The findings of our study indicate that primary HPV screening through self-sampling is a cost-saving approach for cervical cancer screening, compared to the current recommendation of VIA for population-based screening in India. While the total cost of HPV screening may appear higher, the unit cost per test is substantially lower than VIA, primarily due to the higher screening coverage achieved with HPV screening. HPV self-sampling has been widely recognized for its ability to increase participation in cervical cancer screening as it overcomes various barriers; self-sampling effectively encourages more individuals to participate in regular screening programs, especially in low and middle-income countries [14,15]. Existing literature indicates that adopting self-sampling approaches can enhance screening participation among women and potentially lead to cost reductions [16]. According to a meta-analysis of 29 randomized controlled trials, the utilization of cervical cancer screening services was found to be twice as likely among women who underwent self-sampling compared to those who followed standard-of-care screening practices [17]. Women exhibit a preference for self-collection of samples within the convenience of their homes, as opposed to visiting healthcare facilities for screening [18]. It was found that there was a high level of compliance among women who opted for this self-collection method, with fewer operational challenges encountered during its implementation. Self-sampling presents a distinct opportunity to reach populations that are typically difficult to access, making it one of the most viable strategies for post-pandemic screening[19]. Self-sampling for HPV holds the promise of diminishing disparities in cervical screening participation within specific demographics and extending access to underserved and previously unscreened women [20,21].

Although VIA is known as a low-cost test and is recommended in low- and middle-income countries, the implementation of this subjective test is a major challenge. An Indian randomized controlled trial demonstrated that a single HPV test can effectively decrease the incidence of advanced cervical cancer and associated mortality. In contrast, VIA screening did not exhibit similar benefits in terms of cancer prevention and mortality reduction [22]. The significant hurdle to the widespread implementation of the more precise and efficient HPV screening method arises from the substantial upfront expenses required to establish screening programs. Although cost plays a vital role, it should not be the exclusive factor guiding decision-making. It is imperative to consider the well-being of women, along with their overall quality of life and satisfaction [23].

Our study findings also show significant differences in quality of life between women screened by HPV self-sampling who reported higher utility scores and a better quality of life compared to those who underwent VIA. The higher utility scores indicate that women screened through HPV self-sampling experienced better health-related quality of life, potentially due to reduced anxiety, pain and discomfort associated with the self-sampling approach. These results highlight the potential benefits of implementing HPV self-sampling as a preferred screening method, providing women with a more positive screening experience and ultimately contributing to improved health outcomes.

Previous studies have evaluated the cost-effectiveness of HPV self-sampling and VIA for cervical cancer screening [10, 24]. However, unlike these model-based studies, our study uniquely utilizes empirical data, marking the first instance of such an approach in India. An earlier model-based study in India that assessed the cost effectiveness of three screening strategies ie. Papanicolaou test, VIA and clinician based primary HPV testing for cervical cancer screening concluded VIA done every 5 years to be cost effective approach [10]. However, the study measured the health-related quality of life of cervical cancer patients rather than screened women to calculate the utility values. This approach failed to capture the immediate change in quality of life associated with the screening procedure itself. In addition, the study did not take into account the building cost of VIA screening as they reported data from camp-based approach.

Another study that evaluated cost effectiveness of same three screening strategies within a large cluster randomized trial from rural India (Legood R et al., 2005). The study dismissed HPV to be a cost-effective method for cervical cancer screening. It is important to note that this study accounted for all the costs in 2002, during which HPV testing was relatively new and prices were high, likely due to reduced competition in the market. Moreover, the study was conducted in a controlled settings of the trial that would vary from ‘real life’ situations. The ASPIRE randomized controlled trial included a cost-effectiveness study, which determined that community-based self-collected HPV testing is a cost-effective screening strategy [25].

Our study had few limitations. Building costs are typically higher in urban areas compared to rural areas. Differential implementation of HPV testing in urban areas and VIA testing in rural areas could have led to an overestimation of costs associated with the HPV testing strategy and an underestimation of costs associated with the VIA strategy. It is crucial to consider this limitation when interpreting the cost comparisons between the two screening methods. Another limitation of our study originates from the exclusive implementation of HPV screening within the East district of Sikkim [26]. The adoption of HPV screening specifically within urban area in the district has resulted in the inclusion of women who underwent VIA screening solely from rural PHC catchment regions. This specific sampling approach introduces a potential bias in the recruitment of participants, which may in turn limit the generalizability of the study findings.

In this study we have leveraged empirical data to evaluate the cost-utility of population-based self-collected HPV testing that is performed at women’s homes. The findings of this study provide a robust support for advocating the adoption and implementation of HPV self-sampling in India. The results indicate that the benefits obtained outweigh the associated costs, establishing it as a cost-effective approach within the provided threshold.. Further research following a similar framework in diverse settings across India is recommended. These studies would contribute to a more comprehensive understanding of the feasibility of HPV self-sampling as a primary screening method in various regional contexts.