______________________________________________________________________________________________________________________________ 1 The Chronic Diseases Clinic of Ifakara (CDCI) and the Kilombero and Ulanga Antiretroviral Cohort Study (KIULARCO) at the St. Francis Referral Hospital Annual Report for the year 2017 A collaboration between • St. Francis Hospital Referral (SFRH), Ifakara, Tanzania (Chief Medical Officer: Dr. W. Gingo) • Ifakara Health Institute (IHI), Ifakara, Tanzania (Director: Dr. H. Masanja) • Swiss Tropical and Public Health Institute (Swiss TPH), Basel, University of Basel, Switzerland Project Coordinators: PD Dr. Maja Weisser, Prof. Daniel Paris, Prof. Ch. Hatz, Prof. M. Tanner) • Division of Infectious Diseases and Hospital Epidemiology, University Hospital Basel, Basel, Switzerland (Head of Department: Prof. M. Battegay) • Division of Infectious Diseases Inselspital Bern, University of Bern, Switzerland (Head of Department: Prof. HJ. Furrer) Report prepared by: PD Dr. Maja Weisser, MD Ifakara, 25.01.2018
HIV/AIDS remains one of themost important diseases in sub SaharanAfrica despite tremendousachievements inthe last15years.AccordingtotheUNAIDSreport2017andtheTanzania ImpactSurveillancetheHIVprevalenceinTanzania2016was4.7%(similartothepreviousyear).The90-90-90WHOgoalswerenotreachedforthefirstgoal,butforthe2othersnearly:Ofallpersons,50-70%knewtheirHIVstatusand63%-90%wereenrolledincareand88%werevirallysuppressed.
Since2005theChronicDiseaseClinicof Ifakara(CDCI) istheCareandTreatmentCenter(CTC)forPeople livingwith HIV (PLWHIV) of the St. Francis Hospital Referral (SFRH) in Ifakara,Morogoro.CDCIisajointprojectoftheSwissTropicalandPublicHealthInstitute,theIfakaraHealthInstitute,theSFRHandtheUniversityHospitalsBaselandBerne.
Voluntarycounselingandtesting(VCT)isofferedtoallpatientscomingtoseektesting,butalsoas‘provider-initiatedtestingandcounseling(PITC),aimingattestingallpatientsseenatSFRH(in-andoutpatients,pregnancy) irrespectiveoftheclinicalpresentation.Patientswithpositivetestresultsareenrolled intocareonthesameday inordertostartantiretroviraltreatment(‘testandtreat’).CDCI takes care of in-and outpatients with an HIV-infection according to the Tanzanian NationalAIDSControlProgram(NACP)guidelinesandalsoisinchargeofallpatientswithTuberculosis.CDCIworks in close collaboration with district authorities and national stakeholders such as BoreshaAfya.FortheKilomberodistrict,CDCIofferssupervisionandtrainingofstaffofperipheralCTCsandorganizeseducationalcommunityevents,e.g.radiocasting,WorldAIDSday(1.12.2017).
Alongwithclinical services,CDCIaimsat improvingcare throughresearch.Attendingpatientsareasked for informed consent to participate in the Kilombero and Ulanga Antiretroviral Cohort(KIULARCO),adatabaseofdemographicandclinicalinformationandstorageofblood.Thedatabaseprovidesauniqueopportunity to study theepidemiologyandneedsofpatientswithHIV in ruralAfrica.More than9,000patients havebeen enrolled and about 3’600 areunder active care. ThethirdpillarofCDCIistrainingofandcapacitybuildingofyoungmedicaldoctorsandclinicalofficers,nurses,laboratoryscientistsandepidemiologists.Highlightsandachievementsof2017atCDCI- MovingtothenewlyrenovatedOutpatientDepartment- Patient-centeredBloodwithdrawal(onwardroundsandwithintheclinic)- Implementationofyearlyroutineviralloadtesting- Enrolment of baseline patient the sameday (lab and visit by the doctor) in order to reduce
Forty local staff members are employed at the CDCI by four different organizations, namelyIHI/SwissTPH(25),SFRH(6),USAID-BORESHAAFYA(8),andSwissTPH(1).Additionally,6personsworkongrantedresearchorimplementationprojects.TheCDCIteamiscurrentlycomposedof8medical doctors, 1 clinical officer, 7 nurses, 3 counselors, 5 auxiliary nurses, 1 nutritionist, 2pharmacists,2statisticians,6dataclerks,4biologists,1labtechnician,and6auxiliarystaff.Theteamhasbeenquitestableoverthelastyears,allowingtoenhanceestablishedstructures.Until2017, theCDCIwas ledbyPDDr.MajaWeisser,an infectiousdiseasespecialist fromtheUniversityHospitalBasel,Switzerland. In2018,aTanzanianseniordoctor (Dr.HerryMapesi) isheadoftheclinic,supportedbyaPDDr.MajaWeisserandlocallybyDr.AnnaEichenberger,adoctor,specializedinInternalMedicine,fromtheUniversityHospitalBerne,Switzerland.
