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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

Status unknown Last updated 3 November 2020
What this trial tests

trial testing Screening for CIN2+/HSIL in Uterine Cervical Neoplasms in 450 participants. Status unknown.

Timeline
8 May 2019
Primary endpoint
1 January 2021
1 December 2022

Quick facts

Lead sponsorUniversity of Bern
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment450
Start date8 May 2019
Primary completion1 January 2021
Estimated completion1 December 2022
Sites1 location across Zambia

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  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
  4. 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
  5. 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:

Other recruiting trials for Uterine Cervical Neoplasms

Currently open trials in the same condition.

Other University of Bern trials

Trials by the same sponsor.

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Data sources for this page

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