More
Scientists from the International Agency for Research on Cancer (IARC) and partner institutions in India report the results of a randomized controlled trial that demonstrates that a human papillomavirus (HPV) screen, triage, and treat strategy is as effective as an HPV screen and treat strategy to clear HPV infection in women living with HIV. This new study was published in Nature Communications.
Infection with HPV is the primary cause of cervical cancer. Women living with HIV are more than 6 times as likely to develop cervical cancer compared with women who are HIV-negative. This trial included 433 women with HIV who screened positive for HPV infection. The women were randomized to two groups to compare an HPV screen and treat approach (Arm 1) with an HPV screen, triage, and treat approach (Arm 2). After 1 year of follow-up, the women were again tested for HPV to evaluate clearance of HPV infection as the primary outcome and detection of cervical intraepithelial neoplasia grade 2 or higher (CIN2+) as the secondary outcome of the trial.
Among the 173 women followed up in Arm 1, HPV clearance was observed in 56.6% (95% confidence interval, 48.9–64.1%). Among the 191 women followed up in Arm 2, 41.4% (95% confidence interval, 34.3–48.7%) had HPV clearance. According to the pre-specified statistical analysis plan, the difference was non-significant and the results demonstrated that an HPV screen, triage, and treat strategy is non-inferior to an HPV screen and treat strategy in women living with HIV. This is an important finding, because the low specificity of HPV detection tests in women living with HIV results in a high rate of overtreatment when a screen and treat strategy is followed.
Previous guidelines from the World Health Organization (WHO) recommended using triage for all HPV-positive women living with HIV, based on a favourable benefit-to-harm ratio observed in a modelling exercise. This randomized controlled trial provides the real-world evidence to support this conclusion, strengthening the recommendation and providing vital support to a key pillar of the WHO Cervical Cancer Elimination Initiative.
Joshi S, Muwonge R, Bhosale R, Chaudhari P, Kulkarni V, Mandolkar M, et al.
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
Nat Commun. Published online 22 February 2025;
https://doi.org/10.1038/s41467-025-56926-3
