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

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Estimated): 4844
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Edna Viegas, MD, PhD; Phone Number: +258823060500; Email: edna.viegas@ins.gov.mz
• Study Contact Backup: Name: Edna Nhacule, MD; Phone Number: 845210269; Email: edna.nhacule@ins.gov.mz

Study Locations

• Mozambique
  • Maputo, Mozambique
    • Recruiting
    • INSMozambique
    • Contact: Edna Viegas, MD,PhD; Phone Number: +258823060500; Email: edna.viegas@ins.gov.mz
    • Contact: Edna Nhacule, MD; Phone Number: +258827460555; Email: edna.nhacule@ins.gov.mz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Thermo ablation treatment; 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.	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.; Other Names: TA
Other: LEEP treatment; 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.	Procedure: LOOP ELECTROSURGICAL EXCISION PROCEDURE; Cervical tissue excision; Other Names: LEEP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of treatment success rates for biopsy-confirmed CIN 2/3: Thermoablation (TA) vs. Loop Electrosurgical Excision Procedure (LEEP)	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.	12 months

Collaborators and Investigators

• Sponsor: Instituto Nacional de Saúde, Mozambique
• Collaborators: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Edna Viegas, MD, PhD, Instituto Nacional de Saúde, Mozambique

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: February 27, 2024
• First Submitted That Met QC Criteria: March 20, 2024
• First Posted (Actual): March 22, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2024
• Last Update Submitted That Met QC Criteria: May 21, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Disease Attributes; DNA Virus Infections; Tumor Virus Infections; Urogenital Diseases; Genital Diseases; Infections; Communicable Diseases; Papillomavirus Infections
• Other Study ID Numbers: 727/CNBS/23

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No