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PURPOSE Detection of high-risk human papillomavirus (HPV) in self-collected vaginal samples can significantly improve participation of hard-to-reach women; however, the implementation of such an approach in a real-life setting, especially in countries with limited resources, has certain challenges. Our study aimed to evaluate the feasibility, acceptability, and efficacy of implementing an HPV self-sampling–based approach to screen a socioeconomically disadvantaged, unscreened population with support from community health workers (CHWs) for community mobilization, counseling, and navigation. Different triaging options for HPV-positive women were also assessed. METHODS Women age 30 to 65 years from low socioeconomic periurban areas who had never been screened before were motivated by CHWs to attend local community centers and provide self-collected vaginal samples for careHPV testing. Screen-positive women were informed and navigated by CHWs to attend colposcopy clinics where cervical biopsy and same-day ablative treatment were offered. RESULTS Women readily accepted to provide self-collected samples after counseling by CHWs. Screen positivity was 6.4%, and CHWs successfully navigated 65% of HPV-positive women to colposcopy. Cervical intraepithelial neoplasia (CIN) 2+ detection rate was 9.7 per 1,000 women screened. The HPV test had a positive predictive value of 15.3% to detect CIN 2+ lesions. Triage using visual inspection with acetic acid significantly improved the positive predictive value (49.5% to detect CIN 2+), but missed a significant number of CIN 2+ lesions. Colposcopy sensitivity was also suboptimal. Of 51 women with lesions, 80% underwent ablative treatment and the majority accepted same-day treatment. CONCLUSION CHW-driven self-sampling for HPV testing is feasible, well-accepted, and effective for screening unscreened hard-to-reach women. The screen-and-treat approach can ensure strong linkage between screening and treatment.

e17015 Background: Cervical cancer, a malignancy caused by human papillomavirus (HPV) infection, is the most common malignancy in women living in sub-Saharan African countries including Kenya. HIV co-infection accelerates the natural course of cervical cancer. To determine the specific HPV type distribution in HIV-infected women compared to HIV-uninfected women, with and without evidence of cervical dysplasia. Methods: Demographic information, behavioral data, and a cervical swab were collected from women 18 and 45 years of age, HIV-infected or HIV-uninfected, who presented for cervical cancer screening at Moi Referral and Teaching Hospital in Eldoret, Kenya. Women were triaged based on the presence or absence of cervical dysplasia. HPV testing was performed using the Roche Linear Array Assay. Results were compared between women with or without HIV co-infection and between those with or without cervical dysplasia, using Chi-square tests or Fisher’s exact tests. Results: 223 women had normal VIAs. All had HPV testing, 221 had valid results: 115 HIV-infected women (mean age 37 years) and 106 HIV-uninfected (mean age 33 years). 175 women had abnormal VIAs. 143 women had HPV testing performed, 140 had valid results: 70 HIV-infected women (mean age 38.5 years) and 70 HIV-uninfected (mean age 31.3 years). Greater than 90% of all HIV-infected women in both projects were receiving anti-retroviral therapy at enrollment. HPV of any type was detected in 48% of all women with normal VIA vs. 61% of women with abnormal VIA (P = 0.018). High risk (HR)-HPV was detected in 38% of all women with normal VIA vs. 51% of all women with abnormal VIA (P = 0.012). HIV-uninfected women with normal VIA had significantly lower detection of all HPV (P = 0.026), high risk-HPV (P = 0.018), IARC high risk-HPV (P = 0.047), A9 types (P = 0.050), and individual types HPV 16 (P = 0.0274), HPV 18 (P = 0.007), and HPV 51 (P = 0.009) than HIV-uninfected women with abnormal VIA. Among HIV-infected women, there was no difference in detection of any group of HPV types or individual types with respect to VIA results. Conclusions: HIV-uninfected women without cervical dysplasia had lower detection of oncogenic HPV than HIV-uninfected women with dysplasia. In contrast, HPV detection did not differ among HIV-infected women between those with or without cervical dysplasia. In addition, VIA appears to lack specificity for HPV-associated cervical dysplasia, as 39% of women with abnormal VIA examinations did not have any HPV detected, and 49% of women with abnormal VIA examinations did not have any HR-HPV detected.

6045 Background: HPV-related patients (pts) with locally advanced head and neck cancers (LA-HNCs) have a better prognosis than the HPV-negative ones. This study aimed to investigate the prevalence ...

5543 Background: HPV testing is now widely advocated in the work up of oropharyngeal squamous cell carcinoma (OPSCC). The "gold standard" for oncogenic HPV detection is the demonstration of transcriptionally active high-risk HPV in fresh tumour tissue. For clinical utility, testing strategies have necessarily focused on formalin-fixed paraffin-embedded (FFPE) tissue, but this has been at the expense of reduced sensitivity and specificity for oncogenic HPV. This study evaluates a novel RNA-based in situ hybridisation test against the analytical gold standard; detection of high-risk HPV mRNA, derived from fresh frozen tissue samples, by quantitative reverse transcriptase polymerase chain reaction (qPCR). Methods: A tissue-microarray comprising FFPE cores from 79 OPSCC was tested using High Risk HPV RNAscope (Advanced Cell Diagnostics, USA) for HPV16, 18, 31, 33, 35, 52, and 58. Analytical accuracy and capacity for prognostic discrimination was determined by comparison with HPV RNA qPCR for HPV16, 18 and 33. Demographic and tumour parameters were compared by Chi-squared and Kruskal-Wallis tests. Test sensitivity and specificity were calculated against the standard. Kaplan–Meier survival estimates were constructed to assess prognostication. Results: High risk HPV RNAscope had sensitivity and specificity of 97% and 93% respectively (PPV 91%, NPV 98%) by comparison to the gold standard. Kaplan-Meier estimates of disease specific survival (DSS, p=0.002) and overall survival (OS, p

5581 Background: Infection with high-risk HPV is involved in 90%-100% of cervical cancers. HPV detection in cervical cells, used as a supporting test for Pap smear positive patients, are much more sensitive than cytology but less specific for ongoing cervical cancer. Cervical cancer is one of the most common female tumors in countries lacking a screening program such as India. In this study we investigate the feasibility of a urine-based HPV DNA test. Methods: Matching urine and cervical samples were collected from 270 high-risk subjects from STD clinics or district brothels in West Bengal, and 50 low-risk subjects with no known predisposition to disease recruited in Mumbai. The Xenomics HPV DNA test involves isolation of DNA from urine and specific PCR amplification of the HPV E1 region to detect the presence of high-risk HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68. Results were compared to the hc2 high-risk HPV DNA Test (QIAGEN). Discordant samples were resolved by DNA sequencing. Results: Of 320 patients, 248 samples (77.5%) were concordant between the Xenomics and hc2 assays. Of the discordant samples reactive by Xenomics but nonreactive by hc2, 31/38 (81.6%) contained high-risk HPV by DNA sequencing. 10 out of 34 (29.4%) of samples detected by hc2 but not by Xenomics were shown to contain high-risk HPV. Using DNA sequencing as the gold standard, the Xenomics test false negative and false positive rates were 10/180 (5.6%) and 7/140 (5.0%), respectively. The hc2 assay had a false negative and false positive rate of 31/184 (16.8%) and 24/136 (17.6%), respectively. Conclusions: HPV DNA can be isolated from urine samples and detected with sensitivity and specificity equal to or better than current assays based on cervical scraping. [Table: see text]