| Objectives:To describe the status of adherence to antiretroviral therapy(ART)in HIV/AIDS patients who have been enrolled in the free national HIV treatment program;to explore the factors related to ART adherence,to formalize a Chinese tool for measuring the medication adherence,to examine the relationship between adherence to ART and treatment outcome,and to provide scientific evidence for further adherent behavior intervention program.Methods:We applied a field epidemiological method combining cross-sectional study in multi-sites with longitudinal study in fixed sites. The target population of this study was HIV/AIDS patients receiving free ART treatment.This study lasted from March,2006 to January,2007.The ART treatment sites were randomly selected in Hunan,Hubei,and Anhui provinces.Altogether 308 patients were approached in the baseline survey by cluster sampling.Based on the baseline data,113 patients from 4 treatment sites in Hunan and 2 treatment sites in Hubei were randomly selected for the follow-up,which was once every three months,and two times in total.Data collection methods included structured face-to-face interview,review of medical records,and weight measurement.During the baseline study and the follow-up data collection,tools for variable measurement included:a general information sheet(being omitted in the follow-up study)for assessing patients' demographic data,general information about the disease and treatment,knowledge,and social support;a Questionnaire on Adherence to ART adopting a global standard of 7-day recall for measuring patients' medication adherent behaviors; Questionnaire of SF-36 for evaluating patients' quality of life.Each subject's medical records were reviewed to obtain data on CD4~+T cell count and status of opportunity infections.The patient's weight was measured on the fixed scales in the treatment sites.Health economic indicators,including out-patient medical expenses,number of hospitalization,and expenses of hospitalizations were obtained from reviewing related documents in assigned hospitals.The research design and data collection methods were approved by the Human Subject Review Committee of Yale University for the ethical considerations.The investigators strictly followed the principles of informed consent and confidentiality during the study.Results:1.Analysis of cross-sectional data(1)Among the 308 HIV/AIDS patients,243(78.9%)reported taking 100%of the medication in the last 7 days,with an average adherent level of 94%;the other 65 reported missing doses and the main reasons of missing doses were being away from home,simply forgetting,being too busy,and complaining of side effects of the medications.Based on the amount of medications taken in the past 7 days,20.5%of the patients were identified as having poor medication adherent behavior.Only 21.1% of the patients took the pills on time.About 7.5%of the patients took wrong doses.The number of people taking the wrong doses who received ART less than one year was significantly higher than that who received treatment for more than 1 year[OR=5.7,95%(CI 2.4-13.8)].Eighty-four patients took medications containing DDI,and but 11 people did not chew the medication with empty stomach,which did not meet the requirements of the specific medication.(2)Related factors of adherence to ART:χ~2 tests showed that active use of heroine[OR=3.49,95%(CI 1.50-8.13),P=0.007], satisfaction with support from family for taking medication[OR=0.44, 95%CI(0.25-0.78),P=0.005],using medication reminders[OR=0.17, 95%CI(0.09-0.32),P=0.0001],and medication knowledge[OR=0.38, 95%CI(0.21-0.69),P=0.001]were significantly associated with ART adherence.Other factors,including age,sex,education,residency,HIV status disclosure,social support,drinking alcohol,disease status,ART characteristics,and peer education,were not associated with ART adherence.Logistic regression analysis showed that use of heroine [OR=2.48,95%CI(1.00-6.11),P=0.040],use of medication reminders, and knowledge of medication were the independent influencial factors of ART adherence.(3)The scores of all subscales of SF-36 in this sample were significantly lower than those of normal population,in which the score of role limitation due to physical problems(RP)decreased by 75.1% compared with the normal counterparts,followed by social function(SF) and general health(GH).The scores of body pain(BP)and physical function(PF)showed the least differences of 13.9%and 18.2% respectively lower in H/V/AIDS patients than that in normal population.(4)Eighty-nine H/V/AIDS patients had opportunity infections, with a prevalence rate of 28.9%.The most common infections ranked as lung tuberculosis,skin simple herpes,intestinal infections,pneumocytsis carinii pneumonia,and oral candidiasis.2.Analysis of longitudinal data Based on the baseline data,we randomly selected 113 patients from 308 as the follow-up study subjects and accomplished all follow-up interviews in 98 subjects with a follow-up rate of 86.7%.