Screen-and-treat approaches for cervical cancer prevention in low-resource settings: a randomized controlled trial.
BACKGROUND
Non-cytology-based screen-and-treat approaches for cervical cancer prevention have been developed for low-resource settings, but few have directly addressed efficacy.


OBJECTIVE
To determine the safety and efficacy of 2 screen-and-treat approaches for cervical cancer prevention that were designed to be more resource-appropriate than conventional cytology-based screening programs.


METHODS
Randomized clinical trial of 6555 nonpregnant women, aged 35 to 65 years, recruited through community outreach and conducted between June 2000 and December 2002 at ambulatory women's health clinics in Khayelitsha, South Africa.


METHODS
All patients were screened using human papillomavirus (HPV) DNA testing and visual inspection with acetic acid (VIA). Women were subsequently randomized to 1 of 3 groups: cryotherapy if she had a positive HPV DNA test result; cryotherapy if she had a positive VIA test result; or to delayed evaluation.


METHODS
Biopsy-confirmed high-grade cervical cancer precursor lesions and cancer at 6 and 12 months in the HPV DNA and VIA groups compared with the delayed evaluation (control) group; complications after cryotherapy.


RESULTS
The prevalence of high-grade cervical intraepithelial neoplasia and cancer (CIN 2+) was significantly lower in the 2 screen-and-treat groups at 6 months after randomization than in the delayed evaluation group. At 6 months, CIN 2+ was diagnosed in 0.80% (95% confidence interval [CI], 0.40%-1.20%) of the women in the HPV DNA group and 2.23% (95% CI, 1.57%-2.89%) in the VIA group compared with 3.55% (95% CI, 2.71%-4.39%) in the delayed evaluation group (P<.001 and P = .02 for the HPV DNA and VIA groups, respectively). A subset of women underwent a second colposcopy 12 months after enrollment. At 12 months the cumulative detection of CIN 2+ among women in the HPV DNA group was 1.42% (95% CI, 0.88%-1.97%), 2.91% (95% CI, 2.12%-3.69%) in the VIA group, and 5.41% (95% CI, 4.32%-6.50%) in the delayed evaluation group. Although minor complaints, such as discharge and bleeding, were common after cryotherapy, major complications were rare.


CONCLUSIONS
Both screen-and-treat approaches are safe and result in a lower prevalence of high-grade cervical cancer precursor lesions compared with delayed evaluation at both 6 and 12 months. Trial Registration http://clinicaltrials.gov Identifier: NCT00233727.
Denny
Lynette
L
Department of Obstetrics and Gynaecology, University of Cape Town, Cape Town, South Africa.
Kuhn
Louise
L
De Souza
Michelle
M
Pollack
Amy E
AE
Dupree
William
W
Wright
Thomas C
TC
D019342:Acetic Acid; D000328:Adult; D001706:Biopsy; D003127:Colposcopy; D017679:Cryotherapy; D004279:DNA, Viral / Q000032:analysis; D005260:Female; D006295:Health Resources; D006297:Health Services Accessibility; D006801:Humans; D008403:Mass Screening; D008875:Middle Aged; D027383:Papillomaviridae / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000175:diagnosis*; D015995:Prevalence; D013019:South Africa; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis / Q000453:epidemiology / Q000517:prevention & control* / Q000628:therapy; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis / Q000453:epidemiology / Q000517:prevention & control* / Q000628:therapy
D004279:DNA, Viral; D019342:Acetic Acid