| Objective: Men who have sex with men(MSM)has become an important high-risk population affected by human immunodeficiency virus(HIV),and is key population for HIV prevention and control around world.In China,MSM population is also a high-risk population for HIV infection.Although the expansion of HIV testing,free HIV counseling and testing,as well as condom distribution and related education have been targeted at the MSM population in China for more than a decade,the new HIV infection rate of this population is still at a high level,reaching 5.61/100 Person Years(PY).In addition,the proportion of homosexual sexual transmission among HIV /AIDS patients reported in China has been increasing year by year(from 12.2% in 2007 to 25.5% in 2017).In addition,the general public in China does not understand and discriminates against AIDS and homosexual sex,which leads to a high proportion of this group of people using the identity of heterosexual sex to cover up their real orientation,concealed behavior,prominent highrisk behavior,and the risk of bridge transmission of HIV to ordinary women.Therefore,it is urgent to explore effective HIV prevention strategies for this population.Pre-exposure prophylaxis(PrEP)is a promising new HIV prevention strategy in the world.It refers to the use of single or compound antiretroviral drugs to reduce the risk of HIV infection in hiv-negative people.In 2015,the World Health Organization recommended that the PrEP strategy be used in high-risk groups(with a new HIV infection rate of more than 3/100 PY).Advance(Chinese name ventilation,namely Tenofovir(Tenofovir disoproxil fumarate,TDF)and grace he marina(emtricitabine,FTC)compound preparations)as the only international approved drugs to PrEP,always through large-scale randomized controlled clinical trials and crowd some real world research shows that the orders take advance has a good effect of HIV prevention,especially for among MSM population.As of July 2018,40 countries and regions around the world have approved the promotion of Truvada as PrEP drug.However,this strategy has not been approved for promotion and implementation in China.As a developing country,China still lags far behind western countries in terms of economy,culture and medical and health resources.China has never carried out clinical trials of PrEP based on Truvada,and lacks reliable scientific research data as the basis for HIV prevention and control policies.Objectively,however,Chinese health policy makers and relevant health authorities are eager to obtain high-quality first-hand research data to support the preparation of PrEP guidelines with Chinese characteristics.In this context,we intend to truly reflect the promotion and application effect of PrEP in China’s current medical environment through real-world research methods,and provide sufficient real-world evidence for the large-scale promotion and application of PrEP in MSM population at home and abroad.Therefore,this study in the framework of evaluation system of public health policy,from understanding among MSM groups on the accessibility of PrEP,among MSM population in our country step by step to explore the PrEP promotion recruitment methods,based on the experience in recruiting,in shenyang,Beijing,shenzhen,chongqing set up large-scale HIV negative high-risk intervention among MSM population PrEP cohort study,from the PrEP medication adherence,medication after HIV related high-risk sexual behavior related risk compensation behavior(PrEP)change and drug safety,comprehensive evaluation of the effects of oral advance HIV infection among MSM population in China.To provide data support for further promotion and application of PrEP biomedical prevention strategy and exploration of effective control strategies for MSM population epidemic.Methods: In the first part,the HIV voluntary counseling and testing clinic(VCT)of the first affiliated hospital of China medical university was studied to recruit MSM patients for HIV counseling and testing.A one-to-one qualitative interview was conducted to investigate the awareness and attitude of MSM in shenyang region on HIV preexposure prevention,and the motivation of choosing different PrEP methods to prevent HIV infection.The second part,based on the former part of master among MSM cognitive status of design targeted promotion PrEP information,at the same time through their sexual partners to participate in the HIV positive among MSM population mobilization(through each HIV positive people sign up to offer its recommended with PrEP qr code,quantity and relevance)to evaluate the recommended partner and shenyang in the local gay community promotion recruiting PrEP participants in two ways,with subsequent screening into a set of organic integration.Compare the recruitment effects of the two methods.The attitudes of HIV positive MSM towards PrEP as a recommended partner and the acceptance willingness of PrEP as an HIV negative MSM as well as their related socio-demographic,behavioral and psychological characteristics were collected through the online self-filled structured questionnaire.Logistic regression analysis was used to analyze the related factors affecting the acceptance and participation of PrEP in MSM population in China.The third part,based on the above recruiting experience and the study is designed as a multicenter,real-world study with two arms of daily and event-driven TDF-FTC as PrEP among HIV-negative MSM at high risk of HIV infection in four metropolitan cities of China-Shenyang,Beijing,Shenzhen,and Chongqing.participants will choose between daily or event-driven taking Truvada according to their sexual schedule.Participants will be seen at month 1,3,6,9,and 12 for PrEP provision,clinical,questionnaire and laboratory evaluation,and HIV/STIs testing.A weekly online questionnaire detailing daily sexual activity and medication use is also required.The participants are preliminarily evaluated for their drug compliance,sexual behavior changes,and safe sex status,and the related influencing factors were analyzed by the generalized estimation equation(GEE),and the change rules were analyzed by chi-square trend test.Results: in the first part,18 MSM were interviewed in the VCT outpatient department of the first affiliated hospital of China medical university from march to April,2018.Twelve were willing to take PrEP(66.7% acceptance rate),of which two participates chose daily administration and ten chose event-driven administration.The main reason for MSM to choose PrEP is that they believe that PrEP is effective and has higher self-perceived risk.However,the biggest concern of MSM people about PrEP is the side effects of the drug,which is also the reason why they prefer to take the event-driven medication.Second part as a result,(1)two ways to recruit effect,in November 2018-December,through positive with mobilization recruit situation as follows,to obtain 295 valid HIV positive among MSM questionnaire,48.8%(144/295)of HIV among MSM is willing to recommend their sexual partners to PrEP,willing to presenter in higher educational level,their partner know their infection status,sex with serological consistency,past have more than one male sexual partners,think the PrEP work.Finally actually only received 33 from HIV positive sign up questionnaire among MSM mobilization,preliminary meet the inclusion criteria,nine people one by one,to make an appointment after only one person to the scene to accept real PrEP screening,but ultimately screening conforms to be ruled out,at the same time,negative HIV risk among MSM community oriented recruitment situation as follows,we obtained 304 questionnaire from MSM,and PrEP the acceptance rate was 93.4%(294/304),to the recipient in 60.2%(177/294)preliminary accord with standard of behavior into the group,46.9%(83/177)of the actual accepted screening,Screening qualification rate: 96.4%(80/83);(2)logistic multivariate analysis showed that the correlation factors influencing the acceptance and participation of MSM were as follows.The analysis showed that the factors influencing the acceptance of PrEP for MSM included: the number of male partners in half a year was >3(vs.≤3,a OR=4.6);Have chance/business partner(vs.no,a OR = 6.5),had not used condoms was inserted into the anal sex(vs.no,a OR = 4.7),HIV self perceived risk is higher(a OR =2.7),think PrEP effective(vs.invalid/neutral,a OR = 5.3),and received among MSM community groups(CBO)PrEP consulting(vs.no,a OR = 4.4),the factors influencing the actual participation among MSM including,past man number > 3(vs.3 OR less,OR =2.4).The higher the perceived risk of self-infection with HIV(a OR=1.3),those who has received PrEP counseling from CBO(vs.never,a OR=2.9)received 62.2%(189/304)and66.1%(201/304)of daily and event-driven medication,respectively,with p values of less than 0.05.In the third part,From December 19,2018 to February 19,2019,a total of 142 MSM were screened during the PrEP program,among which 115(79.3%)were qualified,41.7%(48/115)were daily served,and 58.2%(67/115)were event-driven.The number of sexual partners in the daily served group was more than that in the event-driven group in the past3 months.A total of 97 MSM(83.5%)completed at least one weekly behavioral and online questionnaire follow-up,with a total follow-up of 63.3 person-months(including 25.03person-months in the daily dose group and 38.07 person-months in the event-driven group).(1)medication compliance status.According to the self-reported weekly medication information of the respondents,GEE analysis showed that the event-driven group was more likely to have poor compliance(i.e.,score <90)than the daily dose group(OR=3.6,95%CI=2.0-6.6).Adverse adherence to PrEP was associated with anal sex without a condom during nearly a week of use(vs.none,a OR=2.1);Medication regimens are entirely up to you(vs.,follow your doctor’s advice,a OR=6.2);The effect of PrEP counseling provided by medical staff(vs.General/unbelief)(believe medical staff’s introduction of symptoms of side effects of drug a OR=0.3,believe medical staff’s explanation of side effects of drug a OR=0.3,believe medical staff’s explanation of the harm of drug omission a OR=0.5),all p values are less than 0.05;(2)the incidence of unprotected sex during PrEP.The chi-square trend analysis showed that the frequency of unprotected anal sex(CAI)reported by MSM weekly without condom in the daily group increased significantly(22.9% to 100%,p=0.016),while the incidence of unprotected sex did not change significantly during the event-driven group.The factors influencing the increase of CAI times during the medication period included: 4 male sexual partners(> vs.4,a OR=1.9)and unprotected anal intercourse more than one times(vs.1,a OR=1.6)in the last 3 months.People who are important to you do not support you taking PrEP(vs.Support)(a OR=2.0),all p values are less than 0.05;(3)the occurrence of drug-related adverse reactions.A total of 65 cases of drug-related adverse reactions were detected,with the majority of drug-related discomfort symptoms,and no abnormal drug-related clinical indicators were found,among which nausea ranked first.Drug-related adverse reactions were mainly concentrated in the first month,and gradually decreased with the time(38.5%to 0,p=0.019),and the monthly income was less than or equal to 3999 yuan(vs.> 3999 yuan,a OR=3.4),and the weekly dose(vs.less than or equal to 1 tablet)(2-6 tablets:a OR=17.3).> 6 tablets: a OR=9.3(all p values were less than 0.05)was the associated factor affecting the occurrence of side effects of drugs.Conclusion: 1.MSM in China has a relatively high willingness to take PrEP and a high self-perceived risk,which is an important reason for MSM to choose PrEP.However,fear of adverse reactions also affects MSM population to take PrEP,which is also an important factor for the higher proportion of people willing to take the medicine before and after sex.2.It is a huge challenge to recruit high-risk MSM to participate in the project from the perspective of single positive partner of HIV positive MSM,with slow recruitment speed and low acceptance rate.It may be related to the low notification rate of fixed HIV test results by MSM in China.It is relatively feasible to recruit respondents to participate in PrEP directly through HIV negative high-risk MSM.Cooperation with gay community organizations,targeted promotion information and quick subsequent enrollment services will help promote MSM people to participate in PrEP.3.Compared with the event-driven medication group,the high-risk behaviors of MSM with daily medication were more prominent.Compared with event-driven medication,the medication compliance of MSM with daily medication was relatively high,and medical staff played an important role in promoting medication compliance in aspects of medication guidance and professional consultation.It was found that the incidence of unprotected sex increased significantly during the period of daily dosing,suggesting that China should emphasize the prevention of PrEP related risk compensation when formulating the PrEP guidelines in the future,so as to reduce the risk of contracting other venereal diseases.At present,no significant side effects such as abnormal changes in relevant clinical indicators have been found in the initial stage of the project.MSM population has a good tolerance to Truvada,which requires further monitoring and research in the future. |
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