NCT06326294

Assessment of the Effectiveness of TA Versus LEEP for Cervical Cancer Risk Reduction in WLHIV in Mozambique

A Randomized Clinical Trial to Assess the Effectiveness of Thermal Ablation Versus Loop Electrosurgical Excision Procedure for Cervical Cancer Risk Reduction in Women Living With Human Immunodeficiency Virus in Mozambique

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 4,844 (estimated)
• Sponsor: Instituto Nacional de Saúde, Mozambique · Other Government
• Sex: Female
• Age: 25 Years – 49 Years
• Healthy volunteers: Not accepted

Summary

Given that WLWH are more likely to develop persistent HPV infection and CC, effective screening and the management and treatment of pre-cancerous cervical abnormalities is critical to decrease the global burden of cervical cancer. The vast majority of WLWH live in SSA, where resources are more constrained. Therefore, simple, affordable, and effective tools are needed for the prevention of cervical cancer in SSA. In this setting, the best method for treatment of screen-positive WLWH has not been determined. The proposed study will compare the effectiveness of TA vs. LEEP, for treating precursor lesions (CIN 2/3) and HPV infection in WLWH, identify the determinants of treatment failure, and develop a strategy to predict patients in whom treatment is likely to fail so that alternative treatments can be provided. Moreover, local evidence of the optimal method of treatments is necessary to inform health policy and promote adherence.

Detailed description

A. General purpose: The goal of this study is to compare TA, an ablative cervical treatment modality, and LEEP, an excisional cervical treatment modality, in screen-positive WLWH patients, for eradication of hrHPV and effectiveness of treating biopsy-confirmed CIN 2/3. B. Specific purposes Primary Objectives: 1. Compare the effectiveness of treating biopsy-confirmed CIN 2/3 by TA versus LEEP 2. Compare the effectiveness of treating hrHPV infection by TA versus LEEP 3. Assess pain and side effects/adverse events due to TA versus LEEP Secondary Objectives: 1. Identify the determinants of treatment failures 2. Develop a deep learning-based automated visual evaluation tool that predicts treatment failure

Conditions

• HIV Infections
• HPV Infection
• CIN 2/3

Interventions

Type	Name	Description
DEVICE	Thermal ablation	Thermal ablative uses heat (100°C to 120°C) to cause localized tissue damage at the cervical transformation zone and destroy the abnormal epithelium.
PROCEDURE	LOOP ELECTROSURGICAL EXCISION PROCEDURE	Cervical tissue excision

Timeline

• Start date: 2024-04-17
• Primary completion: 2027-09-01
• Completion: 2027-12-01
• First posted: 2024-03-22
• Last updated: 2024-05-22

Locations

1 site across 1 country: Mozambique