An interventional study of Thermal ablation and LOOP ELECTROSURGICAL EXCISION PROCEDURE in HIV Infections, HPV Infection and CIN 2/3, sponsored by Instituto Nacional de Saúde, Mozambique. Recruiting at 1 site in Mozambique. Open to female participants aged 25 Years to 49 Years. Per ClinicalTrials.gov, last updated 2024-05-22.
Sponsored by Instituto Nacional de Saúde, Mozambique · Not applicable, Interventional, and Treatment
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.
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:
Secondary Objectives:
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's planned enrollment of 4,844 is above the median of 80 across 3,489 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Instituto Nacional de Saúde, Mozambique is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants allocated in this group will be treated with thermo ablation. Before TA, perform biopsies of any acetowhite lesions by colposcopy and/or positive by AVE and an endocervical curettage (ECC); In women who do not have any lesions noted by colposcopy or AVE, one random cervical biopsy at the squamocolumnar junction and an endocervical curettage (ECC) will be obtained. TA is performed during the same exam (immediately following biopsies/ECC)TA will be done according to the manufacturer's instructions and specifications.
Device: Thermal ablation
Participants allocated in this group will be treated with LEEP. LEEP will be done according to standard procedure. No biopsies are taken, only LEEP is performed, unless clinically indicated.
Procedure: LOOP ELECTROSURGICAL EXCISION PROCEDURE
Thermal ablative uses heat (100°C to 120°C) to cause localized tissue damage at the cervical transformation zone and destroy the abnormal epithelium.
Also known as: TA
Cervical tissue excision
Also known as: LEEP
Comparison of treatment success rates for biopsy-confirmed CIN 2/3: Thermoablation (TA) vs. Loop Electrosurgical Excision Procedure (LEEP)
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.
Time frame: 12 months
Started Apr 2024 (actual). Primary completion is estimated for Sep 2027, 41 months after the start.
Of 393 non-industry interventional studies with no phase under HIV Infections, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 45. This study's planned 41 months is above that.
Counting every sponsor, half of 402 studies reached it within 28 months; a quarter within 16 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
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Instituto Nacional de Saúde, Mozambique