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

Phase 3

Active, not recruiting

• Conditions: HPV Infection

• Registration Number: NCT04794660
• Lead Sponsor: International Agency for Research on Cancer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-01
• Study First Submitted: 2021-02-16
• Study First Submitted QC: 2021-03-08
• Study First Posted: 2021-03-12
• Primary Completion: 2023-12-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-13
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 1500

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Persistence of HPV infection and lesions at one year	up to 14 months	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

Trial Locations

Locations (3)

Roi Baudoin hospital; 🇸🇳 Dakar, Senegal

Wentworth Hospital; 🇿🇦 Durban, South Africa

Frere Hospital; 🇿🇦 East London, South Africa