URBAN ARCH (3/5) Uganda Cohort TB preventive therapy for HIV-infected alcohol users in Uganda: an evaluation of safety tolerability and adherence
URBAN ARCH (3/5) 乌干达针对感染艾滋病毒的酗酒者的乌干达队列结核病预防治疗:安全耐受性和依从性评估
基本信息
- 批准号:10418846
- 负责人:
- 金额:$ 16.5万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2011
- 资助国家:美国
- 起止时间:2011-09-22 至 2023-08-31
- 项目状态:已结题
- 来源:
- 关键词:AIDS/HIV problemAccountingAdherenceAfrica South of the SaharaAlcohol consumptionAlcoholic beverage heavy drinkerAlcoholsAreaBiological MarkersBostonCessation of lifeClinicalCollaborationsControl GroupsDataDiseaseEnzymesEthicsEvaluationExclusionExposure toFamilyGuidelinesHIVHIV InfectionsHIV therapyHIV/TBHairHeavy DrinkingHepatotoxicityLaboratoriesLife ExpectancyLiverMeasuresModelingMonitorMorbidity - disease rateParticipantPatient Self-ReportPersonsPharmaceutical PreparationsPopulationPreventionPreventivePreventive therapyQuality-Adjusted Life YearsRandomizedRecordsRegimenResearchResourcesRifampinRifamycinsRiskRisk FactorsRussiaSafetyToxic effectTuberculosisUgandaUnited States National Institutes of HealthWorld Health Organizationalcohol comorbidityalcohol measurementalcohol researchantiretroviral therapyarmbasecohortcomparative efficacydrinkinghigh riskimprovedinsightisoniazidmortalitynovelphosphatidylethanolpillpreventstandard of carestemtherapy adherencetreatment adherencetuberculosis treatment
项目摘要
ABSTRACT
This application proposes the Alcohol Drinkers' Exposure to Preventive Therapy for TB (ADEPT-TB)
study, a continuation of the Uganda Alcohol Research Collaboration on HIV (ARCH) cohort of HIV-infected
alcohol users in Uganda. Tuberculosis (TB) is the leading cause of mortality in persons with HIV. Isoniazid
(INH) preventive therapy (IPT) decreases all-cause mortality and active TB in persons with HIV by 30-50%
above and beyond the benefits of antiretroviral therapy (ART) alone. Based on these findings, the World Health
Organization (WHO) recommends IPT for all persons with HIV in resource constrained settings, but warns
against IPT for persons with “regular and heavy alcohol use” due to concern for increased hepatotoxicity in
heavy drinkers in settings where liver enzymes are not routinely monitored. Approximately one quarter of HIV-
infected persons in sub-Saharan Africa (SSA) are heavy drinkers, but no studies have systematically assessed
the safety of TB preventive therapy in alcohol users. Thus, the ADEPT-TB study aims to determine the safety
and tolerability of TB preventive therapy for HIV-infected drinkers, and examine if the benefits in preventing TB
outweigh the risks. Adherence to TB preventive therapy impacts the level of benefit and may also impact
hepatotoxicity. Alcohol use is an established risk factor for decreased ART adherence and active TB treatment
discontinuation, but it is not known whether HIV-infected drinkers on daily ART can be adherent to TB
preventive therapy. Standard IPT is comprised of daily INH for 6-9 months; a shorter-course, such as 3 months
of INH plus rifampicin, could improve adherence.
