Operational research on implementation of tuberculosis guidelines in Mozambique Brouwer, Miranda

UvA-DARE (Digital Academic Repository) Operational research on implementation of tuberculosis guidelines in Mozambique Brouwer, Miranda Link to publication Citation for published version (APA): Brouwer, M. A. (2015). Operational research on implementation of tuberculosis guidelines in Mozambique General rights It is not permitted to download or to forward/distribute the text or part of it without the consent of the author(s) and/or copyright holder(s), other than for strictly personal, individual use, unless the work is under an open content license (like Creative Commons). Disclaimer/Complaints regulations If you believe that digital publication of certain material infringes any of your rights or (privacy) interests, please let the Library know, stating your reasons. In case of a legitimate complaint, the Library will make the material inaccessible and/or remove it from the website. Please Ask the Library: http://uba.uva.nl/en/contact, or a letter to: Library of the University of Amsterdam, Secretariat, Singel 425, 1012 WP Amsterdam, The Netherlands. You will be contacted as soon as possible. UvA-DARE is a service provided by the library of the University of Amsterdam (http://dare.uva.nl) Download date: 18 Dec 2017

3. Are' routine' tuberculosis' programme' data' suitable'to'report'on'antiretroviral'therapy'use' of'hivainfected'tuberculosis'patients?' MirandaBrouwer 1,PaulaSamuGudo 2,ChaliceMageSimbe 3,PaulaPerdigão 4,FrankvanLeth 5,6 1 HealthAllianceInternational,TechnicalAssistanceUnit,Maputo,Mozambique 2 MinistryofHealth,Maputo,Mozambique 3 MinistryofHealth,ProvincialDirectorate,Manica,Mozambique 4 Independentchestphysician,Maputo,Mozambique 5 Department of Global Health, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands 6 KNCVTuberculosisFoundation,DenHaag,TheNetherlands BMCResearchNotes2013;6:23. 21

Abstract'' Background:Antiretroviraltherapy(ART)islifesavingforHIV<infectedtuberculosis(TB)patients.ART<use by these patients lag behind compared to HIV<testing and co<trimoxazole preventive therapy. TB programmes provide the data on ART<use by HIV<infected TB patients, however often the HIV services providetheart.weevaluatedwhetherthedataonart<useinthetbregisterwerecompleteandcorrect. ThetimingofARTinitiationwasevaluatedtoassesswhetherreportingonART<usecouldhavehappened withthetbcasefindingreporting.wecollecteddataontbtreatment,hivtestingandartforadulttb casesin2007fromthreetbclinicsinmanicaprovince,mozambique.thesedataonuseofartfromtb registerswerecomparedwiththosefromthehivservices. Findings:Of624patientsincluded,504(81%)weretestedandofthese356(71%)wereHIV<infected.Ofthe co<infectedpatients,81%registeredwiththehivservicesinthesamefacility.thetbregisterwascorrect onart<usein73%ofco<infectedcasesandcompletein74%. InformationonART<usecouldhavebeenreportedwiththeTBcasefindingreportsin56%ofco<infected patients. Conclusion: The TB register is reasonably correct and complete on ART<use. However, the HIV patient recordseemsamuchbettersourcetoprovidethisinformation.reportingonart<useattheendofthe quarterinwhichtbtreatmentstartsprovidestheprogrammewithtimelybutincompleteinformation.a morecompletebutlesstimelypictureisavailableafterayear. 22

