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Screening Test Accuracy of Gynocular™, HR-HPV Testing, VIA for Detection of Cervical Neoplastic Lesions, in Women Living With HIV

NCT03931083UNKNOWNOBSERVATIONAL

Summary

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.

Key Facts

Lead Sponsor

University of Bern

Enrollment

450

Start Date

2019-05-08

Completion Date

2021-01-01

Study Type

OBSERVATIONAL

Official Title

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

Interventions

Screening for CIN2+/HSIL

Conditions

Uterine Cervical NeoplasmsHIV/AIDS

Eligibility

Age Range

18 Years – 65 Years

Sex

FEMALE

Inclusion Criteria:

1. HIV-infected women confirmed through medical records
2. Women residing within Lusaka district and plans to stay in this area for the next 6 months
3. Women between 18 and 65 years of age (age bracket as per Zambian guidelines for cervical cancer screening)
4. Able and willing to consent
5. Willing to undergo a pelvic examination and cancer screening
6. Has had sexual intercourse before
7. Agrees to have follow-up appointment in 6 months

Exclusion Criteria:

1. Women with a history of cervical cancer or previous hysterectomy (where the cervix was also removed)
2. Pregnant women or women who plan to get pregnant within the next 6 months
3. Women who have been vaccinated against HR-HPV

Outcome Measures

Primary Outcomes

Test 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

Secondary Outcomes

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

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

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

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

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

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

Time frame: 6 months

Subgroup analyses for the diagnostic test accuracy of HR-HPV testing: stand alone test

Time frame: 6 months

Subgroup analyses for the diagnostic test accuracy of VIA, HR-HPV testing and Gynocular™: Combined tests

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

Locations

Centre for Infectious Disease Research in Zambia, Lusaka, Zambia

Linked Diseases

Uterine Cervical Neoplasms

Uterine Cervical Neoplasms — a type of gynecological cancer.

Linked Papers

2020-12-18

Screening test accuracy to improve detection of precancerous lesions of the cervix in women living with HIV: a study protocol

Introduction The simplest and cheapest method for cervical cancer screening is visual inspection after application of acetic acid (VIA). However, this method has limitations for correctly identifying precancerous cervical lesions (sensitivity) and women free from these lesions (specificity). We will assess alternative screening methods that could improve sensitivity and specificity in women living with humanimmunodeficiency virus (WLHIV) in Southern Africa. Methods and analysis We will conduct a paired, prospective, screening test accuracy study among consecutive, eligible women aged 18–65 years receiving treatment for HIV/AIDS at Kanyama Hospital, Lusaka, Zambia. We will assess a portable magnification device (Gynocular, Gynius Plus AB, Sweden) based on the Swede score assessment of the cervix, test for high-risk subtypes of human papillomavirus (HR-HPV, GeneXpert, Cepheid, USA) and VIA. All study participants will receive all three tests and the reference standard at baseline and at six-month follow-up. The reference standard is histological assessment of two to four biopsies of the transformation zone. The primary histological endpoint is cervical intraepithelial neoplasia grade two and above (CIN2+). Women who are VIA-positive or have histologically confirmed CIN2+ lesions will be treated as per national guidelines. We plan to enrol 450 women. Primary outcome measures for test accuracy include sensitivity and specificity of each stand-alone test. In the secondary analyses, we will evaluate the combination of tests. Pre-planned additional studies include use of cervigrams to test an automated visual assessment tool using image pattern recognition, cost-analysis and associations with trichomoniasis. Ethics and dissemination Ethical approval was obtained from the University of Zambia Biomedical Research Ethics Committee, Zambian National Health Regulatory Authority, Zambia Medicines Regulatory Authority, Swissethics and the International Agency for Research on Cancer Ethics Committee. Results of the study will be submitted for publication in a peer-reviewed journal. Trial registration number NCT03931083 ; Pre-results.

Linked Investigators

Katayoun Taghavi

Nicola Low