Table 1 Feedback and decisions from engagement meetings

Policy makers e.g. National Malaria Control Program, Cambodia

• Recommendation that Siem Pang district bordering with southern Lao PDR as suitable study site based on malaria transmission and forest coverage

• Choice of trial drugs: artemether-lumefantrine (AL) as antimalarial prophylaxis and multivitamin (MV) as control

• Frequency and duration of antimalarial drug administration as prophylaxis

The recommendations and decisions were incorporated into the protocol design and procedures

Local health and administrative authorities e.g. Provincial and District Health Department, Local Governor Office representatives, commune and village leaders, Village Malaria Workers

• To form a joint team to conduct engagement activities with villagers and forest goers

• To use the words “Health Project” instead of “Research Project” while explaining the trial to participants to avoid confusion and misunderstanding within the community

• To simplify the trial information using posters and pictorial messages

• To explain in detail the safety of the trial drugs, to clarify the possible side effects that may occur after taking them, to explain the side effects that may not be related but participants may associate with the trial drug, to ensure support is available for any side effects experienced by participants

• To address any rumours or concerns that may occur during the trial period by the joint engagement team in the community

The feedback and recommendations were incorporated into the trial implementation and engagement activities. A joint engagement team was formed, and trial procedures were simplified through use of posters and leaflets. Drug safety was discussed with the villagers and their concerns were addressed jointly by the engagement team and trial staff

Villagers and forest goers

• Participants wondered why the yellow medicine (AL) had so many tablets (4 per dose) compared to the pink one (MV)

• Participants asked why children under 16 years are not allowed to join the trial and how they could be protected from malaria when they go to the forest with their parents

• Participants asked if the drug is the same as the one used for malaria treatment in the health centres

• Forest goers wondered how long the drug remains in the body and how it works

• Female participants asked if they could take the study drug while using a contraceptive drug regularly

• Forest goers wanted to know if the study drug can be dangerous or poisonous

• Participants wanted to know if they can continue smoking tobacco and drinking alcohol

We listed the possible queries that may arise from villagers and forest goers. Responses to the queries were prepared in advance and agreed with members of joint engagement team before approaching the villagers and the community

We explained that the drugs are safe and millions of patients have already used them among all age groups. Participants who are pregnant and below 16 years were not included because the National Malaria Control Program first wanted to know whether the proposed antimalarial prophylaxis is effective, safe, and acceptable to the community and in adult participants

Participants were advised to avoid drinking alcohol while taking study drugs and female participants were advised to ask their partners to use condoms to avoid any drug interactions with contraceptive medication