Description
The discovery that human papillomavirus (HPV) is the causative agent of cervical cancer (CC) has brought its elimination within reach, owing to the development of highly effective high-risk HPV (hr-HPV) vaccination and testing methods. With its advantages of lesser invasiveness and superior sensitivity for detecting cervical pre-cancer, the hr-HPV DNA test is an appropriate substitute to traditional Papanicolau cytology as the primary cervical screening method (Davies-Oliveira et al., 2022).
Yet, cervical cancer remains dangerously prevalent in Romania, both in terms of total diagnoses and mortality. Rates of diagnosis are more than twice as high as the EU average (34.2 vs. 15.0) and mortality rates are highest among all member states (Todor et al., 2021). A key reason for this is that uptake of screening is low, with a coverage rate of only 39% in women aged 35-49 over the last six years (Bruni et al., 2022). Screening is opportunistic and voluntary; no invitations to attend are sent to eligible women, and most tests are done outside of organised programmes. Other causes include the high proportion of medical deserts in Romania, wherein too few clinics and medical professionals are present per 10,000 population (AHEAD, 2023), as well as attitudinal barriers including low knowledge, fear of testing, and shame especially among low-resource and immigrant cohorts (Grigore et al., 2017; Grigore et al., 2022). As a result, a large proportion of cervical cancers are diagnosed at late stages, highlighting an urgent need to develop more accessible and systematic testing programmes.
Clinical trials in higher-income countries have demonstrated that mailing hr-HPV self-sampling kits to under-screened women increases participation, but Romanian data are lacking. Building on the methodology and favourable results of the US-based HOME and MBMT-3 trials (Pretsch et al., 2023; Spees et al., 2019; Winer et al., 2018) as well previous Belgian, Dutch and Finnish trials (Arbyn et al., 2018; Bosgraaf et al., 2015; De Pauw et al., 2021; Virtanen et al., 2011), this study aims to deliver the first such two-arm randomised controlled trial in the context of Romania. Specifically, we propose to target Moldavia province, the highest-risk area of Romania as defined by lowest coverage rates of screening, highest mortality rates from cervical cancer and lowest number of medical personnel relative to population (AHEAD, 2023; Furtunescu et al. 2022). The aim is to compare the effect of two programmatic approaches for increasing cervical cancer screening uptake in under-screened women aged 25–64 years: (i) mailed hrHPV self-screening kit, (ii) usual care (outreach by clinics for scheduling screening appointment). Additionally, we aim to identify specific high-risk, fragile sub-groups more or less likely to engage in cervical cancer screening. Together, this acquired knowledge will aid the design of future screening campaigns in Romania.
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