The Study for the "Cervical Cancer Screening and Treatment Algorithms Study Using HPV Testing in Africa" (CESTA)
Primary Purpose
HPV Infection
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
HPV DNA Test
VIA triage test
Treatment by ablative treatment
Colposcopy
Sponsored by
About this trial
This is an interventional screening trial for HPV Infection focused on measuring VIA triage, HIV serostatus
Eligibility Criteria
Inclusion Criteria:
- Willing to disclose HIV status
- 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:
- Women reporting no previous sexual activity
- 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)
Sites / Locations
- Roi Baudoin hospital
- Wentworth Hospital
- Frere HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Arm 1
Arm 2
Arm Description
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.
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
Outcomes
Primary Outcome Measures
Percentage of women treated with high grade lesions in both arms
Percentage of women treated with low grade lesions in both arms
Secondary Outcome Measures
Persistence of HPV infection and lesions at one year
all HPV positive women at screening will be asked to come back at one year to be tested for HPV. HPV positive women at one year will be refered to colposcopy and biopsies will be taken
Full Information
NCT ID
NCT04794660
First Posted
February 16, 2021
Last Updated
February 21, 2023
Sponsor
International Agency for Research on Cancer
Collaborators
World Health Organization, University of KwaZulu, Cheikh Anta Diop University, Senegal, Walter Sisulu University
1. Study Identification
Unique Protocol Identification Number
NCT04794660
Brief Title
The Study for the "Cervical Cancer Screening and Treatment Algorithms Study Using HPV Testing in Africa"
Acronym
CESTA
Official Title
The Study for the "Cervical Cancer Screening and Treatment Algorithms Study Using HPV Testing in Africa"
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
October 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
International Agency for Research on Cancer
Collaborators
World Health Organization, University of KwaZulu, Cheikh Anta Diop University, Senegal, Walter Sisulu University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main objectives of CESTA are (1) to compare the efficacy of two cervical cancer screening algorithms: HPV test followed by visual inspection with acetic acid (VIA) and treatment (HPV + VIA + treat) and HPV test followed by immediate treatment (HPV + treat). The study will be conducted to address its objectives in women living with HIV (from now on called HIV positive women); and 2) To evaluate the performance of other techniques for primary screening and as triage for HPV positives WLHIV.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HPV Infection
Keywords
VIA triage, HIV serostatus
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Masking Description
Care providers and participants are masked to the intervention ahead of the intervention. However, the strategy delivery is not blinded.
Allocation
Randomized
Enrollment
1500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
HPV DNA Test
Intervention Description
Screening for HPV using a HPV DNA test
Intervention Type
Diagnostic Test
Intervention Name(s)
VIA triage test
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Treatment by ablative treatment
Intervention Description
Cryotherapy or Thermal Ablation are performed on the cervix.
Intervention Type
Procedure
Intervention Name(s)
Colposcopy
Intervention Description
Colposcopy visit are offered to women with non visible squamous columnar junction or ineligible for ablative treatment.
Primary Outcome Measure Information:
Title
Percentage of women treated with high grade lesions in both arms
Time Frame
up top 1 month
Title
Percentage of women treated with low grade lesions in both arms
Time Frame
up to 1 month
Secondary Outcome Measure Information:
Title
Persistence of HPV infection and lesions at one year
Description
all HPV positive women at screening will be asked to come back at one year to be tested for HPV. HPV positive women at one year will be refered to colposcopy and biopsies will be taken
Time Frame
up to 14 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
54 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Willing to disclose HIV status
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:
Women reporting no previous sexual activity
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mathilde Forestier, Dr
Phone
0033472738597
Email
forestierm@iarc.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathalie Broutet, Dr
Organizational Affiliation
World Health Organization
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maribel Almonte, Dr
Organizational Affiliation
IARC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roi Baudoin hospital
City
Dakar
Country
Senegal
Individual Site Status
Completed
Facility Name
Wentworth Hospital
City
Durban
Country
South Africa
Individual Site Status
Completed
Facility Name
Frere Hospital
City
East London
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nondumiso Ngxola, Dr
Email
ndumy.ngxola@gmail.com
First Name & Middle Initial & Last Name & Degree
Nondumiso Ngxola, Dr
First Name & Middle Initial & Last Name & Degree
Mfundo Feketshane, Dr
12. IPD Sharing Statement
Learn more about this trial
The Study for the "Cervical Cancer Screening and Treatment Algorithms Study Using HPV Testing in Africa"
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