The Study for the "Cervical Cancer Screening and Treatment Algorithms Study Using HPV Testing in Africa"

HPV Infection Clinical Trial

— CESTA  

Official title:

The Study for the "Cervical Cancer Screening and Treatment Algorithms Study Using HPV Testing in Africa"

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04794660
• Other study ID #: CESTA / PP202104-08
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: October 1, 2019
• Est. completion date: October 1, 2025

Study information

• Verified date: March 2024
• Source: International Agency for Research on Cancer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1500
• Est. completion date: October 1, 2025
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 54 Years

Eligibility

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)

Related Conditions & MeSH terms

• HPV Infection
• Papillomavirus Infections

Intervention

Diagnostic Test:
• 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

Procedure:
• 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.

Locations

Country	Name	City	State
Senegal	Roi Baudoin hospital	Dakar
South Africa	Wentworth Hospital	Durban
South Africa	Frere Hospital	East London

Sponsors (5)

Lead Sponsor	Collaborator
International Agency for Research on Cancer	Cheikh Anta Diop University, Senegal, University of KwaZulu, Walter Sisulu University, World Health Organization

Countries where clinical trial is conducted

Senegal,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of women treated with high grade lesions in both arms		up top 1 month
Primary	Percentage of women treated with low grade lesions in both arms		up to 1 month
Secondary	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	up to 14 months