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Targeted point-of-care testing compared with syndromic management of urogenital infections in women (WISH): a cross-sectional screening and diagnostic accuracy study

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Show simple item record Verwijs, M. C. en_US Agaba, S. K. en_US Sumanyi, J. C. en_US Umulisa, M. M. en_US Mwambarangwe, L. en_US Musengamana, V. en_US Uwineza, M. en_US Cuylaerts, V. en_US Crucitti, T. en_US Jespers, V. en_US van de Wijgert, J. H. H. M. en_US 2020-08-25T09:58:12Z 2020-08-25T09:58:12Z 2019 en_US
dc.identifier.issn 1473-3099 en_US
dc.identifier.doi en_US
dc.identifier.other en_US
dc.identifier.other 30 en_US
dc.identifier.other ITG-C8A; ITG-C9A; ITG-H11X; MULTI; DCS; U-ARLAB; DPH; U-ECHIV; JIF; DOI; PDF; Abstract; ITMPUB; DSPACE68 en_US
dc.description.abstract BACKGROUND: Sexually transmitted and urogenital infections are typically managed by WHO-recommended syndromic algorithms in resource-poor countries, and presumptively in Europe. However, algorithms for vaginal discharge and lower abdominal pain perform poorly in women. The women's improvement of sexual and reproductive health (WISH) study in Kigali, Rwanda, sought to improve case-finding and infection management in women by introducing point-of-care tests. The main aim was to compare the performance of the WISH algorithms and the WHO vaginal discharge and lower abdominal pain algorithms with gold standard testing. METHODS: This cross-sectional screening and diagnostic accuracy study recruited women aged 18 years or older with or without urogenital symptoms at risk of acquiring sexually transmitted infections in Kigali, Rwanda. Recruitment activities were implemented by study staff with the help of community mobilisers at health centres, pharmacies, markets, women's organisations, and at "umuganda" community meetings. At the study visit, participants had a face-to-face interview that included questions about current urogenital symptoms. Participants were first asked without prompting (spontaneous reporting), followed by questions about 14 specific symptoms (structural reporting). Next, the WISH algorithms were implemented. All participants had point-of-care tests for bacterial vaginosis (vaginal pH of 5.0 or above) and Trichomonas vaginalis (immunoassay) regardless of symptom reporting. Women with a positive risk score had point-of-care tests for Chlamydia trachomatis and Neisseria gonorrhoea (nucleic acid amplification tests). Vulvovaginal candidiasis was treated presumptively. Nucleic acid amplification tests for C trachomatis, N gonorrhoeae, T vaginalis, bacterial vaginosis, and vulvovaginal candidiasis were the gold standard, and all patients provided swabs for these. FINDINGS: Participants were recruited between July 5, 2016, and March 14, 2017. 705 participants were enrolled in the study and completed a study visit, and 51 attended 53 additional visits. Prevalence by gold standard testing was 8.5% for C trachomatis, 7.1% for N gonorrhoeae, 16.1% for T vaginalis, 18.1% for bacterial vaginosis, and 8.6% for vulvovaginal candidiasis. The WISH algorithms identified similar numbers of C trachomatis, N gonorrhoeae, and T vaginalis infections, but much higher numbers of bacterial vaginosis and vulvovaginal candidiasis infections. Compared with gold standard testing, the WISH algorithms had a good sensitivity and high specificity for C trachomatis (sensitivity 71.7%, specificity 100%), N gonorrhoeae (sensitivity 76.0%, specificity 100%), and T vaginalis (sensitivity 68.5%, specificity 97.4%), high sensitivity but low specificity for bacterial vaginosis (sensitivity 95.2%, specificity 41.2%), and moderate sensitivity and specificity for vulvovaginal candidiasis (sensitivity 64.4%, specificity 69.4%). The performance of vaginal pH testing for bacterial vaginosis improved by increasing the cutoff to 5.5, followed by confirmatory testing (sensitivity 73.6%, specificity 100%). The WHO algorithms had moderate sensitivity and poor specificity for all infections compared with gold standard testing: C trachomatis sensitivity 58.3%, specificity 44.7%; N gonorrhoeae sensitivity 66.0%, specificity 45.2%; T vaginalis sensitivity 60.4%, specificity 45.6%; bacterial vaginosis sensitivity 61.6%, specificity 46.0%; and vulvovaginal candidiasis sensitivity 74.6%, specificity 50.6%. Two participants attended additional visits because they had a mild allergic reaction to metronidazole. Staff and participants considered point-of-care testing feasible and acceptable. INTERPRETATION: Point-of-care testing for urogenital infections might improve case-finding and infection management and is feasible in resource-poor settings. Point-of-care tests should be further developed, including those targeting multiple conditions. Additional studies in other populations, including populations with low prevalence of sexually transmitted and urogenital infections, are warranted. FUNDING: European and Developing Countries Clinical Trials Partnership. en_US
dc.language English en_US
dc.relation.uri en_US
dc.subject Urogenital infections en_US
dc.subject Sexually transmitted diseases en_US
dc.subject STD en_US
dc.subject Women en_US
dc.subject Diagnosis en_US
dc.subject Screening en_US
dc.subject Rwanda en_US
dc.subject Africa-Central en_US
dc.title Targeted point-of-care testing compared with syndromic management of urogenital infections in women (WISH): a cross-sectional screening and diagnostic accuracy study en_US
dc.type Article en_US
dc.citation.issue 6 en_US
dc.citation.jtitle Lancet Infectious Diseases en_US
dc.citation.volume 19 en_US
dc.citation.pages 658-669 en_US
dc.citation.abbreviation Lancet Infect Dis en_US

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