Discussion
malaria, CNM
MALARIA, ADVERSE EFFECTS
The main objective of the study was to determine the effectiveness and feasibility of engaging forest-goers in a randomized controlled clinical trial of anti-malarial chemoprophylaxis with artemether-lumefantrine (AL) in northeast Cambodia. The community engagement strategy was built on and evolved from the feedback and recommendations from stakeholders. The engagement team, consisting of local community members and research staff, conducted meetings in the community and spent time together throughout the trial period, which strengthened the working relationships and trust between those involved [Feedback from community members and participants during meetings in the community helped the trial team to adopt the implementation activities. For instance, participants were worried about possible adverse effects of the trial drugs and wanted to know more about how to get support in case health problems occurred. Provision of free health care (ancillary health care) by the research team that included health check-ups and medications for common health problems was positively received by the participants and the community. Ancillary health care has been found to play an important role in promoting participation in trials [A frequent recommendation from community members was to include all age groups in the trial, particularly children who travel to the forest together with their parents. In the actual trial, only people aged 16 to 65 years were eligible to participate. Reasons for this included stakeholders from CNM stating a preference to focus on adult participants, as well as practical concerns with the complex weight-based dosing in smaller children and the low recorded incidence of malaria among those under 16 in the trial area.Overall, high (84%) compliance with the trial procedures and drug intake was observed. This finding was consistent with findings from the qualitative study [Women were less likely to participate in the trial than men (female: 23% vs male: 77%). This was mostly due to the large majority of forest goers being male. Other reasons recorded by the engagement team in their field notes without numerical estimations included: the desire to become pregnant and, therefore, not being able to comply with the trial procedures; unfamiliarity with or reluctance to use contraceptives for a longer duration; and absence of permission to participate from their husbands. In the wider literature around sexual and reproductive health, unwillingness to use contraceptives, particularly condoms, which could potentially interfere with sexual pleasure may have contributed to reluctance to participate [The engagement strategy in this trial entailed a continuous adaptation with the concerns and feedback from the local staff, trial participants and other stakeholders. For instance, as the trial was implemented amidst the evolving COVID-19 pandemic, critical adaptations included use of face masks, maintaining social distance, frequent use of sanitizers, and reinstating hygiene to avoid possible transmission of COVID-19. Such messages were reassuring to community members as they helped to allay the ongoing fear, and build confidence and trust towards the research team. Findings in this study corroborate the qualitative research [