Consistency And Cost-effectiveness Of Home Self-sampling And Site Sampling For HPV Testing Among Men Who Have Sex With Men

Objectives: Men who have sex with men(MSM)are a key population for the prevention and control of human papillomavirus(HPV).Although many interventions have been used to promote early detection of HPV in this population,HPV detection rates in MSM populations remain at a low level.In recent years,the World Health Organization has proposed STD self-sampling.The STD self-sampling strategy can alleviate various obstacles to site sampling so that the subjects have high autonomy,convenience,and privacy in STD detection,which can be used to promote the early detection of HPV in key STDs.The current research on the accuracy of HPV self-sampling test results in MSM populations mostly focuses on European and American countries,but due to the differences in Chinese social background,these results cannot be directly applied to MSM populations in China,and most of the current studies are self-sampling in medical settings,and it is unknown whether more flexible home self-sampling can achieve the same accurate results.In addition,there is currently no cost analysis of different HPV sampling strategies in China.This study aimed to evaluate the consistency between HPV home self-sampling and site sampling in multi-site MSM populations in China and to evaluate the costeffectiveness of the HPV home self-sampling strategy in detecting HPV infection.Methods: This is a cross-sectional study and was included in four sites in Beijing,Tianjin,Shenyang,and Harbin from February 2021 to May 2021 through online publicity and onsite recruitment.The study subjects first completed the sampling of rectal exfoliated cells in the relevant institutions and then completed the self-sampling of home rectal exfoliated cells within 24-36 hours.All rectal exfoliated cell samples were mailed to the Shenyang laboratory,and 23 HPV typing tests were performed using the human papillomavirus nucleic acid typing test kit produced by Guangdong Kaipu Biotechnology Co.,Ltd.using fluorescence polymerase chain reaction(PCR).The paired Mc Nemar’s χ2 test was used to analyze the difference in HPV positivity rate between HPV home self-sampling and site sampling,and the kappa consistency test was used to explore the consistency of the detection results of the two sampling methods.In addition,based on the cost data generated during the study(HPV testing costs,specimen transportation costs,sampling illustration printing costs,staff labor costs,site rent,water and electricity costs,sampling tools and freezer costs,transportation costs,lost work costs)combined with the outcome of household self-sampling and site sampling to detect HPVpositive people,the incremental cost-effectiveness ratio was estimated to evaluate whether HPV household self-sampling was cost-effective.Results: 419 eligible MSM were included in the final paired analysis,and 454 MSM were included in the cost-benefit analysis.The results showed that the positive rate of any HPV sampled by all the study subjects was 72.8%,the positive rate of any HPV sampled in the place was 73.7%,and there was no significant difference in the positive rate of any HPV between the two sampling strategies(p=0.585).The positive rate of any high-risk human papillomavirus(HR-HPV)in home self-sampling was 57.5%,and the positive rate of any HR-HPV in place sampling was 59.2%,and it could not be considered that there was a statistical difference in the positive rate between the two sampling strategies(p =0.410).The Cohen’s kappa value of 0.82(p <0.001)for detecting any HPV was 0.82(p<0.001)for the home self-sampling strategy and the site sampling strategy,and the Cohen’s kappa value for detecting any HR-HPV was 0.74(p <0.001).In addition,in this study,the cost of finding a positive case of HPV in a family self-sampling was 171 yuan,and the cost of finding a positive case of HPV in routine place sampling was 528 yuan.The incremental cost-benefit ratio of household self-sampling compared with conventional sampling is18867 yuan,which is lower than China’s per capita GDP of 80976 yuan in 2021.Conclusion: This study shows that HPV home self-sampling and routine site sampling results are in good agreement with routine site sampling in the MSM population in China.Compared with the current conventional site sampling,HPV home self-sampling is cheaper and cost-effective.The results of this study can provide a reference for expanding HPV detection in the MSM population in China in the future.