Summary

• MAMaZAgainstMalariaworkedwithZambia’sgovernmenttotestthefeasibilityofintroducingapre-referralinterventionforchildrenwithseveremalariainacommunitysetting.

• Rectalartesunate(qualityassuredRAS100mg)hasconsiderablepotentialtoreduceseveremalariamortalityamonghard-to-reachpopulations,butisnotyetavailablefornationaluse.

• Theprojectincreasedtheaccessofruralinterventioncommunitiestotimely,qualityseveremalariacare,andwasassociatedwithareductionintheseveremalariacasefatalityrateamongyoungchildrenreportedbyinterventionhealthfacilities.Severemalariacasefatalityreducedby96%.

• ThereareplanstorolloutRASacrossthecountryinfuture.ImportantlessonsfromthepilotinSerenjecouldusefullyinformthescale-upprocess.

According to Zambia’s national Health Management Information System (HMIS), a reported 1,851 Zambians died of malaria in 2016. Many other malaria deaths occur at community level and go unrecorded. Reported malaria cases increased between 2015-2016. If Zambia is to achieve the global target of a 40% reduction in malaria incidence by 2020, a priority focus on areas of highest mortality, including severe malaria in young children, will be important.[1][2]

RuralcommunitiesinZambiafaceenormouschallengesinaccessinghealthcare.Asaresult,alargeproportionofseveremalariaillnessesanddeathsoccuroutofsightoftheformalhealthsector.WorkinginpartnershipwiththeZambiangovernmentandMedicinesforMalariaVenture,MAMaZAgainstMalariatestedthefeasibilityofapre-referralintervention-rectalartesunate(RAS)-foryoungchildrensufferingfromseveremalariainhard-to-reachcommunitysettings.BuildingontheworkoftheMobilisingAccesstoMaternalHealthServicesinZambiaproject(MAMaZ)andthefollow-onproject,MOREMAMaZ,thepilotwasdesignedtoaddressthewiderangeofhouseholdandcommunitybarriersanddelaysthatpreventedchildrenwithseveremalariareceivingtimelyhealthcare.[3]Italsointervenedtoaddressphysicalaccessbarriersandimproveseveremalariacasemanagementinruralhealthfacilities.Theprojectsuccessfullydemonstratedthepotentialtoincreasehard-to-reachcommunities’timelyaccesstoseveremalariatreatment.

Key Results from MAMaZ Against Malaria – A Pilot Project Focused on Increasing Rural Communities’ Access to Rectal Artesunate

TECHNICAL BRIEF

1WorldHealthOrganisation,2015,GlobalTechnicalStrategyforMalaria2016-2030.2WHO,2014,‘SevereMalaria’,TropicalMedicineandInternationalHealth,Vol19(suppl1).3MAMaZ(2010-13)wasfundedbytheUKDepartmentforInternationalDevelopment,andMOREMAMaZ(2014-16)wasfundedbyComicRelief.

Background and Context

Anestimated70%oftheworld’sburdenofsevereandfatalmalariafallsonyoungchildren.[4]Severemalariacanberecognisedinchildrenatcommunitylevelbyobservingdangersigns(i.e.feverplusoneormoreofthefollowing:inabilitytoeatordrink,repeatedvomiting,convulsions,unusuallysleepyorunconsciousness).Inpractice,manycasesaremissed.A2011studyinZambiafoundthatlessthanhalfofseveremalariacasesinchildrenunderfiveyearsoldreachedahealthfacility.[5]

Manybarriersanddelaysathouseholdandcommunitylevelsaffectrecognitionofseveremalariadangersignsandpromptuptakeofmalariaservices.

Thecasefatalityrateamongseveremalariapatientswhofailtoreachahealthfacilityisestimatedashighas90%.[6]

Accesstoqualitydrugsandeffectivecasemanagementofseveremalariaarealsocommonchallenges.RandomisedcontrolledtrialshaveshownthatRASreducestheriskofdeathandneurologicaldisabilityinchildrenagedsixmonthstosixyearsoldwhoshowsignsofseveremalariaandhavelimitedaccesstotreatment.[7]

However,althoughWHOGuidelinesfortheTreatmentofMalariahaverecommendedtheuseofRASforovertenyears,itwasnotuntilDecember2016thattime-limitedapprovalforRASwassecuredfromtheGlobalFund.

