Cervical precancer thermal ablation versus LLETZ excision comparative efficacy study in WLWH (TALL Study): protocol for a randomised clinical trial in South Africa
Abstract
Background: Cervical cancer remains a significant global health concern and is the fourth most prevalent cancer among women. In South Africa, it is the leading cause of cancer-related deaths in women aged 15-44 years. The disease is typically preceded by persistent high-risk HPV infection, leading to cervical intraepithelial neoplasia and eventually cancer. Currently, in South Africa, management primarily involves excision, particularly through large loop excision of the transformation zone, which has associated risks and limitations. Thermal ablation is an alternative cost-effective treatment method, providing a straightforward approach to treatment, particularly advantageous in environments characterised by limited resources. The study aims to assess the efficacy, safety and patient experience of thermal ablation, providing valuable data for potential integration into South Africa's cervical cancer prevention policies.
Methods: Randomised controlled trial in which 420 women living with HIV aged 30-60 years will be recruited from the Colposcopy Clinic at Tygerberg Hospital and will be followed up for a period of two years. The primary study endpoint is a test of cure that will be assessed by HPV genotyping, cervical cytology and histology at six month intervals. Other endpoints include the occurrence of adverse events.
Ethics and dissemination: The study protocol has been approved by the Health Research Ethics Committee of Stellenbosch University (Ethics Reference No:…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 420 participants or records.
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