First follow-up health and <u>education surveys</u>

# **11. Ethical considerations**

# _Informed consent process_

Prior to the onset of the study, parent-teacher association meetings will be held with the parents/guardians of children enrolled in standards 1-5 to describe the purpose of the study, the procedures to be followed, and the risks and benefits of participation. Information sheets (Appendix 11) will be provided to the parents or guardians for their review. For those parents who not attend these meetings, follow-up will be made through community leaders and household visits.

The parents or guardians will be asked to sign consent for their child (if aged under 18 years) to participate in the research study (Appendix 11). If the child is aged 18 years or over, is married or is a mother (so-called emancipated minor by Kenyan law), they will be asked to provide consent themselves. If a parent, guardian or older child is unable to read or write, his/her fingerprint will be used in substitute for a signature, and a signature from a witness to the informed consent discussion will be obtained. Parents and guardians will have the chance to ask questions and will be informed that participation of their child(ren) in the study is completely voluntary and that they may withdraw from the study at any time.

Information about all children, including age, gender, and any history of known allergies or adverse reactions to study medications, will be obtained from parents/guardians and captured on an initial screening form (Appendix 2). Details about the location of the students’ homes will also be obtained from the parent/guardians to facilitate tracing in the event of absence from school on subsequent follow-up visits. A record will be made of those children for whom consent is provided and will be cross-checked against school registers.

Written consent to participate in the stakeholder interviews and focus groups discussions will be sought.

Verbal assent to participate in the study will also be obtained from the child at the time of screening (Appendix 11).

# _Training for those involved in administering consent_

All fieldworkers will undergo training prior to both studies. Training will educate fieldworkers on the purpose of the study, the importance of consent and how to administer both the consent forms and questionnaires. While in the field, fieldworkers will have continuous contact through the use of a mobile phone with the team leaders in case of any queries.

# _Community engagement_

Prior to the onset of the study, meetings will also be held with officials from the District Education Office, the District Health Management Team and District Commissioner’s office to sensitize them about the study and plans for recruitment and followup. Similar meeting will also be held with official at the national level in Nairobi.

Upon completion of the study, a two page ‘Research Brief’ will be developed, similar to that developed for the Bondo study. In addition, a one-day meeting with head teachers of participating schools, district health and education staff will be held, where the results of the study will be presented and discussed. Head teachers will be asked to distribute the Research Brief to interested parents. At the national level, results will be disseminated primarily to the Division of Malaria Control (Ministry of Public Health and Sanitation) and the School Health and Nutrition Programme (Ministry of Education). Finally, a half-day workshop will be convened in Nairobi by the World Bank where the implications of the results will be discussed in light of current school health plans.

# _Ethical approval_

Ethical approval for this study will be obtained from KEMRI National Ethical Committee and the London School of Hygiene and Tropical Medicine before commencement of the study.

# _Benefits_

This study has been designed to address several areas of major public health and educational significance for Kenyan schoolchildren. If we are able to show that malaria treatment improves educational outcomes, millions of African schoolchildren living in malaria endemic regions may benefit.

Children randomized to treatment intervention arms will benefit from free medical treatment for asymptomatic malaria infections. Rapid malaria tests will be performed for those who have a history of fever or raised temperature so that those with malaria parasites can immediately receive treatment, or referred to the nearest health facility, instead of waiting for the slides to be read.

# _Risks_

Parents/guardians and children will be informed of all potential risks.

This study involves collection of finger-prick blood samples which may lead to minor temporary discomfort or pain for children. Precautions will be taken to avoid bleeding by immediate application of sterilized cotton wool and pressure at the prick site. Risks of infection will be minimized by using disposable lancets, one for each child to avoid cross contamination/transmission of infectious agents. Stool and urine sample collection may be embarrassing for the children, but this discomfort will be minimized by guaranteeing children’s privacy during stool collection.

The study involves specific risks from the from the artemisinin-based combination therapy (ACT) drugs. ACTs are remarkably well tolerated in humans, with no serious adverse events or significant toxicity reported.

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