Simplifying HIV Treatment and Monitoring (STREAM2): Point-of-Care Urine Tenofovir Adherence and Viral Load Testing to Improve HIV Outcomes in South Africa
简化艾滋病毒治疗和监测 (STREAM2):护理点尿液替诺福韦依从性和病毒载量检测,以改善南非的艾滋病毒治疗结果
基本信息
- 批准号:10665728
- 负责人:
- 金额:$ 34.8万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2019
- 资助国家:美国
- 起止时间:2019-07-23 至 2025-06-30
- 项目状态:未结题
- 来源:
- 关键词:AdherenceBehavior TherapyBiological AssayCaringChronicClinicClinicalClinical TrialsCollaborationsComplementComplicationDataDevelopmentDiagnosticEffectivenessEligibility DeterminationEnsureEvaluationFocus GroupsGoalsHIVHIV diagnosisHealthHealth PersonnelInterventionLaboratoriesMethodsModelingMonitorOutcomeParticipantPatient Self-ReportPatient-Focused OutcomesPatientsPersonsPilot ProjectsPoliciesPrincipal InvestigatorProviderQualifyingQuestionnairesRandomizedRegimenResearchServicesSocial BehaviorSouth AfricaSouth AfricanStructureTenofovirTestingTimeTrainingTreatment outcomeUrineValidationViralViral Load resultViremiaantiretroviral therapyarmclinical efficacyclinical research sitecostcost effectivecost effectivenesscost estimatedisability-adjusted life yearseconomic impactefavirenzexperienceimplementation scienceimplementation trialimprovedintervention costlow and middle-income countriesmicrocostingnovelpoint of carepoint of care testingpreventprocess evaluationstandard of caretherapy adherencetransmission processtreatment as usual
项目摘要
ABSTRACT
For millions of people living with HIV (PLHIV) receiving antiretroviral therapy (ART), adequate ART adherence
and routine HIV viral load (VL) monitoring are critical to ensure viral suppression and good health outcomes.
Initiation and management of life-long ART in low- and middle-income countries (LMICs) is challenging for both
PLHIV and providers in part due to the reliance on self-reported adherence and delays with lab-based VL testing,
which are part of the usual care. Drs. Drain and Garrett (co-principal investigators) recently completed a pilot
study in South Africa demonstrating that point-of-care (POC) VL monitoring for PLHIV receiving efavirenz-based
ART increased VL suppression and retention in care by 14% (95% CI 6-21%) over a 12-month period compared
to standard lab testing. However, the applicability of these findings to the context of newer, more robust
dolutegravir-based ART regimens being introduced in several LMICs, including South Africa, is not known. To
complement POC VL monitoring, we have recently completed the development and initial evaluation of a novel
POC urine tenofovir assay, in collaboration with Abbott Diagnostics, which can monitor ART adherence in clinic-
based settings in real-time. Building on our pilot study results, our objective in this application is to determine the
clinical efficacy and cost effectiveness of implementing an integrated HIV care model using POC tenofovir
adherence testing and POC VL monitoring in maintaining durable VL suppression among PLHIV receiving
tenofovir-based ART in South Africa. Our central hypotheses are that POC tenofovir adherence testing and POC
VL monitoring will improve VL suppression rates and retention in care, while being a feasible, acceptable, and
cost-effective strategy for ART management. We will objectively test our central hypotheses with three specific
aims: (1) to determine if an integrated model for HIV monitoring using a POC tenofovir adherence assay and a
POC VL test will improve VL suppression and retention in care; (2) to monitor implementation and assess patient
and provider perspectives of real-time POC tenofovir adherence testing and POC VL monitoring in South Africa;
and (3) to estimate the costs and cost-effectiveness of implementing POC tenofovir adherence testing with POC
VL monitoring, compared to no objective adherence testing and lab-based VL monitoring. To complete these
aims, we will randomize 534 participants (1:1) at ART initiation into regular POC tenofovir adherence testing with
POC VL monitoring (Arm 1) or standard-of-care with no objective tenofovir adherence testing and lab-based VL
monitoring (Arm 2). Participants will be followed to compare a primary composite outcome of VL suppression
and retention in care between the study arms at 18 months after ART initiation. This randomized controlled
implementation trial will provide crucial data on the clinical efficacy, acceptability, and cost-effectiveness of an
integrated model of POC adherence and VL testing to inform global policy on improving HIV care in LMICs.
