The Study for the "Cervical Cancer Screening and Treatment Algorithms Study Using HPV Testing in Africa"
NCT ID: NCT04794660
Last Updated: 2024-03-13
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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ACTIVE_NOT_RECRUITING
PHASE3
1500 participants
INTERVENTIONAL
2019-10-01
2025-10-01
Brief Summary
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1,500 women living with HIV WLHIV will be recruited from HIV care clinics, also called antiretrovirals (ARV) clinics in South Africa. After giving informed consent, women will be screened with HPV testing and those that have a HPV positive test will be randomized at a 4:1 ratio into HPV + VIA + treat (Arm 1) and HPV + treat (Arm 2). Women in Arm 1 will receive VIA and only positive for VIA will be treated. In Arm 2, all HPV positive women will be treated. Women that are eligible for ablative treatment will be randomized into treatment with TA or cryotherapy in both arms. Others will be referred to colposcopy. After VIA in Arm 1 or before treatment in Arm 2, the nurses will collect 2-4 biopsies on all HPV positive women. The biopsies will be used as gold standard for disease detection. Treated women will be called by telephone after 1 week and 1 month to assess side-effects and satisfaction with the procedures. Cervical samples from women will be tested with HPV DNA test and HPV mRNA test to evaluate different screening tests for WLHIV. All women with a positive HPV test (treated or not) will be called back after 1 year for a follow-up visit. At this visit, women will be screened with HPV testing and VIA and 2-4 colposcopy-directed biopsies will be taken from all HPV positive women. Women with remaining/recurrent CIN2+ disease will receive appropriate management.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
DOUBLE
Study Groups
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Arm 1
In this arm, HPV-positive women will undergo a Visual Inspection with Acetic Acid (VIA) triage test followed by biopsies. Treatment by thermal ablation (or cryotherapy in South Africa) will be applied to VIA positive women eligible for ablative treatment. Non eligible women will be referred to colposcopy.
HPV DNA Test
Screening for HPV using a HPV DNA test
VIA triage test
VIA is a technique in which cervical neoplastic lesions are visually diagnosed after application of 3-5% acetic acid without using any magnification device.
After application of 3 - 5% acetic acid, using the naked eye, the cervix is examined for the presence of an aceto-white lesion located in the transformation zone. The results are classified as either positive or negative, inadequate or suspicion of cancer
Treatment by ablative treatment
Cryotherapy or Thermal Ablation are performed on the cervix.
Colposcopy
Colposcopy visit are offered to women with non visible squamous columnar junction or ineligible for ablative treatment.
Arm 2
In this arm, HPV positive women will get biopsies and receive an ablative treatment by thermal ablation (or cryotherapy in South Africa) if they are eligible to ablative treatment. Non eligible women will be referred to colposcopy
HPV DNA Test
Screening for HPV using a HPV DNA test
Treatment by ablative treatment
Cryotherapy or Thermal Ablation are performed on the cervix.
Colposcopy
Colposcopy visit are offered to women with non visible squamous columnar junction or ineligible for ablative treatment.
Interventions
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HPV DNA Test
Screening for HPV using a HPV DNA test
VIA triage test
VIA is a technique in which cervical neoplastic lesions are visually diagnosed after application of 3-5% acetic acid without using any magnification device.
After application of 3 - 5% acetic acid, using the naked eye, the cervix is examined for the presence of an aceto-white lesion located in the transformation zone. The results are classified as either positive or negative, inadequate or suspicion of cancer
Treatment by ablative treatment
Cryotherapy or Thermal Ablation are performed on the cervix.
Colposcopy
Colposcopy visit are offered to women with non visible squamous columnar junction or ineligible for ablative treatment.
Eligibility Criteria
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Inclusion Criteria
* HIV negative women aged 30-54 years; HIV positive women aged 25-54 years
* Mentally competent to give informed consent
* Physically able to have a pelvic exam
Exclusion Criteria
* History of cervical cancer
* Treatment for cervical precancer in the last six months
* Hysterectomy
* Pregnancy
* Serious pre-existing medical conditions (e.g. history of bleeding disorders, serious physical or mental disease)
25 Years
54 Years
FEMALE
Yes
Sponsors
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World Health Organization
OTHER
University of KwaZulu
OTHER
Cheikh Anta Diop University, Senegal
OTHER
Walter Sisulu University
OTHER
International Agency for Research on Cancer
OTHER
Responsible Party
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Principal Investigators
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Nathalie Broutet, Dr
Role: PRINCIPAL_INVESTIGATOR
World Health Organization
Maribel Almonte, Dr
Role: PRINCIPAL_INVESTIGATOR
IARC
Locations
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Roi Baudoin hospital
Dakar, , Senegal
Wentworth Hospital
Durban, , South Africa
Frere Hospital
East London, , South Africa
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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CESTA / PP202104-08
Identifier Type: -
Identifier Source: org_study_id
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