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Assessment of the Effectiveness of TA Versus LEEP for Cervical Cancer Risk Reduction in WLHIV in Mozambique
Sponsor: Instituto Nacional de Saúde, Mozambique
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.
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
Key Details
Gender
FEMALE
Age Range
25 Years - 49 Years
Study Type
INTERVENTIONAL
Enrollment
4844
Start Date
2024-04-17
Completion Date
2027-12
Last Updated
2024-05-22
Healthy Volunteers
No
Conditions
Interventions
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.
LOOP ELECTROSURGICAL EXCISION PROCEDURE
Cervical tissue excision
Locations (1)
INSMozambique
Maputo, Mozambique