Smita Joshi

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

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.

Performance of HPV Self-Sample Collected by a Novel Kit in Comparison with Clinician Collected Sample for Cervical Cancer Screening

We are reporting the performance of HPV self-sample collected by a novel kit in comparison with clinician collected cervical sample for HPV testing for cervical cancer screening. Consenting, eligible women aged 25 to 60, with a positive cervical cancer screening test report in the past one year but without any prior treatment for cervical abnormalities were enrolled in the study. Each woman provided 2 samples for the HPV test (vaginal self-sample collected with the CERVICHECKTM, an indigenous kit from India and cervical sample collected by the clinician). These samples were analysed using cobas HPV test on 4800 platform and for liquid-based cytology. We enrolled 156 eligible, consenting participants at 2 study sites. The agreement for the sample collected by CERVICHECKTM and clinician collected sample for any high-risk HPV was 95.1% (k= 0.90, SE 0.036, 95% CI 0.83-0.97). The agreement for HPV 16 or 18 only was 95.1%, (k=0.88, SE 0.045, 95% CI 0.79-0.97). The overall acceptability of the kit was good, participants expressed that self-sampling was easy and > 90% women were willing to recommend it to their friends. There was almost perfect or perfect agreement between the HPV self-sample collected by CERVICHECKTM and clinician collected cervical sample. Self-sampling was highly acceptable to the participating women.