A cluster randomized controlled trial of visual, cytology and human papillomavirus screening for cancer of the cervix in rural India.
The impact of screening by visual inspection with acetic acid (VIA), cytology or HPV testing on cervical cancer incidence and mortality is investigated in a cluster randomized controlled trial in India. We report findings after the screening phase, when 52 clusters, with a total of 142,701 women aged 30-59 years in Osmanabad District, India, were randomized into 4 arms for a single round of screening by trained midwives with either VIA, cytology or HPV testing as well as a control group. All laboratory tests were done locally. Test-positive women underwent investigations (colposcopy/biopsy) and treatment in the base hospital. Data on participation, test positivity, positive predictive value and detection rates of cervical neoplasia were analyzed using cluster design methodology. Of the eligible women, 72-74% were screened. Test positivity rates were 14.0% for VIA, 7.0% for cytology and 10.3% for HPV. The detection rate of high-grade lesions was similar in all intervention arms (0.7% for VIA, 1.0% for cytology and 0.9% for HPV testing) (p = 0.06, Mann-Whitney test). While the detection rate for VIA dropped to 0.5% with declining test positivity during the course of the study, it remained constant for cytology and HPV testing. Over 85% of women with high-grade lesions received treatment. Our results show that a high level of participation and good-quality cytology can be achieved in low-resource settings. VIA is a useful alternative but requires careful monitoring. Detection rates obtained by HPV testing were similar to cytology, despite higher investments.
Sankaranarayanan
Rengaswamy
R
Screening Group, International Agency for Research on Cancer, Lyon, France. sankar@iarc.fr
Nene
Bhagwan M
BM
Dinshaw
Ketayun A
KA
Mahe
Cedric
C
Jayant
Kasturi
K
Shastri
Surendra S
SS
Malvi
Sylla G
SG
Chinoy
Roshini
R
Kelkar
Rohini
R
Budukh
Atul M
AM
Keskar
Vijay
V
Rajeshwarker
Raghevendra
R
Muwonge
Richard
R
Kane
Shubhada
S
Parkin
Donald Maxwell
DM
Chauhan
Madanmohan K
MK
Desai
Sangeetha
S
Fontaniere
Bernard
B
Frappart
Lucien
L
Kothari
Ashok
A
Lucas
Eric
E
Panse
Nandkumar
N
D019342:Acetic Acid; D000328:Adult; D003363:Cost Control; D003584:Cytological Techniques / Q000191:economics; D004279:DNA, Viral / Q000032:analysis; D005260:Female; D006801:Humans; D007194:India; D008403:Mass Screening / Q000191:economics / Q000379:methods*; D008875:Middle Aged; D010358:Patient Participation; D011237:Predictive Value of Tests; D015203:Reproducibility of Results; D012424:Rural Population; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000473:pathology / Q000821:virology*
D004279:DNA, Viral; D019342:Acetic Acid