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NCT03931083
Screening Test Accuracy of Gynocular™, HR-HPV Testing, VIA for Detection of Cervical Neoplastic Lesions, in Women Living With HIV
trial testing Screening for CIN2+/HSIL in Uterine Cervical Neoplasms in 450 participants. Status unknown.
1 January 2021
Quick facts
| Lead sponsor | University of Bern |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 450 |
| Start date | 8 May 2019 |
| Primary completion | 1 January 2021 |
| Estimated completion | 1 December 2022 |
| Sites | 1 location across Zambia |
Drugs / interventions tested
- Screening for CIN2+/HSIL
Conditions studied
- Uterine Cervical Neoplasms — all drugs for Uterine Cervical Neoplasms →
- HIV/AIDS — all drugs for HIV/AIDS →
Sponsor
University of Bern
Who can join
Adults 18 to 65, female only, with Uterine Cervical Neoplasms or HIV/AIDS. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Clinical Trials for Treatment and Prevention of HIV-Associated Malignancies in Sub-Saharan Africa: Building Capacity and Overcoming Barriers.
Lin LL, Lakomy DS, Chiao EY, Strother RM, et al · · 2020 · cited 19× · PMID 32697667 · DOI 10.1200/go.20.00153 -
Screening test accuracy of portable devices that can be used to perform colposcopy for detecting CIN2+ in low- and middle-income countries: a systematic review and meta-analysis.
Taghavi K, Rohner E, Basu P, Low N, et al · · 2020 · cited 13× · PMID 33198721 · DOI 10.1186/s12905-020-01121-3 -
Screening test accuracy to improve detection of precancerous lesions of the cervix in women living with HIV: a study protocol.
Taghavi K, Moono M, Mwanahamuntu M, Basu P, et al · · 2020 · cited 6× · PMID 33371015 · DOI 10.1136/bmjopen-2020-037955 -
Accuracy of screening tests for cervical precancer in women living with HIV in low-resource settings: a paired prospective study in Lusaka, Zambia.
Taghavi K, Moono M, Mwanahamuntu M, Roumet M, et al · · 2024 · cited 3× · PMID 39886160 · DOI 10.1136/bmjonc-2023-000111 -
Accuracy of screening tests for cervical pre-cancer in women living with HIV in low-resource settings: a paired prospective study in Lusaka, Zambia
Taghavi K, Moono M, Mwanahamuntu M, Roumet M, et al · · 2023 · DOI 10.1101/2023.05.31.23290779
Verify or expand the search:
- PubMed search for NCT03931083
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03931083 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Bern
- Last refreshed: 3 November 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03931083.
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