ChildrenwhoaregivenRASatcommunitylevelneedtobetransferredwithoutdelaytoahealthfacilitywheretheycanbegivenacourseofinjectableartesunate.Variousdrugtrialshaveproventhelife-savingefficacyofinjectableartesunateinthecontextofP.falciparummalariacomparedtootherdrugoptionsandthefactthatithasfewerandlesssevereside-effectsthanalternativetreatments.[8]WhentheprojectstartedRASwasnotyetavailableinZambia,andinjectableartesunatewasnotavailablebelowDistrictHospitallevel.

Strategy

MMVinitiatedtheprojectwitharequestforinformationtoaddresstheaccesschallengeofdevelopinganinnovativeapproachtoincreaseruralaccesstocommoditiesforthetreatmentandcasemanagementofseveremalaria.MAMaZAgainstMalariawasestablishedinJuly2017asa12-monthpilottotestthefeasibilityofincreasingcommunities’accesstoseveremalariacasemanagementthroughtheintroductionofRASinhard-to-reachsettings.TheprojectwasimplementedinSerenjeDistrict,CentralProvince,inpartnershipwiththeDistrictHealthManagementTeam(DHMT)andZambia’sNationalMalariaEliminationCentre(NMEC).

Theprojectapproachwasdevelopedtoaddressthelocally-specificfactorsathouseholdandcommunitylevelthatwerepreventingpromptrecognitionofseveremalariadangersigns,promptreferralfortreatment,andadherencetotreatment.Anevidence-basedcommunityengagementapproach,triedandtestedbytwoearlierprojects,MAMaZandMOREMAMaZ,wasadaptedtoincludechildhoodillness.Communitiesweremobilisedaroundaseveremalariaandbroaderchildhealthagendaby477trainedCommunityHealthVolunteers(CHVs).Theapproachempoweredcommunitiestotakeactioninresponsetoseveremalariaandotherlife-threateninghealth

4Worldmalariareport2017.Geneva:WorldHealthOrganization;2017.Licence:CCBY-NC-SA3.0IGO.5MudendaS.S.,KamochaS,MswiaR,etal,2011,‘FeasibilityofusingaWorldHealthOrganization-standardmethodologyforSampleVitalRegistrationwithVerbalAutopsy(SAVVY)toreportleadingcausesofdeathinZambia:resultsofapilotinfourprovinces,2010’.PopulationHealthMetrics9,40.6ThwingJ.,EiseleT.P.andSteketee,R.W.,2011,‘Protectiveefficacyofmalariacasemanagementandintermittentpreventivetreatmentforpreventingmalariamortalityinchildren:asystematicreviewfortheLivesSavedTool’,BMCPublicHealth,11,(Suppl3),S14.7Gomes,M.,etal,2008,‘Rectalartemisininsformalaria:areviewofefficacyandsafetyfromindividualpatientdatainclinicalstudies’,BMCInfectiousDiseases,8:39.doi:10.1186/1471-2334-8-39.8See:Sinclair,D.,etal,‘Artesunateversusquininefortreatingseveremalaria’,CochraneDatabaseSystRev.2012;6:CD005967.[PubMed];Dondorp,A.M.,etal2010,‘ArtesunateversusquinineinthetreatmentofseverefalciparummalariainAfricanchildren(AQUAMAT):anopen-label,randomisedtrial’,Lancet376:1647–1657.doi:10.1016/S0140-6736(10)61924-1.

MAMaZ Against Malaria Scope

Projectdistrict:Serenje,CentralProvince

Projectinterventioncommunities:45

Interventionhealthfacilities:8

Populationreached:54,000

conditionsaffectingyoungchildren.A‘wholecommunityengagementapproach’aimedtoreachentirefamiliesandallpartsofthecommunity,includingthevulnerableandexcluded,whooftencarrythehighestburdenofill-health.

Communitiesthathadalreadyadoptedacommunity-managedemergencytransportsystem(ETS)basedonbicycleambulancesweretrainedtosupportchildhealthemergencies.ETSwasalsonewlyestablishedinasmallnumberofsites.HealthprovidersininterventionhealthfacilitiesweretrainedinseveremalariacasemanagementandtosupporttheactivitiesofCHVs.TheprojectencouragedandsupportedtheDHMTtoleadandinstitutionalisetheinterventiontoensuresustainability.