Background' Theuseofthepotentiallylifesavingantiretroviraltherapy(ART)fortuberculosis(TB)patientsco<infected with the Human Immunodeficiency Virus (HIV) did not progress as much as would be necessary in addressingthedualtbandhivepidemic.globally,thehivprevalenceamongnewtbpatientsis13%.in Mozambique this figure is 61%. 1 Worldwide, 29% of co<infected patients used ART in 2005, which had increased to 46% in 2010. In the same period, the percentage of TB patients knowing their HIV<status increasedfourfoldandprovisionofco<trimoxazolepreventivetherapy(cpt)reached75%ofhiv<infected TBpatients. TheWorldHealthOrganization(WHO)reportsthesefiguresyearlyinitsglobalTB<controlreport.Although in many countries the HIV services provide ART, also to TB patients, national tuberculosis programmes (NTPs)providethedataforthisreport.However,itisnotknownhowcompleteandcorrectthedataon ART<use are within NTPs. This is relevant as access to ART is one of the main indicators of TB<HIV collaborativeactivities. 2 To use routine programme data to monitor progress on implementation, ideally the data are correct, completeandtimelyavailable. 3 WHOrecommendsreportingofHIV<testingforTBpatientswiththeTBcase finding data at the end of the quarter. 4 Data are thus available shortly after the end of the quarter. However, for CPT and ART<use the recommendation is to report with the treatment outcome data 12 monthsafterthestartoftbtreatment.thisisnottimelyreportingandprecludesatimelyresponsefrom theprogrammeincaseofunder<utilization. In Mozambique TB treatment staff offer HIV<testing to all TB patients and CPT to the co<infected since 2006.ForfurthercareandtreatmentincludingART,theyrefertheco<infectedpatientstotheHIVservices. TBstaffreportbothHIVtestingofTBpatients,andCPTandART<usebytheco<infectedtogetherwiththe TBcasefindingdataattheendofthequarter.ThereforethedataonCPTandART<useareearlieravailable totheprogrammeincomparisontothewhorecommendedreportingtimeline.thisearlyavailabilitycan beusefulforprogrammemanagementpurposesifthedataarecorrectandcomplete. ThisstudythereforeevaluatedthecorrectnessandcompletenessoftheroutineTBregistersonART<use amonghiv<infectedtbpatients.weaddressedthefollowingquestions:1)howcorrectandcompleteare thedatainthetbregisteronart<use?2)howcompletecouldthedataonart<usebeforreportingatthe endofthecasefindingquarter? Methods' ' Studydesignandsetting We selected purposefully three health facilities in Manica province, Mozambique. Criteria for selection includedatleast150tbpatientsnotifiedin2007andthepresenceofbothtbandhivtreatmentservices inthesamefacility.theparticipatinghealthfacilitieswereanurbanfacilityintheprovincialcapitalandtwo ruralfacilitiesabout20and80kilometresfromtheprovincialcapital. In the TB recording and reporting system of Mozambique all TB cases receive a unique number in the notifyingfacility stbregister.patientshavetheirhivtestresultandthestartdateofartrecordedinthis register.allpatientsregisteredatthehivclinichaveapatientrecord,whichcontainsclinicalinformation, andauniquenumberforidentificationpurposes.alinkbetweenthetbregisterandhivpatientrecord doesnotexist.theuniquehivpatientnumberisnotsystematicallyrecordedinthetbregister,thoughtb 23

staff is encouraged to do so. The three selected health facilities have, in addition to the government s paperrecordingsystem,anelectronichivpatientdatabaseinstalledbyaninternationalnon<governmental organisation. Datacollection WeincludedallnotifiedTBcasesaged15yearsandolderfromJanuary1 st untildecember31 st,2007from theparticipatingfacilities.thefacility stbsupervisorcollectedthedatausingstandardizedforms.firstly, datafromthetbregisterwerecollected.theseincluded:thestartdateoftbtreatment,thehivtestresult andinitiationdateofartifthepatientusedart. Next,weusedtheuniqueHIVpatientnumber,ifavailableintheTBregister,toidentifytheHIVrecordsof thehiv<positivetbpatients.inaddition,localstafffamiliarwiththepatientsidentifiedsomerecords.if these methods did not lead to identification of the HIV patient record, we performed a search in the electronichiv<databaseusingthepatient snameandagetakenfromthetbregister.wetooktheunique HIVpatientnumberfromtheelectronicdatabaseandusedittolocatetheHIVpatientrecordforpositive matches.welimitedtheidentificationofthehivpatientrecordtothosehiv<positivetbpatientsreferred tothehivservicesinthesamehealthfacility. WecollectedCD4+cellcountresultsanddatesfrom12weeksbeforeandduringTBtreatment,ART<use, andthestartdateforartfromthehivpatientrecord. ToevaluatewhethertheTBregisterwascorrectandcompleteonART<use,wecomparedthedataonART< usefromthetbregisterwiththoseofthehivpatientrecord.incaseofdiscrepancyonart<use,wetook the data from the HIV patient record as correct for assessing ART<use because the HIV services provide ART.WealsoverifiedifthepatientshouldhavestartedARTaccordingtothenationalguidelinesforthose co<infectedpatientnotonart.atthetimeofthestudy,co<infectedpatientswereeligibleforartwhen theircd4+countequalledorwasbelow350cells/mm 3. 5 Welimitedouranalysistothepatientsforwhom boththetbregisterinformationandthehivpatientrecordwereavailable. WeevaluatedwhetherthepatientstartedARTbeforeorinthesamequarterasTBwasdiagnosedtoassess howcompletethedatacouldbeattheendofthetbcasefindingquarter. WeusedstandardWHOtreatmentoutcomestodefinetheendofTBtreatment. 6 Thiswasnecessaryto determinewhetherthepatientinitiatedartduringthecourseoftbtreatment. Statisticalanalysis We used EpiData version 3.1 for data entry and performed descriptive analysis with EpiData Analysis V2.2.1.171. Ethics The study protocol was approved by the National Bio<ethic Committee of the Ministry of Health of Mozambique and by the Institutional Review Board of the University of Washington in Seattle, USA. Becauseweusedroutinelyavailabledata,wedidnotobtaininformedconsent. Findings' Between January 1 st and December 31 st, 2007, the three health facilities notified 628 TB patients of 15 yearsandolder.figure4showsabreakdownofthetbnotificationsforwhichweidentifiedthehivpatient records(n=267).table2showsthetb<hivdatafortheindividualhealthfacilities. 24

