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      Scale-Up of an Human Papillomavirus Testing Implementation Program in El Salvador

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          Abstract

          Scale-up of a low-cost human papillomavirus testing implementation project in El Salvador showed that the follow-up completion rate with screen-and-treat management was twice that with colposcopy management.

          Abstract

          Objective

          The Cervical Cancer Prevention in El Salvador is a demonstration project to introduce a lower-cost human papillomavirus (HPV)-DNA test into a public sector project. Started in October 2012, The Cervical Cancer Prevention in El Salvador consists of 3 phases and will ultimately screen 30,000 women. Results of phase 2 of the project are presented. The objective of this project was to compare colposcopy and noncolposcopy-based management for HPV-positive women.

          Material and Methods

          In phase 2, a total of 8,050 women, aged 30 to 49 years, were screened; 6,761 provided both self- and provider-collected specimens and 1,289 provided only provider-testing specimens. HPV results from self-collected specimens were not used in clinical management decisions. Women with provider-collected HPV-positive results were treated based on the strategy assigned to their community; the strategy was colposcopy management (CM) or screen-and-treat (ST) management if they were cryotherapy eligible or colposcopy if not eligible. Outcomes were assessed 6 months after screening.

          Results

          Overall, 489 (12.3%) of 3,963 women receiving CM and 465 (11.4%) of 4,087 women receiving ST tested HPV positive. In the CM cohort, 216 (44.2%) of 489 completed their intervention (203 treated, 11 diagnosed negative, 2 pregnant). In the ST cohort, 411 (88.4%) of 465 completed their intervention (407 treated, 2 diagnosed negative, 1 pregnant). Overall agreement between HPV test results from self-collected and provider-collected specimens was 93.7%, with a κ value of 0.70 (95% CI = 0.68–0.73).

          Conclusions

          Human papillomavirus testing with ST management resulted in an approximately twice completion rate compared with CM management. Agreement between self- and provider-based sampling was good and might be used to extend screening to women in areas that are more difficult to reach.

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          Cost-effectiveness of cervical-cancer screening in five developing countries.

          Sue Goldie, Lynne Gaffikin, Jeremy D. Goldhaber-Fiebert … (2005)
          Cervical-cancer screening strategies that involve the use of conventional cytology and require multiple visits have been impractical in developing countries. We used computer-based models to assess the cost-effectiveness of a variety of cervical-cancer screening strategies in India, Kenya, Peru, South Africa, and Thailand. Primary data were combined with data from the literature to estimate age-specific incidence and mortality rates for cancer and the effectiveness of screening for and treatment of precancerous lesions. We assessed the direct medical, time, and program-related costs of strategies that differed according to screening test, targeted age and frequency, and number of clinic visits required. Single-visit strategies involved the assumption that screening and treatment could be provided in the same day. Outcomes included the lifetime risk of cancer, years of life saved, lifetime costs, and cost-effectiveness ratios (cost per year of life saved). The most cost-effective strategies were those that required the fewest visits, resulting in improved follow-up testing and treatment. Screening women once in their lifetime, at the age of 35 years, with a one-visit or two-visit screening strategy involving visual inspection of the cervix with acetic acid or DNA testing for human papillomavirus (HPV) in cervical cell samples, reduced the lifetime risk of cancer by approximately 25 to 36 percent, and cost less than 500 dollars per year of life saved. Relative cancer risk declined by an additional 40 percent with two screenings (at 35 and 40 years of age), resulting in a cost per year of life saved that was less than each country's per capita gross domestic product--a very cost-effective result, according to the Commission on Macroeconomics and Health. Cervical-cancer screening strategies incorporating visual inspection of the cervix with acetic acid or DNA testing for HPV in one or two clinical visits are cost-effective alternatives to conventional three-visit cytology-based screening programs in resource-poor settings. Copyright 2005 Massachusetts Medical Society.
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            Interobserver reproducibility of cervical cytologic and histologic interpretations: realistic estimates from the ASCUS-LSIL Triage Study.

