Screen-and-treat approaches for cervical cancer prevention in low-resource settings - A randomized controlled trial

Department of Epidemiology, Columbia University, New York, New York, United States
JAMA The Journal of the American Medical Association (Impact Factor: 30.39). 12/2005; 294(17):2173-81. DOI: 10.1001/jama.294.17.2173
Source: PubMed

ABSTRACT Non-cytology-based screen-and-treat approaches for cervical cancer prevention have been developed for low-resource settings, but few have directly addressed efficacy.
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.Design, Setting, and
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.
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.
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.
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.
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 Identifier: NCT00233727.

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    • "The review also concluded that cryotherapy was as effective as other outpatient treatment methods, particularly for treating mild and moderate lesions (CIN 1–2). Other ACCP studies have similarly shown extremely low rates of serious adverse events requiring hospitalization, with the most common side effects being fever, pain, watery discharge, bleeding and cramping (Denny et al., 2005; Gaffikin et al., 2003; Sankaranarayanan et al., 2007b). "
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    ABSTRACT: Cervical cancer remains the most frequent cancer in women from the developing world. More than 88% of deaths occur in low-income countries, and it is predicted to climb to 91.5% by 2030. Although Pap-based screening programmes have shown to be effective in reducing the disease burden in high-resource countries, implementation and sustention of cytology-based programmes is quite challenging in low-resource settings. The present paper reviews evidence-based alternatives of screening methods, triaging algorithm, treatment of cervical precancerous lesions, and age-group at screening appropriate for low-income countries. Evidence shows that visual inspection methods using diluted acid acetic or Lugol's iodine, and HPV-DNA testing are more sensitive tests than the Pap-smear screening test. Visual inspection allows an immediate result and, when appropriate, may be immediately followed by cryotherapy, the so called "screen-and-treat" approach, achieved in a single visit, by trained nurses and midwives. Examples of cervical cancer prevention programmes in India and selected low-income countries are given.
    Asian Pacific journal of cancer prevention: APJCP 04/2012; 13(4):1699-703. DOI:10.7314/APJCP.2012.13.4.1699 · 2.51 Impact Factor
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    • "The clinical protocol was developed on the basis of recommendations from the WHO's Comprehensive Guide to Cervical Cancer Control for resource-limited settings, coupled with relevant evidence from recent clinical trials [10] [11] [12]. The protocol uses visual inspection with 3–5% acetic acid (VIA) as a screening test, followed by colposcopy and biopsy to confirm cervical intraepithelial neoplasia 2/3 (CIN2/3), a precancerous lesion needing treatment [13] (Fig. 1). "
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    ABSTRACT: To evaluate outcomes of cervical cancer screening within HIV care and treatment clinics in Kenya. Beginning in October 2007, visual inspection with acetic acid (VIA), colposcopy, and loop electrosurgical excision procedure (LEEP) were added to the clinical services offered at Family AIDS Care and Education Services (FACES) clinics in Kisumu, Kenya, after a systematic campaign to build capacity and community awareness. From October 2007 to October 2010, 3642 women underwent VIA as part of routine HIV care. Cervical intraepithelial neoplasia 2/3 was identified in 259 (7.1%) women, who were offered excisional treatment by LEEP in the clinic. Among those women offered screening, uptake was 87%. Clinical staff reported a high level of satisfaction with training for and implementation of cervical cancer screening strategies. Cervical cancer screening and prevention are feasible, acceptable, and effective within HIV care and treatment clinics. Screening test performance characteristics need to be defined for an HIV-positive population to determine the cost/benefit ratio of lower cost strategies that will ultimately be necessary to provide universal access to cervical cancer screening in low-resource settings.
    International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics 05/2011; 114(2):106-10. DOI:10.1016/j.ijgo.2011.02.009 · 1.56 Impact Factor
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    • "Alternative strategies based on visual inspection of the cervix with acetic acid (VIA) or Lugol's Iodine (VILI) increase the feasibility of screening in resource-poor settings (Sankaranarayanan et al. 2005; FIGO 2009). These strategies require little laboratory infrastructure and provide immediate or very rapid results, allowing treatment with cryotherapy where required in the same visit (Denny et al. 2005). "
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    ABSTRACT: To estimate the incremental costs of visual inspection with acetic acid (VIA) and cryotherapy at cervical cancer screening facilities in Ghana; to explore determinants of costs through modelling; and to estimate national scale-up and annual programme costs. Resource-use data were collected at four out of six active VIA screening centres, and unit costs were ascertained to estimate the costs per woman of VIA and cryotherapy. Modelling and sensitivity analysis were used to explore the influence of observed differences between screening facilities on estimated costs and to calculate national costs. Incremental economic costs per woman screened with VIA ranged from 4.93 US$ to 14.75 US$, and costs of cryotherapy were between 47.26 US$ and 84.48 US$ at surveyed facilities. Under base case assumptions, our model estimated the costs of VIA to be 6.12 US$ per woman and those of cryotherapy to be 27.96 US$. Sensitivity analysis showed that the number of women screened per provider and treated per facility was the most important determinants of costs. National annual programme costs were estimated to be between 0.6 and 4.0 million US$ depending on assumed coverage and adopted screening strategy.   When choosing between different cervical cancer prevention strategies, the feasibility of increasing uptake to achieve economies of scale should be a major concern.
    Tropical Medicine & International Health 03/2011; 16(3):379-89. DOI:10.1111/j.1365-3156.2010.02722.x · 2.30 Impact Factor
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