Development, field testing and evaluation of the efficacy of a hand-held, portable and affordable thermo-coagulator to prevent cervical cancer in low- and middle-income countries -admin supplement

International Agency For Res On Cancer, Lyon

Investigators

Linked publications, trials & patents

Abstract

Supplement to Original NCI Grant No: 5UH3CA202721-05 Project summary A study nested in the cervical cancer screening programme in Lusaka, Zambia was initiated in July 2016 with the general aim of developing, evaluating, and validating a robust, user- friendly treatment device for cervical cancer precursors suitable for settings with limited medical resources. The study was implemented in two phases – UH2 and UH3. UH2 phase of the study successfully developed a battery-driven lightweight affordable thermal ablator (a.k.a. thermo-coagulator) from its prototype stage and evaluated the same in a pilot randomized trial. The ongoing UH3 phase study is a larger randomized controlled trial that aims to compare the efficacy, acceptability, and safety of thermal ablation with other `standard of care' techniques to treat cervical precancers (cryotherapy and LLETZ) in `screen and treat' setting in Zambia. The primary objective of UH3 phase randomized controlled trial is to compare the treatment success rate of thermal ablation to that of cryotherapy and large loop excision of transformation zone (LLETZ aka LEEP) to treat VIA positive women who are eligible for ablative treatment. The study aims to recruit 3,123 VIA positive women (equally distributed across three treatment arms) and follow them up at 12 months post-treatment to achieve adequate statistical power. Due to the disruptions created by the COVID pandemic in Zambia it was not possible to complete the targeted recruitment within the stipulated time and funding was utilized to protect and support the participants and project staff, increase the number of study sites (by three times) to maintain recruitment target, pay for the COVID mitigation measures and retain all the study staff. We need to recruit an additional 524 participants and follow them over 18 months.