Partha Basu M.D. Screening Group/ Early Detection & Prevention Section

Transcription

1 VIA from Research to Programs - Opportunities and Challenges Partha Basu M.D. Screening Group/ Early Detection & Prevention Section

2 Disclosures No financial disclosure NO conflict of interest to disclose

3 Visual inspection with acetic acid (VIA) Cervix before application of dilute acetic acid VIA +ve: White patch 1 minute after application of acetic acid

4 Study Site Number (25-65 yrs) VIA +ve Sensitivity Specificity HSIL Burkina Faso % Kolkata, India % Congo % Guinea % Jaipur, India % Mali % Mumbai, India % Niger % Trivandrum, India % ALL %

5 Kolkata Cervical Cancer Screening Demonstration Project (N=39740) Sensitivity (CIN 3+) (Verification Bias Corrected) Specificity (CIN 3+) (Verification Bias Corrected) PPV (CIN 3+) VIA 67.9 ( ) 93.2 ( ) 4.0 ( ) HPV Test 91.2 ( ) 96.9 ( ) 8.1 ( ) Basu et al. Int J Cancer 2015 Mittal et al. Cancer Causes & Control 2016

6 Trends in Test Positivity (IARC Multi-centric study) 25 Positivity rate (%) VIA Cytology HPV Rank of the group of 3,000 consecutive women screened

7 First study to show impact of VIA screening on mortality cervical cancer Sankaranarayanan et al. Lancet 2007

8 Comparative efficacy of visual inspection with acetic acid, HPV testing and conventional cytology in cervical cancer screening: a randomized intervention trial in Osmanabad District, Maharashtra State, India Study design Women aged yrs in 52 clusters HPV 13 clusters (N = ) Cytology 13 clusters (N = ) VIA 13 clusters (N = ) Control 13 clusters (N = ) Diagnosis and treatment of screenpositive women Diagnosis and treatment of screenpositive women Diagnosis and treatment of screenpositive women Health education, routine existing care Follow-up for cervical cancer incidence and mortality (passive and active) Follow-up for cervical cancer incidence and mortality (passive and active) Follow-up for cervical cancer incidence and mortality (passive and active) Follow-up for cervical cancer incidence and mortality (passive and active) Sankaranarayanan et al., N Engl J Med 2009;360: Study

9 Comparative efficacy of visual inspection with acetic acid, HPV testing and conventional cytology in cervical cancer screening: a randomized intervention trial in Osmanabad District, Maharashtra State, India Hazard ratios of incidence of stage II+ cervical cancer and cervical cancer mortality ( ) Group Stage II+ cervical cancer incidence Cases Person years of follow-up Control , Hazard ratio* (95% CI) HPV , ( ) Cytology , ( ) VIA , ( ) Cervical cancer mortality Control , HPV , ( ) Cytology , ( ) VIA , ( ) CI: confidence interval * Age-adjusted Sankaranarayanan et al., N Engl J Med 2009;360: In collaboration with TMC, Mumbai and NDMCH, Barshi, India Study

10 Link between screening (testing), diagnosis and treatment is critical for success of cervix cancer screening

11 Screen and Treat Single-visit Approach Eligibility criteria for screen & treat: VIA &/or HPV positive SCJ fully visible Lesion ectocervical only Not occupying more than 75% of cervix Can be covered by largest cryo probe (if Cryotherapy is used)

12 The Cape Town Study: Reduction in CIN 2/3 at 36 months after screen & treat Characteristic HPV screen-and-treat (N= 2163) VIA screen-andtreat (N=2227) Delayed evaluation control group (N=2165) Cumulative frequency of CIN 2 and 3 lesions 29 (1.5%) 71 (3.8%) 105 (5.6%) Rate ratio (95% CI) 0.27 ( ) 0.68 ( ) 1.0 Percentage of CIN 2/3 prevented (95% CI) 73 (60-85) 32 (11-53) - Denny et al., J Natl Cancer Inst. 2010;102(20):

13 WHO guidelines for screening and treatment of precancerous lesions for cervical cancer prevention 2013 Decision Making for Cervical Screening Do you have a screening programme in place? No Yes; VIA Yes; Cytology Do you have resources to introduce HPV Test? Does the program meet quality indicators? HPV test followed by VIA HPV test only VIA alone Cytology or HPV test Cryotherapy and/or LEEP must be part of a screen-and-treat program

14 Global Progress in Visual Inspection (VIA) for Cervical Cancer Screening August 2015

15 Cervical Screening Facilities in HIV Clinics in Sub-Saharan Africa VIA in 80% sites VIA-cryo in 74% sites Colposcopy in 19% Histology in 15% Coleman JS J Low Genit Tract Dis. 2016

16 Bangladesh National Cervical Screening Program ( ) Aims to provide VIA screening to >70% of year old women Women are screened by 1499 providers in 373 VIA screening centers 334 trained doctors provide colposcopy and treatment services in 15 colposcopy/treatment centres 1,157,032 women have been screened; 5.1% were VIA+ve 90% of screen positives have been further investigated and treated Ashrafunnessa. High-level Convening on Cervical Cancer Prevention and Control in India and Beyond. New Delhi October 2016

17 Rangpur RpMCH Distribution of the responsibilities to Medical College and District Hospitals Colposcopy clinics Rajshani RajMCH MMCH BSMMU DMCH SSMC & MH Dhaka OMCH Sylhet FMCH CoMCH KMCH Khulna SBMCH Barisal CMCH Chittagong Well developed Moderately developed

18 District-level expansion across Zambia ( ) and projected (2016) of the Cervical Cancer Prevention Program in Zambia (CCPPZ) VIA/Cryotherapy (2) clinics LEEP (1) clinic VIA/Cryotherapy (33) clinics LEEP (18) clinics VIA/Cryotherapy (100) clinics LEEP (20) clinics Parham et al., PLoS One. 2015;10(4):e

19 Cervical Cancer Prevention Program in Zambia Rates of screening positivity, cryotherapy eligibility and cryotherapy-ineligiblity by age categories and overall Trends in rates of screening positivity and cryotherapy rates over calendar years Trends in rates of same day-services and rates of appropriate referral over calender years Parham et al., PLoS One. 2015;10(4):e

20 Scaling up of VIA screening in Tamil Nadu: promising yet has to be prudent! Based on the success of the pilot and the lessons learnt, the NCD intervention programme has been scaled up to the entire state of Tamil Nadu, targeting: Cancer cervix Cancer breast Hypertension Diabetes Mellitus Phasing of districts Phase I (16 districts) Phase II (16 districts) Krishnagiri Dharmapuri Solem Erode The Nilgiris Narnakkal Coimbatore Karur Dindigul Thiruvallur Vellore Tiruvan-namalai Kancheepuram Viluppuram Cuddalore Perambular Tiruchirappalli Karaikal Thanjavur Thiruvarur Nagapattinam Pudukkottai Theni Madurai Sivaganga Virudhunagar Ramanathapuram Tirunelveli Thoothukkudi Tamil Nadu state Kanniyakumari

21 Cervical screening using VIA: Coverage and detection rates TNHSP* ( ) Osmanabad** ( ) Dindigul** ( ) Target population 14,392,034 34,074 49,320 Screened (%) 7,420,556 (52%) 26,275 (78.5%) 31,343 (63.6%) VIA positive (%) 279,711 (3.8%) 3,733 (13.9%) 3,088 (9.9%) Compliance to colposcopy 132,380 (47.3%) 3,684 (98.7%) 3,052 (98.8%) Biopsy 45,743 (34.6%) 2,359 (82.2%) CIN 2+ detection rate 0.5/1000 women screened 10/1000 women screened 9/1000 women screened

22 Single visit screen & treat screening in Thailand: program driven by research Ministry of Health trained 1175 nurses and 150 doctors in single visit VIA screen and treat approach Nurse providers screened around women aged years at PHCs in 29 provinces 3 5% were VIA positive Around 90% received immediate cryotherapy

23 Thailand National VIA Screening Program 139,143 women aged years were screened during VIA positivity: 3.1% Immediate cryotherapy could be done: 45% Cryotherapy on a later date: 5.5% Refused cryotherapy: 36.7% Redesigned program to perform cryotherapy at secondary level of care

24 Key Attributes to Successful Scale up Geographic distribution of services Adequate staff & facilities Availability of equipment & consumables Access Quality Community education Provider training Referral pathways/treatment Performance monitoring Health info system Trust & acceptance Convenience Knowledge Societal support Community mobilization efforts Adherence Health systems/providers Screening program Patient/community Subramanian S et al. J Cancer Policy 2016

25 Thank You!