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

NCT04794660 | Active Not Recruiting Phase 3

• 1 other identifier: CESTA / PP202104-08
• Study Type: interventional
• Target: 1,500
• Locations: 2 countries
• Sites: 3

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.

Conditions

HPV Infection

Keywords

VIA triage; HIV serostatus

Outcome Measures

Primary Outcomes (2)

• Percentage of women treated with high grade lesions in both arms

  up top 1 month

• Percentage of women treated with low grade lesions in both arms

  up to 1 month

Secondary Outcomes (1)

• Persistence of HPV infection and lesions at one year

  up to 14 months

Study Arms (2)

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.

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

Diagnostic Test: HPV DNA Test; Procedure: Treatment by ablative treatment; Procedure: Colposcopy

Interventions

HPV DNA Test DIAGNOSTIC_TEST

Screening for HPV using a HPV DNA test

Arm 1; Arm 2

VIA triage test DIAGNOSTIC_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

Arm 1

Treatment by ablative treatment PROCEDURE

Cryotherapy or Thermal Ablation are performed on the cervix.

Arm 1; Arm 2

Colposcopy PROCEDURE

Colposcopy visit are offered to women with non visible squamous columnar junction or ineligible for ablative treatment.

Arm 1; Arm 2

Eligibility Criteria

• Age: 25 Years - 54 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• International Agency for Research on Cancer: lead
• World Health Organization: collaborator
• University of KwaZulu: collaborator
• Cheikh Anta Diop University, Senegal: collaborator
• Walter Sisulu University: collaborator

Study Sites (3)

Roi Baudoin hospital

Dakar, Senegal

Location

Wentworth Hospital

Durban, South Africa

Location

Frere Hospital

East London, South Africa

Location

MeSH Terms

Conditions

Papillomavirus Infections

Interventions

Human Papillomavirus DNA Tests; Colposcopy

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Molecular Diagnostic Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Diagnostic Techniques, Obstetrical and Gynecological; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Obstetric Surgical Procedures; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Nathalie Broutet, Dr

  World Health Organization

  PRINCIPAL INVESTIGATOR

• Maribel Almonte, Dr

  IARC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Care providers and participants are masked to the intervention ahead of the intervention. However, the strategy delivery is not blinded.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: March 12, 2021
• Study Start: October 1, 2019
• Primary Completion: December 31, 2023
• Study Completion: October 1, 2025
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

SE (1); ZA (2)