Use of Thermal Ablation in Low-Resource Settings: Experience From Three Multicenter Noninferiority Randomized Clinical Trials.

Abstract

Thermal ablation (TA) is now a widely used treatment for cervical precancer in low- and middle-income countries. Over the past decade, TA devices have been redesigned to be more portable, user-friendly, and affordable. This analysis combines data from three large randomized clinical trials comparing the efficacy, safety, and acceptability of TA with those of the previous standard, gas-based cryotherapy. This analysis used Human Papillomavirus (HPV) test results at 1-year post-treatment as the primary outcome. Secondary outcomes included side effects and patient satisfaction. Of the 2,948 participants treated with either TA or gas-based cryotherapy, 80.9% and 81.8% completed HPV testing at 1 year, respectively. Overall, 60.7% tested negative for HPV at follow-up, with slightly higher rates in the TA group (62.5%) compared with cryotherapy (58.7%), although the difference was not statistically significant (<i>P</i> value = .14). Side effects were minimal for both treatments. Severe pain was slightly more common with TA (7.6% <i>v</i> 3.9% for cryotherapy), but vasovagal responses were less frequent (2.3% <i>v</i> 7.6%). Satisfaction with treatment was high (approximately 98%) across both groups. Our findings support the efficacy of TA in treating cervical precancer, offering an effective and practical alternative in low-resource settings. However, future research is urgently needed to address critical questions, including the standardization of treatment protocols and tailored approaches for women living with HIV.