Engagement strategies and activities
diarrhoea, communityThe, malaria, gastritis, CNM, ’ complaints, muscle pain, hypertensive
MALARIA, GASTRITIS, MINOR, ADVERSE EVENTS, RECRUITMENT, VITAMIN DEFICIENCY
Community engagement strategies were adopted to engage community members and forest goers to ensure that they understood the trial procedures and potential benefits and harms associated with the trial drugs, and to make independent judgements and decisions about whether to participate in the trial without any external influence. To achieve this, we enlisted the following strategies (Fig. Engaging stakeholders, communities and participantsKey engagement strategies and activitiesA series of meetings was conducted (small- and large-scale) with national and local health authorities, local administrations, community leaders, health workers and villagers prior to, and during, trial implementation. The engagement meetings were open to all people independent of socioeconomic status, cultural and traditional backgrounds, or political views. The meetings with stakeholders and community members were designed as a two-way communication platform, which enabled listening to participants’ opinions and concerns and encouraged responsiveness. The feedback and recommendations from the meetings were incorporated into the trial protocol, training and study materials that provided information related to the trial and activities. Discussions took place with investigators from CNM on protocol design and activities, particularly on the selection of trial drugs. Following agreements on trial design and approval from CNM, an orientation meeting was held with the representatives from provincial and local health departments, district administration, village leaders, and VMWs prior to the implementation of the trial activities. During the meeting, information related to trial design and planned activities was presented in detail. Concerns and recommendations from the meeting were addressed and incorporated into trial implementation activities (Fig. Co-development of informational materialsMeetings conducted by joint engagement teamExplaining the trial rationale and its procedures to potential participants and the wider community in a comprehensible way, adapted to their language, ethnic and educational backgrounds was felt likely to be a significant challenge. Prior to engagement activities in the villages, posters that presented key messages of trial-related information were prepared jointly with stakeholders (Fig. Formation of a joint engagement team with stakeholdersKey messages about malaria and prophylaxisA joint engagement team was formed with stakeholders during the orientation meeting to conduct engagement activities in all trial villages and to address any concerns, rumours or other challenges that emerged during the implementation of the trial activities. The stakeholder-researcher team consisted of representatives from local administration, health authority, community leaders, VMWs and trial staff. Two large meetings were held by the team prior to the recruitment of trial participants in the initial two villages in March 2020. Due to the onset of the COVID-19 pandemic, meetings in subsequent villages had to be held on a smaller scale.VMWs and village and community leaders took the central role in organizing and conducting the meetings. They selected the venues and went house-to-house to invite the villagers to the meeting and distributed an invitation letter to each family in the village. Trial staff were introduced by the engagement team to the community members during the meetings.Conducting group and individual consentThe consent process took place in several stages. Firstly, trial information was presented to all invited community members using the posters showing key messages. Next, interested groups of forest goers were invited to join the full consent process. Written informed consent was obtained from all participants prior to enrolment. For those who could not read or write, the information sheet and consent form were read to them and a fingerprint was obtained and the form countersigned by an impartial witness. A copy of the signed informed consent documents was given to the participants. For participants aged 16 to 18 years, written informed assent was obtained in addition to their parent or guardian signing a consent form.Caution was taken to maintain privacy strictly with every female participant at fertile age to make them feel comfortable during the consent process. A female team member discussed with each female participant and her partner in private. Specifically, if they were willing to use condoms during and after the written informed consent (at the start of the study), they were enrolled.Addressing the needs and concerns of the communityThe study population resides in remote areas and most villages do not have convenient access to health care. Considering the situation, the engagement team undertook meetings with community health workers (village malaria workers and mobile malaria workers), and community representatives (village leaders) about the common health problems in the village. The team concluded that it would be important to offer support to the community for the health problems they face, otherwise there could be a negative impact on the acceptability of the trial. The team identified some common health problems, such as muscle pain, minor wounds, gastritis, diarrhoea, and vitamin deficiency that were of concern to the community and within the scope of the trial staff to support. Medications for these health problems were offered to the participants and villagers irrespective of their participation in the trial. In addition, to avoid pregnancy during participation in the trial, counselling was provided and offered condoms to female participants as part of provisional health care to participants.Health check-ups such as measuring blood pressure were offered to participants in high-risk groups and those found to be hypertensive were advised to go to the health centre. The trial team were available to address all kinds of adverse events regardless of their relationship to the study drugs. Being prompt and responsive to trial participants’ complaints and offering a sense of continuous presence in the community built trust and relationships. The trial team were also proactive to meet the challenges related to participation in the trial. For instance, when participants were not able to participate in the study or were unable to come for follow-up because they were busy, the team tried to minimize these barriers by either reaching out to them with study drugs, or simply providing them with the means of transportation.Selection of community representatives and allocating responsibilitiesThe population of the trial area consists of many ethnic minority groups, often speaking different native languages. This diversity was also observed within a single village. It was vital to involve representatives from different minority groups in project activities to ensure that they were not excluded from the research. A village leader or VMW who belonged to a particular ethnic minority was selected to take additional responsibilities e.g. explaining key trial messages, assisting with the consent process, explaining trial procedures (particularly drug administration), fielding questions and doubts from participants, and mediating discussions. Approximately 54% of VMWs were female and only one village leader was female. To balance the gender gap of representation, a female representative was selected in each village where there was no female VMW. This was done following suggestions from local community members.Sharing responsibilities with trial participantsDuring the implementation process, previous research findings that forest goers travel to the forest in groups of up to 10 persons [