A randomised controlled non-inferiority trial to compare the efficacy of ‘HPV screen, triage and treat’ with ‘HPV screen and treat’ approach for cervical cancer prevention among women living with HIV

Abstract

Abstract We report results of a randomized controlled trial to compare ‘HPV screen and treat’ (Arm 1) and ‘HPV screen, triage and treat’ (Arm 2) in women living with HIV (WLHIV), using visual inspection with acetic acid (VIA) as the triaging test. Treatment was offered to all HPV-positive women in Arm 1 and to VIA-positive women in Arm 2 with either thermal ablation or large loop excision. All women underwent a repeat HPV test one year after randomization. The primary outcome was non-inferiority of HPV clearance of Arm 2 at one-year follow up when compared to Arm 1. Of 544 HPV-positive consenting WLHIV, 433 were randomised in a 1:1 ratio to trial arms. At baseline, CIN 2/3 lesions were detected in 16.7% and 13.3% women in Arm 1 and Arm 2 respectively. HPV clearance was observed in 56.6% (95%CI 48.9-64.1) women in Arm 1 and 41.4% (95%CI 34.3-48.7) women in Arm 2 at follow-up in the intention-to-treat population (P = 0.004). ‘HPV screen, VIA triage and treat’ strategy was non-inferior to the ‘screen and treat’ strategy as the lower bound of the 95% confidence interval from the regression model was greater than 0.49 in both intention-to-treat analysis (RR 0.73, 95%CI 0.59-0.91) and per-protocol analysis (RR 0.74, 95%CI 0.60-0.93) according to the pre-specified analysis plan. Clinical trial registration: CTRI/2020/02/023349.