Shift the child urgently to the nearest health facility or hospital

Do not freeze or refrigerate. Do not store above 25°C. Avoid excursions above 30°C.

Artesunate 100mg suppositories

Artesunate100mg suppositories

How to administer artesunate suppositoryIMPORTANT: Artesunate suppository is only for children between 6 months to 6 years

D:\Old Pc Data\D drive\ATUL\Prashant J\WHO\Artesunate rectal capsules 100 mg Carton.ai

Date: 10/10/2017

Artesunate

10

0m

gsuppositories

ARTEC PAArtesunate Rectal Capsules 100 mg

Artésunate Capsules Rectales 100 mg

For Pediatric use only

À usage pédiatrique uniquement

ANTIMALARIAL

ANTIPALUDIQUE

2 Capsules

Each Rectal caps contains: Artesunate 100 mg

Storage: Store at 25°C (77°F); Excursions permitted to 15°C to 30°C (59° to 86°F). Avoid excursions over 30°C. Do not freeze. Keep out of reach of children. For full prescribing information, consult enclosed packaging insert.

Chaque capsule rectale contient: Artésunate 100 mg

Conservation: Conserver à 25° C (77° F); Excursions autorisées de 15° à 30° C (59° à 89° F). Ne pas Congeler. Evitez des excursions au dessus de 30°C. Tenir hors de portée des enfants. Pour les informations posologiques complètes, consulter la notice ci - inclus.

2 Capsules

1034290

N O V A R N I S H Z O N E

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CP

A

BNMFGEXP

} Details to be overprint

NO VARNISH ZONE

ARTEC PAArtesunate Rectal Capsules 100 mg / Artésunate Capsules Rectales 100 mg

94 x 20 x 80mm

ARTECAP (Artesunate Rectal capsules 100mg)

WHO

1034290

CMYK 4

1.0

1x2’s

Carton

Side open, reverse tuck.

300 GSM CFFB with spot aqueous varnish. Board thickness in microns 453.

Code No.: KR/DRUGS/KTK/25/415/98

Manufactured by:

Strides Shasun Limited36/7, Suragajakkanahalli, Indlavadi Cross,Anekal Taluk, Bangalore - 562 106, INDIA.

NA

NA

1034290 1027660 PCT-ARTECAP-100mg-1X2's-MVV, WHO -R2

PRINTED CARTON-[94x20x80mm][ARTECAP][ARTESUNATE RECTAL CAPSULES 100mg][1X2's][MVV, WHO][KRSG][ENG/FRN/PORT][REVD FOR COMPANY NAME CHANGE][4714]

4714

4714

CUT 5MM LONG ATCENTER NOT’THRU

(OFF-CUT) FOREASY FOLDING

CUT 47MM LONG ATCENTER NOT’THRU

(OFF-CUT) FOREASY FOLDING

CUT 5MM LONG ATCENTER NOT’THRU

(OFF-CUT) FOREASY FOLDING

CUT 5MM LONG ATCENTER NOT’THRU

(OFF-CUT) FOREASY FOLDING

CUT 47MM LONG ATCENTER NOT’THRU

(OFF-CUT) FOREASY FOLDING

F.P.O

ARTEC PAArtesunate Rectal Capsules 100 mg

Artésunate Capsules Rectales 100 mg

For Pediatric use only

À usage pédiatrique uniquement

ANTIMALARIAL

ANTIPALUDIQUE

2 Capsules

Each Rectal caps contains:

Artesunate 100 mg

Storage:

Store at 25°C (77°F); Excursions permitted to 15°C to 30°C (59° to 86°F).

Avoid excursions over 30°C. Do not freeze. Keep out of reach of children.

For full prescribing information, consult enclosed packaging insert.

Chaque capsule rectale contient:

Artésunate 100 mg

Conservation:

Conserver à 25° C (77° F); Excursions autorisées de 15° à 30° C

(59° à 89° F). Ne pas Congeler. Evitez des excursions au dessus de 30°C.

Tenir hors de portée des enfants. Pour les informations posologiques

complètes, consulter la notice ci - inclus.

