To hear about similar clinical trials, please enter your email below
Trial Title:
Assessment of the Effectiveness of TA Versus LEEP for Cervical Cancer Risk Reduction in WLHIV in Mozambique
NCT ID:
NCT06326294
Condition:
HIV Infections
HPV Infection
CIN 2/3
Conditions: Official terms:
Infections
Communicable Diseases
Papillomavirus Infections
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Thermal ablation
Description:
Thermal ablative uses heat (100°C to 120°C) to cause localized tissue damage at the
cervical transformation zone and destroy the abnormal epithelium.
Arm group label:
Thermo ablation treatment
Other name:
TA
Intervention type:
Procedure
Intervention name:
LOOP ELECTROSURGICAL EXCISION PROCEDURE
Description:
Cervical tissue excision
Arm group label:
LEEP treatment
Other name:
LEEP
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
Criteria for 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.
Gender:
Female
Minimum age:
25 Years
Maximum age:
49 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
INSMozambique
Address:
City:
Maputo
Country:
Mozambique
Status:
Recruiting
Contact:
Last name:
Edna Viegas, MD,PhD
Phone:
+258823060500
Email:
edna.viegas@ins.gov.mz
Contact backup:
Last name:
Edna Nhacule, MD
Phone:
+258827460555
Email:
edna.nhacule@ins.gov.mz
Start date:
April 17, 2024
Completion date:
December 2027
Lead sponsor:
Agency:
Instituto Nacional de Saúde, Mozambique
Agency class:
Other
Collaborator:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Source:
Instituto Nacional de Saúde, Mozambique
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06326294