IV. Infrastructure
Since January 2017 the CDCI is located at the newoutpatient department of SFRH,which hasbeenfundedbytheSwissAgencyforDevelopmentandCollaboration(SDC).CDCIroomsareontheposteriorsideofthebuildingwithanextrabuildingforTB-patientsandanadditionaltestingroomwithinthegeneralpatienttriage.
Theclinicconsistsofthefollowingrooms- reception- triage- 2testingandcounselingrooms- 6clinician’soffices- bloodwithdrawalroom- 2drugdispensingrooms(1HIV,1TB)- 1-dayhospitalroom- dataandserverroom- meetinghall- toiletsforpatientsandstaffThe One Stop Clinic, the integrated serviceclinic for HIV-affected families is locatedwithin the Reproductive and Child HealthClinic(RCHC)ofSFRH.The pharmacy storage room remainedwithin the SFRH in order to closely link to the hospitalpharmacy with an integrated electronic system to order antiretroviral drugs from thegovernmental pharmacyMSD (ELMIS). The drug dispensing room is located at the clinic. ThelaboratoryactivitiesarelocatedwithintheIfakaraHealthInstitutelaboratory,incloseproximitytothehospital.
V. ClinicalActivitiesHIVtestingservicesThreetrainedcounselors(2foradultpatients,1forpediatricpatientsandfamilies)areinchargeof voluntary counseling and testing (VCT) and provided-initiated testing and counseling (PITC)accordingnationalguidelines.Duringregularworkinghours(seeFigure1)thisisachieved.Duringweekends and nights, we still face challenges with universal testing. Testing numbers areregisteredandregularlyreportedtohospitalstaffandtothedistrictauthorities.Additionally,theteamtakescareofcounselingofpatientswithadherenceissuesonanindividualpatientlevel.CDCIactivitieswithintheOutpatientDepartmentNewly diagnosed patients from SFRH areenrolled on the same day into HIV care.Blood is withdrawn at the clinic forbaseline investigations (full blood count,creatinine, alanine aminotrans-ferase,CD4, VDRL, hepatitis B serology,cryptococcus antigen (if CD4<150/ul)). Ifdiarrhea, stool is analyzed for parasites.All patients receive a chest xray. Thepatient is seen by the counselor and ifpossibleonthesamedaybytheclinician.Follow-upcontrolsaredoneevery3months–(2/yearby a nurse and 2/year by a clinician).Monitoring of treatment response by CD4 cell count andnewlyviral loadaswellassafety laboratoryhasbeenreducedtoonceyearly instablepatients.Additionally, ifclinicalor immunological treatmentfailure issuspected,viral load ismeasured. If>1000copies/ml, resistance testing is done. Patientswith TB are seen by clinicians and treatedaccordingNationalGuidelines.ImprovingRetentionincareTotackleretentionincare,patientsarecalledwithin2weeksofamissedvisit.Ifpatientscannotbereached,anetworkofmorethan30volunteersfundedbyUSAID-BoreshaAfyatrackspatientsattheirhome,incollaborationwithadataclerkfromourteam.Sinceimplementationofroutineviralloadtestingwealsotrackpatientswithapositiveviralloadresultsforcounseling,retestingandifneeded,switchtosecond-linetreatment.
CDCIactivitieswithinSFRHWardsHospitalizedpatientswithanHIVorTBinfectionareseenbyadesignateddoctorfromtheCDCI,whotakescareofthesepatientstogetherwithaninternfromtheSFRHdoingdailywardrounds.OnceaweekagrandroundisconductedunderthesupervisionoftheheadofCDCI.IntegrationofHIVandTuberculosisActivitiesTBbeing themost commoncomorbidity inHIV-infectedpatients,we integrated - inagreementwith the hospital directorate - the TB clinic into CDCI in order to screen both patient groupsaccordinglyandtomanageco-infectionsproperlyandinapatient-centeredcaremodel.Confirmation of TB after clinical suspicion and chest x-ray is done with Xpert MTB/RIF fromsputumaccordingtheTuberculosisandLeprosyNationalControlProgramme(NTLP).Forpatients,includedintheTBcohort(TBDAR),sputumissentfortestingtoIHIlaboratoryinBagamoyo. Within the research projects, other materials such as pleural, pericardial fluid,ascites,cerebrospinalfluidaretestedbyxpert.Sonographyisperformedincaseofsuspicionofextrapulmonary TB according to the FASH protocol (focused assessmentwith Sonography forHIV-associatedTuberculosis).Accordingtogovernmentrequirements,thesetupofawardandoutpatientdepartmenttotreatmultidrugresistance(MDR)TB isplanned inorder forSFRHtobecomeoneofthereferralcentersforMDR-TBinTanzania.
IntegrationoftheCDCIwiththeantenatalandunder-fiveclinicofSFRHToimproveservicesforHIV-infectedpregnantwomen,measurestoreduce/eliminatemother-to-child transmission and early infant diagnosis, the ‘One Stop Clinic’ was funded 2013 andintegratedinthenormalAntenatalandUnder-fiveClinicofSFRH.Withinthisspecificproject,anintegralpartofCDCI,ateamoftwomedicaldoctors,acounselorandanursetakecareforHIV-infectedpregnantwomen,HIV-exposedandHIV-positivechildrenandtheirfamilies inonesite.ThemodelprojectissponsoredbyaMerck-for-Mothers’grant.BesidesclinicalcaretheOneStopClinic functions as a referral clinic at the Kilombero district, offers twice yearly training forhealthcareworkers fromotherdistrictsanddoesa lotof community-activities.E.g.during thisyears’WorldAIDSdayaninformationandtestingcampaignwasperformedintwolocalprisons–forprisonersandstaff.FormoredetailsontheOneStopClinicofIfakara,seeAnnexII.
CareforHIV-infectedmothersandtheirinfantswithintheKilomberoDistrictTo improve care for HIV-infected mothers and their infants within the Kilombero District weappliedandsuccessfullyimplementedanimplementationprojectfundedbyESTHERSwitzerland.Theaimoftheone-year’sproject (July2017–June2018) is toensureEarly InfantDiagnosis inthe periphery and reduce turnaround time for testing and result delivery by twice weeklycollectionofsample,transporttothecentrallabandreturnofresultstotheclinicianassoonasavailable. Also awareness campaigns for affected families, training for healthcare staff andcapacity-buildingispartoftheproject.PaperlessClinicSinceJune2013,patientdataarecapturedwithinanelectronicdatacollectionsystembasedonan Open Medical Record System (www.openmrs.org), allowing simultaneous access for allcollaborators in chargeofpatient services (clinicians, triage, registration,pharmacy, laboratory).AlsoitallowsaharmonizedpatientdocumentationamongCDCIcliniciansandisfurthermorethebasisfordataextractionforscientificprojects.AtechnicalupgradeoftheOpenMRSsystemtoacurrentversionhasbeensuccessfullydonethisyearincollaborationwiththeUniversityCenterofComputing Sciences in Dar es Salaam. Updates of the collected information is still an ongoingprocess.JuliusMkumbo,ourstatisticianandqualitymanagerwasawardedascholarshiptoattendOpenMRSImplementers'ConferenceinMalawion12-16December2017,ameeting,thatgatherstogetherallvaluablemembersofOpenMRScommunityaroundtheworld.FortheNationalAIDSControlprogram,manuallycompletedpaperformsareadditionallyenteredintothenationaldatabase,andwasalsosuccessfullyupdatedthisyear.NACPworkscurrentlyonanopenMRS-baseddatabasetobeimplementedthecomingyears.PharmacyAntiretroviral