Clinical trial NCT06326294: Assessment of the Effectiveness of TA Versus LEEP for Cervical Cancer Risk Reduction in WLHIV in Mozambique
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Infections
HPV Infection
CIN 2/3
Lead sponsor: Instituto Nacional de Saúde, Mozambique
Sponsor class: OTHER_GOV
Collaborators: name: M.D. Anderson Cancer Center
First posted: 2024-03-22
Enrollment: 4844
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Comparison of treatment success rates for biopsy-confirmed CIN 2/3: Thermoablation (TA) vs. Loop Electrosurgical Excision Procedure (LEEP)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Maputo
country: Mozambique
facility: INSMozambique
Study officials:
affiliation: Instituto Nacional de Saúde, Mozambique
name: Edna Viegas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: