| Autor: |
Raffaella Ravinetto, Jean-Pierre Van Geertruyden, Pierre Van Damme, Gwen Lemey, Ynke Larivière, Vivi Maketa, Patrick Mitashi, Trésor Zola, Hypolite Muhindo-Mavoko, Bernard Isekah Osang'ir, Primo Kimbulu, Solange Milolo, Engbu Danoff, Yves Tchuma |
| Jazyk: |
angličtina |
| Rok vydání: |
2024 |
| Předmět: |
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| Zdroj: |
BMJ Global Health, Vol 9, Iss 6 (2024) |
| Druh dokumentu: |
article |
| ISSN: |
2059-7908 |
| DOI: |
10.1136/bmjgh-2024-015259 |
| Popis: |
Introduction Clear guidelines to implement ancillary care (AC) in clinical trials conducted in resource-constrained settings are lacking. Here, we evaluate an AC policy developed for a vaccine trial in the Democratic Republic of the Congo and formulate policy recommendations.Methods To evaluate the AC policy, we performed a longitudinal cohort study, nested in an open-label, single-centre, randomised Ebola vaccine trial conducted among healthcare personnel. Participants’ demographic information, residence distance to the study site and details on the financial and/or medical support provided for any (serious) adverse events ((S)AE) were combined and analysed. To assess the feasibility of the AC policy, an expenditure analysis of the costs related to AC support outcomes was performed.Results Enrolment in this evaluation study started on 29 November 2021. The study lasted 11 months and included 655 participants from the Ebola vaccine trial. In total, 393 participants used the AC policy, mostly for AE management (703 AE and 94 SAE) via medication provided by the study pharmacy (75.3%). Men had a 35.2% (95% CI 4.0% to 56.6%) lower likelihood of reporting AE compared with women. Likewise, this was 32.3% lower (95% CI 5.8% to 51.4%) for facility-based compared with community-based healthcare providers. The daily AE reporting was 78.8% lower during the passive vs the active trial stage, and 97.4% lower during unscheduled vs scheduled visits (p |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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