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<0.001). Participants living further than 10 km from the trial site more frequently reported the travel distance as a reason for not using the policy (p<0.04). In practice, only 1.1% of the operational trial budget was used for AC policy support. Conclusion The trial design, study population and local health system impacted the use of the AC policy. Nonetheless, the AC policy implementation in this remote and resource-constrained setting was feasible, had negligible budgetary implications and contributed to participants' healthcare options and well-being.

In this paper, we discuss challenges associated with implementing a policy for Ancillary Care (AC) for related and unrelated (serious) adverse events during an Ebola vaccine trial conducted in a remote area of the Democratic Republic of the Congo. Conducting clinical trials in resourceconstrained settings can raise context-related challenges that have implications for study participants’ health and wellbeing. During the Ebola vaccine study, three participants were injured in road traffic accidents, but there were unexpected difficulties when trying to apply the AC policy. First, because of the nature of the adverse events, the insurer refused to cover the costs. Second, the AC policy did not address treatments by traditional medicine, even though traditional medicines are frequently used and highly trusted in the study community. This highlighted a contrast between the researchers’ well-intentioned AC approach and the participants’ legitimate preferences. The way in which researchers should address their responsibility to provide AC is not straightforward; it requires contextualization. Our experience highlights the importance of involving community representatives and the local ethics committee to ensure development of an AC policy that is culturally and ethically appropriate. Additionally, the insurance contract should clearly stipulate which adverse events are linked to the trial participation, and thus eligible for coverage, to avoid controversies when claims are made.

Dengue is a worldwide public health concern. The current study assessed the extent of human exposure to the dengue virus in relation to the distribution pattern of Aedes aegypti and Ae. albopictus in Kinshasa. Cross-sectional surveys were carried out in 2021 and 2022. The baseline entomological survey involved 19 municipalities using a grid cell sampling approach. All containers holding water were inspected for the presence of larvae in each grid. The collected larvae were kept in an insectary until the adult emergence for morphological identification. Four hundred febrile patients attending the hospital were screened for the presence of dengue antibodies (IgG, IgM) and NS1 antigen using a rapid diagnostic test (RDT) Biosynex®. Residences of positive cases were geo-referenced. We evaluated 1850 grid cells, of which 19.5% were positive for Aedes larvae. The positive grid cells were identified in the Ndjili (44.0%), Mont Ngafula (32.0%) and Ngaliema (26.0%), and Limete (32.0%) municipalities. The Ae. aegypti (11.2%) predominated in the northwestern, and Ae. albopictus (9.1%) appeared in the high vegetation coverage areas. Of 61 (15.3%) participants exposed to dengue, 8.3% presented acute dengue. Young, (6–17 years), male, and Mont Amba district participants were most exposed to dengue. In conclusion, dengue occurrence in Kinshasa overlaps somewhat the geographical and ecological distributions of Ae. aegypti and Ae. albopictus. Both species are not homogenously distributed, likely due to environmental factors. These findings can assist the targeted control activities.

Background The knowledge of key elements of the ecosystem affecting mosquito distribution and their population dynamics is essential for designing mosquito-borne disease interventions. The present study characterized the physicochemical properties of Aedes mosquito breeding habitats in Democratic Republic of the Congo. Methods A cross-sectional survey was carried out in Kinshasa, from February to April 2021. The physicochemical characteristics of the natural and artificial aquatic habitats of Aedes were measured using a multiparametric device. Results Out of 438 breeding habitats inspected, 273 (62.3%) contained mosquito larvae. The Aedes mosquitoes identified in 76.19% of positive breeding sites were Aedes albopictus (67.30%) and Aedes aegypti (37.98%). The median values of dissolved oxygen (DO) (1.0), turbidity (19.15), and salinity (0.115) in water breeding sites of Aedes were respectively 0.8, 55.0, and 0.29 in Culex breeding sites (p < 0.05). The physicochemical characteristics of the breeding habitat for Ae. aegypti and Ae. albopictus were almost identical. In urban areas, the median temperature was 29.82 while it was 29.60 in suburban areas (p < 0.05). Significantly, the salinity was higher in bamboo and metal containers while DO was higher in tins. After analysis using simple linear regression, total dissolved solids (r = 0.23; p = 0.000), conductivity (r = 0.23), salinity (r = 0.23), and temperature (r = 0.13) were associated with larval density (p < 0.05). In the final model (r = 0.30, p = 0.01), salinity (r = 0.23) and DO (r = 0.138) adjusted to temperature, pH, and turbidity were associated positively to larvae density. Conclusion The Aedes breeding sites and mosquito density were significantly influenced by water salinity, DO, temperature, pH, and turbidity.