The ADEPT-TB study will examine the safety and tolerability of, and adherence to, 6 months of daily
INH (6H) and 3 months of daily INH plus rifampicin (3HR) in 380 HIV-infected drinkers in Uganda. We will
randomize participants to one of the two regimens (n=190 per arm). Our first aim is to evaluate the safety and
tolerability within each regimen and by level of alcohol use. Our second aim is to compare adherence by
regimen; we hypothesize that adherence will be greater in the 3HR arm compared to the 6H arm. Self-reported
measures of alcohol use will be augmented by phosphatidylethanol (PEth), an established biomarker of alcohol
use. Objective measures of adherence will include electronic pill bottle monitoring and a novel measure of INH
exposure, INH concentration in hair. We will actively monitor for hepatotoxicity using the U.S. standard of care
for TB preventive therapy for heavy drinkers. We will use the safety, tolerability, and adherence results,
together with the known efficacy and mortality benefit of TB preventive therapy in HIV-infected persons in SSA,
and an established decision analytic model of TB preventive therapy to conduct our third aim: to determine
whether the benefits of TB preventive therapy outweigh the toxicity risks for HIV-infected drinkers in resource
limited settings. These data will provide critical insights to inform the guidelines for TB preventive therapy for
alcohol-using, HIV-infected persons in TB endemic areas where HIV and alcohol use are common.
摘要
该申请提出了酒精饮酒者暴露于结核病预防治疗(ADEPT-TB)
乌干达艾滋病毒酒精研究合作组织(UNAIDS)艾滋病毒感染者队列研究的延续
乌干达的酗酒者结核病是艾滋病毒感染者死亡的主要原因。异烟肼
(INH)预防性治疗(IPT)将艾滋病毒感染者的全因死亡率和活动性结核病降低30-50%
远远超出了抗逆转录病毒疗法(ART)本身的好处。根据这些发现,世界卫生组织
世界卫生组织(WHO)建议在资源有限的环境中对所有艾滋病毒感染者进行IPT,但警告说
由于担心肝毒性增加,
在肝酶没有常规监测的环境中酗酒者。大约四分之一的艾滋病毒-
撒哈拉以南非洲(SSA)的感染者是酗酒者,但没有研究系统地评估
酒精使用者结核病预防性治疗的安全性。因此,ADEPT-TB研究旨在确定
和耐受性的结核病预防性治疗艾滋病毒感染的饮酒者,并检查是否有利于预防结核病
超过了风险坚持结核病预防性治疗会影响获益水平,
肝毒性饮酒是降低抗逆转录病毒疗法依从性和积极结核病治疗的既定风险因素
但目前尚不清楚每天接受抗逆转录病毒治疗的艾滋病毒感染饮酒者是否会坚持结核病
预防性治疗标准IPT包括6-9个月的每日INH;较短疗程,如3个月
INH加利福平可提高依从性。
ADEPT-TB研究将检查6个月每日一次给药的安全性、耐受性和依从性。
INH(6 H)和3个月的每日INH加利福平(3 HR)在380艾滋病毒感染的饮酒者在乌干达。我们将
将参与者随机分配至两种方案之一(每组n=190)。我们的首要目标是评估安全性,
每种治疗方案内的耐受性和酒精使用水平。我们的第二个目标是通过以下方式比较依从性:
方案;我们假设3 HR组的依从性高于6 H组。
磷脂酰乙醇(PEth)是一种已确定的酒精生物标志物,
使用.依从性的客观指标将包括电子药瓶监测和一种新的INH指标
暴露、头发中的INH浓度。我们将使用美国标准治疗积极监测肝毒性
为酗酒者提供结核病预防治疗。我们将使用安全性、耐受性和依从性结果,
加上撒哈拉以南非洲艾滋病毒感染者结核病预防治疗的已知疗效和死亡率效益,
建立了结核病预防治疗决策分析模型,以实现我们的第三个目标:
结核病预防性治疗的益处是否超过艾滋病毒感染者饮酒的毒性风险
有限的设置。这些数据将提供重要的见解,为结核病预防治疗指南提供信息,
在艾滋病毒和酒精使用普遍的结核病流行地区,
项目成果
期刊论文数量(6)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
Comparison of automated determination of phosphatidylethanol (PEth) in dried blood spots (DBS) with previous manual processing and testing.
- DOI:10.1016/j.alcohol.2021.11.001
- 发表时间:2022-02
- 期刊:
- 影响因子:2.3
- 作者:Fatch, Robin;Luginbuhl, Marc;Cheng, Debbie M.;Gaugler, Stefan;Emenyonu, Nneka, I;Ngabirano, Christine;Adong, Julian;Muyindike, Winnie R.;Samet, Jeffrey H.;Bryant, Kendall;Hahn, Judith A.
