| Part 1 A longitudinal study among methadone maintenance treatment patients who enrolled during 2006-2007 in WuhanObjective:We aimed to understand the epidemiological characteristics and long-term dynamic trends of a cohort of methadone maintenance treatment patients who enrolled during 2006-2007 in Wuhan,Hubei,and to explore treatment features,HIV/HCV seroconversion,and mortality among MMT patients and their associated factors.Methods:With a longitudinal study design,16 MMT clinics that established during2006-2007 in Wuhan were selected as our research units,and new patients in these MMT clinics from March 30 th 2006 to December 31 st 2007 were enrolled as a fixed cohort and followed up to 31 December 2015.Baseline questionnaire and HIV/HCV test were applied to all participants.Follow-up records included daily methadone dosage administered,monthly urine tests to assess illicit opiate use,drop-out and death records,annual follow-up questionnaire and HIV/HCV test.Based on the collected information above,the profile of treatment characteristics,including dosages,treatment phases,treatment retention rate,urine test and serological test results etc.,and changing trends of the cohort were described.HIV and HCV seroconversion rates and potential risk factors were analyzed by GEE;All-cause mortality was calculated and factors predicting mortality were identified using Cox regression analyses.Result:1)A total of 3154 participants were enrolled in the longitudinal study.The mean age was 37.33 years,and 75.21% were male.The average years of illegal substance use were 10.93(SD: 4.43)years,and 74.28% had injected drugs in the last month.The number of participants decreased year by year.The retention rate fluctuated and reached to 16.42% at the end of our study.2)Majority of participants had experienced multiple treatment episodes.The average days of treatment decreased gradually as the increasing of treatment episodes(P <0.001).The number of patients in treatment declined year by year,but the average episodes per capita increased each year(P<0.001).The average prescribed daily dosage increased annually from 57.80 mg in 2006 to 78.37 mg in 2015(P<0.001).The percentage of low dosage group decreased from 22.12% in 2006 to 6.76% in2015 while medium and high dosage group increased from 42.6% in 2006 to 75.40%in 2015,which showed significant differences(P<0.001).The average admitted daily dosage decreased firstly then rose up as the treatment episodes increased.The induction dosage and the final taper dosage increased gradually as the treatment episodes increased while the percentage of low dosage group was at extremely low level all the time.The rate of on treatment decreased gradually as treatment episodes increased(P<0.001).The positive rate of urine test for illicit opiate drugs presented an overall rise trend(P<0.001).After adjusting for confounding variables,the risks of drop-out at the end of follow-up were analysed.Younger patients showed lower risk than older ones.Patients who lived alone or lived with family had higher risk of drop-out at the end of follow-up,patients who had good relationship with family members had lower risk of drop-out.Patients who did not share needles with others in the last month had lower risk of drop-out.Patients who had fewer treatment episodes showed higher risk of drop-out at the end of follow-up,and patients who received higher dosage had lower risk of drop-out at the end of follow-up.3)Only one person had gotten HIV seroconversion in this cohort,and the HIV incidence rate was 0.08 per 1000 person-years.The rate of HCV seroconversion was13.40(95%CI: 11.72-15.09)per 100 person-years.After other analysis variables were adjusted,significant independent predictors of HCV conversion included injection drug use in the past 30 days(OR 1.74,95%CI: 1.13-2.66,P=0.01)and family relationship(OR 0.49,95%CI: 0.25-0.97,P=0.04).4)A total of 215 deaths were observed within 9229.85 person-years of follow-up for an all-cause mortality rate of 23.29(95%CI: 20.18-26.41)per 1000 person-years.The Standard Mortality Rate was 9.67 and the leading cause of death was drug overdose(58 cases).The results of Cox proportional hazards regression models were presented as followings,adjusting for confounding variables,younger patients had lower risk of death,male patients had higher risk of death than female patients(HR=2.55,95%CI: 1.60-4.09),patients who lived alone and had fewer number of treatment period had higher risk of death.Being HIV-negative was associated with lower risk of death(HR=0.12,95%CI: 0.06-0.24).Conclusions:1)The typical characteristic of methadone maintenance treatment among the cohort population was drop-out after treatment repeatedly.The safe use of methadone had become a serious issue,and the following high risk and outcomes should be drawn attention and in-depth analysis.Age,living status,family relationship,sharing needles in the last month,treatment episodes and dosage were associated with the status of on-treatment at the end of follow-up.2)The incidence of HCV among the cohort was high.Injection drug use contributed to higher risk of HCV infection while harmony family relationship reduced the risk of infection with HCV.3)High mortality was observed among the cohort,which was 9.67 times as high as general population in Hubei province.The primary cause of death was overdose,which indicated that the combination of drug use during the maintenance treatment increased the risk of death.There were several independent risk factors for the death of the cohort including age,sex,living status,treatment episodes and HIV infection.Part 2 Effectiveness evaluation of counselling interventions among methadone maintenance treatment patients in Wuhan: A multi-center randomized Controlled trialObjective:We aimed to evaluate the effectiveness of behavioral drugs and HIV risk reduction counselling and Educational counselling among methadone maintenance treatment patients,which could provide scientific basis for further optimizing methadone maintenance intervention services.Methods:A multi-center prospective randomized controlled trial was designed.According to geographical distribution and research willingness,3 clinics in Wuhan city were selected.New admitted MMT users were recruited from these three clinics for a total of 40 weeks.The recruitment lasted from September 1,2011 to November 30,2015.All of the participants were provided standard MMT services and randomized to one of the three groups,BDRC group,EC group or TAU group.A weekly intervention of BDRC or EC was provided to the patients in BDRC group or EC group respectively for 16 weeks.Patients in TAU group received treatment services provided by clinic staff as usual.All the patients were surveyed at baseline,at the end of the counselling phase(week 16),and at the end of the follow-up phase(week 40).During the study period,methadone maintenance treatment records and the results of urine test for illegal substances were collected.The basic characteristics of each group,addiction severity,mental health,treatment records and urine test results were compared.Repeated measurement data statistical analysis was performed on the baseline,counselling phase and follow-up phase data to assess the effect of counselling intervention.Result:1)A total of 325 participants who signed consent forms and completed baseline survey,were randomized to BDRC group(109 cases),EC group(107 cases)and TAU group(109 cases).There were no statistically significant differences in demographic characteristics,drug abuse and sexual behaviors among BDRC group,EC group and TAU group.There were also no statistically significant differences in the condition of addiction severity,mental health,and depression situation.2)During counselling intervention phase,there were no statistically significant differences in treatment attendance days and average dosages(P> 0.05).There was no significant group difference in the changes of the urine positive rate of morphine,other drugs and the overall drugs before and after intervention(P >0.05).All three groups were associated with significant reductions from baseline in the urine positive rate of morphine and the overall drugs(P<0.001).During follow-up phase,there was no significant difference in the urine positive rate of morphine,other drugs and the overall drugs(P>0.05).3)Generalized estimation equation(GEE)was applied in the analysis of repeat measure data of urine test in counselling intervention phase and follow-up phase.There were no significant group differences in the urine positive rate of morphine,other drugs and the overall drugs(P>0.05).However,there was significant higher level of the urine positive rate of morphine in follow-up phase than that in the counseling intervention phase(P<0.01).Further,GEE analysis was applied by three groups respectively,and the results presented that there was no time effect in BDRC group and EC group,and there were significant higher levels of the urine positive rate of morphine and total drugs in follow-up phase than that in counseling intervention phase in TAU group(P<0.01).4)There were no significant group differences and interaction of group and time in the addiction severity,mental health,and depression situation.However,there were significant time effect in the following dimensions,Alcohol addiction,legal status,mental health,education and employment in addiction severity index.And there were significant time effect in somatization,obsession-compulsion,anxiety,phobic anxiety and psychoticism in BSI.These significant time effect indicated higher scores in follow-up phase than that in baseline and counseling intervention phase.Conclusions:On the basis of standard methadone maintenance treatment,there were no significant differences between groups on the improving treatment attendance,addiction severity,and mental health.BDRC had a certain advantage in promoting the patients to achieve counseling services and reduce illegal drugs use.The problems in the mental health were not improved with the increase in the duration of treatment,and in some areas,there was a tendency to be more serious,which should be given more attention. |
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