drugs are provided by theGovernment sponsored by International Partners anddelivered by the governmental Medical Stores Department (MSD). Drug order and supply isorganizedwithin an electronic ordering systemaccording consumption reports integrated intothehospital (ELMIS). Twopharmacistsareworkingat theCDCIwith support from thehospitalpharmacy. During the last years almost no shortages in ARTs occurred, thanks to big effortstogetherwiththelocal,regionalandnationalauthoritiesandinstitutions.TheNational AIDS control program announced for next year the availability of a new class ofARTs,theintegraseinhibitors,whichsofarhasnotbeenavailable,thereplacementoftenofovirdisoproxilfumaratewithtenofovir-alafenamide,alesstoxicformulationandtheadditionoftheproteaseinhibitordarunavirwithahighefficacyandexcellentsafetyprofile.ImplementationofaMalnutritionProjectSincetheendof2016CDCIrunsanimplementationprojectforcareofmalnourishedHIV-positiveandnegativechildren.Theproject is fundedexternallybyaAfricaViva,aSpanishOrganization.Withintheproject,therapeuticfoodsaredeliveredtomalnourishedchildrenandpropercare
during hospitalization is ensured. Also information for caregivers, family members andhealthcareworkersisacentralpart.Theprojectisnowfullyintegratedintohospitalroutine.Themalnutritionteamconsistsofanutritionistandanurseandissupervisedbyoneofourdoctors,Dr. G. Mollel, who is also a member of a national stakeholder panel to validate NationalguidelinesonIntegratedManagementofAcuteMalnutrition.
VI. LaboratoryactivitiesMonitoringofHIV-TherapyandScreeningandDiagnosisofOpportunisticInfectionsLaboratoryscreeningandmonitoringisdoneasperNationalAIDSControl guidelines. At baseline, full blood and CD4 counts,creatinine, transaminases, screening for syphilis (VDRL) andchronic Hepatitis B (HBsAg) is done. Additionally, patientswith aCD4 cell count <150/ul receive a cryptococcal antigen test. Inpatients with symptoms for TB, an Xpert TB/RIF in sputum isperformed. Stool is analyzed for parasites if clinically indicated.Follow-up examinations in stable patients are done once yearly(safetylab,CD4cellcountandnewlyHIVViralLoad).Currently,stillmostreagentsarefundedthroughtheproject,astheGovernmentfailstodeliverreagentsfornecessarytestingcountrywide.RoutineViral loadsare sent to the regional laboratory inMorogoro.Weexpect to receivegovernmentreagents in short terms to runViral loadsonanAbbottmachine inourown laboratory,whichwould shorten turnaround time greatly. Discussions with Stakeholders (NACP and MSD) tobecomeareferencelaboratoryforthedistrictareongoing.Resistancetestingisdoneincaseofvirologicalfailurethroughprojectfunds.EarlyInfantDiagnosisDNAPCR for early infant diagnosis has been routinely implemented at IHI labwith a 2weeksturnaroundtime.Duetotheinabilityofthecompanytoprovidereagents,wehavetemporarilychanged to a sample transport system to Morogoro with result pickup to ensure rapidnotificationofnewlydiagnosedHIV-positivechildren
VII. Researchactivities
Projects nested within the ongoing Kilombero and Ulanga Antiretroviral Cohort (KIULARCO)allowtotackleandanswermanyquestionsregardingtreatmentoutcome,retentionincare,co-infections and other comorbidities. The aim of research is to improve patient services byimproved knowledge, but also to help the national authorities to better understand themanagement of HIV/AIDS patient in peripheral rural areas of the country. Moreover, theresearchactivitiesprovideauniqueopportunityforcapacitybuildingandcareerdevelopmentof the local staff. Also we integrate regularly prospective observational and interventionalstudies,aimingatbestpatientcare.
Research projects are mostly initiated by the local team – often in close collaboration withresearchers from IHI, Swiss TPH and the Universities of Basel and Berne. Additionally, someprojects are donewithin international expert networks, such as the studies on cryptococcalinfections (Infectious Diseases Institute, Makerere University in Kampala, Uganda, and theUniversity of Minnesota, USA), an immunological trial on broadly neutralizing antibodies(UniversityofLausanne,G.Pantaleo,SwissTPH,C.Dauenberger)oramultisitestudyfromtheDrug forNeglectedDiseases Initiative (DnDi) evaluating for Lopinavir/r Pellet formulations inchildrenupto3years.Thesecollaborationsallowactiveparticipationininternationalresearchconsortia, increase visibility of the project and ultimately revert in a better quality of care,trainingandresearch.AlistofpublicationsoftheCDCIcanbefoundinAnnexI.This yearwewerepresent in severalnational and international conferencesand contributedimportantpresentationsonourwork:PresentationsattheInternationalAIDSSociety’sConferenceinParis,France,July2017o G.Sikalengo:Distinctpatternsofclinicalcharacteristicsandhelminthcoinfectionsinadulttuberculosispatients
PeopleLivingwithHIVinRuralSub-SaharanAfrica(Poster)OralpresentationsatMUHASNationalConference,DaresSalaam,June2017o R.Ndege:SonographicsignsofextrapulmonarytuberculosisinHIV-positiveandHIV-negativepatientso A.V.Kalinjuma:Ratesofandfactorsassociatedwithlosstofollow-upofHIV-infectedpersonsinruralTanzaniaInadditiontocorefunding,conferenceparticipationwasmadepossibleforseveraldoctorsoftheCDCI throughongoing collaborationwith theDivisionof InfectiousDiseases andHospitalEpidemiology at theUniversityHospital Basel and thanks to generous support ofGilead andViiV.
Thefirstworkinghoureverydayisreservedforeducationandtrainingofstaffincludingclinicalcasediscussions,stateoftheartlecturesonHIVandassociateddiseases,resistancecommitteeandjournalclubs.Eachsessioniscoordinatedbyateammemberonarotationalbasis,therebycontributing to a continuous medical education and fostering clinical discussion among themembersoftheteam.This year, 2 medical doctors from CDCI successfully completed a training abroad: Dr. HerryMapesi did a MSc in Epidemiology at the Swiss TPH and Dr. Lameck B. Luwanda a masterprogram inOxford,UK.CurrentlyNamvuaKimera,a laboratoryscientist isat theUniversityofManchesterforamasterinbacteriologybyanEquity&MeritScholarship.
IX. Conclusions
TheexcellentcollaborationbetweenSwissTPH,IHIandtheSFRHarethekeytothesustainabilityofthisproject,togetherwiththeongoingfinancialcommitmentoftheCantonBasel-Stadt,whichallowstoruntheclinic long-termandtoestablish functioningstructures.Plans fora long-termfinancialsustainabilityarebeingdevelopedtogetherwiththeTanzaniangovernmentalandnon-governmentalinstitutions.BesidesservingalargenumberofpatientsfromtheIfakaraarea,CDCIisalsoareferralcenterforsmallerCTCs intheKilombero/Ulangadistricts.Teachingandtrainingofstaff includingcapacitybuildingareintegratedintodailyroutine,andresearchiscrucialformotivationandcommitmenttoimprovehealthcareofpatients.Theuniqueconjunctionofclinicalcareformorethan10’000patients,goodtrainingandresearchpossibilities in a rural African setting, together with the strong links with national andinternational partners providing expertise in different key areas for success, makes theCDCI/KIULARCO project an ideal platform to generate evidence tackling the real challenges ofHIVinAfrica,whichmaybeextrapolatedtosimilarsettingsinTanzaniaandabroad.