2 Capsules

ANTIMALARIAL

ANTIPALUDIQUE

1034290

N O V A R N I S H Z O N E

ARTEC PA

AR

TE

CP

A

BNMFGEXP

} Details to be overprint

NO VARNISH ZONE

ARTEC PAArtesunate Rectal Capsules 100 mg

Artésunate Capsules Rectales 100 mg

For Pediatric use only

À usage pédiatrique uniquement

94 x 20 x 80mm

ARTECAP (Artesunate Rectal capsules 100mg)

WHO

1034290

CMYK 4

1.0

1x2’s

Carton

Side open, reverse tuck.

300 GSM CFFB with spot aqueous varnish. Board thickness in microns 453.

Code No.: KR/DRUGS/KTK/25/415/98

Manufactured by:

Strides Shasun Limited36/7, Suragajakkanahalli, Indlavadi Cross,Anekal Taluk, Bangalore - 562 106, INDIA.

NA

NA

4714

4714

CUT 5MM LONG ATCENTER NOT’THRU

(OFF-CUT) FOREASY FOLDING

CUT 47MM LONG ATCENTER NOT’THRU

(OFF-CUT) FOREASY FOLDING

CUT 5MM LONG ATCENTER NOT’THRU

(OFF-CUT) FOREASY FOLDING

CUT 5MM LONG ATCENTER NOT’THRU

(OFF-CUT) FOREASY FOLDING

CUT 47MM LONG ATCENTER NOT’THRU

(OFF-CUT) FOREASY FOLDING

F.P.O

Posologie et Méthode d'administration

Instructions d'administration

Artesunate capsules rectales doivent être insérées dans le rectum avec le bout rond d'abord (Comme dessiné ci-dessous)

Elles doivent être administrées aussitôt qu'un diagnostic présomptif de paludisme sévère est fait, le patient est jugé incapable de prendre les médicaments oralement, et il est probable que ce soit quelques heures avant que le patient ne puisse être traité dans un centre médical. Le traitement doit être suivi dès que possible suivant un transfert dans un hôpital. Des soins doivent être pris pour être sur que la capsule est gardé après insertion. Spécialement chez les jeunes enfants, les fesses doivent être retenues ensemble pendant environ 10 minutes pour prévenir l'expulsion de la capsule d'Artesunate. Dans le cas où la dose est exclue du rectum dans les 30 minutes qui suivent l'insertion, une dose répétée doit être insérée.

Posology and Method of Administration

Administration Instructions

Artesunate rectal capsules should be inserted in the rectum with the rounded end first (as drawn below).

It should be administered as soon as a presumptive diagnosis of severe malaria is made, the patient is judged unable to take oral medication and it is likely to be some hours before the patient can be treated at a health facility. Treatment should be followed as soon as possible by transfer to a hospital.

Care should be taken to be sure that the capsule is retained after insertion Especially in young children, the buttocks should be held together for about 10 minutes to prevent expulsion of the artesunate capsule. In the event that the dose is expelled from the rectum within 30 minutes of insertion, a repeat dose should be inserted.

Project Approach

• RASwasprocuredbytheprojectforuseininterventionsites.NMECensuredthatthedistricthadanun-interruptedsupplyofseveremalariadrugsandcommodities.

• Atraininginseveremalariacasemanagementwasprovidedtohealthprovidersininterventionhealthfacilities.

• AcommunityengagementapproachfacilitatedbytrainedCHVsmobilisedinterventioncommunitiesaroundaseveremalariaandbroaderchildhealthagenda.

• Communitysystemsprovidedsafetynetsforfamilieswithsickchildren.Theseaddressedbarriersofaccess,affordabilityandlackofsocialsupport,andincludedemergencytransport,savingsschemes,andfoodbanks.

• AcommunitymonitoringsystemoperatedbyCHVsgenerateddataonseveremalariapatientsandotherchildrensupportedbytheproject.

• ApartnershipapproachwiththeDHMTandNMEChelpedensurethatkeyactivitieswereledandsupportedbygovernment,helpingpavethewayforfuturescale-up.

• SubstantiallyimprovedknowledgeofseveremalariadangersignsamongCHVs:forexample,CHVswhoknew‘notbeingabletoeatordrink’asadangersignincreasedfrom29%atbaselineto86%atendline.

