Dataset Information

Prospective Evaluation of Cervicovaginal Self- and Cervical Physician Collection for the Detection of Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium Infections.

ABSTRACT: BACKGROUND:This study aimed to examine the agreement between sexually transmitted infection (STI) screening using self-collected specimens and physician-collected specimens, and to investigate the acceptability of self-collection for screening in an 18-month study of female sex workers in a high-risk, low-resource setting. METHODS:A total of 350 female sex workers in Nairobi, Kenya, participated in a prospective study from 2009 to 2011. Women self-collected a cervicovaginal specimen. Next, a physician conducted a pelvic examination to obtain a cervical specimen. Physician- and self-collected specimens were tested for Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium (MG) using Aptima nucleic acid amplification assays (Hologic). Specimens were collected at 3-month intervals over 18-month follow-up. ? Statistics measured agreement of positivity between self-collection and physician collection. RESULTS:Baseline STI prevalence was 2.9% for N. gonorrhoeae, 5.2% for C. trachomatis, 9.2% for T. vaginalis, and 20.1% for MG in self-collected samples, and 2.3%, 3.7%, 7.2%, and 12.9%, respectively, in physician-collected samples. ? Agreement was consistently strong (range, 0.66-1.00) for all STIs over the 18-month study period, except for MG, which had moderate agreement (range, 0.50-0.75). Most participants found self-collection easy (94%) and comfortable (89%) at baseline, with responses becoming modestly more favorable over time. CONCLUSIONS:Self-collected specimen screening results showed strong agreement to clinical-collected specimens, except for MG, which was consistently detected more commonly in self-collected than in physician-collected specimens. Acceptability of the self-collection procedure was high at baseline and increased modestly over time. In high-risk, low-resource settings, STI screening with self-collected specimens provides a reliable and acceptable alternative to screening with physician-collected specimens.

SUBMITTER: Lockhart A

PROVIDER: S-EPMC7398605 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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Prospective Evaluation of Cervicovaginal Self- and Cervical Physician Collection for the Detection of Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium Infections.

Lockhart Alexandre A Psioda Matt M Ting Jie J Campbell Sara S Mugo Nelly N Kwatampora Jessie J Chitwa Michael M Kimani Joshua J Gakure Anne A Smith Jennifer S JS

Sexually transmitted diseases 20180701 7

<h4>Background</h4>This study aimed to examine the agreement between sexually transmitted infection (STI) screening using self-collected specimens and physician-collected specimens, and to investigate the acceptability of self-collection for screening in an 18-month study of female sex workers in a high-risk, low-resource setting.<h4>Methods</h4>A total of 350 female sex workers in Nairobi, Kenya, participated in a prospective study from 2009 to 2011. Women self-collected a cervicovaginal specim ...[more]

PMID: 29465667

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Project description:BACKGROUND:The vaginal microbiota may modulate susceptibility to human papillomavirus (HPV), Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium infections. Persistent infection with a carcinogenic HPV is a prerequisite for cervical cancer, and C. trachomatis, N. gonorrheae and M. genitalium genital infections are all associated with pelvic inflammatory disease and subsequent infertility issues. OBJECTIVES:To evaluate the association between these infections and the vaginal microbiota. DATA SOURCES:The search was conducted on Medline and the Web of Science for articles published between 2000 and 2016. STUDY ELIGIBILITY CRITERIA:Inclusion criteria included a measure of association for vaginal microbiota and one of the considered STIs, female population, cohort, cross-sectional and interventional designs, and the use of PCR methods for pathogen detection. METHODS:The vaginal microbiota was dichotomized into high-Lactobacillus vaginal microbiota (HL-VMB) and low-Lactobacillus vaginal microbiota (LL-VMB), using either Nugent score, Amsel's criteria, presence of clue cells or gene sequencing. A random effects model assuming heterogeneity among the studies was used for each STI considered. RESULTS:The search yielded 1054 articles, of which 39 met the inclusion criteria. Measures of association with LL-VMB ranged from 0.6 (95% CI 0.3-1.2) to 2.8 (95% CI 0.3-28.0), 0.7 (95% CI 0.4-1.2) to 5.2 (95% CI 1.9-14.8), 0.8 (95% CI 0.5-1.4) to 3.8 (95% CI 0.4-36.2) and 0.4 (95% CI 0.1-1.5) to 6.1 (95% CI 2.0-18.5) for HPV, C. trachomatis, N. gonorrhoeae and M. genitalium infections, respectively. CONCLUSIONS:Although no clear trend for N. gonorrhoeae and M. genitalium infections could be detected, our results support a protective role of HL-VMB for HPV and C. trachomatis. Overall, these findings advocate for the use of high-resolution characterization methods for the vaginal microbiota and the need for longitudinal studies to lay the foundation for its integration in prevention and treatment strategies.

Project description:BackgroundTimely detection and treatment are important for the control of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. The objective of this study was to measure the performance of the Visby Medical Sexual Health Test, a single-use, point-of-care PCR device.MethodsWomen aged 14 years and older who presented consecutively to ten clinical sites across seven US states were enrolled for a cross-sectional, single-visit study. Patients who consented to participate, and who had not used any exclusionary products in the genital area in the previous 48 h, provided self-collected vaginal swabs for testing with the investigational device. Untrained operators received the specimens and ran the device using the guide provided. Specimens had to be run within 2 h of collection to be considered valid. For comparison, patient-infected status was derived by testing clinician-collected vaginal specimens with the Hologic Aptima Combo 2 Assay and Aptima Trichomonas vaginalis Assay, as well as the BD ProbeTec CT/GC Qx Amplified DNA Assay and BD ProbeTec Trichomonas vaginalis Qx Assay. If the results of those assays did not match, the BD MAX CT/GC/TV was used as a tiebreaker. The primary outcomes were the sensitivity and specificity of the investigational device for the detection of C trachomatis, N gonorrhoeae, and T vaginalis compared with patient-infected status.FindingsBetween Feb 25, 2019, and Jan 6, 2020, 1585 participants aged between 14 years and 80 years (mean 34·8 [SD 14·2]) were enrolled. 1555 participants had tests run with the investigational device, of whom 1532 (98·5%) had a valid result on either the first or repeat test. Among the patients with evaluable results (including a determinate patient-infected status), the device had a sensitivity of 97·6% (95% CI 93·2-99·2) and specificity of 98·3% (97·5-98·9) for C trachomatis (n=1457), sensitivity of 97·4% (86·5-99·5) and specificity of 99·4% (98·9-99·7) for N gonorrhoeae (n=1468), and sensitivity of 99·2% (95·5-99·9) and specificity of 96·9% (95·8-97·7) for T vaginalis (n=1449).InterpretationThis innovative, rapid, easy-to-use, single-use, point-of-care device to detect C trachomatis, N gonorrhoeae, and T vaginalis infections showed excellent sensitivity and specificity, and could represent an important advance in the development of rapid diagnostics for sexually transmitted infections and other infectious diseases.FundingDivision of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases.

Dataset Information

Prospective Evaluation of Cervicovaginal Self- and Cervical Physician Collection for the Detection of Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium Infections.

Publications

Prospective Evaluation of Cervicovaginal Self- and Cervical Physician Collection for the Detection of Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium Infections.

Similar Datasets

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