- 通讯作者:Hahn, Judith A.
Exploring the Association Between Social Support and Hazardous Alcohol Use Among Persons Living with HIV in South Western Uganda.
- DOI:10.1007/s10461-021-03557-6
- 发表时间:2022-07
- 期刊:
- 影响因子:4.4
- 作者:Ngabirano, Christine;Fatch, Robin;Muyindike, Winnie R.;Emenyonu, Nneka I.;Adong, Julian;Weiser, Sheri D.;Samet, Jeffrey H.;Cheng, Debbie M.;Hahn, Judith A.
- 通讯作者:Hahn, Judith A.
Bar Attendance and Alcohol Use Before and After COVID-19 Related Restrictions Among HIV-infected Adults in South-Western Uganda.
- DOI:10.1007/s10461-022-03934-9
- 发表时间:2023-06
- 期刊:
- 影响因子:4.4
- 作者:Asiimwe, Caroline;Fatch, Robin;Cheng, Debbie M.;Emenyonu, Nneka, I;Ngabirano, Christine;Muyindike, Winnie R.;Hahn, Judith A.
- 通讯作者:Hahn, Judith A.
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
数据更新时间:{{ journalArticles.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ monograph.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ sciAawards.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ conferencePapers.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ patent.updateTime }}
JUDITH ALISSA HAHN其他文献
JUDITH ALISSA HAHN的其他文献
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
{{ truncateString('JUDITH ALISSA HAHN', 18)}}的其他基金
Biomarkers for Alcohol/HIV Research (BAHR) Study
酒精/艾滋病毒研究生物标志物 (BAHR) 研究
- 批准号:
10615910 - 财政年份:2022
- 资助金额:
$ 16.5万 - 项目类别:
Biomarkers for Alcohol/HIV Research (BAHR) Study
酒精/艾滋病毒研究生物标志物 (BAHR) 研究
- 批准号:
10481535 - 财政年份:2022
- 资助金额:
$ 16.5万 - 项目类别:
The Role of Alcohol Use in Incident TB Infection and Active TB Disease Among Persons Living with HIV
饮酒在艾滋病毒感染者结核感染和活动性结核病中的作用
- 批准号:
10303986 - 财政年份:2021
- 资助金额:
$ 16.5万 - 项目类别:
The Role of Alcohol Use in Incident TB Infection and Active TB Disease Among Persons Living with HIV
饮酒在艾滋病毒感染者结核感染和活动性结核病中的作用
- 批准号:
10683770 - 财政年份:2021
- 资助金额:
$ 16.5万 - 项目类别:
Interventions to reduce alcohol use and increase adherence to TB preventive therapy among HIV/TB co-infected drinkers (DIPT 1/2)
减少饮酒并提高艾滋病毒/结核病合并感染饮酒者对结核病预防治疗依从性的干预措施(DIPT 1/2)
- 批准号:
9767523 - 财政年份:2017
- 资助金额:
$ 16.5万 - 项目类别:
Interventions to reduce alcohol use and increase adherence to TB preventive therapy among HIV/TB co-infected drinkers (DIPT 1/2)
减少饮酒并提高艾滋病毒/结核病合并感染饮酒者对结核病预防治疗依从性的干预措施(DIPT 1/2)
- 批准号:
10238903 - 财政年份:2017
- 资助金额:
$ 16.5万 - 项目类别:
Interventions to reduce alcohol use and increase adherence to TB preventive therapy among HIV/TB co-infected drinkers (DIPT 1/2)
减少饮酒并提高艾滋病毒/结核病合并感染饮酒者对结核病预防治疗依从性的干预措施(DIPT 1/2)
- 批准号:
9408285 - 财政年份:2017
- 资助金额:
$ 16.5万 - 项目类别:
Mobile technology to extend clinic-based counseling for HIV+s in Uganda
