Community health worker training and participant follow-up in the CANTAM-
bleeding, contusions, nausea;, fatigue, fever, malaria, stomachache, faintness, hepatotoxicity, Hypersensitivity, rash, jaundice, pruritus, breathlessness, ill, flushing
BLEEDING, ADVERSE EVENTS, MALARIA, HYPERSENSITIVITY, LOSS OF APPETITE, REMISSION, MALARIA, EVENTS, HYPERSENSITIVITY
To neither jeopardize participants’ reporting behavior nor overlook important safety signals, continuous training was paramount for CHWs to remain alert of their responsibilities. Training was given during the site initiation visit and included an explanation of material and procedures as well as role play. Role plays were used to simulate real-life scenarios and discuss solutions. CHWs who had previously been involved in studies with home-based participant follow-up shared their experiences with the others. Re-trainings were provided by the site investigators during formalized training sessions or regular team meetings, and during monitoring visits as needed.For self-training purposes, CHWs received a “memory aid” to carry with them for reference but they were not supposed to use it during direct participant contact to avoid any bias in participants’ reporting. The memory aid contained a general part, with a description of the seriousness criteria and the query whether treatment or medical attention was necessary. If any of the listed was answered with “yes”, the CHW was required to inform the investigator immediately and direct the participant to the study center to receive further medical attention. The second part of the memory aid focused on adverse events of special interest, these being hepatotoxicity and hypersensitivity. Warning signs for hepatotoxicity included fatigue of unusual intensity that remained after cure of the malaria episode or worsened; fever that either remained after cure of the malaria episode or returned after initial remission; nausea; vomiting; loss of appetite; stomachache; pruritus or skin rash. In addition, images of dark urine; putty or mastic colored stools; jaundice, and contusions, indicating spontaneous sub-cutaneous bleeding, were provided to facilitate CHWs in recognizing these signs. Hypersensitivity events were identified by any signs of flushing; the appearance of wheals/urticaria; breathlessness and faintness and/or decrease in blood pressure. CHWs found the memory aid to be a useful and self-explanatory tool.To reflect real-life conditions as much as possible and avoid over-reporting of adverse events, suggestive questions were not permitted. Instead, the CHW was instructed to ask open questions and document (1) whether the participant noticed anything special or abnormal concerning their health status since the last contact with study staff or since the study drug intake and (2) whether the CHW noticed anything special or abnormal in the participant. In case the participant reported specific medical conditions or the CHW observed danger signs, they were referred to the study center for further investigation.Home visits also included additional examinations within the CHW competence in the respective country. On day 7 ± 1 day, measurement of body temperature; enquiry of pregnancy status; assessment of compliance to study drug intake, and documentation of signs and symptoms of malaria and new and concomitant medication were performed. In addition, at day 28 ± 2 days, measurement of body temperature; pregnancy test where relevant; preparation of thick blood smear and blood spots on filter paper were conducted. Where CHWs were not allowed to collect blood, they were accompanied by a laboratory technician. If malaria or pregnancy was suspected, the CHW was instructed to refer the participant to the study center immediately.Source documents for all home visits of the day, i.e., the standardized notes taken by the CHW, were reviewed by and discussed with the site investigator on the CHW's return to the study center. The investigator was responsible for the final judgment, documentation on the case report form, and further actions for adverse events. Based on this, if the investigator spotted the need for further medical evaluation or treatment, the participant was notified and instructed to attend the study center for further investigation. Malaria microscopy was performed on all thick blood smears at the center to assess response to the study treatment. In case a blood smear was positive participants were notified and directed to the study center to receive antimalarial rescue treatment.Overall, CHWs appeared to be highly trusted by the target population and participants referred their peers to the CHWs for study participation when they were ill. This trust was largely based on the CHWs’ long-term activities in the communities and/or the fact that the CHWs were trusted community members. None of the study sites reported barriers when talking to participants. Challenges sometimes arose when participants lived far from the study site when participants’ residential areas were not well mapped, or when participants were not at home for scheduled visits. This was mitigated by calling participants, providing CHWs with cars or other means of transport, and being creative in describing participants’ homes (e.g., near the banana market, etc.).