• DemandforRASfrominterventioncommunities:1,215suspectedseveremalariacaseswereidentifiedbyCHVsandgivenRAS.

• 100%referralratefromhometohealthfacilityforchildrenwithsuspectedseveremalaria.

• Highfollow-uprateofRASbeneficiaries:94%ofCHVsfollowedupchildrenwhohadbeengivenRASontheirreturnfromthehealthfacility.

• Highdemandforemergencytransportininterventioncommunities,with71%ofsuspectedseveremalariacasessupportedbyETSinareaswithbicycleambulances.

TheprojectsupportedtheZambianGovernmenttoprepareforthefutureroll-outofcommunityRASbyencouragingvisitsbynationalandprovincialpolicymakerstotheprojectinterventionsites,participatinginthenationalMalariaTechnicalWorkingGrouptosharelearning,anddisseminatingtheproject’sapproachandresultsatconferencesandotherevents.

Results

Changesinthepilotprojectinterventionsitesweremeasuredvia:

• BaselineandendlinesurveysconductedinJuly2017andMay2018respectively.

• ACommunityMonitoringSystemmanagedbytrainedCHVs.

• MonthlyassessmentandreviewofHMISandotherdataininterventionhealthfacilities.

ThesedatasourcesconfirmedthatMAMaZAgainstMalariahadsuccessfullydemonstratedthepotentialtoreduceseveremalariadeathsamongruralpopulationslocatedalongdistancefromthenearesthealthfacility.Theprojectledto:

• A reduction in expected deaths of young children with severe malaria at health facilities from 8% at baseline to 0.25% at endline.

• Highdemandforsupportfromcommunityemergencysavingsschemes,with42%ofallsuspectedseveremalariacasesininterventionsitesupportedbythissystem.

• Improvedknowledgeofotherlife-threatingchildhoodillnesses:forexample,knowledgeofbloodystoolasaseverediarrhoeadangersignincreasedfrom21%to77%.

“Wehadonemonthwheretenchildrendiedfromseveremalaria.ButsinceMAMaZAgainstMalariastartedworkinghere,notasinglechildhasdied,andthecommunityareawareofthedangersignsofseveremalaria.”JosephineMupeta,CHVandETSrider,ChiefSerenje(personalperspectivefromCHVinoneprojectinterventioncommunity)

Thedataalsoshowedsignificanteffectsontheactivities,confidenceandmotivationofCHVs.

BaselineEndlineIndicator

CHVswhomanagedacaseofmalariainthelastyear

CHVswhoknewatleastthreeseveremalariadangersigns

CHVswhoreferredchildrenwithsuspectedmalariatoahealthfacility

CHVswhosaidtheywereconfidenttoadministerRAS

CHVswhointendtocontinuevolunteering‘forever’

Endlinesurveyresults-CommunityHealthVolunteers

66%

50%

98%

99%

85%

97%

71%

66%

N/A

N/A

Severemalariamortalityrecordedatinterventionhealthfacilities(children6months-6years)

Baseline: 8%

Endline: 0.25%.

Reduction in the death rate from severe malaria: 96%.

For more information:info@transaid.org,GH_UKinfo@dai.com,info@developmentdata.info,disacaretrust@gmail.comorinfo@MMV.org

MAMaZAgainstMalariaisfundedbyMedicinesforMalariaVenture.TheprojectisimplementedbyTransaid,DAIGlobalHealthLimited,DevelopmentDataandDisacareinpartnershipwithNMECandSerenje’sDistrictHealthManagementTeam.

Useofacascadetrainingapproachhelpedensurethattheprojectwascost-effective.Thecostoftraining,equippingandsupervisingasinglecommunityRASvolunteerwasK1,000(USD100).Thecostpercommunity(averagepopulation,3,000)oftraining14CHVsandprovidingETS(bicycleambulanceandridertrainingandequipment)wasK21,000(USD2,095).

