ensure manageable workload and high quality of care.
During the 2018–2020 Ebola virus disease (EVD) outbreak, residents in Goma, Democratic Republic of the Congo, were offered a two-dose prophylactic EVD vaccine. This was the first study to evaluate the safety of this vaccine in pregnant women. Adults, including pregnant women, and children aged ≥1 year old were offered the Ad26.ZEBOV (day 0; dose 1), MVA-BN-Filo (day 56; dose 2) EVD vaccine through an open-label clinical trial. In total, 20,408 participants, including 6635 (32.5%) children, received dose 1. Fewer than 1% of non-pregnant participants experienced a serious adverse event (SAE) following dose 1; one SAE was possibly related to the Ad26.ZEBOV vaccine. Of the 1221 pregnant women, 371 (30.4%) experienced an SAE, with caesarean section being the most common event. No SAEs in pregnant women were considered related to vaccination. Of 1169 pregnancies with a known outcome, 55 (4.7%) ended in a miscarriage, and 30 (2.6%) in a stillbirth. Eleven (1.0%) live births ended in early neonatal death, and five (0.4%) had a congenital abnormality. Overall, 188/891 (21.1%) were preterm births and 79/1032 (7.6%) had low birth weight. The uptake of the two-dose regimen was high: 15,328/20,408 (75.1%). The vaccine regimen was well-tolerated among the study participants, including pregnant women, although further data, ideally from controlled trials, are needed in this crucial group.