HPV InfectionPhase 3CESTANCT04794660
The Study for the "Cervical Cancer Screening and Treatment Algorithms Study Using HPV Testing in Africa"
A Phase 3 study testing HPV DNA Test, VIA triage test and Treatment by ablative treatment in people with HPV Infection, run by International Agency for Research on Cancer at 3 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 25 to 54 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV Infection
- What is being tested?
- HPV DNA Test, VIA triage test and Treatment by ablative treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Oct 2019to 1 Oct 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 54 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
About this study
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.
- Conditions
- HPV Infection
- Being tested
- HPV DNA Test, VIA triage test, Treatment by ablative treatment, Colposcopy
- Keywords
- VIA triage, HIV serostatus
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV DNA TestDiagnostic test
Screening for HPV using a HPV DNA test
VIA triage testDiagnostic 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 treatmentProcedure or surgery
Cryotherapy or Thermal Ablation are performed on the cervix.
ColposcopyProcedure or surgery
Colposcopy visit are offered to women with non visible squamous columnar junction or ineligible for ablative treatment.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | 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. Receives: Diagnostic Test: HPV DNA Test; Diagnostic Test: VIA triage test; Procedure: Treatment by ablative treatment; Procedure: Colposcopy |
| Arm 2 | Active comparator | 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 Receives: Diagnostic Test: HPV DNA Test; Procedure: Treatment by ablative treatment; Procedure: Colposcopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of women treated with high grade lesions in both arms
Measured: up top 1 month
Percentage of women treated with low grade lesions in both arms
Measured: up to 1 month
Secondary outcomes (1)
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
Measured: up to 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start1 Oct 2019
- Primary completion31 Dec 2023
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Agency for Research on Cancer
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization, University of KwaZulu, Cheikh Anta Diop University, Senegal, Walter Sisulu University
- Responsible party
- Sponsor
- Investigators
- Nathalie Broutet, Dr, Principal investigator, World Health OrganizationMaribel Almonte, Dr, Principal investigator, IARC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04794660
- Sponsor's protocol ID
- CESTA / PP202104-08
- Acronym
- CESTA
- Status last verified
- Mar 2024
- First submitted
- 16 Feb 2021
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study for the "Cervical Cancer Screening and Treatment Algorithms Study Using HPV Testing in Africa"
- ClinicalTrials.gov ID
- NCT04794660
- Acronym / sponsor ID
- CESTA / CESTA / PP202104-08
- Conditions
- HPV Infection
- Keywords
- VIA triage, HIV serostatus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- International Agency for Research on CancerUniversity, hospital or other
- Collaborators
- World Health Organization, University of KwaZulu, Cheikh Anta Diop University, Senegal, Walter Sisulu University
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 12 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Diagnostic Test: HPV DNA Test, Diagnostic Test: VIA triage test, Procedure: Treatment by ablative treatment, Procedure: ColposcopyIn 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 2 | Active comparator | Diagnostic Test: HPV DNA Test, Procedure: Treatment by ablative treatment, Procedure: ColposcopyIn 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 |
Who may qualify
- Ages
- 25 to 54 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Women reporting no previous sexual activity
- History of cervical cancer
- Treatment for cervical precancer in the last six months
- Hysterectomy
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPV DNA TestScreening for HPV using a HPV DNA test | Diagnostic test | Arm 1, Arm 2 |
| VIA triage testVIA 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 | Diagnostic test | Arm 1 |
| Treatment by ablative treatmentCryotherapy or Thermal Ablation are performed on the cervix. | Procedure or surgery | Arm 1, Arm 2 |
| ColposcopyColposcopy visit are offered to women with non visible squamous columnar junction or ineligible for ablative treatment. | Procedure or surgery | Arm 1, Arm 2 |
Primary outcome
Percentage of women treated with high grade lesions in both arms
Time frame: up top 1 month
Percentage of women treated with low grade lesions in both arms
Time frame: up to 1 month
1 secondary outcome
Persistence of HPV infection and lesions at one year
Time frame: up to 14 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathalie Broutet, Dr principal investigator
World Health Organization
Maribel Almonte, Dr principal investigator
IARC
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HPV DNA Test, VIA triage test and Treatment by ablative treatment in people with HPV Infection, run by International Agency for Research on Cancer at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Africa, Senegal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of women treated with high grade lesions in both arms (time frame: up top 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.