Theproject’ssupply-sidecomponent,whichfocusedonimprovinghealthworkers’skillsinseveremalariacasemanagement,andensuringareliablesupplyofseveremalariadrugsandcommoditiesinruralhealthfacilities,contributedtothereductioninreportedseveremalariadeathsintheproject’sinterventionsites.Allofthe32healthproviderstrainedduringtheprojectmanagedatleastonecaseofseveremalariaovertheprojecttimeframe.However,aninternalreviewfoundthatafewhealthproviderslackedconfidencetoadministerinjectableartesunateintravenously,preferringinsteadtoadministeritviatheslower-actingintramuscularroute.Arefreshertrainingisplannedtoensurethatallhealthprovidersareconfidenttoadministerartesunateintravenously.

Aself-assessmenttoolwasusedtomeasuretheextenttowhichprojectactivitieshadbecomeinstitutionalisedintotheday-to-dayactivitiesofthedistrict.Thisidentifiedahighleveloflocalownershipandleadershipofprojectactivities.MembersofthedistricthealthteamweretrainedascorecommunityRAStrainers,helpingtoensurethattrainingcapacityremainswithinthedistrict.TheDHMThastakenstepstoensurethatkeyprojectactivitiesaremonitoredduringtheroutineperformanceassessmentprocess.HealthfacilitiesdevisedvariouswaysinwhichtheycouldsupportandsuperviseCHVsandETSridersonanon-goingbasis,includingthroughunder-fiveoutreachsessions.

Policy Implications

• NMECisplanningtorolloutRASacrossthecountryinthefuture.ThegovernmentshouldconsideradoptingtheapproachusedbyMAMaZAgainstMalariawhereavarietyofCHVs(SMAGsandi-CCMvolunteers)weresuccessfullytrainedincommunitycasemanagementofmalaria.Thisbuildsonexistingstructures,increasescommunitycoverage,promotesequityofaccesstoseveremalariaservices,helpstosustaintheworkofthevolunteers,andiscost-effective.

• MAMaZAgainstMalaria’sevidence-basedRAStrainingapproachcaneasilybeadaptedforinclusioninnationalCHVtrainingmanuals,includingthosefori-CCMandSMAGvolunteers.

• AsqualityassuredRASisrolledoutacrossZambia,itwillbeimportanttoensureanuninterruptedsupplyofinjectableartesunateandmalariacommodities(suchasrapiddiagnostictestsanddisposalgloves)atruralhealthfacilities.

• Community-managedbicycleambulanceshelptoreducejourneytimestothehealthfacility,andofferpatientsandtheircarersacomfortableandconvenientmeanstotravel.Bicycleambulancescanbesuccessfullymanagedandmaintainedatcommunitylevel.DistrictsareadvisedtobudgetforreplacementvehiclesafterfourorfiveyearsandtofindawaytosupportETSridersviaroutinesupervisoryprocesses.

Lessons Learned

Keylessonslearnedinclude:

• Theprojectwasimplementedinareaswheretherewerelargenumbersofhighlymotivatedandwell-trainedmaternalhealthvolunteers(SafeMotherhoodActionGroupvolunteers-SMAGs).SMAGsweretrainedalongsideintegratedcommunitycasemanagementofmalaria(i-CCM)volunteersandprovedjustaseffectiveasthelatteratidentifyingandmanagingseveremalariacases.

• Theprojecttrainedupto14CHVsperinterventionsite.ThelargenumberofCHVsnotonlyhelpedincreasecoverageoftheprojectactivities,butalsocreatedanetworkofvolunteerswhocouldsupporteachother.ThiswaspositiveforCHVmotivationandforsustainability.

• ‘Wholecommunity’approachesareneededtochangesocialnormsinfavourofimprovedchildhealthcareseeking.AwholecommunityresponsecannotbeachievedinsituationswhereonlyoneortwoCHVsaretrainedpercommunity.

• Intheproject’shard-to-reachinterventionsitestheaveragedistancetothehealthfacilitywasjustunder14kilometres.Community-managedemergencytransportsystemscansignificantlyreducetraveltimestothehealthfacility,andbeapositivefactorinencouragingpromptreferralofverysickchildren.

• Increasingdemandforseveremalariaservicesisonlyfullyeffectivewhenacomparableimprovementinthesupply-sideoccurs.Areliablesupplyofdrugsandconsumables,andwell-trainedhealthprovidersweresignificantfactorsinencouraginguseofseveremalariaservices.Healthfacilitiesalsoneedtobeaccessibleatalltimes.