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Performance of OncoE6TM Cervical Test in detecting cervical precancer lesions in HIV-positive women attending an HIV clinic in Bujumbura, Burundi: a cross-sectional study.

ABSTRACT: OBJECTIVE:New rapid and low-cost molecular tests for cervical cancer screening, such as the OncoE6 Cervical Test, are emerging and could be alternatives for low-income and middle-income countries. To this end, we evaluated the clinical performance of the OncoE6 Cervical Test in detecting cervical intraepithelial neoplasia (CIN) among HIV-infected women in Bujumbura, Burundi. METHODS:From June to December 2017, a cross-sectional study was conducted in 680 HIV-positive women at the University Hospital. Women aged 25-65 years who declared having had vaginal intercourse were consecutively recruited, and cervical specimens for OncoE6, liquid-based cytology and human papillomavirus (HPV) genotyping were obtained and visual inspection with acetic acid performed. Thereafter, participants underwent a colposcopic examination. The sensitivity, specificity, and positive and negative predictive values of the different tests were calculated with reference to 'colposcopic-histological' diagnoses, and areas under the receiver operating curves of OncoE6 and cytology tests were compared. RESULTS:The prevalence of CIN was 4.9%, and OncoE6 positivity was 3.1%. OncoE6 sensitivity varied from poor to low with increasing disease severity (42.1%, 95% CI 19.9% to 64.3% at CIN2+ threshold; and 58.3%, 95% CI 30.4% to 86.2% at CIN3+ threshold). OncoE6 had the highest specificity compared with all other tests used together. The performance of the OncoE6 test was significantly lower compared with cytology at atypical squamous cell of undetermined significance (ASCUS+) cut-off (AUC=0.68 vs 0.85, p=0.03) and low-grade squamous intraepithelial lesion (LSIL+) cut-off (AUC=0.68 vs 0.83, p=0.04) for CIN2+ diagnoses. However, the performance of the OncoE6 test was similar to that of cytology at high-grade squamous intraepithelial lesion (HSIL+) cut-off (AUC=0.68 vs 0.76; p=0.30) for CIN2+ diagnoses and was also similar to that of cytology at all cut-offs (ASCUS+, LSIL+ and HSIL+) for CIN3+ diagnoses (p1=0.76, p2=0.95 and p3=0.50, respectively). CONCLUSION:The current OncoE6 test proved to be a point-of-care test. However, given its poor performance for CIN2+ diagnoses, we do not recommend it for primary screening. We recommend to enrich it with more oncogenic HPV types, which may improve the performance of the test akin to that of cytology.

SUBMITTER: Ndizeye Z

PROVIDER: S-EPMC6731839 | biostudies-other | 2019 Sep

REPOSITORIES: biostudies-other

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Performance of OncoE6<sup>TM</sup> Cervical Test in detecting cervical precancer lesions in HIV-positive women attending an HIV clinic in Bujumbura, Burundi: a cross-sectional study.

Ndizeye Zacharie Z Menon Sonia S Van Geertruyden Jean-Pierre JP Sauvaget Catherine C Jacquemyn Y Y Bogers John-Paul JP Benoy Ina I Vanden Broeck Davy D

BMJ open 20190906 9

<h4>Objective</h4>New rapid and low-cost molecular tests for cervical cancer screening, such as the OncoE6 Cervical Test, are emerging and could be alternatives for low-income and middle-income countries. To this end, we evaluated the clinical performance of the OncoE6 Cervical Test in detecting cervical intraepithelial neoplasia (CIN) among HIV-infected women in Bujumbura, Burundi.<h4>Methods</h4>From June to December 2017, a cross-sectional study was conducted in 680 HIV-positive women at the ...[more]

PMID: 31494606

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Project description:Although screening for cervical cancer is recommended for women in most countries, the incidence of cervical cancer is greater in developing countries. Our goal was to determine the prevalence and factors associated with high-grade lesions/cervical cancer among women attending a reference clinic in Brazil and evaluate the correlation of histology with cytology, colposcopy and the high-risk HPV (HR-HPV) tests.A cross-sectional study of women attending a colposcopy clinic was carried out. The patients were interviewed to collect demographic, epidemiological and clinical data. Specimens were collected for cervical cytology, Chlamydia trachomatis and HPV testing using the Hybrid Capture (HC) and PCR tests. Colposcopy was performed for all patients and biopsy for histology when cell abnormalities or cervical intraepithelial neoplasia (CIN) were present.A total of 291 women participated in the study. The median age was 38 years (DIQ: 30-48 years). The prevalence of histologically confirmed high-grade lesions/cervical cancer was 18.2% (95%, CI: 13.8%-22.6%), with 48 (16.5%) cases of CIN-2/CIN-3 and 5 (1.7%) cases of invasive carcinoma. In the final logistic regression model, for ages between 30 and 49 years old [OR = 4.4 (95%: 1.01-19.04), history of smoking [OR = 2.4 (95%, CI: 1.14-5.18)], practice of anal intercourse [OR = 2.4 (95%, CI: 1.10-5.03)] and having positive HC test for HR-HPV [OR = 11.23 (95%, CI: 4 0.79-26, 36)] remained independently associated with high-grade lesions/cervical cancer. A total of 64.7% of the cases CIN-3\Ca in situ were related to HPV-16. Non-oncogenic HPV were only found in CIN-1 biopsy results. Compared to histology, the sensitivity of cytology was 31.8%, the specificity 95.5%; the sensitivity of colposcopy for high-grade lesions/cervical cancer was 51.0%, specificity was 91.4% and the concordance with HPV testing was high.The results confirm an association of HR-HPV with precursor lesions for cervical cancer. These data emphasize that cytological screening to detect precursor lesions is still important in some regions and that HR-HPV should be included for screening.

Project description:BackgroundContraception helps prevent unplanned pregnancies and mother to child Human Immune Virus (HIV) transmission among human immune virus positive women. Ethiopia has made remarkable progress in increasing contraceptive use rate but there is still a disparity of contraceptive use within the country. Although there were some studies about contraceptive use in Ethiopia, evidences about contraceptive use among sexually active HIV positive women was limited. Understanding the extent of and barriers in Ethiopia is important for learning how to best improve level of contraceptive use. Therefore, this study aimed to assess contraceptives use and associated factors among HIV positive sexually active women at anti-retroviral therapy clinic at Felege Hiwot Referral Hospital ART clinic in Bahir Dar, Ethiopia.MethodA facility-based cross-sectional study was conducted from June 01-30, 2018 among (n = 308) randomly selected HIV positive women at Felege Hiwot Referral Hospital. Data were collected using a pretested interviewer-administered questionnaire and analyzed using SPSS version 20. Survey logistic regression analysis was employed to identify determinants of contraceptive use. Statistical significance was declared at p-value <0.05.ResultsOut of three hundred eight participants, 118 (38.3%) reported contraceptive use at the time of the study. Injectable is the most preferred (43.5%) contraceptive method. Participants with age 15-34 years (AOR = 3.09, 95%CI: 1.59-5.99), disclosed their status to sex partner, (AOR = 2.7, 95%CI: 1.14-6.66), had history of contraception use; (AOR = 3.36, 95%CI: 1.68-6.74), were sexually active (AOR = 5.45, 95%CI: 2.72-10.91) had higher odds of contraceptive use. However, participants who had drinking habit (AOR = 4.35, 95%CI: 1.82-10.38) had lower odds of contraceptive use.ConclusionA significant proportion of HIV positive women had low level of contraceptive use that was lower than the national recommended level. Participants with younger age (15-34years), who disclosed HIV status to sex partner, had history of contraceptive use, and who were sexually active six months prior to the study were more likely to use contraception. However, participants who had drinking habit were less likely to use contraception. These results suggest that multi-sectorial and multi-disciplinary approaches are needed to increase contraceptive use in the HIV positive women.