            M H Stoler, Rhett Schiffman, (2001)
            Despite a critical presumption of reliability, standards of interpathologist agreement have not been well defined for interpretation of cervical pathology specimens. To determine the reproducibility of cytologic, colposcopic histologic, and loop electrosurgical excision procedure (LEEP) histologic cervical specimen interpretations among multiple well-trained observers. The Atypical Squamous Cells of Undetermined Significance-Low-grade Squamous Intraepithelial Lesion (ASCUS-LSIL) Triage Study (ALTS), an ongoing US multicenter clinical trial. From women enrolled in ALTS during 1996-1998, 4948 monolayer cytologic slides, 2237 colposcopic biopsies, and 535 LEEP specimens were interpreted by 7 clinical center and 4 Pathology Quality Control Group (QC) pathologists. kappa Values calculated for comparison of the original clinical center interpretation and the first QC reviewer's masked interpretation of specimens. For all 3 specimen types, the clinical center pathologists rendered significantly more severe interpretations than did reviewing QC pathologists. The reproducibility of monolayer cytologic interpretations was moderate (kappa = 0.46; 95% confidence interval [CI], 0.44-0.48) and equivalent to the reproducibility of punch biopsy histopathologic interpretations (kappa = 0.46; 95% CI, 0.43-0.49) and LEEP histopathologic interpretations (kappa = 0.49; 95% CI, 0.44-0.55). The lack of reproducibility of histopathology was most evident for less severe interpretations. Interpretive variability is substantial for all types of cervical specimens. Histopathology of cervical biopsies is not more reproducible than monolayer cytology, and even the interpretation of LEEP results is variable. Given the degree of irreproducibility that exists among well-trained pathologists, realistic performance expectations should guide use of their interpretations.
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              Acceptability of self-collection sampling for HPV-DNA testing in low-resource settings: a mixed methods approach

              Pooja Bansil, Scott Wittet, Jeanette L Lim … (2014)
              Background Vaginal self-sampling with HPV-DNA tests is a promising primary screening method for cervical cancer. However, women’s experiences, concerns and the acceptability of such tests in low-resource settings remain unknown. Methods In India, Nicaragua, and Uganda, a mixed-method design was used to collect data from surveys (N = 3,863), qualitative interviews (N = 72; 20 providers and 52 women) and focus groups (N = 30 women) on women’s and providers’ experiences with self-sampling, women’s opinions of sampling at home, and their future needs. Results Among surveyed women, 90% provided a self- collected sample. Of these, 75% reported it was easy, although 52% were initially concerned about hurting themselves and 24% were worried about not getting a good sample. Most surveyed women preferred self-sampling (78%). However it was not clear if they responded to the privacy of self-sampling or the convenience of avoiding a pelvic examination, or both. In follow-up interviews, most women reported that they didn’t mind self-sampling, but many preferred to have a provider collect the vaginal sample. Most women also preferred clinic-based screening (as opposed to home-based self-sampling), because the sample could be collected by a provider, women could receive treatment if needed, and the clinic was sanitary and provided privacy. Self-sampling acceptability was higher when providers prepared women through education, allowed women to examine the collection brush, and were present during the self-collection process. Among survey respondents, aids that would facilitate self-sampling in the future were: staff help (53%), additional images in the illustrated instructions (31%), and a chance to practice beforehand with a doll/model (26%). Conclusion Self-and vaginal-sampling are widely acceptable among women in low-resource settings. Providers have a unique opportunity to educate and prepare women for self-sampling and be flexible in accommodating women’s preference for self-sampling.
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                Author and article information

                Journal
                Journal ID (nlm-ta): J Low Genit Tract Dis
                Journal ID (iso-abbrev): J Low Genit Tract Dis
                Journal ID (publisher-id): LGT
                Title: Journal of Lower Genital Tract Disease
                Publisher: Lippincott Williams & Wilkins
                ISSN (Print): 1089-2591
                ISSN (Electronic): 1526-0976
                Publication date (Print): January 2017
                Publication date (Electronic): 23 December 2016
                Volume: 21
                Issue: 1
                Pages: 26-32
                Affiliations
                [1] 1Obstetrics, Gynecology & Women's Health Institute, Cleveland Clinic Lerner College of Medicine, Cleveland, OH; 2Basic Health International, San Salvador, El Salvador; 3National Unit of Control and Prevention of Cancer, Ministry of Health, San Salvador, El Salvador; 4Department of Pathology, University of Southern California, Los Angeles, CA; 5Division of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, MD; 6Albert Einstein College of Medicine, Bronx, NY; 7Global Coalition Against Cervical Cancer, Arlington VA; and 8Center for Health Decision Science, Harvard T.H. Chan School of Public Health, Boston, MA
                Author notes
                Correspondence to: Miriam Cremer, MD, MPH, Obstetrics, Gynecology & Women's Health Institute, Cleveland Clinic Lerner College of Medicine, 9500 Euclid Ave, Cleveland, OH. E-mail: bhisubmissions@ 123456gmail.com
                Article
                Publisher ID: LGT50163 Accession ID: 00007
                DOI: 10.1097/LGT.0000000000000280
                PMC ID: 5201413
                PubMed ID: 27922905
                SO-VID: a15ce013-04b4-4647-afd0-0e48acf61985
                Copyright © © 2016, American Society for Colposcopy and Cervical Pathology
                History
                Page count
                Pages: 0
                Categories
                Subject: Original Research Articles: Cervix and HPV

                Keywords: cervical cancer,human papillomavirus,screening and care of human papillomavirus
                Data availability:
                Keywords: cervical cancer, human papillomavirus, screening and care of human papillomavirus

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