移动技术在乌干达扩大艾滋病毒临床咨询
- 批准号:
9906836 - 财政年份:2017
- 资助金额:
$ 16.5万 - 项目类别:
Training in Research Program on Alcohol Use by Persons with or at Risk for HIV
关于艾滋病毒感染者或高危人群饮酒研究计划的培训
- 批准号:
8603091 - 财政年份:2013
- 资助金额:
$ 16.5万 - 项目类别:
Training in Research Program on Alcohol Use by Persons with our at Risk for HIV
艾滋病毒高危人群饮酒研究项目培训
- 批准号:
9918815 - 财政年份:2013
- 资助金额:
$ 16.5万 - 项目类别:
相似海外基金
Unraveling the Dynamics of International Accounting: Exploring the Impact of IFRS Adoption on Firms' Financial Reporting and Business Strategies
揭示国际会计的动态:探索采用 IFRS 对公司财务报告和业务战略的影响
- 批准号:
24K16488 - 财政年份:2024
- 资助金额:
$ 16.5万 - 项目类别:
Grant-in-Aid for Early-Career Scientists
Mighty Accounting - Accountancy Automation for 1-person limited companies.
Mighty Accounting - 1 人有限公司的会计自动化。
- 批准号:
10100360 - 财政年份:2024
- 资助金额:
$ 16.5万 - 项目类别:
Collaborative R&D
Accounting for the Fall of Silver? Western exchange banking practice, 1870-1910
白银下跌的原因是什么?
- 批准号:
24K04974 - 财政年份:2024
- 资助金额:
$ 16.5万 - 项目类别:
Grant-in-Aid for Scientific Research (C)
CPS: Medium: Making Every Drop Count: Accounting for Spatiotemporal Variability of Water Needs for Proactive Scheduling of Variable Rate Irrigation Systems
CPS:中:让每一滴水都发挥作用:考虑用水需求的时空变化,主动调度可变速率灌溉系统
- 批准号:
2312319 - 财政年份:2023
- 资助金额:
$ 16.5万 - 项目类别:
Standard Grant
A New Direction in Accounting Education for IT Human Resources
IT人力资源会计教育的新方向
- 批准号:
23K01686 - 财政年份:2023
- 资助金额:
$ 16.5万 - 项目类别:
Grant-in-Aid for Scientific Research (C)
An empirical and theoretical study of the double-accounting system in 19th-century American and British public utility companies
19世纪美国和英国公用事业公司双重会计制度的实证和理论研究
- 批准号:
23K01692 - 财政年份:2023
- 资助金额:
$ 16.5万 - 项目类别:
Grant-in-Aid for Scientific Research (C)
An Empirical Analysis of the Value Effect: An Accounting Viewpoint
价值效应的实证分析:会计观点
- 批准号:
23K01695 - 财政年份:2023
- 资助金额:
$ 16.5万 - 项目类别:
Grant-in-Aid for Scientific Research (C)
Accounting model for improving performance on the health and productivity management
提高健康和生产力管理绩效的会计模型
- 批准号:
23K01713 - 财政年份:2023
- 资助金额:
$ 16.5万 - 项目类别:
Grant-in-Aid for Scientific Research (C)
New Role of Not-for-Profit Entities and Their Accounting Standards to Be Unified
非营利实体的新角色及其会计准则将统一
- 批准号:
23K01715 - 财政年份:2023
- 资助金额:
$ 16.5万 - 项目类别:
Grant-in-Aid for Scientific Research (C)
Improving Age- and Cause-Specific Under-Five Mortality Rates (ACSU5MR) by Systematically Accounting Measurement Errors to Inform Child Survival Decision Making in Low Income Countries
通过系统地核算测量误差来改善特定年龄和特定原因的五岁以下死亡率 (ACSU5MR),为低收入国家的儿童生存决策提供信息
- 批准号:
10585388 - 财政年份:2023
- 资助金额:
$ 16.5万 - 项目类别: