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CERVICAL CANCER / CLUSTER RANDOMISED INTERVENTION TRIALS IN INDIA
Osmanabad district screening programme, Maharashtra, India: 4 arms (VIA, Cytology, HPV testing, Control)
Osmanabad district is one among the industrially and socioeconomically most backward districts in India. Women aged 30-59 years (N=160,000), living in villages (N=502) under 52 primary health centres (PHC) in this district, have been randomised (randomization unit: PHC) to receive one time screening with either visual inspection with acetic acid (VIA), conventional cytology, HPV DNA testing, or to join a control group. Each arm includes 13 PHCs, i.e. around 40,000 eligible women. The objective of this cluster randomized screening trial is to evaluate the comparative efficacy and cost effectiveness of screening programmes with VIA, cytology or HPV testing. The comparative efficacy will be judged in terms of outcomes such as detection rates of high-grade cervical cancer precursor lesions (cervical intraepithelial neoplasia grade 2-3 (CIN 2-3)), survival from cervical cancer, incidence of and mortality from cervical cancer.
As there were no readily available listing of household addresses and eligible women, each household in the district was enumerated and the eligible women were personally identified and interviewed by the project staff. The programme was explained to women and their spouses at the time of household survey. Groups of eligible women and their spouses and elders were addressed in a group meeting with video and audio presentations to motivate them to participate in screening. Screening clinics are organized in the villages. Women are personally invited to testing and screen positive women are then investigated (with colposcopy and, depending on colposcopy findings, a biopsy is taken). Women found with CIN are treated at the main hospital and followed up. Women in the control group receive health education on cervical cancer and are advised about the available cancer prevention and detection services in the district.
As at end of December 2003, of the 142,701 eligible women identified, 136,583 have been interviewed. Of those 100,800 were invited for screening in one of the 3 screening arms, and 78.8% participated and received screening. Screening was completed in December 2003.
The detection rates of high-grade cervical cancer precursor lesions (CIN 2-3) are similar in all the three screening programme arms. Of the subjects detected with CIN 2-3, 86.5% (609/704) received treatment; the treatment rates are similar across the screening arms. The proportion of cervical cancer patients receiving treatment are also similar in all the study arms. Of the treated patients, 60% have reported for follow-up at 1-year. 1061 Cryotherapy, 1135 LEEP, 6 colonisation, 302 surgical and 70 radiotherapeutic procedures have been performed.
The cervical cancer incidence in the district is actively monitored by the Osmanabad district population-based cancer registry.
The preliminary results from the programme are given here.
the Barshi study
Resume of the
Video Cervical Cancer
Prevention in Barshi
Windows Media player/56k
Windows Media player/100k
Windows Media player/256k
Dindigul district screening programme, Tamil Nadu: 2 arms (VIA, Control)
This large cluster-randomized controlled intervention trial aims to evaluate the efficacy and by active yearly follow-up of once a lifetime screening with VIA, performed by health workers and nurses, in reducing the incidence of and mortality from cervical cancer. Eligible women (30-59 years, N=78,392) living in 113 village clusters (randomization unit; village cluster) in the district have been randomised either to receive screening with VIA (57 village panchayaths, 48,225 women) or to join a control group (56 village panchayaths, 30,167 women). Households have been enumerated and eligible women have been interviewed.
The programme is explained to the women and their spouses during the household enumeration and interviews. They are again addressed in group meetings on the day prior to the screening. A loud speaker in a van is used to announce the invitation for screening on the day of the clinic.
Screening clinics are provided in the villages. Of the 48,225 eligible women of the VIA group, 30,577 (63.4%) have been screened. All screen- positive women are investigated with colposcopy and biopsy, depending on colposcopy findings. Those with colposcopically diagnosed CIN and suitable for cryotherapy are treated in the field itself after directing a biopsy. LEEP is provided by doctors in the base hospital. Screening, colposcopy, biopsy and cryotherapy are all carried out by trained nurses.
2,296 Cryotherapy, 165 LEEP, 5 surgical and 32 radiotherapeutic procedures have been performed. All treated patients are under active follow-up. A population-based cancer registry covers the entire district to monitor cervical cancer incidence.
The preliminary results of the programme are given here.
Study profile (pdf file)
the Ambillikai study