Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 3:42 AM
Study NCT ID:
NCT06326294
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of the Effectiveness of TA Versus LEEP for Cervical Cancer Risk Reduction in WLHIV in Mozambique
Sponsor:
Instituto Nacional de Saúde, Mozambique
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: