A preparatory study to inform the design of the Targeting school-Age Children for malaria Transmission Interruption at Community level trial (PreTACTIC study) in Burkina Faso: Cohort
Malaria
A cohort of randomly selected individuals, stratified by age (recruited from age groups <5, 5-15, and >15, in a 1:1:2 ratio – to maximise observations from adults [see sample size]), will be enrolled from two LHFs catchment area (covering 20 villages and 20,000 individuals, on average 50 individuals per village). The enrolled individuals will receive a study ID card, then a curative dose of antimalarial (Co-artem; Artemether-lumefantrine) prior to the beginning of the malaria season (June). Fourteen days later, clearance will be confirmed by microscopy. Those individuals who are negative will be enrolled in the cohort and routinely assessed (fortnightly) for clinical malaria infection. Enrollment will continue until the requisite sample size (n=1000) is reached, and all enrollees will be given a study ID card for presentation at LHFs. Blood smears and spots will be collected during home visits but will only processed at the end of the follow up for molecular infection detection (PCR). During the home visit an objective fever or reported history of fever within the past 48 hours will prompt referral to the catchment LHF for testing for malaria using a rapid diagnostic test (RDT). For the duration of the study (maximum 9 visits, over 18 weeks, between enrolment and the cross sectional survey), participants will be instructed to attend to the LHF at any time they feel unwell between home visits by the study team. Study nurses at the LHF will manage those coming for illness visit. A malaria RDT will be done if indicated for prompt case management, and a blood smear a dried blood spot will be collected for confirmatory reading later on. The final diagnosis will be recorded in the participant file. For easy recognition of the participant, his/her study ID card will be used. A listing of all enrolled participants with ID details will also be available and the nurse could make reference to this in case of the participant did not bring his/her ID card.
1. Consented to be a part of the wider study census 2. Age 3 months or older 3. If aged ≥18 years, provides informed consent to participate in the cohort study 4. Parent or guardian provides consent for the child's participation (as relevant, according to age) in the cohort study 5. Child provides assent for participation (as relevant, according to age) in the cohort study 6. Willing to provide up to 18 blood samples, up to a total volume of 2.5 mL, over a maximum of 18 visits 7. If aged <5 years (recipient of SMC delivered by the national control programme): 7.1. Eligible to receive SPAQ as part of standard SMC delivery by the national malaria control programme according to NMCP guidelines, and has received any SMC dose (1st, 2nd, or 3rd) within 3 days of the enrolment visit
If aged <5 years (recipient of SMC delivered by national control program): 1. Does not provide consent to participate in the study 2. Anaemia (Hb <8 g/dL) 3. Any chronic illness that requires immediate or continuous clinical care 4. Severe malnutrition (weight-for-height below -3 standard deviations or less than 70% of the median of the NCHS/WHO reference values) 5. Current participation in malaria vaccine or drug trials, or participation in vaccine trials within the last 2 years If aged >5 years (recipient of presumptive second-line treatment): 1. Currently pregnant and has attended the first ANC visit 2. Anaemia (Hb <8 g/dL) 3. Any chronic illness that requires immediate clinical care 4. Family history of sudden death or congenital or clinical conditions known to prolong the QTcB or QTcF interval, for example family history of symptomatic cardiac arrhythmias, clinically relevant bradycardia, or severe cardiac disease 5. Any treatment that can induce prolongation of the QT interval 6. Known history of hypersensitivity, allergic reactions, or adverse reactions to the study drugs or their components 7. Severe malnutrition (weight-for-height below -3 standard deviations or less than 70% of the median of the NCHS/WHO reference values) 8. Current or previous participation in malaria vaccine trials