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

NCT ID: NCT06326294

Condition: HIV Infections
HPV Infection
CIN 2/3

Conditions: Official terms:
Infections
Communicable Diseases
Papillomavirus Infections

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: 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.

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: Thermal ablation
Description: Thermal ablative uses heat (100°C to 120°C) to cause localized tissue damage at the cervical transformation zone and destroy the abnormal epithelium.
Arm group label: Thermo ablation treatment

Other name: TA

Intervention type: Procedure
Intervention name: LOOP ELECTROSURGICAL EXCISION PROCEDURE
Description: Cervical tissue excision
Arm group label: LEEP treatment

Other name: LEEP

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

Criteria for eligibility:
Criteria:
Inclusion Criteria: - ages 25-49 years; - confirmed HIV infection; - physically and mentally willing and able to participate in the study, and provide informed consent. Exclusion Criteria: - currently pregnant or <6 weeks post-partum; - had a hysterectomy and no longer have a cervix; - a history of cervical cancer or treatment for cervical abnormalities; and - any medical, psychiatric, or other condition that would interfere with protocol adherence, assessment of safety, and/or ability/competence to provide informed consent.

Gender: Female

Minimum age: 25 Years

Maximum age: 49 Years

Healthy volunteers: No

Locations:

Facility:
Name: INSMozambique

Address:
City: Maputo
Country: Mozambique

Status: Recruiting

Contact:
Last name: Edna Viegas, MD,PhD

Phone: +258823060500
Email: edna.viegas@ins.gov.mz

Contact backup:
Last name: Edna Nhacule, MD

Phone: +258827460555
Email: edna.nhacule@ins.gov.mz

Start date: April 17, 2024

Completion date: December 2027

Lead sponsor:
Agency: Instituto Nacional de Saúde, Mozambique
Agency class: Other

Collaborator:
Agency: M.D. Anderson Cancer Center
Agency class: Other

Source: Instituto Nacional de Saúde, Mozambique

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06326294

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