NCT04794660

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,500 (estimated)
• Sponsor: International Agency for Research on Cancer · Academic / Other
• Sex: Female
• Age: 25 Years – 54 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	HPV DNA Test	Screening for HPV using a HPV DNA test
DIAGNOSTIC_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.
PROCEDURE	Colposcopy	Colposcopy visit are offered to women with non visible squamous columnar junction or ineligible for ablative treatment.

Timeline

• Start date: 2019-10-01
• Primary completion: 2023-12-31
• Completion: 2025-10-01
• First posted: 2021-03-12
• Last updated: 2024-03-13

Locations

3 sites across 2 countries: Senegal, South Africa