Study On An Anonymous Urine HIV Testing Model Based On A Mobile Medical APP

BackgroundIn China,more than 90%HIV infection was transmitted by sexual,and about one third was transmitted by homosexual behavior among men who sex with other men(MSM),In addition,the prevalence in young students is increasing year by year.Despite the wide distribution of laboratory network for serological testing throughout China,and the implementation of free HIV testing has been worked in the Disease Control and Prevention System(CDC)for many years,the detection frequency among high-risk populations is not high.The nationwide diagnostic data showed that the total number of HIV testing had increased to 144 million in 2015,accounting for almost one third of the global total number;however,there were only about 460,000 tests has been tested in MSM.The main reasons of this low rate are as follows:(1)High-risk populations have a low level of willingness to proactively be tested for HIV,due to the fear of discrimination and the special need for privacy protection.(2)High-risk populations refuse to be tested for HIV at clinics as they feel that it is troublesome.3)The HIV test takes an average of more than 1-2 weeks,it's time consuming.Although the blood test is the most widely used sample for HIV testing,the oral swab HIV test has recently been commonly used.Urine is another suitable sample for the detection of HIV-1 antibodies and its use has gained popularity owing to its advantages of non-infectious,non-invasive,and convenient sampling.Herein,we took these advantages into account to carry out a study of the innovative anonymous urine HIV testing based on the Mobile Medical Application(APP)platform.By focusing on the confidentiality,accuracy,safety,and rapidity aspects,our objectives in this study were to improve the willingness of the MSM population to proactively test for HIV,and to promote the accessibility of HIV testing among high-risk population.Our ultimate goals is to achieve a the first 90%target for the prevention and control of AIDS by 2020(i.e.,90%of those living with HIV are aware of their sero-status)and to provide innovative approaches and technical support in this regard.Objectives1.To evaluate the feasibility of HIV-1 antibody detection of urine samples after delivery2.To investigate of the acceptability of the Mobile Medical APP-based anonymous urine HIV-1 antibody test by high-risk populations3.Study on the application of the Mobile Medical App-based anonymous urine HIV test in high-risk populations in order to evaluate the field acceptability,feasibility,and availability of the test modeMethods1.Laboratory evaluation of the urine collection deviceTo evaluate whether the collection device(used to store the urine)had any impact on detection of HIV-1 antibody in the urine,the urine samples were tested and assessed for within-disc,within-batch,and batch-to-batch variations(CV%).To investigate the optimum storage temperature and validity period of the collection device,the changes in optical density of urine stored in the collection device at different temperatures(-20?,4?,room temperature,and 37?)over time were determined.Finally,to determine whether transportation of the urine collection device by mail had any impact on the accuracy of the urine HIV-1 antibody test,the urine samples stored in the collection devices were tested before and after being transported by mail and the results were compared and statistically analyzed using the SPSS 19.0 software.2.Clinical evaluation of the urine test after transportIn order to verify the consistency of results between blood and urine tests and to confirm the accuracy of the urine HIV-1 antibody test,paired samples of blood and urine were collected from different populations and tested for the HIV antibody,and the results were compared.The confirmatory blood test results were considered as the gold standard for the comparisons.3.Investigation of the acceptability of the Mobile Medical App-based anonymous urine HIV testA questionnaire-based survey was conducted on the MSM population in Beijing and on students of a high school in a highly endemic area of HIV infection in order to study the acceptability of the anonymous urine HIV-1 antibody test by these two populations.The questionnaire included information on sex,age,HIV test within the last year,the reason for not testing for HIV,the preferred type of samples for HIV test,the advantages of urine for HIV test,and the factors and testing sites of concern in the anonymous urine transport for testing.4.Study of the application of the Mobile Medical APP-based anonymous urine HIV testThe anonymous urine HIV-1 antibody test was subjected to a field study by providing the anonymous urine test service packs to college students of a university located in Guangxi Province and to two MSM populations(Shijingshan District of Beijing and Nanchang City of Jiangxi Province).The service packs were distributed by four different modes:(1)Online reservation;(2)Drugstore display;(3)Field test:the sample was collected and tested on-site;(4)Take-away-and-return:the urine collection device was taken away from the testing site and the sample was sent back afterward.The acceptability,feasibility,and accessibility of the field Application of the different test distribution methods were studied.Results1.Laboratory evaluation of the urine collection deviceUrine samples stored in the urine collection devices were tested using the basic urine test disc,and the results fulfilled the requirements.Homogeneity test:The within-batch and batch-to-batch CV values of the low-quality control material A were 8.0%and 13.7%,respectively.The within-batch and batch-to-batch CV values of the high-quality control material B were 6.0%and 11.6%,respectively.The measurement data were compared with single factor analysis of variance and