Project description:BackgroundHuman immunodeficiency virus (HIV) affects a highly significant number of people and is responsible for the deaths of many people in sub-Saharan African countries alone. The best prevention method for this virus is through consistent condom utilization which can help to prevent drug-resistant HIV infection and acquisition of new infection. Therefore, this study aimed to assess consistent condom utilization and associated factors among HIV-positive individuals attending an antiretroviral therapy clinic at Pawi general hospital, North West Ethiopia in 2020.MethodsAn institutional based cross-sectional study was conducted among 419 HIV-positive individuals who have follow-up in the Pawi general hospital antiretroviral therapy clinics, from January to February 2020. The study subjects were reached using a systematic sampling technique and data were collected using a pretested and structured questionnaire. Data entry and analysis were performed using epi-data version 3.1 and SPSS version 23 respectively. Binary and multivariable analyses with a 95% confidence level were performed. In the final model, variables with P < 0.05 were considered statistically significant.ResultsA total of 419 antiretroviral therapy study participants were participated in the study with a response rate of 100%. In this finding, the consistent condom utilization rate was 49.2% [95% CI: 42.2-56.5%]. After controlling for possible confounding factors, the results showed that place of residence [AOR = 2.16, 95% CI: 1.05, 4.45], marital status [AOR = 0.19, 95%CI: 0.05, 0.67], number of partners [AOR = 0.19, 95% CI: 0.07, 0.55] and level of education [AOR = 5.33, 95% CI: 1.57, 18.08] were associated factors of consistent condom utilization.ConclusionConsistent condom utilization among HIV-positive clients attending antiretroviral therapy clinics at Pawi general hospital was low. Residence, marital status, level of education and number of partners were significantly associated factors of consistent condom use. Health education program and counseling services should be started to increase knowledge about way of transmission and appropriate use of condoms, increase self-efficacy towards condom use and reduction in the number of sexual partners.

Project description:BackgroundDetermining cervical precancer risk among human immunodeficiency virus (HIV)-infected women who despite a normal Pap test are positive for oncogenic human papillomavirus (oncHPV) types is important for setting screening practices.MethodsA total of 2791 HIV-infected and 975 HIV-uninfected women in the Women's Interagency HIV Study were followed semiannually with Pap tests and colposcopy. Cumulative risks of cervical intraepithelial neoplasia grade 2 or greater (CIN-2+; threshold used for CIN treatment) and grade 3 or greater (CIN-3+; threshold to set screening practices) were measured in HIV-infected and HIV-uninfected women with normal Pap tests, stratified by baseline HPV results, and also in HIV-infected women with a low-grade squamous intraepithelial lesion (LSIL; benchmark indication for colposcopy).ResultsAt baseline, 1021 HIV-infected and 518 HIV-uninfected women had normal Pap tests, of whom 154 (15%) and 27 (5%), respectively, tested oncHPV positive. The 5-year CIN-2+ cumulative risk in the HIV-infected oncHPV-positive women was 22% (95% confidence interval [CI], 9%-34%), 12% (95% CI, 0%-22%), and 14% (95% CI, 2%-25%) among those with CD4 counts <350, 350-499, and ≥500 cells/µL, respectively, whereas it was 10% (95% CI, 0%-21%) in those without HIV. For CIN-3+, the cumulative risk averaged 4% (95% CI, 1%-8%) in HIV-infected oncHPV-positive women, and 10% (95% CI, 0%-23%) among those positive for HPV type 16. In HIV-infected women with LSIL, CIN-3+ risk was 7% (95% CI, 3%-11%). In multivariate analysis, HIV-infected HPV16-positive women had 13-fold (P = .001) greater CIN-3+ risk than oncHPV-negative women (referent), and HIV-infected women with LSIL had 9-fold (P < .0001) greater risk.ConclusionsHIV-infected women with a normal Pap result who test HPV16 positive have high precancer risk (similar to those with LSIL), possibly warranting immediate colposcopy. Repeat screening in 1 year may be appropriate if non-16 oncHPV is detected.

Dataset Information

Performance of OncoE6TM Cervical Test in detecting cervical precancer lesions in HIV-positive women attending an HIV clinic in Bujumbura, Burundi: a cross-sectional study.

Publications

Performance of OncoE6<sup>TM</sup> Cervical Test in detecting cervical precancer lesions in HIV-positive women attending an HIV clinic in Bujumbura, Burundi: a cross-sectional study.

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