A community-based approach to cervical cancer prevention in western Kenya: An AMPATH feasibility project.

Objectives: Centralized programs have been ineffective in reducing the burden of cervical cancer among Kenyan women. A community-based pilot study was initiated to screen Kenyan women for cervical cancer and to vaccinate their children against human papillomavirus (HPV). Methods: Women were educated about cervical cancer prevention at community meetings. Women then provided self-collected vaginal swabs for oncogenic HPV testing using the Roche Cobas Assay. All women were then referred to the local clinic for Visual Inspection with Acetic Acid (VIA). Women were offered the quadrivalent HPV vaccine for their children if and when it became available for the study. Results: Women in western Kenya were invited to participate in community meetings. A total of 200 women were enrolled: 151 (75.5%) were HIV-uninfected and 49 (24.5%) were HIV-infected; the median age for all women was 42 years. High-risk (HR)-HPV types were detected in 49 of swabs from all 200 participants (24.5%) including 20.5% of HIV-uninfected women and 36.7% of HIV-infected women (P = .022). VIA was performed on 198 women: 192 had normal examinations and six had abnormal examinations. Five cervical biopsies revealed two cases of CIN 2 and one CIN 3. Although all mothers were willing to have their children (N = 432) vaccinated, the HPV vaccine could not be delivered to Kenya during the study period. Conclusions: Kenyan women were willing to attend community meetings to learn about prevention of cervical cancer, to provide self-collected vaginal swabs for HPV testing, to travel to the Webuye Clinic for VIA following the collection of swabs, and to have their children vaccinated against HPV. HR-HPV was prevalent, especially in HIV-infected women. As a result of this pilot study, this community-based strategy to prevent cervical cancer will be continued in western Kenya.

Evaluation of reliability of self-collected vaginal swabs over physician-collected samples for diagnosis of bacterial vaginosis, candidiasis and trichomoniasis, in a resource-limited setting: a cross-sectional study in India.

OBJECTIVES: Self-collected vaginal swabs can facilitate diagnosis of vaginal discharge (VD) in resource-limited settings, provided reliability of the method is established. The aim of this study was to evaluate the concordance between self-collected and physician-collected vaginal swabs for aetiological diagnosis of VD and to determine the prevalence of bacterial vaginosis (BV), vulvovaginal candidiasis (VVC) and trichomonas vaginitis (TV). METHODS: A total of 550 females (median age: 32 years; range: 18-45 years) attending two sexually transmitted infection/reproductive tract infection (STI/RTI) clinics with VD from January 2015 to May 2016 were included in the study after obtaining written informed consent. Swabs were self-collected by patients after instructions and subsequently by a physician under speculum examination. Samples were processed for standard bedside tests, Gram staining, wet mount and culture (gold standard) according to the national guidelines. Concordance between the two methods was determined by the Cohen's kappa value. RESULTS: BV, VVC and TV were diagnosed in 79 (14.4%), 144 (26.2%) and 3 (0.5%) patients, respectively. VVC coexisted with BV in 58 (10.5%) patients. There was no coinfection of TV with BV or VVC. Candida albicans was isolated in 84 (58.3%) VVC cases. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of self-collected swabs for diagnosing BV was 91.1%, 100%, 100% and 98.5%, respectively, while for the C. albicans VVC and TV, sensitivity, specificity, PPV and NPV all were 100% as compared with physician-collected swabs. Highly concordant results were obtained between two methods by the Kappa values of 0.95 (BV), 0.99 (VVC) and 1.0 (TV). CONCLUSION: The comparative performance of self-collected and physician-collected vaginal swabs establishes self-collection of samples for BV, VVC and TV as a viable alternative tool in the management of STIs/RTIs, especially in peripheral and resource-constrained settings. This would be effective in implementing the diagnostic approaches for STIs/RTIs in community-based surveillance studies at national or regional level and therefore strengthening the National STI/RTI Control Programme.

Acceptability of study procedures (self-collected introital swabs, blood draws and stool sample collection) by students 10-16 years for an HPV vaccine effectiveness study: a pilot study.

BACKGROUND: A cohort study was planned to evaluate vaccine immunogenicity and effect of malaria and helminth co-infections on the bivalent Human papilloma virus (HPV) vaccine. The study would involve self collected introital swabs, blood draws and stool sample collection. We therefore conducted a pilot study to assess the acceptability of these procedures among the students and their parents. RESULTS: A cross-sectional study among forty four students from two purposively selected primary schools of Western Uganda. Exit interviews and two focus group discussions (FGD) (for parents) were conducted. Acceptability was measured by willingness to undergo the procedures again, recommending the procedures to others as well as proportion of introital swabs positive for ß globulin. FGD determined acceptability of the parents and explored opinions and perceptions that would influence their decisions. HPV-16/18 and ß globulin deoxyribonucleic acid (DNA) were analysed using a polymerase chain reaction (PCR) kit. All the students (100%) in the study were willing to provide a self- collected introital swab and a stool sample as well as recommending their friends while (86.3%) were willing for blood draws. There were 40/44 (90.1%) self collected introital swabs that had positive result for human ß globulin though none of them was positive for HPV-16/18. In the FGD, it emerged that parents concerns were on the blood draws and introital swab collection which were addressed. CONCLUSIONS: The study procedures were highly acceptable among this study population of students and their parents. Follow-up to assess HPV vaccine effectiveness and factors that may influence the vaccine in this age group is feasible.