Figure&4&Breakdown&of&notified&TB&patients&and&their&linkage&to&the&HIV&patient&record& HIV<testresultinTB register HIV<positive(ofthosewith HIVtestresult) ART<useregisteredinTB register(ofthehiv< infected) FacilityA(Urban,in provincialcapital, n=153) FacilityB(Rural,20 kmfromprovincial capital,n=245) FacilityC(Rural,80 kmfromprovincial capital,n=226) Total (n=624) N(%) N(%) N(%) N(%) RegistrationwithHIV servicesinthesamehealth facility(ofthehiv<infected) 147(96) 170(69) 187(83) 504(81) 107(71) 118(69) 133(71) 356(71) 16(15) 59(50) 86(65) 161(45) 81(77) 94(80) 112(84) 287(81) HIVPatientrecordavailable 74(91) 83(88) 110(98) 267(93) ART<useinHIVpatient record(ofthehiv<infected) 47(45) 59(50) 70(53) 176(49) Table&2&Results&of&HIV&testing,&registration&with&HIV&services&and&ART9use&in&the&three&health&facilities& 25

Of 157 co<infected patients recorded in the TB<register as using ART, 130 (83) were confirmed when crosscheckingthehivpatientrecord.ofthe110co<infectedpatientsrecordedinthetbregisternottobe usingart,64(58%)wereconfirmed.intotal,194(73%)entriesofart<useinthetb<registerwerecorrect. TheHIVpatientrecordshad176patientsrecordedasonART.Ofthose,130patientshadART<userecorded inthetbregister,acompletenessof74%. Inadditiontothe176patientsonARTintheHIVpatientrecord,23patientsnotonARTshouldhavebeen on ART according to the national guidelines because they had CD4+ cell counts equal to or below 350 cells/mm 3 during or before TB treatment. In total, 199 co<infected patients should have started or continuedonartwhilstontbtreatment.ofthese199patients,150(75%)couldhavebeenreportedat theendofthequarterwiththetbnotifications.potentially,theinformationinthetbregistercouldhave beencompletefor150/267(56%)attheendofthetbcasefindingquarter.whenreportedwiththetb treatmentoutcomes,thetbregisterwouldhavebeencompleteonart<usefor199ofthe267(75%)co< infectedpatients. Discussion' ThedataonART<useintheTBregisterwerecorrectin73%andcompletein74%.Thereportingattheend ofthecasefindingquartercouldhavebeen56%complete,ifdataonart<usefromthehivpatientrecords wereoptimallytranscribedinthetbregisters. The Global Fund to fight AIDS, Tuberculosis and Malaria assesses performance of grants on their programmaticachievements.theglobalfundconsidersaprogressagainsttargetachievementbetween60 and89%asadequate. 7 Usingthisperformanceassessment,ourstudyshowedthattheinformationofthe TBregisteronART<usehadanadequatelevel. However,thereismuchthatcanbeimprovedinreportingonART<useinco<infectedpatients.Areduction oftheincorrectrecordingofpatientsinthetbregisterasusingartofwhomart<usewasnotconfirmed bythehivpatientrecordwouldimprovedataquality.inourstudywefoundthisincorrectrecordingon ART<use in 17% of co<infected patients. We did not evaluate the reasons for this. Anecdotal evidence informedusthatpatientsattimesstatetheyalreadyuseart,whereasinfacttheydonot.reasonswhy patientsdonotstatetheirart<usecorrectlymightbeevenmorecomplexthanthereasonswhypatients do not start ART. A recent qualitative study in Malawi found that not starting ART was related to both healthsystemandpatientreasons. 8 ReasonsintheformercategoryincludedARTnotbeingofferedand non<availabilityofartdrugs.fearofdrugtoxicitywasthemainpatientrelatedreason.thestudyshowed thattoimplementtherecommendationtostartallco<infectedpatientsonartirrespectiveofthecd4+cell countrequiressubstantialeffortsfromthehealthsystem. 9 AstudyinCameroonexplainedatestrateof 95% partly because patients usually follow health care providers recommendations. 10 This shows the importanceofthehealthcareproviderofferingart. Inaddition,moreimprovementcouldcomefrommorecompleterecordingofART<useintheTBregister. Thisstudyshowedthat26%ofco<infectedpatientswererecordedintheTBregisterasnotonARTbutthe HIVpatientrecordedshowedtheywereinfactusingART. TheNTPinMozambiquereportedanART<useof33%forthewholecountryin2007. 11 Thiswaslowerthan the73%correctlyrecordedco<infectedpatientsinthetbregisteronartthatwefound.wecollectedthe datamorethan12monthsaftertbtreatmentstarted,whereasthentpdatawerereportedattheendof thequarterinwhichtbtreatmentstarted.thispartlyexplainsthedifference.anotherreasoncouldbethat 26