result showed that FA=0.28,PA = 0.60(>0.05),whereas FB = 0.69,PB = 0.42(>0.05),with no statistically significant difference.Stability test:The urine could be stored in the urine collection device at 37? for 7 days,at room temperature for 1 month,and at 4?and-20? for 1 year.2.Clinical evaluation of the urine test after transportThe consistency of the urine HIV-1 antibody ELISA test results of a total of 240 urine samples taken from the collection devices before and after transportation were compared.The results showed that the test had good consistency,with K= 0.96,P=0.00.The sensitivity and specificity of the urine HIV antibody test were 97.3%(250/257)and 99.1%(947/956),respectively,and the coincidence rate of the urine HIV antibody test with the blood HIV antibody test was 98.7%.The sensitivity and specificity of the urine HIV antibody test in each population ranged from 94.3%to 100%and 95.4%to 100%,respectively,of which the population addicted to drugs had the lowest specificity of 95.4%.The sensitivity of the urine HIV antibody test in the population positive for HIV antibodies and currently receiving an anti-retroviral therapy was 88.7%(86/97),which was significantly lower than that in the other populations.3.Investigation of the acceptability of the Mobile Medical App-based anonymous urine HIV testA total of 468 college students participated in this survey,of which 33.1%(155/468)were males and 96.6%had never been tested for HIV,mainly due to the reasons "they feel that it is impossible to be infected with HIV"(58.9%,269/457)and"they do not know where they can be tested for HIV"(32.4%,148/457).Students selecting the blood,urine,and saliva samples for testing accounted for 65.8%(308/468),60.9%(285/468),and 37.0%(173/468),respectively.A total of 84.2%(390/463)of the students were willing to accept these test modes whereas the remaining students refused to accept the method,mainly because of the "complicated sample collection process" and "accuracy concern,"which accounted for 61.1%and 37.0%,respectively.In terms of the factors of concern for the anonymous test,the highest was the "accuracy of test results"(69.0%,323/468),followed by "satisfaction over subsequent post-test counseling and services"(39.5%,185/468),expenses,and the waiting time for the test results.There was no significant difference between males and females on these factors.The acceptable waiting times for the test results were 7 days(33.8%,158/468),3 days(29.3%,137/468),and 5 days(28.2%,132/468),and 63.0%(282/468)of participants selected RMB 100 to 150 as the acceptable expense.A total of 566 participated in this survey,.The MSM participants were mainly 18-25 years old,accounting for 56.2%(318/566).A total of 58.5%(331/566)of the MSM participants have never been tested for HIV,mainly because "they feel that it is impossible to be infected with HIV"(69.1%,163/236).MSM participants who selected the blood,urine,and saliva samples for testing accounted for 73.5%(416/566),62.5%(354/566),and 61.8%(350/566),respectively.In terms of the factors of concern for the anonymous urine test,the highest was the "accuracy of test results"(85.0%,481/566),followed by cost(46.3%,262/566),and the waiting time of the test results(39.8%,225/566).Most participants selected 3 days(64.1%,363/566)as the expected test result waiting time,and 78.8%(446/566)selected RMB 100 to 150 as the acceptable expense.4.Study of the field Application of the Mobile Medical APP-based anonymous urine HIV test4.1 Study of the Application of the anonymous urine transport for HIV testing in college studentsA total of 16 urine collection devices were returned out of the 300 anonymous urine test service packs distributed,giving a recovery rate of 5.3%(16/300).All 16 urine samples tested negative for the HIV-1 antibody and the positive rate of the preliminary HIV-1 antibody screening was 0.4.2 Study of the Application of anonymous urine transport for HIV testing in the MSM populationThe online reservation mode issued a total of 130 anonymous urine test service packs,with a recovery rate of 86.9%(113/130)and a positive rate of preliminary urine HIV-1 antibody screening of 28.3%(32/113).The total query rate of the test results was 78.7%(83/113).The drugstore display mode issued a total of 294 anonymous urine test service packs,with a recovery rate of 73.5%(216/294)and a positive rate of preliminary urine HIV-1 antibody screening of 19.4%(42/216).The total query rate of the test results was 93.1%(195/216).The field test mode issued a total of 59 anonymous urine test service packs,with a recovery rate of 100%(59/59)and a positive rate of the preliminary urine HIV-1 antibody screening of 6.8%(4/59).The total query rate of the test results was 90.1%(48/59).The take-away-and-return mode issued a total of 569 anonymous urine test service packs,with a recovery rate of 67.2%(405/569)and a positive rate of the preliminary urine HIV-1 antibody screening of 13.3%(54/405).The total query rate of the test results was 58.1%(248/405).Conclusions1.The use of a urine collection device has no impact on the experimental results.The urine can be stored at room temperature for 1 month and at 4? or-20?for 1 year.The urine collection device can be used for the transport of urine for HIV testing.2.The college students and MSM populations demonstrated a high acceptability to anonymous urine transport for HIV testing.3.The Mobile Medical App-based anonymous urine transport for HIV testing is operable and easily accepted by high-risk populations.4.The Mobile Medical App-based anonymous urine transport for HIV testing can effectively promote proactive HIV testing among the MSM population and college students and has a higher positive detection rate than conventional test approaches.Therefore,it can be used as an effective technique and approach to achieve the first 90%target of this study.