Purpose: The WHO now recommends thermal ablation as an alternative to cryotherapy within "screen-and-treat" cervical cancer programs in low- and middle-income countries (LMICs). We conducted a safety and acceptability clinical trial of thermal ablation in a Kenyan Ministry of Health hospital among women living with HIV (WLWH; ClinicalTrials.gov identifier: NCT04191967).
Methods: Between August 2019 and February 2020, WLWH age 25-65 years underwent human papillomavirus (HPV) self-collection in western Kenya. HPV-positive women underwent visual inspection with acetic acid, biopsy, and treatment with thermal ablation performed by a nonphysician clinician, if eligible by standard guidelines. A questionnaire was administered after treatment to assess for pain and treatment acceptability. Adverse events (AEs) were evaluated 4-6 weeks after treatment with a standardized grading tool.
Results: A total of 293 HPV-positive WLWH underwent thermal ablation in the study period. The mean age was 40.4 years (standard deviation, 8.7 years). After treatment, 15 (5.1%), 231 (78.8%), 42 (14.3%), and 5 (1.8%) reported none, mild, moderate, and severe pain with treatment, respectively. At follow-up, spotting, vaginal discharge, and pelvic pain were reported by 99 (37.8%), 258 (98.5%), and 46 (17.6%), respectively, for a median of 3.3 (interquartile range [IQR], 2-3), 14 (IQR, 7-21), and 7 (IQR, 3-7) days, respectively. Most participants graded their AEs as mild (grade 1): 94 (95.0%) for bleeding, 125 (48.5%) for vaginal discharge, and 37 (80.4%) for pelvic pain. No grade 3 or 4 AEs were reported. The vast majority (99.2%) were satisfied with the treatment and would recommend it to a friend.
Conclusion: Thermal ablation performed by nonphysicians in the public health sector in Kenya proved safe and highly acceptable in treating HPV-positive WLWH.