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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06326294
• Other study ID #: 727/CNBS/23
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: December 2027

Study information

• Verified date: March 2024
• Source: Instituto Nacional de Saúde, Mozambique
• Contact: Edna Viegas, MD, PhD
• Phone: +258823060500
• Email: edna.viegas[@]ins.gov.mz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 4844
• Est. completion date: December 2027
• Est. primary completion date: September 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• CIN 2/3
• Communicable Diseases
• HIV Infections
• HPV Infection
• Infections
• Papillomavirus Infections

Intervention

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

Country	Name	City	State
Mozambique	INSMozambique	Maputo

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Nacional de Saúde, Mozambique	M.D. Anderson Cancer Center

Country where clinical trial is conducted

Mozambique, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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