A Randomized Clinical Trial to Compare Thermal Ablation Versus Loop Electrosurgical Excision Procedure for Cervical Cancer Risk Reduction in Women Living with HIV in Mozambique

What this Trial Is About

Women living with HIV (WLWH) are more likely to develop persistent HPV infection and cervical cancer (CC). Effective screening and treatment of pre-cancerous cervical abnormalities are critical to reduce the burden of cervical cancer, especially in sub-Saharan Africa where most WLWH live and resources are limited. This research aims to compare two treatment methods, thermal ablation (TA) and loop electrosurgical excision procedure (LEEP), to determine which is more effective in treating cervical pre-cancerous lesions (CIN 2/3) and HPV infection, and to identify factors linked to treatment failure. The study randomly assigns WLWH who test positive on cervical screening to receive either TA or LEEP. TA uses heat to destroy abnormal cervical tissue and is performed immediately after taking biopsies and curettage if needed. LEEP involves removing cervical tissue and is done following standard procedures, usually without prior biopsies. The study also evaluates pain and side effects related to each treatment and aims to develop an automated tool to predict treatment failure. Participants will undergo assessments including biopsies, colposcopy, and endocervical curettage as needed. Researchers will monitor treatment success at 12 months by comparing cure rates of CIN 2/3 lesions between the two methods. Safety, side effects, and pain are also tracked. The trial runs until December 2027 and is conducted by Instituto Nacional de Saúde, Mozambique, focusing on women aged 25 to 49 living with HIV.

Assessment of the Effectiveness of TA Versus LEEP for Cervical Cancer Risk Reduction in WLHIV in Mozambique