Initial results from a randomized trial of cervical visual screening in rural south India

Abstract

The impact of a single round of screening of visual inspection with acetic acid (VIA) on cervical cancer incidence and mortality was investigated in a cluster randomized trial in south India. Women 30 -59 years of age in 113 clusters in Dindigul District were randomized to VIA screening (57 clusters, 48,225 women) by nurses and to a control group (56 clusters, 30,167 women). 30,577 eligible women were screened between May 2000 and April 2003; 2,939 (9.6%) screen-positive women were investigated with colposcopy by nurses and 2,777 (9.1%) women had biopsy. CIN 1 was diagnosed in 1,778 women, CIN 2-3 lesions were found in 222, and there were 69 screen detected invasive cervical cancers. The detection rates of lesions per 1,000 screened women were 58.2 for CIN 1, 7.3 for CIN 2-3, and 2.3 for invasive cancer. The detection rate of high-grade lesions in our study was 2-3-fold higher than those observed in repeatedly screened populations in developed countries. 71% of women with CIN 1 and 80% of those with CIN 2-3 lesions accepted cryotherapy provided by nurses and surgical treatment by mid-level clinicians. Overall, 97 and 34 incident cervical cancer cases were observed in the intervention and control arms, respectively. The intervention arm accrued 124,144 person years and the control arm accrued 90,172 during the study period. The age standardized cervical cancer incidence rates were 92.4/ 100,000 person-years in the intervention and 43.1/100,000 in the control arms. In the screened arm, 35.0% of cases were in Stage I as opposed to none in the control arm. The preliminary findings from our study indicate that not only is a VIAbased screening programme feasible, safe and acceptable to a population in rural settings, it also results in early detection of cervical neoplasia. © 2004 Wiley-Liss, Inc. Key words: visual inspection with acetic acid; VIA; cytology; cervical cancer; screening; detection; prevention; control; developing countries India is a high-risk country for cervical cancer accounting for 25% (126,000 new cases, 71,000 deaths around the year 2000) of the world burden. 1 The age-standardized incidence rates varies between 11-55/ 100,000 women in different regions. 2,3 Most cases present in advanced stages and the overall 5-year survival is Ͻ40%. 4 Although prevention of cervical cancer is a priority of the National Cancer Control Programme of India, no organized screening programs exist in the country. The financial and logistics burden of operating an organized screening programme based on cytology is considerable, and has encouraged the evaluation of alternative methods such as visual inspection with acetic acid (VIA). [5][6][7][8] VIA is a simple, inexpensive test that can be provided by midwives, nurses and health workers. The sensitivity and specificity of VIA have been widely studied and found to be satisfactory. 6 -16 Although model based studies 17,18 suggest VIA will be a cost-effective method of reducing cervical cancer burden, reduced incidence and mortality from cervical cancer following...

A cluster randomized controlled trial of visual, cytology and human papillomavirus screening for cancer of the cervix in rural India

“…The detection rate of CIN 2=3 (0.7%) by VIA in our study was similar to that in an RCT of VIA screening in south India. 19 Our results indicate that, although VIA is a useful alternative to cytology in low-resource settings, the test positivity and detection rate of lesions have to be carefully monitored to maintain a satisfactory performance. HPV testing with HC II is more objective and reproducible than cytology or VIA.…”

“…18 It is obvious that VIA leads to an excess detection of low-grade abnormalities, due to the naked eye-detectable acetowhitening of lesions. 7,19 Test-positive women in the VIA arm had higher compliance with colposcopy as it was performed in the field immediately after screening. The low frequency of inconclusive colposcopy in VIA-positive women is not surprising as VIA essentially detects lesions on the ectocervix close to the SCJ or the external os and, thus, the SCJ is visible in almost all VIA-positive women.…”

Effect of Screening on the Risk Estimates of Socio Demographic Factors on Cervical Cancer - A Large Cohort Study from Rural India

“…The details of the study have been described earlier 2004;. The study was conducted in 113 local administrative units called panchayaths .The panchayaths were randomised into two groups 57 in the intervention arm and 56 in the control arm.…”

Papillomavirus infection in rural women in southern India

“…After excluding the 113 village panchayats that participated in a concurrent IARC randomised trial of cervical visual screening (Sankaranarayanan et al, 2004), we stratified the remaining village panchayats according to their total population (small: o3000; intermediate: 3000 -5000; large: X5000 people). We then randomly extracted nine small size, three intermediate size, and one-third of a large size village panchayat in order to obtain an approximately equal number of women from each stratum.…”

“…All samples were stored at þ 41C until shipment to the Department of Pathology at the Vrije University Medical Center, Amsterdam, The Netherlands, for HPV testing and liquid-based cytology. In order to meet the immediate screening needs of participating women, visual inspection with acetic acid and, in the presence of suspicious lesions, colposcopy, were performed (Sankaranarayanan et al, 2004). Acetowhite lesions were treated, mainly with cryotherapy.…”