Screening Test Accuracy of a Gynocular™, HR-HPV Testing, and VIA for Detection of Cervical Intraepithelial Neoplasia, Grade Two and Above, in Women Living With HIV in Lusaka, Zambia
试验速览
- 阶段
- 不适用
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Test accuracy (sensitivity, specificity) of the Gynocular™ when used as stand-alone tests to detect CIN2+
研究概览
简要总结
Cervical cancer in HIV-positive women is largely preventable through regular screening. The World Health Organization (WHO) recommends cervical screening for HIV-positive women every three years. Currently the least costly method for screening and the most viable option for many countries is visual inspection after application of acetic acid (VIA). Alternative testing methods are HPV testing and assessment with a portable magnification device. The investigators plan to assess and compare the screening test accuracy of these screening tests in women living with HIV. All women will receive histopathology reference standard.
详细描述
The simplest and least costly method for cervical cancer screening is visual inspection after application of acetic acid (VIA). However, the ability of this screening method to correctly identify precancerous lesions (sensitivity) and women free from these lesions (specificity) is limited. The investigators aim to identify alternative screening methods which maximize sensitivity and specificity, particularly in HIV-infected women in receiving care in Southern Africa. The investigators will evaluate the screening test accuracy of a new portable magnification device , the Gynocular™ with Swede score assessment, in women who are HIV-positive and eligible for cervical cancer screening. The investigators will assess the accuracy of the device when used as a stand alone test, as well as when used subsequent to positive VIA or HPV tests. The investigators will make comparisons with current screening practices (VIA alone), as well as, recommended screening practices (HPV testing). The investigators will enrol 450 HIV-positive women receiving care for HIV/AIDS at the Centre for Infectious Disease Research in Zambia, in Lusaka, Zambia. Consenting women will be screened with VIA, HPV testing and visual assessment with Gynocular™. All women undergo biopsy (reference standard) and receive treatment as indicated and in accordance with national guidelines.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •HIV-infected women confirmed through medical records
- •Women residing within Lusaka district and plans to stay in this area for the next 6 months
- •Women between 18 and 65 years of age (age bracket as per Zambian guidelines for cervical cancer screening)
- •Able and willing to consent
- •Willing to undergo a pelvic examination and cancer screening
- •Has had sexual intercourse before
- •Agrees to have follow-up appointment in 6 months
排除标准
- •Women with a history of cervical cancer or previous hysterectomy (where the cervix was also removed)
- •Pregnant women or women who plan to get pregnant within the next 6 months
- •Women who have been vaccinated against HR-HPV
结局指标
主要结局
Test accuracy (sensitivity, specificity) of the Gynocular™ when used as stand-alone tests to detect CIN2+
时间窗: 6 months
To estimate the sensitivity and specificity of the Gynocular when used as a standalone tests to detect CIN2+ among WLHIV.
Test accuracy (sensitivity, specificity) of HR-HPV when used as stand-alone tests to detect CIN2+
时间窗: 6 months
To estimate the sensitivity and specificity of HR-HPV when used as a standalone tests to detect CIN2+ among WLHIV.
Test accuracy (sensitivity, specificity) of VIA when used as stand-alone tests to detect CIN2+
时间窗: 6 months
To estimate the sensitivity and specificity of VIA when used as a standalone tests to detect CIN2+ among WLHIV.
次要结局
- Investigations to inform telemedicine capacity: use of static images(6 months)
- Diagnostic test accuracy of HR-HPV testing followed by AI tool to detect CIN2+/HSIL: test combination(6 months)
- Diagnostic test accuracy of the Gynocular™to detect CIN2+/HSIL: other estimates, stand alone(6 months)
- Diagnostic test accuracy of HR-HPV testing followed by Gynocular™ to detect CIN2+/HSIL: test combination(6 months)
- Diagnostic test accuracy of the Gynocular™ followed by HR-HPV testing to detect CIN2+/HSIL: test combination subgroup analyses(6 months)
- Diagnostic test accuracy VIA followed by Gynocular™ to detect CIN2+/HSIL: test combination(6 months)
- Investigations to inform telemedicine capacity: Comparison of image quality(6 months)
- Diagnostic test accuracy of HR-HPV testing to detect CIN2+/HSIL: other estimates, stand alone(6 months)
- Diagnostic test accuracy of VIA to detect CIN2+/HSIL: other estimates, stand alone(6 months)
- Diagnostic test accuracy of HR-HPV testing followed by Gynocular™ to detect CIN2+/HSIL: test combination - subgroup analyses(6 months)
- Diagnostic test accuracy of the Gynocular™ followed by HR-HPV testing to detect CIN2+/HSIL: test combination(6 months)
- Diagnostic test accuracy of the Gynocular™ followed by VIA to detect CIN2+/HSIL: test combination(6 months)
- Diagnostic test accuracy of the HR-HPV followed by VIA to detect CIN2+/HSIL: test combination(6 months)
- Subgroup analyses for the diagnostic test accuracy of HR-HPV testing: stand alone test(6 months)
- Subgroup analyses for the diagnostic test accuracy of VIA, HR-HPV testing and Gynocular™: Combined tests(6 months)
- Investigation of Swede Score in WLHIV(6 months)
- Investigation of co-infections of premalignant and malignant disease (STIs/HR-HPV)(6 months)
- Diagnostic test accuracy VIA followed by Gynocular™ to detect CIN2+/HSIL: test combination - subgroup analyses(6 months)
- Diagnostic test accuracy of the HR-HPV followed by VIA to detect CIN2+/HSIL: test combination - subgroup analyses(6 months)
- Diagnostic test accuracy of the VIA followed by HR-HPV to detect CIN2+/HSIL: test combination(6 months)
- Diagnostic test accuracy of the VIA followed by HR-HPV to detect CIN2+/HSIL: test combination subgroup analyses(6 months)
- Diagnostic test accuracy of the Gynocular™ followed by VIA to detect CIN2+/HSIL: test combination - subgroup analyses(6 months)
- Subgroup analyses for the diagnostic test accuracy of Gynocular™: stand alone test(6 months)
- Investigation of Trichomonas vaginalis prevalence and persistence in association with menstrual hygiene practices(6 months)
- Diagnostic test accuracy of AI tool to detect CIN2+/HSIL: other estimates, stand alone(6 months)
- Subgroup analyses for the diagnostic test accuracy of VIA: stand alone test(6 months)
- Investigations to inform telemedicine capacity: ROC curve for Swede score(6 months)
- Artificial Intelligence (AI) for improving the detection of precancerous cervical lesions: testing AI algorithm(6 months)
- Artificial Intelligence for improving the detection of precancerous cervical lesions: improve AI algorithm(6 months)
- Investigations to inform telemedicine capacity: Live versus static assessors(6 months)