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| Osmanabad District Cervical Cancer Prevention Programme | |
- Nargis Dutt Memorial Cancer Hospital (NDMCH), Barshi, India
- Tata Memorial Center (TMC), Mumbai, India
- International Agency for Research on Cancer (WHO/IARC), Lyon, France
Study funded by the Bill & Melinda Gates Foundation through the Alliance for Cervical Cancer Prevention (ACCP) | |
Study location : Osmanabad district, India | | | 
NOTIONAL MAP SHOWING OSMANABAD DISTRICT, MAHARASHT
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Background: | | The impact of single round screening by visual inspection with acetic acid (VIA), cytology, or human papilloma virus (HPV) testing on cervical cancer incidence and mortality is investigated in a cluster randomised controlled trial in India.
Women aged 30-59 years in 52 clusters of 497 villages in Osmanabad District, India, were randomised to a single round of screening by trained midwives with either VIA (N=34,149), cytology (N=32,136), HPV testing (N=34,515) or to a control group (N=30,378).
All laboratory tests were done locally. Test-positive women had further investigations (colposcopy/biopsy) and treatment in the base hospital (NDMCH).
Data on participation, test positivity, cervical intraepithelial neoplasia (CIN) detection and treatment rates were analysed. We report the preliminary findings after the screening phase (February 2000 to November 2003).
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Objectives: | |
- To evaluate the reduction in cervical incidence and mortality associated with single round of screening with VIA, cytology or HPV testing, as compared to a control group with no screening
- To evaluate the cost-effectiveness (CE) of the above three approaches
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| | To evaluate:
- The determinants of participation for screening/diagnosis/treatment
Safety and effectiveness of cryotherapy by nurses
- Safety and effectiveness of LEEP by mid-level clinicians
- Over-treatment associated with treatment decisions based on colposcopy
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Study design: | | | 
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Study design: Randomisation: | | The programme covers four sub-districts from OSMANABAD district:
- Osmanabad
- Kalamb
- Tuljapur
- Umarga
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Training of staff: | | | The project staff were intensively trained in all project activities such as enumeration, interviews, counselling, screening, diagnosis and treatment.
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Inauguration of the programme 25 June 2000: | | | Left to Right : Dr. K. A. Dinshaw, Director TMC, Dr. P. Kleihues, Director IARC and Mr. Digvijay Khanvilkar, Minister of Health and Family Welfare, Government of Maharashtra, on the occasion of the formal inauguration of the project. | 
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Enumeration: | | | Household survey of the village by male health worker for enumeration of the population and identification of eligible women
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Household survey data checking: | |
- Number of households
- Comparing enumerated population with 1991 census population
- Number of locked houses
- Number of cancer cases in the village
- Completeness of village map
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Data entry of household survey in epidemiology unit: | | | Data entry and printing of the list of eligible women from the household survey forms. | 
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Interviews of eligible women: | | | Interviewing eligible women in the villages to collect information on demographic, socio-economic and reproductive variables using the individual forms. | 
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Checking of the individual forms: | | Checking of individual forms by senior staff at project office
Consistency checks for:
- Unique Number
- Age of the woman
- Socio-demographic and reproductive history
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Preparation of the screening clinics: | | Planning for village screening clinics by the programme office in consultation with the male health worker
- Date of the clinic
- Staff allotment
- Selection of the screening clinic venues in villages
- Number of clinic days required
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Meeting with the State Government authority: | |
- Every four months, progress reports of the screening activities are provided to the District Collector, District Chief Officer of Zilla Parishad and to the District Health Officer
- Planned activities for the subsequent four months are submitted and requests for them to extend their co-operation to the programme are made
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Discussion between the project coordinator and dis
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Clinic invitation cards: | | | Writing invitation cards for screening by the clerical staff of the project
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Distribution of the invitation cards | |
- Senior staff of the project, medical social workers, male and female health workers work together to organize screening clinics
- Female and male health workers distribute the invitation cards, personally, invite eligible women for screening, and conduct group meetings
- Senior staff and male health workers meet community leaders and husbands of eligible women
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Person to person invitation and distribution of invitation cards: | | | 
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Information about screening and clinical procedures in group meetings: | | | 
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Information about the screening programme: | |
- Message for children to motivate their mothers and family members to participate in the screening programme.
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Student marches with banners announcing village screening clinics.
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Health education programme: | | | Senior staff of the project and male health workers conduct the health education programme in the evening before screening clinics.
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Health education messages: | | Health education messages were given in a very simple language so that both the participants and their husbands could understand.
We explain
- How cervical cancer develops
- How to prevent cervical cancer
- The importance of hygiene
- Signs and symptoms of cervical cancer
- Why is it essential to undergo a screening
- Information about the screening test: VIA, cytology, HPV diagnosis and treatment for screen-positive women
- The facilities provided by the programme, e.g. transportation, free treatment etc.
- That we are bringing services to prevent cervical cancer to the participants doorstep. We appeal them to participate and prevent themselves from getting cervical cancer
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Registration at the village clinic: | | | 
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Screening clinics in the villages: | | | Lady medical officers and female nursing staff conduct the screening clinics in the villages.
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Medical consultation in a clinic: | | | 
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Distribution of medicine in a clinic: | | | 
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Definition of screen positivity: | |
- VIA: Well-defined acetowhite lesions near/in the transformation zone
- Cytology: Atypical squamous cells of undetermined significance (ASCUS), low-grade squamous intraepithelial lesions (LSIL), high-grade squamous intraepithelial lesions (HSIL), invasive cancer
- HPV testing: RLU/PC ratio of 1 or more (5000 or more viral copies)
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Smear diagnosis in the project laboratory: | |
- Processing and reporting of cytology smears in the project laboratory
- HPV results in process
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Quality control cytology/histopathology: | | | All positive and 10% negative cases of cytology and histology slides were sent to TMH every week by courier for review as part of internal quality control measures. | 
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Discussion of histopathology problem cases: | | | Tata Memorial Hospital pathologist (tele-pathology unit) discussing with NDMCH pathologist. | 
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Discussion of cytopathology problem cases: | | | TMH cytologist discussing cases with NDMCH cytologist. | 
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Quality control procedures in the NDMCH HPV Laboratory: | | | 
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Diagnosis of screen-positive women: | |
- Results delivered to screen-positive women by the male health worker within 2 weeks of screening
- Appointments for colposcopy/treatment at NDMCH
- Transportation of screen-positive women to NDMCH from the village by project vehicle for diagnosis and treatment. Male health worker co-ordinate this activity along with community leaders
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Screen-positive women coming for diagnosis and treatment having lunch at the canteen of NDMCH/ | | | 
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Education for the screened positive women on diagnosis, treatment and follow-up: | |
- Senior staff educate the screened positive women on further investigations (colposcopy/biopsy) and treatment
- Cryotherapy and LEEP procedures are explained
- Women are encouraged to ask for clarifications
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Screen-positive women investigated with colposcopy/biopsy: | | | 
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Treatment of cervical intraepithelial neoplasia (CIN): | | | Treatment of CIN by cryotherapy/LEEP based on colposcopy diagnosis after directing biopsy. | 
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Treatment of cancer by surgery/radiotherapy: | |
- Radical hysterectomy
- Radiotherapy
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Follow-up of the treated women: | |
- Within 10 days of treatment male health workers contact the women who have been treated with cryo/LEEP to assess from the patient and her husband whether she is having any problem
- Appointment for the treated women for 3 month and annual follow-up
- Annual follow-up survey of the entire village to assess the vital status of the women
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Reimbursing transportation charges to women coming for their post-treatment follow-up: | | | 
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Felicitating the community leaders: | | To enthuse the villagers a shield and certificate are given to villages with
high compliance.
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Dr K. A. Dinshaw, Director, TMC, Mumbai felicitating leaders from women's organisations
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Dr. B. M. Nene, Director, NDMCH, Barshi felicitating village leaders
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Control arm: | |
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Eligible women enumerated and interviewed
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Informed about cervical cancer symptoms, signs and treatment options
Informed about from where preventive and treatment services can be availed
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Free diagnosis and treatment facility to cervical cancer patients at NDMCH
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Continuing education of the project staff: | | | 
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Scientific review of the work each month: | | | Epidemiologists reviewing protocol adherence, data management and
interim results. | 
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Clinical review meetings: | | | 
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Periodical review in IARC: | | | Periodical review of the programme by Dr. D. M. Parkin and his team.
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External quality control: | | | External quality control of cytopathology and histopathology by Dr. B. Fontaniere and Dr. L. Frappart from Lyon, France.
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Providers | |
- 9 midwives
- 9 doctors
- 2 pathologists
- 2 statistical clerks
- 11 laboratory technicians
- 6 data entry operators
- 33 health workers
- 7 drivers
- 7 helpers
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Who provides what to whom ? | | Health workers (33)
- Enumerated 130,699 households in 497 villages
- Identified 142,701 target women (30-59 years)
- Interviewed 135,583 women
- Invited 100,800 women for screening
Midwives (9) provided in the field
- VIA to 26,755 women
- Collected cervical cells from 52,694 women for cytology/HPV testing
- Cryotherapy to 1,061 women in the central clinic
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| | Laboratory technicians (11)
- Processed and reported on 28,000 smears
- Processed and reported on 35,159 HPV samples
- Processed > 5,000 biopsy specimens
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| | Doctors (9) provided
- Colposcopy to 7,919 women
- Performed 4,707 colposcopic biopsies
- LEEP to 1,135 women
- Treated 370 women with cancer
Pathologists (2) reported on >8000 biopsy specimens
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| | Data Entry operators (6)
Entered 500,000 records in the database
system
- Household forms
- Individual forms
- Screened records
- Colposcopy forms
- Histopathology forms
- Treatment forms
- Follow-up forms
- Confidentiality of records maintained
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Data Management and statistical analysis: | | | 
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Detection rates of cervical neoplasia in study arms: | | | 
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Conclusions: | |
- Over 75% of women complied with invitation to screening
- Over 80% of screen-positive women investigated and treated
- VIA has a higher test positivity rate (14%) than cytology (7%) and HPV testing (10%)
- VIA detected significantly higher CIN 1 as compared with cytology and HPV testing (p<0,001)
- VIA detected significantly lower CIN 2-3 than for cytology (p=0,005); cytology and HPV testing have similar detection rates
- VIA is a useful alternative, but requires careful monitoring and quality assurance
- HPV testing is not associated with improved detection of CIN 2-3 lesions compared to cytology, despite high investments
- With minimal investments in training and quality assurance, good quality cytology can be achieved
- The ultimate effectiveness of the 3 approaches will become clear with follow-up for cancer incidence and mortality
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Visitor: | | | Dr. Gordon Perkin from the Bill & Melinda Gates Foundation visited the programme on 3rd December 2003. | 
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| | | Dr Jacqueline Sherris from PATH/ACCP
visited the programme on 3rd December 2003. | 
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| | | Dr. Paul Kleihues, Director, WHO-IARC visited the programme on 6-7 January 2003. | 
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Certificate of appreciation from PATH/ACCP, IARC and Bill & Melinda Gates Foundation: | | | The work done by Dr. B. M. Nene and his colleagues from NDMCH and by Dr. K. A. Dinshaw and her colleagues from TMH was greatly appreciated by Bill & Melinda Gates Foundation, PATH and IARC. Drs. G. Perkin, J. Sherris and R. Sankaranarayanan presented a certificate of appreciation to Dr. B. M. Nene and Dr. S. G. Malvi on 3rd December 2003. | 
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Project Director and Principal Investigators: | |
- Dr. R. Sankaranarayanan, Project Director, IARC-WHO
- Dr. B. M. Nene, Principal Investigator
Nargis Dutt Memorial Cancer Hospital, Barshi
- Dr. K. A. Dinshaw, Principal Investigator, Tata Memorial Centre, Mumbai
- Mrs. K. Jayant
Consultant Epidemiologist/ Co-investigator, Nargis Dutt Memorial Cancer Hospital, Barshi
- Dr. S. S. Shastri, Nodal officer / Co-investigator, Tata Memorial Centre, Mumbai
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Acknowledgments: | | | The investigators gratefully acknowledge the generous support of the Bill & Melinda Gates Foundation through the Alliance for Cervical Cancer Prevention (ACCP). We thank the Ministry of Health, Government of Maharashtra, District Collector, District Zilla Parishad Chief Executive, District Health Officer of Osmanabad and civic administrations for their cooperation. We especially thank the women and their families for their participation.
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CERVICAL CANCER / OSMANABDAD DISTRICT CERVICAL CANCER PREVENTION PROGRAMME)
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