Monitoring coverage, safety, efficacy and impact of SMC KAMPALA PARTNERS MEETING TH JANUARY 2016

Plan of monitoring activities SMC Malaria sentinel surveillance Case- control Population surveys for molecular markers Molecular markers in clinical cases Coverage surveys Case- control Selection SMC areas and quantification Follow-up of SAEs Targetted spontaneous reporting of adverse drug reactions

ACCESS-SMC Research partners MRC Kalifa Bojang Serign Ceesay UCAD Jean Louis Ndiaye Abdoulaye Diallo MRTC Alassane Dicko Issaka Sagara Abdoulaye Djimde GANU Kovana Marcel Loua IRSS Jean Bosco Ouedraogo Issaka Zongo CERMES Ibrahim Laminou Musa Kana (Kaduna State University) EPICENTRE Matt Coldiron Rebecca Grais Aime Makimere CSSI Daugla Doumagoum Jean Pierre Gami Tony Eloike Sonny Ogboi (JEDIMA)

Core Team Instit.PlaceNameRole LSHTM LondonPaul MilliganCoordination, + any LSHTM LondonManuela ClaiteAdmin, LSHTM LondonChantelle ThomasAdmin, UCAD DakarJean Louis NDiayeCoordination. WARN. UCAD DakarAbdoulaye DialloNiger, Chad, Guinea, WHO/TDR GenevaCorinne MerleCoordination; Safety LSHTMLondonMatt Cairns Mapping and quantification. Survey sampling. Data analysis. Modelling. LSHTMLondonPaul Snell Data capture; Databases; Data sharing; Tablet PCs; questionnaires; Web access; Data archiving LSHTMLondonColin SutherlandDrug resistance, lab methods. Head of LSHTMLondonKhalid BeshirLab methods, sample LSHTMLondonJulian M-KarugabaLab,

Collaborators Pharmacovigilance Centre Anti-Poison de Maroc and WHO Collaborating Centre for PVRabat Rachida Souleymani TDRGeneva Corinne Merle, Christine Halleux, Piero Olliaro WHO Safety of Medicines DepartmentGeneva Shanti Pal, Noha Iessa WHO Collaborating Centre for PVAccra Alex Dodoo PNLP SenegalDakar Ibrahima Diallo Drug resistance: WWARNOxford Philippe Guerin WHO Antimalarial Efficacy and ResponseGeneva Pascal Ringwald SMC: MMVGeneva Andre WARN/CARN SMC GroupDakarClaude Emile, Marie-Reine, Hadiza, Balla, Jean Louis, Philippe WHO-GMPGenevaPeter Olumesi MERGA Noor

Coverage survey % children who received 0,1,2,3,4 treatments Reasons for missed treatments Adherence to daily dose, reasons for missed doses, for the most recent SMC treatment Perceived side effects Treatments outside age range (% of 6-yr-olds who were treated) Education and socio-economic status of the caregiver Mode of delivery Time and costs to get SMC Bednet coverage (all age groups)

Rapid assessment How did you hear about SMC and about dates of SMC this month Caregiver’s understanding of key messages about SMC and how to administer doses Adherence to daily doses, check of left-over medication Side effects: incidence of symptoms, and symptom severity

Case control study Efficacy of SMC treatments (% reduction in malaria cases, duration of protection) ◦Malaria confirmed by microscopy ◦Adherence to doses ◦Confounding factors (bednet use, socio-economic status) Markers of drug resistance in early failures

Survey to measure prevalence of molecular markers of resistance to SMC drugs Prevalence of infection by PCR, in children and in older individuals Prevalence of markers of resistance to SP and AQ in children <5yrs and in individuals too old to have received SMC (Genetic factors related to drug side effects) Bednet use and treatment seeking behaviour to see if any change after SMC Any SMC and antimalarial treatments received (effect on prevalence of markers of resistance)

Follow-up of severe cases of adverse drug reactions Causality: ◦timing and dosage of all medications received in relation to onset of symptoms ◦description of the symptoms ◦underlying medical conditions ◦treatment providers since onset of symptoms Duration of hospitalisation Patient outcome Check appropriate patient care, follow-up, reimbursement Blood sample for genetics

Sentinel surveillance Incidence of outpatient malaria, inpatient malaria, in all age groups All cases tested or treated for malaria (% treatments based on RDT) ◦Date, age, gender, symptoms, diagnostic, treatment ◦Dates of SMC treatment of malaria cases in children Used RDT cassettes retained for analysis of molecular markers or resistance Reminders about PV