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| HIV感染高危人群暴露前预防用药临床试验依从性分析 |
| 高菲菲1,钟晓妮1*,彭斌1,张燕1,梁浩2,邹云峰3,戴江红4,刘倩萍5,宋本莉5,黄文祥6,黄爱龙7 |
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(1. 重庆医科大学公共卫生与管理学院卫生统计学教研室,重庆 400016
2. 广西医科大学公共卫生学院流行病与卫生统计学教研室,南宁 530021
3. 广西医科大学公共卫生学院毒理学教研室,南宁 530021
4. 新疆医科大学公共卫生学院流行病与卫生统计学教研室,乌鲁木齐 830000
5. 四川省西昌市皮肤病性病防治站,西昌 615000
6. 重庆医科大学附属第一医院感染病科,重庆 400016
7. 重庆医科大学感染性疾病分子生物学教育部重点实验室,重庆 400016
*通信作者) |
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| 摘要: |
| 目的了解HIV感染高危人群暴露前预防用药(pre-exposure prophylaxis,PrEP)临床试验的依从性及可能的影响因素。方法采用非概率抽样法筛选出352名受试者进入研究队列,其中男男性行为者(MSM) 153人、女性性工作者(FSW)36人、HIV感染者固定性伴侣(PAR) 163人,随机决定其每日1次或每周2次服药方式,分别在0、4、8、12、16、20、24、28周进行随访观察,从队列保持和药物漏服两个方面了解PrEP依从性情况。采用Cochran-Mantel-Haenszel (CMH)检验进行单因素分析,多因素分析采用logistic回归分析。结果本次高危人群PrEP临床试验中有76.70%(270/352)完成了28周的观察期,药物漏服者所占比例在随访期间波动约为35%,总体依从性得分平均(82.12±27.48)分,中位数95.24分。经logistic回归分析,影响本次PrEP临床试验队列保持的因素为月收入水平、试验期间是否有担心和困难、试验期间是否有医疗服务需求、随访管理模式；影响药物漏服的因素为婚姻状况、服药方式、试验期间是否有担心和困难、是否出现不良反应；影响总体依从性得分的因素为人群类别、性伴侣数、是否有伴随用药、试验期间是否有医疗服务需求、随访管理模式。结论本次HIV感染高危人群PrEP临床试验的整体依从性高,影响因素多,在后续研究中应特别加强流动性较强的MSM和FSW人群的依从性管理,并继续推广由专人随访的队列管理模式,适当增加随访次数,不同特征个体分类管理,从而确保临床试验的高依从性。 |
| 关键词: HIV感染 高危人群 暴露前预防用药 临床试验 依从性 |
| DOI：10.3724/SP.J.1008.2012.001186 |
| 投稿时间：2012-06-06修订日期：2012-10-15 |
| 基金项目:国家科技重大专项 (2008ZX10001-016). |
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| Pre-exposure prophylaxis for HIV high-risk groups: an analysis of clinical compliance |
| GAO Fei-fei1,ZHONG Xiao-ni1*,PENG Bin1,ZHANG Yan1,LIANG Hao2,ZOU Yun-feng3,DAI Jiang-hong4,LIU Qian-ping5,SONG Ben-li5,HUANG Wen-xiang6,HUANG Ai-long7 |
(1. Department of Medical Statistics, School of Public Health and Management, Chongqing Medical University, Chongqing 400016, China
2. Department of Epidemiology and Health Statistics, School of Public Health, Guangxi Medical University, Nanning 530021, Guangxi, China
3. Department of Toxicology, School of Public Health, Guangxi Medical University, Nanning 530021, Guangxi, China
4. Department of Epidemiology and Health Statistics, School of Public Health, Xinjiang Medical University, Urumchi 830000, Xinjiang, China
5. Xichang Station for Prevention and Control of Dermatosis and STD, Xichang 615000, Sichuan, China
6. Department of Infectious Diseases, The First Affiliated Hospital, Chongqing Medical University, Chongqing 400016, China
7. The Key Laboratory of Molecular Biology of Infectious Diseases of Ministry of Education, Chongqing Medical University, Chongqing 400016, China
*Corresponding author.) |
| Abstract: |
| Objective To investigate the factors influencing the compliance of pre-exposure prophylaxis (PrEP) among high-risk groups of human immunodeficiency virus (HIV). MethodsA total of 352 subjects were selected into the cohort by non-probability sampling, including 153 men who have sex with men (MSM), 36 female sex workers (FSMs), and 163 fixed sex partners(PARs) of HIV carriers. Each subject was randomly given a medication regimen of either once daily or twice a week. The pre-exposure prophylaxis compliance was evaluated by observing the maintenance of the cohort and medication omission every 4 weeks from week 0 to week 28. Cochran-Mantel-Haenszel (CMH) test was employed to conduct univariate analysis and logistic regression was adopted for multiple variable analysis. Results It was found that 76.70% (270/352) of the subjects finished the 28-week-observation in this PrEP clinical trial among high-risk groups of HIV. The medication omission rate fluctuated around 35% during the follow-up, with the total compliance score being 82.12±27.48 and the median score being 95.24. Logistic regression suggested that the monthly income, presence of worries or difficulties during the trials, need for medical service, and the way of follow-up were the factors influencing the maintenance of cohort. The marital status, medication method, presence of worries or difficulties during the trial, and presence of adverse effect were the influencing factors of medication omission. The population type, number of sex partners, taking of other drugs at the same time, need of medical service during the trial, and way of follow-up were the factors impacting the overall compliance score. Conclusion The compliance of the present PrEP clinical trials among high-risk groups of HIV is high, and it has multiple influencing factors. Compliance management should be reinforced among MSM and FSW populations with greater motility. The cohort management model of follow-up by fixed specialists should be continued with more frequent follow-up; meanwhile, classified management should be implemented for individuals with different characters, so as to ensure a good compliance during the clinical trials. |
| Key words: HIV infections high-risk group pre-exposure prophylaxis clinical trial compliance |
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