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NCT Number: NCT06326294

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

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Key information

Conditions

HIV Infections Blood-Borne Infections CIN 2/3 Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases HPV Infection Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

25 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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:

  • Compare the effectiveness of treating biopsy-confirmed CIN 2/3 by TA versus LEEP
  • Compare the effectiveness of treating hrHPV infection by TA versus LEEP
  • Assess pain and side effects/adverse events due to TA versus LEEP

Secondary Objectives:

  • Identify the determinants of treatment failures
  • Develop a deep learning-based automated visual evaluation tool that predicts treatment failure

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Thermal Ablation

Device

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

loop electrosurgical excision procedure

Procedure

Cervical tissue excision

Other names: LEEP

Primary outcomes

  1. Comparison of treatment success rates for biopsy-confirmed CIN 2/3: Thermoablation (TA) vs. Loop Electrosurgical Excision Procedure (LEEP)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Edna Nhacule, MD

CONTACT

[email protected]

845210269

Edna Viegas, MD, PhD

CONTACT

[email protected]

+258823060500

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Saúde, Mozambique

Other Gov

Collaborators

  • M.D. Anderson Cancer Center

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 22, 2024
Registry last updated
May 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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