Cervical cancer screening i Tanzania

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1 Cervical cancer screening i Tanzania Vibeke Rasch, Professor, Overlæge, Dr Med Gynækologisk Obstetrisk Afdeling Odense Universitets Hospital/Syddansk Universitet

2 2

3 Global-Hpv burden Forman D,De Martel C,Lacey,Soerjomataram L, Lortet-Tieulent J, Bruni L et al.global burden of Human Papillomavirus and related diseases.vacciine 2012;30(S5):F12-23

4 Cervical Cancer Latest data on cervical cancer incidence and mortality: Globally 528,000 cases diagnosed per year: 85% of all cases in developing world Globally 266,000 deaths: 87% of all deaths in developing world Cervical cancer is the most common cancer in women in Eastern and Middle Africa Source: 4 December 2017

5 Cervical cancer in Tanzania

6 CONCEPT Project Comprehensive Cervical Cancer Prevention in Tanzania Timeline: Aug Dec Aim: Improve cervical cancer prevention in Tanzania

7 CONCEPT Project Comprehensive Cervical Cancer Prevention in Tanzania 4 senior researchers 1 postdoc Prof. Vibeke Rasch Prof. Susanne Krüger Kjær Dr. Julius Mwaiselage Dr. Rachel Manongi Dr. Crispin Kahesa 4 PhD projects Patricia Swai Bariki Mchome Ditte S. Linde Johnson Katanga 1 MA student/ research assistant Aleksandra Bakiewicz

8 CONCEPT Project Comprehensive Cervical Cancer Prevention in Tanzania Project outline Workpackage 1: Workpackage 2: Workpackage 3: Workpackage 4: Workpackage 5: Acquisition patterns of high-risk (HR) HPV with special focus to HIV status Persistence patterns of HR HPV types and absolute risk of severe cervical lesions with special focus on HIV status Test performance of CareHPV testing, pap smear and VIA for detection of cervical precancerous lesions Continuity of care among HPV-positive women by use of mhealth intervention Health service capacity building for cervical cancer prevention 8

9 CONCEPT Project Comprehensive Cervical Cancer Prevention in Tanzania 3 Research Sites Kilimanjaro Christian Medical Center, Kilimanjaro Mawenzi Regional Hospital, Kilimanjaro Ocean Road Cancer Institute, Dar es Salaam

10 Procedure Questionnaire interview HIV testing CareHPV, Thin prep VIA

11 Study population 4058 Women recruited, 2288 KCMC 1770 ORCI 20 inadequate samples, no barcodes etc 4038 analysed 48 Missing data 3990 Cytology HPV genotyping

12 Specimens shipped to Dept of Pathology, Vejle Hospital - Bethesda system was used to diagnose abnormal cytology Specimen Shipped to Tuebingen University Hospital, Germany - HC2-HPV test - HPV positive DNA Genotype-(LiPaExtra; Innogenetics, Gent, Belgium)

13 Workpackage 1 Dr Bariki Mchome (MD, MMED, Phd student)

14 Objective To describe risk factor for detection of high risk human papilloma virus in Tanzania, with a special view to HIV positive women and the role of CD4 count

15 Summary findings Prevalence of HR HPV in HIV Positive: 37.5% Prevalence of HR HPV in HIV Negative: 13.7% Risk factors for HPV - HIV infection odds - Sexual debut<15 years odds - No of lifetime partners odds - Low BMI Low CD4 count increase odds for HR HPV infection

16 Hpv distribution vs cytology

17 Hiv related factors vs HrHPv

18 Workpackage 2 Dr Patricia Swai (MD, MMED, Phd student)

19 Objective To assess high-grade cervical lesions in relation to reproductive characteristics, HIV status and CD4 count among women in Tanzania

20 Summary cytology findings 88, ,32 3,45 0 Negative Low grade High grade missing 39 samples

21 Summary findings Women with high grade lesions were more likely to: - Having had sexual intercourse before age 21 (OR=2.68;95%CI: ) - Having delivered first child before age 21 (OR=2.78;95%CI: ) - Having delivered 3 children or more (OR= 1.46;95%CI: ) Women who were HIV positive had a 6 times increased odds (OR=5.84;95%CI: ) for having high-grade lesions Among HIV positive women, an association between CD4 count <500 and highgrade lesion was found (OR= %CI; )

