Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06326294
NA

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

Sponsor: Instituto Nacional de Saúde, Mozambique

View on ClinicalTrials.gov

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

Interventions

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

Locations (1)

INSMozambique

Maputo, Mozambique