Abstract
The World Health Organization recommends thermal ablation (TA) as an alternative to cryotherapy within "screen-and-treat" cervical cancer programs in low- and middle-income countries (LMICs), including among women living with HIV (WLWH). Data on TA efficacy among WLWH are limited, however. We conducted a clinical trial to evaluate efficacy of TA for treatment of biopsy-confirmed cervical intraepithelial neoplasia grades 2 and 3 (CIN2/3) among WLWH in Kenya. Nonpregnant HPV-positive WLWH age 25 to 65 years underwent colposcopy-directed biopsy, and same-day treatment with TA, if eligible. Women with biopsy-confirmed CIN2/3 at baseline had colposcopy-directed biopsies at 12 months to determine cure. A total of 376 participants underwent TA during the study period. At baseline, 238 (63.3%) had normal histology, 39 (10.4%) had CIN1, 15 (4.0%) had CIN2, 55 (14.6%) had CIN3, 7 (1.9%) had microinvasive cancer and 22 (5.6%) had indeterminate results. Twelve-month follow-up pathology results are available for 59 of 70 (84.3%) participants with CIN2/3 at baseline. Of these, 39 (66.1%, 95% CI 0.54-0.99) had successful treatment, defined as biopsy-confirmed CIN1 or normal findings, while 20 (33.9%, 95% CI 0.22-0.46) had treatment failure, defined as persistent biopsy-confirmed CIN2 or worse. Treatment failure was 23.1% (95% CI 0.17-0.46) and 39.9% (95% CI 0.23-0.51) among women with CIN2 and CIN3 at baseline, respectively. HIV-positive women with CIN2/3 have high rates of treatment failure at 1-year following thermal ablation. This highlights a significant limitation in the current WHO cervical cancer secondary-prevention strategy and calls for strategies to optimize cervical precancer treatment in this population.