22 Workpackage 3 Dr Johnson Katanga ) (MD, Phd student)

23 Screening in Tanzania VIA easy, cheap, allows on site treatment Subjective to health provider lead to false negative or positive Overtreatment/under treatment

24 VIA 5% acetic acid, cotton wool Speculum Clean gloves

25

26 HPV DNA testing Hybrid capture 2 (HC2) Good results on CIN2+ (cost effective) With cytology increase prediction of CIN 3 Reduce lifetime risk of getting cervical cancer by half Expensive, good infrastructure, skilled personel

27 Rapid HPV DNA (CareHPV) Derived from HC2 Less expensive, easy to use Processing time 2.5hrs instead of 6hrs Self sampling

28 Care HPV

29

30 General Workflow for carehpv Test System REMINDERS Patient results can be produced in ~2.5 hours for possible same day follow-up (denaturation to plate read) Denature Shaker Hybrid & Capture Shaker Add Conjugate Shaker Process samples per day or 1-2 assay runs per day 30 min Detect 45 min Add Substrate 30 min Wash Beads Optimization: Test 90 samples per assay run because the kit can only be used once Luminometer Shaker Magnetic Plate 5 min 15 min 15 min

31 Table 2: Results of different tests performed Test performed Frequency (N) Percentage (%) VIA positive negative HC2 positive negative CareHPV positive negative Cytology normal atypical cells LSIL HSIL

32 Sensitivity, specificity and predictive values of tests in detection of HSIL + lesions Test Sensitivity (%) Specificity (%) PPV (%) NPV (%) Overall CareHPV HC2 VIA

33 Workpackage 4 Ditte Søndergaard Linde

34 . Connected2Care Text Messages to Increase Attendance to Cervical Cancer Screening Follow-up Appointments Among HPV-positive Tanzanian Women: A Randomised Trial Ditte Søndergaard Linde Cand.Scient.San.Publ. PhD stud., Department of Clinical Research

35 Hypothesis

36 Trial Profile

37 Hello! We are here to help you. Cervical cancer is the most common type of cancer and the main cause of cancerrelated death among women in Tanzania. Often women cannot feel cervical cancer and it shows no signs at an early stage. Therefore, it is important to attend screening even though you do not feel sick or have symptoms of cervical cancer. Thank you for reading our message. 10 educative SMS in Swahili Hello! It is time for your screening appointment. Go to your health clinic tomorrow. When you go to your screening appointment it will help you to stay healthy and free of cervical cancer. We are here to help you. Thank you for reading our message. 5 reminder SMS in Swahili

38 Qualitative study Acceptability of SMSs and barriers for returning to screening Time period July 2017 Data 15 individual, semi-structured interviews with women from SMS-group 2 individual, semi-structured interviews with screening nurses 1 focus group discussion with 4 home visit nurses Road to home interview Setting: Dar es Salaam Ocean Road Cancer Institute Private homes of women Translation Simultaneous, social worker from ORCI Personal belongs: Fish bucket & phone

39 Future perspectives The use of telepathology in control of cervical cancer in Kilimanjaro region, Northern Tanzania 39

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43 HPV testing and the use of telepathology in control of cervical cancer in Kilimanjaro region, Northern Tanzania 43

44 HPV testing and the use of telepathology in control of cervical cancer in Kilimanjaro region, Northern Tanzania Sub-study 1:To assess if HPV testing on self-collected specimens is equivalent to HPV testing on provider-collected specimens. 44

45 HPV testing and the use of telepathology in control of cervical cancer in Kilimanjaro region, Northern Tanzania Sub-study 1:To assess if HPV testing on self-collected specimens is equivalent to HPV testing on provider-collected specimens. Sub-study 2: To determine test performance between two different screening approaches for cervical cancer prevention: HPV test + VIA versus HPV test + cytology 45

46 HPV testing and the use of telepathology in control of cervical cancer in Kilimanjaro region, Northern Tanzania Sub-study 1:To assess if HPV testing on self-collected specimens is equivalent to HPV testing on provider-collected specimens. Sub-study 2: To determine test performance between two different screening approaches for cervical cancer prevention: HPV test + VIA versus HPV test + cytology Sub-study 3: To investigate whether histological diagnosis of cervical biopsies can be improved by telepathological consultations 46

47 Thank you for listening

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