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

Not Applicable

Recruiting

• Conditions: HIV Infections; HPV Infection; CIN 2/3
• Interventions: Device: Thermal ablation; Procedure: LOOP ELECTROSURGICAL EXCISION PROCEDURE

• Registration Number: NCT06326294
• Lead Sponsor: Instituto Nacional de Saúde, Mozambique

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

Study Timeline

• Study First Submitted: 2024-02-27
• Study First Submitted QC: 2024-03-20
• Study First Posted: 2024-03-22
• Study Start: 2024-04-17
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-21
• Last Update Posted: 2024-05-22
• Primary Completion: 2027-09
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 4844

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thermo ablation treatment	Thermal ablation	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.
LEEP treatment	LOOP ELECTROSURGICAL EXCISION PROCEDURE	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.

Primary Outcome Measures

Name	Time	Method
Comparison of treatment success rates for biopsy-confirmed CIN 2/3: Thermoablation (TA) vs. Loop Electrosurgical Excision Procedure (LEEP)	12 months	The treatment success rate (12-month efficacy) of LEEP (pL) and that of ablation (pA) for participants with ablation-eligible CIN 2/3 will be measured by assessing the proportion of patients in each treatment group whose lesions completely regress or are successfully treated without recurrence over a defined follow-up period.

Trial Locations

Locations (1)

INSMozambique; 🇲🇿 Maputo, Mozambique