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.
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.
Study Type
OBSERVATIONAL
Enrollment
450
The investigators will compare three different screening methods: visual assessment with portable magnification device , visual inspection after application of acetic acid, screening for high risk variants of HPV. All patients will receive cervical biopsies and histopathological examination.
Centre for Infectious Disease Research in Zambia
Lusaka, Zambia
RECRUITINGTest accuracy (sensitivity, specificity) of the Gynocular™ when used as stand-alone tests to detect CIN2+
To estimate the sensitivity and specificity of the Gynocular when used as a standalone tests to detect CIN2+ among WLHIV.
Time frame: 6 months
Test accuracy (sensitivity, specificity) of HR-HPV when used as stand-alone tests to detect CIN2+
To estimate the sensitivity and specificity of HR-HPV when used as a standalone tests to detect CIN2+ among WLHIV.
Time frame: 6 months
Test accuracy (sensitivity, specificity) of VIA when used as stand-alone tests to detect CIN2+
To estimate the sensitivity and specificity of VIA when used as a standalone tests to detect CIN2+ among WLHIV.
Time frame: 6 months
Diagnostic test accuracy of the Gynocular™to detect CIN2+/HSIL: other estimates, stand alone
To determine other estimates of test accuracy of the Gynocular™ (including positive and negative predictive values, positive and negative likelihood ratios, false positive rate, false negative rate, number needed to screen and area under the ROC curve (AUC).
Time frame: 6 months
Diagnostic test accuracy of HR-HPV testing to detect CIN2+/HSIL: other estimates, stand alone
To determine other estimates of HR-HPV testing test accuracy (including positive and negative predictive values, positive and negative likelihood ratios, false positive rate, false negative rate, number needed to screen and area under the ROC curve (AUC).
Time frame: 6 months
Diagnostic test accuracy of VIA to detect CIN2+/HSIL: other estimates, stand alone
To determine other estimates of VIA test accuracy (including positive and negative predictive values, positive and negative likelihood ratios, false positive rate, false negative rate, number needed to screen and area under the ROC curve (AUC).
Time frame: 6 months
Diagnostic test accuracy of HR-HPV testing followed by Gynocular™ to detect CIN2+/HSIL: test combination
To determine estimates of test accuracy for combinations of screening tests, i.e. HR-HPV followed by Gynocular™
Time frame: 6 months
Diagnostic test accuracy of HR-HPV testing followed by Gynocular™ to detect CIN2+/HSIL: test combination - subgroup analyses
To investigate the effects of age, menopause, parity, ART status, HIV RNA, education, contraception, CD4 cell count, previous treatment for precancerous disease and sexually transmitted infections (STIs) on test accuracy of test combination in subgroup analyses
Time frame: 6 months
Diagnostic test accuracy of the Gynocular™ followed by HR-HPV testing to detect CIN2+/HSIL: test combination
To determine estimates of test accuracy for combinations of screening tests, i.e. Gynocular™ followed by HR-HPV
Time frame: 6 months
Diagnostic test accuracy of the Gynocular™ followed by HR-HPV testing to detect CIN2+/HSIL: test combination subgroup analyses
To investigate the effects of age, menopause, parity, ART status, HIV RNA, education, contraception, CD4 cell count, previous treatment for precancerous disease and sexually transmitted infections (STIs) on test accuracy of test combination in subgroup analyses
Time frame: 6 months
Diagnostic test accuracy VIA followed by Gynocular™ to detect CIN2+/HSIL: test combination
To determine estimates of test accuracy for combinations of screening tests, i.e. VIA followed by Gynocular™
Time frame: 6 months
Diagnostic test accuracy VIA followed by Gynocular™ to detect CIN2+/HSIL: test combination - subgroup analyses
To investigate the effects of age, menopause, parity, ART status, HIV RNA, education, contraception, CD4 cell count, previous treatment for precancerous disease and sexually transmitted infections (STIs) on test accuracy of test combination in subgroup analyses
Time frame: 6 months
Diagnostic test accuracy of the Gynocular™ followed by VIA to detect CIN2+/HSIL: test combination
To determine estimates of test accuracy for combinations of screening tests, i.e. Gynocular™ followed by VIA
Time frame: 6 months
Diagnostic test accuracy of the Gynocular™ followed by VIA to detect CIN2+/HSIL: test combination - subgroup analyses
To investigate the effects of age, menopause, parity, ART status, HIV RNA, education, contraception, CD4 cell count, previous treatment for precancerous disease and sexually transmitted infections (STIs) on test accuracy of test combination in subgroup analyses
Time frame: 6 months
Diagnostic test accuracy of the HR-HPV followed by VIA to detect CIN2+/HSIL: test combination
To determine estimates of test accuracy for combinations of screening tests: HR-HPV followed by VIA.
Time frame: 6 months
Diagnostic test accuracy of the HR-HPV followed by VIA to detect CIN2+/HSIL: test combination - subgroup analyses
To investigate the effects of age, menopause, parity, ART status, HIV RNA, education, contraception, CD4 cell count, previous treatment for precancerous disease and sexually transmitted infections (STIs) on test accuracy of test combination in subgroup analyses
Time frame: 6 months
Diagnostic test accuracy of the VIA followed by HR-HPV to detect CIN2+/HSIL: test combination
To determine estimates of test accuracy for combinations of screening tests: VIA followed by HR-HPV.
Time frame: 6 months
Diagnostic test accuracy of the VIA followed by HR-HPV to detect CIN2+/HSIL: test combination subgroup analyses
To investigate the effects of age, menopause, parity, ART status, HIV RNA, education, contraception, CD4 cell count, previous treatment for precancerous disease and sexually transmitted infections (STIs) on test accuracy of test combination in subgroup analyses
Time frame: 6 months
Subgroup analyses for the diagnostic test accuracy of Gynocular™: stand alone test
To investigate the effects of a age, menopause, parity, ART status, HIV RNA, education, contraception, CD4 cell count, previous treatment for precancerous disease and sexually transmitted infections (STIs) on test accuracy of test combination in subgroup analyses.
Time frame: 6 months
Subgroup analyses for the diagnostic test accuracy of VIA: stand alone test
To investigate the effects of age, menopause, parity, ART status, HIV RNA, education, contraception, CD4 cell count, previous treatment for precancerous disease and sexually transmitted infections (STIs) on test accuracy of test combination in subgroup analyses.
Time frame: 6 months
Subgroup analyses for the diagnostic test accuracy of HR-HPV testing: stand alone test
To investigate the effects of age, menopause, parity, ART status, HIV RNA, education, contraception, CD4 cell count, previous treatment for precancerous disease and sexually transmitted infections (STIs) on test accuracy of test combination in subgroup analyses
Time frame: 6 months
Subgroup analyses for the diagnostic test accuracy of VIA, HR-HPV testing and Gynocular™: Combined tests
To investigate the effects of age, menopause, parity, ART status, HIV RNA, education, contraception, CD4 cell count, previous treatment for precancerous disease and sexually transmitted infections (STIs) on test accuracy of test combination in subgroup analyses
Time frame: 6 months
Investigation of Swede Score in WLHIV
Area under the receiver operating characteristic (ROC) curve for Swede score determined by Gynocular™ in WLHIV
Time frame: 6 months
Investigation of co-infections of premalignant and malignant disease (STIs/HR-HPV)
Descriptive analysis of the STI and HR-HPV type distribution associated with each stage of CIN, and when there is persistent disease in WLHIV.
Time frame: 6 months
Investigation of Trichomonas vaginalis prevalence and persistence in association with menstrual hygiene practices
Descriptive analysis of the prevalence and persistence of Trichomonas vaginalis in association with vaginal and menstrual hygiene practices.
Time frame: 6 months
Investigations to inform telemedicine capacity: Comparison of image quality
Description of image quality from static assessors, in terms of the assessors' ability to adequately evaluate the images.
Time frame: 6 months
Investigations to inform telemedicine capacity: use of static images
Proportion of correctly diagnosed CIN2+ through static images obtained by the Gynocular™.
Time frame: 6 months
Investigations to inform telemedicine capacity: ROC curve for Swede score
Area under the ROC for static image Swede score obtained by Gynocular™ in WLHIV.
Time frame: 6 months
Investigations to inform telemedicine capacity: Live versus static assessors
Cohen's kappa coefficient to assess agreement between live and static assessors.
Time frame: 6 months
Artificial Intelligence (AI) for improving the detection of precancerous cervical lesions: testing AI algorithm
Test accuracies of AI deep learning tool retrospectively using coded images obtained in the study through the Gynocular™ and smartphone.
Time frame: 6 months
Artificial Intelligence for improving the detection of precancerous cervical lesions: improve AI algorithm
Inform and improve AI deep learning tools to detect HSIL by using images or GIFs obtained in the study through the Gynocular™ and smartphone.
Time frame: 6 months
Diagnostic test accuracy of AI tool to detect CIN2+/HSIL: other estimates, stand alone
To estimate the sensitivity and specificity of HR-HPV when used as a standalone tests to detect CIN2+/HSIL among WLHIV.
Time frame: 6 months
Diagnostic test accuracy of HR-HPV testing followed by AI tool to detect CIN2+/HSIL: test combination
To determine estimates of test accuracy for combinations of screening tests, i.e. HR-HPV followed by AI tool
Time frame: 6 months
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