Randomized control trial of thermal ablation of the cervix in women living with the human immunodeficiency virus in Zambia

Abstract

<h3>Objectives:</h3> A randomized control trial of a battery-operated thermocoagulator for the treatment of precancerous cervical lesions is ongoing in Lusaka, Zambia. We describe preliminary results of treatment efficacy in HIV-positive women. <h3>Methods:</h3> Visual inspection with acetic acid (VIA) screen-positive women eligible for ablative treatment are randomized to receive thermal ablation (TA), cryotherapy or large loop excision of the transformation zone (LLETZ). Demographic information is collected, including human immunodeficiency virus (HIV) status and antiretroviral therapy (ART) use. Human papillomavirus (HPV) DNA sampling for known or suspected oncogenic HPV types is performed at baseline and follow-up. Treatment efficacy is based on VIA and HPV status at 6- and/or 12-month follow-up. Side-effects, pain and client satisfaction are scored and recorded, however, these data are not included in this analysis. <h3>Results:</h3> Of the 1,683 women who have been randomized to treatment, 994 (59%) are HIV-positive with the vast majority (97%) on anti-retroviral therapy (ART). HIV-positive women were equally distributed between treatment arms (p=0.28). Among the 1328 (79%) eligible for follow-up, follow-up data are available on 722 women (54%), of which 383 are HIV-positive. Based on VIA results alone for cure, HIV positive women had lower overall cure rates than HIV-negative women (77% vs 88%, respectively, p<0.001), regardless of treatment type. HIV-positive women, who were also positive for HPV 16 at baseline, had significantly lower cure rates (HPV 16 clearance and VIA negative) across all study arms, compared to HIV-negative women (73% vs 88%, respectively, p<0.001). When all HPV types are considered, overall cure rates (clearance of baseline type-specific HPV and VIA negative) in HIV positive women decreased to 49% and did not differ based on duration of HIV infection (<2 years, 43%; >2yrs, 55%; p=0.072). <h3>Conclusions:</h3> In May 2020, the 173^rd World Health Assembly adopted the Global Strategy to Eliminate Cervical Cancer. This sub-analysis of data from a randomized control trial of locally ablative methods for cervical precancer highlights the challenges in eradicating this disease in women living with HIV. Investigations are underway to determine the underlying causes of these findings. (NCI Grant No. 4UH3CA202721-03)