(1)During the observation of 6 months,there was a slightly fluctuation in the adherence level.The level of adherence in the second interview was higher than that of the first while the level of the third was the lowest.Friedman M test showed that there was no significant difference in the average level of adherence in the 98 patients at 0,3, and 6-month(P=0.56).Among the 98 subjects,56 persons reported good adherence during the 3 interviews,accounting for 57.1%,and 42 (42.9%)persons reported poor adherence at least once in the 3 interviews.(2)All subscales of SF-36 were improved to some extent as the treatment time prolonged.Repeated measures analysis of variance showed that there were significant differences in PF(F=6.01,P=0.016), RP(F=4.19,P=0.043),BP(F=6.45,P=0.013),role limitation due to emotional problems(RE)(F=19.37,P=0.0001),and mental health(MH) (F=12.27,P=0.001)among different time levels,and no significant difference was found in GH,vitality(VT),and SF.The scores of PF (F=9.72,P=0.001),GH(F=4.99,P=0.009),VT(F=4.32,P=0.016),SF (F=7.78,P=0.001),and MH(F=3.9,P=0.023)of patients with good adherent behaviors were significantly higher than those of patients with poor adherent behaviors,while there was no difference in the scores of RP,BP,and RE between the two groups.(3)The change of CD4~+ cell counts:Repeat measure analysis of variance indicated that CD4~+ cell counts of different time points were significantly different(F=10.67,P=0.0001).Kruskal-Wallis Test showed that the rate of CD4~+ cell growth in patients with good adherent behaviors were significant higher than that in patients with poor adherent behaviors (χ~2=4.64,P=0.031)(4)There was a growth in the weight of 98 patients,but the result of repeat measure F test didn't prove its significant changes among 0,3,and 6-month(F=0.11,P=0.89),and the rate of weight growth in the adherent group was not significantly higher than that in the non-adherent group(χ~2=0.02,P=0.88)(5)During the 6-month observation,31 patients(31.6%)had been hospitalized at least once.Compared with patients with good ART adherence,those with poor ART adherence had higher expense of hospitalization(χ~2=7.45,P=0.006),longer hospital stay(χ~2=7.91 P=0.005),and more hospitalizations(χ~2=7.92,P=0.005).There was no significant difference in the out-patient expense between the two groups.(6)Kaplan Meier survival analysis was used to examine the impact of the levels of adherence on the survival time.The survival rate was 98.2% in patients with good adherence,with a mean survival time of 21 months, while it was 89.7%in patients with poor adherence,with a mean survival time of 18 months.Log Rank test showed that there was a significant difference in the survival time between the two groups(χ~2=4.42, P=0.036).Patients with poor ART adherence had higher risk of death than patients with good ART adherence.Conclusion:1.The average level of ART medication adherence was 94%.The common reasons for missing doses included being away from home,simply forgetting,being too busy,and complaining of side effects of the medications.Though there was no significant difference among the 3 measurements,medication adherence was not static.We identified new adherence problem at each interview.The assessment of adherence needs to be performed periodically.2.The use of heroine,no medication reminder,and wrong medication knowledge were the risk factors of poor ART adherence.3.HIV/AIDS patients with ART still had low level of quality of life and scores of all aspects were lower than those of normal people, especially in RP,SF,and GH,which decreased by about 50%. Longitudinal data showed that ART improved patients' quality of life in physical aspects,but failed to show obvious impact on the aspects of role function and mental health.4.The adherence to ART influenced 5 aspects of quality of life significantly.HIV/AIDS patients with good ART adherence had better PF, GH,VT,SF,and MH,compared with patients with poor medication adherence.There was no significant difference in the aspects of RP,BP and RE between the two groups.5.Analysis on the ART adherence on physical indicators showed that good adherence contributed to faster rate of CD4~+T cell growth,low incidence of opportunity infections,and little effect on patients' weight gain. 6.ART with good adherence led to reduced utilization of medical resources,such as less number of hospitalizations,shorter hospital stay, and less expense for hospitalization.7.ART adherence was associated with patients' survival time after receiving treatment.Patients with poor adherence had higher risk of death.8.Self-reported method of adherence assessment is a practical and effective method both in the research and practice.Adherence measured by self-reported method was significantly correlated with 5 aspects of SF-36,growth rate of CD4~+ T cell,incidence of opportunity infection, number of hospitalizationS,expense of hospitalization,and hospital stay, which illuminated that this measurement had good predictive values and it can be applied in both research and practice in the assessment of ART adherence.
|
PDF Full Text Request