Effect of Self-Sampling HPV DNA Testing on Cervical Cancer Screening in Singapore's Primary Care: Pragmatic Randomized Controlled Trial.

Abstract (English)

BACKGROUND: In Singapore, cervical cancer screening rates remain suboptimal, with only clinician sampling included in the national screening program. Self-sampling human papillomavirus (HPV) DNA testing might overcome barriers to clinician-based screening and improve uptake. We assessed the effect of offering self-sampling alongside clinician sampling on screening uptake and high-risk HPV detection compared with clinician sampling alone. METHODS: This pragmatic, 2-arm randomized controlled trial with Zelen design was conducted across NHG Polyclinics, NHG Health in Singapore. Women aged 30-69 years due for cervical cancer screening were randomly assigned (1:1) to intervention (offered selection of clinician sampling followed by self-sampling) or usual care (clinician sampling alone). The primary outcome was high-risk HPV DNA detection, and the secondary outcome was screening uptake. We performed subgroup analysis to examine both outcomes by prior screening history. Multivariable analysis identified factors associated with screening choices. RESULTS: From August 2024 to February 2025, 650 women were randomized, and 640 were included in the analysis (320 per arm). Significantly more high-risk HPV was detected in the intervention arm (3.1% vs 0.3%; absolute difference 2.8%; 95% CI, 0.8-4.8;<i>P</i> < .001), driven by greater screening uptake (56.6% vs 42.8%; absolute difference 13.8%; 95% CI, 6.0-21.4; <i>P</i> < .001), particularly among women with regular screening history and those with no prior screening. Among screened participants in the intervention arm, 56.4% chose self-sampling. Lower educational attainment was associated with lower odds of choosing self-sampling over declining screening. CONCLUSIONS: Offering self-sampling HPV DNA testing alongside clinician sampling significantly increased screening uptake and high-risk HPV detection rates. However, uptake remained lower among women with less education, highlighting the need for targeted engagement strategies.Abstract also available in: عرب&#x64a; (Arabic); Deutsch (German); Espa&#xf1;ol (Spanish); Francais (French); ह&#x93f;न&#x94d;दी (Hindi); Indonesia (Indonesian); (Chinese); (Japanese); Portugues (Portuguese).