Veil-Based Collector Device Enabling Self-Collected Cervicovaginal Sampling for Site-of-Care Primary HPV-Based Cervical Cancer and Sexually Transmitted Infections Screening: A Pilot Feasibility Study in Romania.

Background/

Objectives

High-risk human papillomavirus (HR-HPV) causes cervical cancer, but other sexually transmitted infections (STIs) act as possible cofactors. We herein evaluated the feasibility, logistics, and epidemiology of a community-based screening program in Romania using an innovative veil-based self-sampling device and a digital platform.

Methods

Adult women self-collected genital secretions using the Vaginal Veil Collector V-Veil UP2™ device (V-Veil-Up Production SRL, Pitesti, Romania). A digital platform managed registration and results. Dry impregnated veils were transported at ambient temperature via standard courier to an accredited French laboratory for molecular testing using in parallel the Allplex™ HPV HR Detection assay (Seegene, Seoul, Republic of Korea), detecting 14 HR-HPVs, and the Allplex™ STI Essential Assay (Seegene), detecting 7 major pathogens causing STIs [Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium, Trichomonas vaginalis, Mycoplasma hominis, Ureaplasma urealyticum, Ureaplasma parvum].

Results

Among 960 included women (mean age 41.3 years), technical success was high: 97.7% of samples yielded valid results for HR-HPV and 97.4% for STIs. Sample stability at ambient temperature eliminated cold-chain requirements. Overall, 17.2% of women were positive for HR-HPV and 26.7% for an STI. The most frequent genotypes were HPV-68 (3.0%), HPV-16 (2.9%), and HPV-31 (2.3%); Ureaplasma parvum (24.0%) was the most prevalent bacterial pathogen. The 18-29 age group exhibited the highest risk for HR-HPV (22.2%) and STIs (36.8%). Multivariate analysis revealed strong biological associations: Chlamydia trachomatis was independently associated with overall HR-HPV (aOR: 4.52; 95% CI: 1.26-16.11) and multiple HR-HPV infections (aOR: 13.96; 95% CI: 3.70-52.64). Mycoplasma hominis and Ureaplasma species were also independently associated with HR-HPV (aOR: 1.83 and 1.67, respectively) or nonvaccine types (aOR: 2.75 and 5.03, respectively).

Conclusions

Veil-based self-sampling combined with digital logistics is highly feasible, scalable, and overcomes geographical barriers. The marked association between Chlamydia trachomatis, Mycoplasma hominis, Ureaplasma species, and HR-HPV strongly advocates for integrated molecular co-testing models in public health screening programs.