RecruitingNot ApplicableNCT06326294

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

Sponsor

Instituto Nacional de Saúde, Mozambique

Enrollment

4,844 participants

Start Date

Apr 17, 2024

Study Type

INTERVENTIONAL

Conditions

HIV Infections HPV Infection CIN 2/3

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.

Eligibility

Sex: FEMALEMin Age: 25 YearsMax Age: 49 Years

Plain Language Summary

Simplified for easier understanding

This trial compares two cervical cancer prevention procedures — thermal ablation (TA) and LEEP — in women living with HIV in Mozambique to see which is safer and more effective. **You may be eligible if...** - You are between 25 and 49 years old - You are living with confirmed HIV infection - You are physically and mentally able to participate and provide informed consent **You may NOT be eligible if...** - You are currently pregnant or less than 6 weeks postpartum - You have had a hysterectomy - You have a history of cervical cancer or prior treatment for cervical abnormalities - You have a medical, psychiatric, or other condition that would interfere with your ability to participate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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