Multi-center Real-world Study On The Risk Compensation Of Pre-exposure Prophylaxis In Men Who Have Sex With Men In China

Background: Men who have sex with men(MSM)are 19 times more likely to be infected with human immunodeficiency virus(HIV)than normal people due to their special sexual behavior characteristics.MSM population their HIV epidemic has caused widespread concern at home and abroad.Traditional HIV prevention strategies,such as the “ABC” strategy(ie.Abstinence,Be loyalty,Condoms),have limited effectiveness in controlling HIV epidemics in MSM populations.Pre-exposure Prophylaxis(Pr EP)refers to the means of reducing the risk of infection by taking antiretroviral drugs in high-risk populations without HIV infection.It has been reported that the protective effect of Pr EP can reach 92% or more under the condition of high drug adherence.In 2012,the US Food and Drug Administration approved the use of the Pr EP drug Truvada.The World Health Organization(WHO)recommended the use of Pr EP for one tablet per day.Studies abroad have found that event-driven regimen(ie,before and after sexual activity)can achieve the same protective effect as daily regimen.Internationally,the results of changes in high-risk sexual behaviors after using Pr EP drugs and Sexually Transmitted Infections(STIs)infection rates(Risk Compensation)are inconsistent,same as the risk compensation of participates using different Pr EP regimens.There is still no such research data in our country.This study will explore the risk compensation phenomenon in MSM population who taking Truvada daily or event-driven in real-world research by simulating the real clinical enviroment in China.Objectives: 1.Obtain the sociodemographic characteristics and the differences in high-risk sexual behaviors of the two Pr EP regimens participants in the baseline;2.Hold the high-risk sexual behavior changes at baseline and the first month of follow-up,and explore whether there is a risk compensation after taking the drug for one month;3.Understand the weekly changes in high-risk sexual behavior after taking the drug,and explore the continuous changes in weekly sexual behavior.Methods: 2018-2019,in Shenyang,Beijing,Shenzhen,Chongqing,daily and event-driven real-world study of taking Truvada.Participates voluntarily chose the Prep regimen for a one-year follow-up.The participates were followed up in the clinic at 1,3,6,9,and 12 months after taking the drug,including physical examination(liver and kidney function,Hematuria,HIV/STIs,etc.),clinical consultation,epidemiological questionnaire,and drug collection.Participates also need to complete a weekly online survey to record weekly sexual behavior and medication.Comprehensive assessment of the risk compensation of Pr EP.Results: As of February 17,2019,a total of 134 people were successfully enrolled.There were no significant differences in sociodemographic characteristics between the two groups.The baseline sex behavior frequency of the daily group was higher than that of the event-driven group(56.67% vs.28.38%,P=0.002).A total of 20 participates completed the first month of follow-up.The follow-up survey found that the average number of male sexual partners(3.64±5.12)in the past month was higher than baseline(1.23±1.00),P=0.015.The first month follow-up survey found that the average number of casual male sexual partners in the past month(4.22±4.54)was higher than that in the past one month(1.92±1.64),P=0.005;The characteristics of sexual behaviors in the two regimens were(0.83±0.92)times in the first-week event-driven group,and the mean sexual behavior in the daily group was(1.43±1.54)times,P=0.047.The mean of the second-week event-driven group was(1.92±1.35)times,and the mean sexual behavior of the daily medication group was(2.00±1.80)times,P=0.009.The number of weekly sexual behaviors in the daily medication group was higher than event-driven medication group.Based on the first week,the high-risk behavioral changes after taking the drug were compared.The average number of sexual behaviors in the second week(0.76±1.36)was higher than that in the first week(0.38±0.70),P=0.031.The chi-square trend test was used to analyze the trend of the proportion of weekly unspoken behavior over time.The proportion of six-week sexual behavior was 40.34%,49.97%,48.62%,58.00%,66.67%,P=0.001,respectively.The proportion of weekly sexual behaviors increased with time.Conclusion: The investigation found that the sociodemographic information of the subjects in the two regimens did not have bias.The baseline high-risk behavioral characteristics of the daily group were higher than those of the event-driven group,indicating that the majority of participates who chose to take the daily group were sexually active.The first-month follow-up survey compared with the baseline sex behavior found that the number of sexual partners in the past month increased after one month of medication.The weekly network survey also found that the number of sexual partners and the proportion of condomless sex behavior of the participates showed an upward trend.That is,in the initial stage of the study,the risk compensation appeared through the self-reported high-risk sexual behavior,and then it should be further verified by the results of laboratory.If the risk compensation is still evident as the study progresses,the investigator should take the necessary interventions to reduce the high-risk behavior of the participates to avoid the infection of HIV or STIs..