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

Instituto Nacional de Saúde, Mozambique

Status: Enrolling

Conditions: HPV Infection; CIN 2/3; HIV Infections

Treatments: Device: Thermal ablation; Procedure: LOOP ELECTROSURGICAL EXCISION PROCEDURE

Study type: Interventional

Funder types: Other

Identifiers

NCT06326294

727/CNBS/23

Details and patient eligibility

About

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.

Full 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

Enrollment: 4,844 estimated patients

Sex: Female

Ages: 25 to 49 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4,844 participants in 2 patient groups

Thermo ablation treatment

Other group

Description:

Participants allocated in this group will be treated with thermo ablation. Before TA, perform biopsies of any acetowhite lesions by colposcopy and/or positive by AVE and an endocervical curettage (ECC); In women who do not have any lesions noted by colposcopy or AVE, one random cervical biopsy at the squamocolumnar junction and an endocervical curettage (ECC) will be obtained. TA is performed during the same exam (immediately following biopsies/ECC)TA will be done according to the manufacturer's instructions and specifications.

Treatment:

Device: Thermal ablation

LEEP treatment

Other group

Description:

Participants allocated in this group will be treated with LEEP. LEEP will be done according to standard procedure. No biopsies are taken, only LEEP is performed, unless clinically indicated.

Treatment:

Procedure: LOOP ELECTROSURGICAL EXCISION PROCEDURE