the HIV services provide ART and little collaboration or integration between the TB and HIV services existed.however,thehealthfacilitieshaveanartcommitteeofwhichthetbsupervisorisamember.the committeediscussespatientsthatareabouttostartartandassuchthetbsupervisorpotentiallyisaware oftheartstatusofthepatient. WefoundquiteadifferencebetweentheindividualhealthfacilitiesonHIVtestingandonART<use.Itisnot clearwherethesedifferencescomefrom.forhiv<testing,stockoutsofhiv<testkitscouldbeaproblem. Theurbanhealthfacilityisclosetotheprovincialdistributioncentreandmaybesufferslessfromstockouts orforashorterperiodoftime.thedifferenceinart<useseemedmuchmorerelatedtothedataexchange between the two services. According to the TB register in facility A, only 15% used ART, while the HIV< recordsshowedauseof45%. ThereportingonART<useattheendofthecasefindingquarterwasestimatedtobecompleteinonly56%. ReportingofART<usewiththeTBtreatmentoutcomes12monthsafterthestartofTBtreatmentincreased completenessto75%,butreducesthetimelyavailabilityofinformation.furthermore,inmanycountries thereportingontreatmentoutcomesislimitedtosputumsmear<positivecaseswhereasreportingonart< usewouldneedtobeforallhiv<infectedtbcases.thisdiscrepancymayinfluencethequalityofreporting on ART<use. Electronic data systems could facilitate data collection but also provide prompts to remind healthcareproviderstotakecertainaction,forexampletocollectabloodsampleforacd4+cellcountor tostartart. 12 Inourstudy12%oftheco<infectedpatientsdidnothaveasingleCD4+cellcountavailable duringtbtreatment.potentiallymorepatientwouldhavebeeneligibletostartart. Even though the data in the TB register on ART<use were adequately correct and complete, this study showed that services provided by one programme and reported data on these services by another programmeleadtoinconsistencies.datareportingisnotagoalonitsown,butprovidesprogrammeswith essential information on their performance. Ultimately, we want to improve patient outcome and integrationoftbandhivservicesmaybetheanswertothat.arecentpublishedsystematicreviewshowed thatintegrationofartprovisionintotbcareseemstoimprovepatientsoutcomes,however,theevidence isnotyetsufficient. 13 Limitations Thiswasaretrospectivestudybasedonroutinedata.Selectionbiasmayhaveoccurredbyincludingonly facilitieswherebothtbandhivserviceswerepresentinoneprovinceinmozambique.potentially,art< usemaybehigherinfacilitieswithbothservicesavailablethaninfacilitieswithonlytbtreatmentandthis mayhaveledtoapotentialoverestimationoftheart<use. AnothersourceofselectionbiasmightbethatnotallHIVpatientrecordscouldbetraced.However,we havenoevidencetoassumethatthepresenceofanhiv<recordisassociatedwithadequatereportingof data.furthermore,wemayhaveunderestimatedthecompletenessofdatabecausewedidnotverifyart statusofpatientsreceivingartinotherhealthfacilitiesthantheonewheretheyweretreatedfortb. We considered the information on ART<use from the HIV patient record, partially from an electronic database,ascorrect.potentiallythehivpatientrecordcontainsincorrectdata.however,arecentstudy from the same study area validated the electronic database used in our study. 14 That study found high levelsofmorethan95%agreementforthecd4+cellcount,thedateofthecd4+cellcountandthestart dateofart. Wecollectedthedata18to30monthsafterthestartofTBtreatment.TheWHOrecommendedreporting onart<use,is12monthsafterthestartoftbtreatment.ourfindingsmaypresentanoverestimationof 27

completeness though we think that little incentive exists for TB staff to update their registers after reportingthetreatmentoutcomes. Conclusion' ThedataonART<useinTBregisterarereasonablycorrectandcomplete.However,theTBregistermaynot bethebestsourcetoreportonart<useduringtbtreatmentbecausetheinformationinthehivpatient recordismuchmoreaccurate.reportingonart<useattheendofthequarterinwhichtbtreatmentstarts providestheprogrammewithtimelybutincompleteinformation.amorecompletebutlesstimelypicture isavailableafterayear. Futureresearchshouldfocusonhowtouseoptimallytheavailabledatainawaythatdoesnotaddan extraburdentohealthcareworkers. 28

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