Experiencia con un método de autotoma de muestra vaginal para la detección de infección por Chlamydia trachomatis y Neisseria gonorrhoeae en mujeres jóvenes / Screening of Neisseria gonorrhoeae and Chlamydia trachomatis using techniques of self collected vaginal sample in young women

Chlamydia trachomatis and Neisseria gonorrhoeae are responsible for 3-10% of sexually transmitted diseases in adolescents. 75% are asymptomatic. International standards recommend annual screening for C. trachomatis in sexually active women under 26 years. Self-collected vaginal swab is one of the less invasive screening methods, it is well accepted by patients and rarely used in our country. Aim: To determine the frequency of C. trachomatis and N. gonorrhoeae by a self-sampling method of vaginal swab and its acceptability in a group of adolescents and young adults. Patients and Methods: Women 18 to 25 years old. Vaginal samples were processed by nucleic acid amplification tests, Gen Probe APTIMA Combo2. Data were collected on sexual behavior and perception of self-sampling by survey. Results: We studied 344 patients with an average age of 21.7 years. Detection of C. trachomatis was positive in 7.9% women and it was not found in any of the patients studied for N. gonorrhoeae. 98% considered self-sampling instructions easy to understand, 87.5% felt comfortable taking the sample. Conclusions: Prevalence of C. trachomatis in the study population was similar to that described in other national and international studies. N. gonorrhoeae was not found in this series, which is consistent with literature reports. The self-sampling technique of vaginal sample was well accepted by the patients. However, they were anxious about the quality of the sample. According to our results, it is important to emphasize the importance of annual detection of these pathogens and that self-sampling technique is a valid alternative.

Chlamydia trachomatis y Neisseria gonorrhoeae son causantes de 3 a 10% de las infecciones de transmisión sexual en adolescentes. Las normas internacionales recomiendan su detección anual en mujeres sexualmente activas menores de 26 años. La adherencia a este tamizaje en mujeres jóvenes está limitada por el temor al examen ginecológico y alto costo del examen. Objetivo: Determinar la frecuencia de detección de C. trachomatis y N. gonorrhoeae por un método de auto-toma de muestra vaginal y su aceptabilidad en un grupo de adolescentes y jóvenes adultas. Pacientes y Método: Se incluyeron mujeres de 18 a 25 años atendidas en Clínica Las Condes y el Servicio de Salud Estudiantil de la Universidad de Chile, que fueron instruidas para autotoma de muestra vaginal. Luego de dar su consentimiento, las muestras fueron estudiadas mediante reacción de polimerasa en cadena para la detección de C. trachomatis y N. gonorrhoeae. Se recopilaron datos sobre conductas sexuales y percepción de la autotoma mediante encuesta. Se determinó la relación entre estos factores y la aceptabilidad del método. Resultados: Se reclutaron 344 mujeres, con una edad promedio de 21,7 años. La detección de C. trachomatis fue de 7,9% y no se encontró muestra positiva para N. gonorrhoeae. El reporte de flujo vaginal por la paciente se asoció a 1,5 veces mayor riesgo de C. trachomatis. El 98% consideró las instrucciones de la autotoma fáciles de entender, 87,5% se sintió cómoda al tomar la muestra. Conclusiones: La prevalencia de C. trachomatis en la población estudiada fue similar a lo descrito en otras series nacionales e internacionales; no se encontró N. gonorrhoeae en esta serie, lo que coincide con lo reportado en el extranjero. La técnica de autotoma de muestra vaginal fue bien aceptada por las pacientes; sin embargo, manifestaron ansiedad acerca de la seguridad de una toma adecuada. De acuerdo a nuestros resultados, es importante insistir en la detección anual de estos patógenos siendo la técnica de autotoma una alternativa válida.

Performance of cobas® 4800 and m2000 real-time™ assays for detection of Chlamydia trachomatis and Neisseria gonorrhoeae in rectal and self-collected vaginal specimen.

A prospective, multicenter trial was designed to compare the performance characteristics of the cobas® 4800 (Roche Diagnostics, Indianapolis, IN, USA) and m2000 real-time™ (Abbott Molecular Inc., Des Plaines, IL, USA) assays for detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) in rectal and self-collected vaginal swabs. Rectal (n = 234) or self-collected vaginal swabs (n = 687) were obtained from consenting individuals visiting their general practitioners, dermatologists, gynecologists, sexually transmitted disease clinics, or family planning centers from May 2010 to February 2011. High concordance rates (≥96%) were observed between the cobas® 4800 and m2000 real-time™ assays for CT/NG detection in both rectal and self-collected vaginal swabs. The performance profiles confirm the usefulness of both kinds of swab types for CT and NG detection using described nucleic acid amplification tests assays. Based on this study, rectal and self-collected vaginal swabs offer a noninvasive alternative, which may improve screening for CT and NG infections.