HIV Infections, HPV Infection, CIN 2/3
Conditions
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
Interventions
DEVICEThermal 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.
Cervical tissue excision
Sponsors
M.D. Anderson Cancer Center
Instituto Nacional de Saúde, Mozambique
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 49 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of treatment success rates for biopsy-confirmed CIN 2/3: Thermoablation (TA) vs. Loop Electrosurgical Excision Procedure (LEEP) | 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. |
Countries
Mozambique
Contacts
Primary ContactEdna Viegas, MD, PhD
Backup ContactEdna Nhacule, MD
Outcome results
None listed