Screening Test Accuracy of Gynocular™, HR-HPV Testing, VIA for Detection of Cervical Neoplastic Lesions, in Women Living With HIV
NCT ID: NCT03931083
Last Updated: 2020-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
450 participants
OBSERVATIONAL
2019-05-08
2022-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Portable magnification device (Gynocular™)
The Gynocular™ examination will be performed following the steps involved in colposcopy as described in the IARC colposcopy manual. These steps include: visualization of the vagina, vulva and cervix following insertion of a speculum, magnified assessment after application of normal saline, examination of cervical vessel patterns using the red-free mode (or green filter), application of 5% acetic acid for 1 minute and finally assessment following application with Lugol's iodine. The findings of the live examination will be documented using the parameters of the Swede score. Each parameter is scored between zero and two. Treatment will be based on the results found at histopathology, unless the woman is also VIA positive in which case, after biopsy she will undergo routine treatment as per local guidelines. The results will be used to determine the optimal threshold for treatment in WLHIV.
Screening for CIN2+/HSIL
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.
Testing for high risk HPV (HRHPV)
To reduce the number of examinations undergone by the study participant during the same day, HRHPV testing will be carried out at the time of the first gynecological examination by the VIA nurse (see next arm). Using specific single-use cervical cytobrush provided by GeneXpert, a specimen will be collected immediately prior to VIA examination. Cervical cytobrush specimens will be placed into ThinPrep PreservCyt (Cepheid, Sunnyvale, CA) immediately after collection. The HR-HPV testing of cervical specimens will be conducted by a GeneXpert™ machine (Cepheid, Sunnyvale, CA), which will be placed at the health facility and will be operated by a trained nurse in accordance with the manufacturer's instructions. Additionally, as part of the baseline clinical characteristics of the study participant, the study participant will undergo an STI test at the same time. The sample will be collected and tested using the same GeneXpertTM platform.
Screening for CIN2+/HSIL
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.
Visual inspection with acetic acid (VIA)
VIA, which is standard of care for cervical cancer screening in Zambia, will be carried out using the methodology described by IARC. This is summarized as follows: visualization of the vagina, vulva and cervix following insertion of a speculum; assessment with the naked eye after application of normal saline; and further assessment after application of 5% acetic acid for 1 minute. This will be recorded as normal or abnormal by the assessor.
Screening for CIN2+/HSIL
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.
Histopathological examination of tissue biopsies
All acetowhite lesions will be biopsied. When no lesion is seen, one biopsy is taken from each quadrant at the squamocolumnar junction. Biopsies will be sent and examined in a South African based lab. All histological slides will also be verified independently by an IARC trained pathologist at the end of the study. Histological endpoints are defined by the CIN classification system: CIN 1 affects only the lower third of the epithelium (mild dysplasia), CIN 2 involves two thirds of the epithelium and CIN 3 involves the full thickness (severe dysplasia and carcinoma in situ). These findings can be dichotomized by the Lower Anogenital Squamous Terminology into low-grade squamous intraepithelial lesions (LSIL) and high-grade squamous intraepithelial lesions (HSIL). All patients with CIN grade 2 that stained diffusely positive for p16 are considered as HSIL, all patients with CIN 3 are considered as HSIL. Expression of p16 will be visually assessed by immunohistochemistry.
Screening for CIN2+/HSIL
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.
Interventions
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Screening for CIN2+/HSIL
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.
Eligibility Criteria
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Inclusion Criteria
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
2. Pregnant women or women who plan to get pregnant within the next 6 months
3. Women who have been vaccinated against HR-HPV
18 Years
65 Years
FEMALE
No
Sponsors
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Centre for Infectious Disease Research in Zambia
OTHER
Cervical Cancer Prevention Program in Zambia
UNKNOWN
International Agency for Research on Cancer
OTHER
University of Bern
OTHER
Responsible Party
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Principal Investigators
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Locations
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Centre for Infectious Disease Research in Zambia
Lusaka, , Zambia
Countries
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Central Contacts
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Facility Contacts
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References
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Taghavi K, Moono M, Mwanahamuntu M, Roumet M, Limacher A, Kapesa H, Madliwa T, Rutjes A, Basu P, Low N, Manasyan A, Bohlius J. Accuracy of screening tests for cervical precancer in women living with HIV in low-resource settings: a paired prospective study in Lusaka, Zambia. BMJ Oncol. 2024 Feb 10;3(1):e000111. doi: 10.1136/bmjonc-2023-000111. eCollection 2024.
Taghavi K, Moono M, Mwanahamuntu M, Roumet M, Limacher A, Kapesa H, Madliwa T, Rutjes A, Basu P, Low N, Manasyan A, Bohlius J. Accuracy of screening tests for cervical pre-cancer in women living with HIV in low-resource settings: a paired prospective study in Lusaka, Zambia. medRxiv [Preprint]. 2023 Jun 1:2023.05.31.23290779. doi: 10.1101/2023.05.31.23290779.
Taghavi K, Moono M, Mwanahamuntu M, Basu P, Limacher A, Tembo T, Kapesa H, Hamusonde K, Asangbeh S, Sznitman R, Low N, Manasyan A, Bohlius J. Screening test accuracy to improve detection of precancerous lesions of the cervix in women living with HIV: a study protocol. BMJ Open. 2020 Dec 18;10(12):e037955. doi: 10.1136/bmjopen-2020-037955.
Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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KFS-4156-02-2017
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
Esther17G9
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
GYNOCULAR
Identifier Type: -
Identifier Source: org_study_id