摘要
对于数百万接受抗逆转录病毒治疗的艾滋病毒感染者,
和常规HIV病毒载量(VL)监测对于确保病毒抑制和良好的健康结果至关重要。
在低收入和中等收入国家(LMICs)启动和管理终身抗逆转录病毒治疗对双方都具有挑战性。
艾滋病毒感染者和提供者的部分原因是依赖自我报告的依从性和基于实验室的VL检测的延迟,
这是常规护理的一部分。Drs. Drain和加勒特(共同主要研究者)最近完成了一个试点项目
南非的一项研究表明,接受基于依法韦仑的艾滋病毒感染者的床旁(POC)VL监测
ART在12个月期间使VL抑制和护理保留增加了14%(95% CI 6-21%),
进行标准实验室测试然而,这些发现的适用性,以较新的背景下,更强大的
包括南非在内的几个中低收入国家正在采用以度鲁特韦为基础的抗逆转录病毒疗法,目前尚不清楚。到
补充POC VL监测,我们最近完成了一种新的开发和初步评估
POC尿液替诺福韦检测,与雅培诊断公司合作,可以监测临床上的ART依从性-
基于实时设置。基于我们的试点研究结果,我们在本申请中的目标是确定
使用POC替诺福韦实施艾滋病综合护理模式的临床疗效和成本效益
坚持检测和POC VL监测在维持持久的VL抑制中的PLHIV接受者
在南非的替诺福韦抗逆转录病毒疗法。我们的中心假设是,POC替诺福韦坚持测试和POC
VL监测将提高VL抑制率和护理保留率,同时是一种可行的,可接受的,
具有成本效益的ART管理策略。我们将客观地测试我们的中心假设与三个具体的
目的:(1)确定使用POC替诺福韦粘附试验和
POC VL测试将改善VL抑制和保持护理;(2)监测实施和评估患者
和供应商对南非实时POC替诺福韦依从性检测和POC VL监测的看法;
以及(3)估计用POC实施POC替诺福韦依从性测试的成本和成本效益
与无客观依从性测试和基于实验室的VL监测相比,VL监测。完成这些
目的,我们将在ART启动时随机分配534名参与者(1:1)进行常规POC替诺福韦依从性测试,
POC VL监测(第1组)或标准治疗,无客观替诺福韦依从性检测和实验室VL
监测(组2)。将对参与者进行随访,比较VL抑制的主要复合结局
在ART开始后18个月,研究组之间的护理保持率。该随机对照
实施试验将提供关于临床疗效、可接受性和成本效益的关键数据,
这是一个POC依从性和VL检测的综合模式,为改善中低收入国家艾滋病毒护理的全球政策提供信息。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Paul K Drain其他文献
Micronutrients in HIV-positive persons receiving highly active antiretroviral therapy
- DOI:
10.1093/ajcn/85.2.333 - 发表时间:
2007-02-01 - 期刊:
- 影响因子:
- 作者:
Paul K Drain;Roland Kupka;Ferdinand Mugusi;Wafaie W Fawzi - 通讯作者:
Wafaie W Fawzi
A systematic review of hepatic tuberculosis with considerations in human immunodeficiency virus co-infection
- DOI:
10.1186/s12879-015-0944-6 - 发表时间:
2015-05-06 - 期刊:
- 影响因子:3.000
- 作者:
Andrew J Hickey;Lilishia Gounder;Mahomed-Yunus S Moosa;Paul K Drain - 通讯作者:
Paul K Drain
Paul K Drain的其他文献
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{{ truncateString('Paul K Drain', 18)}}的其他基金
A novel REverSe Transcriptase Chain Termination (RESTRICT) assay for near-patient, objective monitoring of long-term PrEP adherence
一种新型 REverSe 转录酶链终止 (RESTRICT) 测定,可用于患者附近长期 PrEP 依从性的客观监测
- 批准号:
10300073 - 财政年份:2020
- 资助金额:
$ 34.8万 - 项目类别:
A novel REverSe Transcriptase Chain Termination (RESTRICT) assay for near-patient, objective monitoring of long-term PrEP adherence
一种新型 REverSe 转录酶链终止 (RESTRICT) 测定,可用于患者附近长期 PrEP 依从性的客观监测
- 批准号:
10159767 - 财政年份:2020
- 资助金额:
$ 34.8万 - 项目类别:
A novel REverSe Transcriptase Chain Termination (RESTRICT) assay for near-patient, objective monitoring of long-term PrEP adherence
一种新型 REverSe 转录酶链终止 (RESTRICT) 测定,可用于患者附近长期 PrEP 依从性的客观监测
- 批准号:
10513809 - 财政年份:2020
- 资助金额:
$ 34.8万 - 项目类别:
Simplifying HIV Treatment and Monitoring (STREAM2): Point-of-Care Urine Tenofovir Adherence and Viral Load Testing to Improve HIV Outcomes in South Africa
简化艾滋病毒治疗和监测 (STREAM2):护理点尿液替诺福韦依从性和病毒载量检测,以改善南非的艾滋病毒治疗结果
- 批准号:
10203799 - 财政年份:2019
- 资助金额:
$ 34.8万 - 项目类别:
Drug Resistance Genotypic and Phenotypic Correlates of Efavirenz and Dolutegravir based Treatment Outcomes across Non-B HIV-1 subtypes
非 B HIV-1 亚型依非韦伦和多替拉韦治疗结果的耐药性基因型和表型相关性
- 批准号:
9973184 - 财政年份:2019
- 资助金额:
$ 34.8万 - 项目类别:
Drug Resistance Genotypic and Phenotypic Correlates of Efavirenz and Dolutegravir based Treatment Outcomes across Non-B HIV-1 subtypes
非 B HIV-1 亚型依非韦伦和多替拉韦治疗结果的耐药性基因型和表型相关性
- 批准号:
10202449 - 财政年份:2019
- 资助金额:
$ 34.8万 - 项目类别:
Drug Resistance Genotypic and Phenotypic Correlates of Efavirenz and Dolutegravir based Treatment Outcomes across Non-B HIV-1 subtypes
非 B HIV-1 亚型依非韦伦和多替拉韦治疗结果的耐药性基因型和表型相关性
- 批准号:
10662274 - 财政年份:2019
- 资助金额:
$ 34.8万 - 项目类别:
Simplifying HIV Treatment and Monitoring (STREAM2): Point-of-Care Urine Tenofovir Adherence and Viral Load Testing to Improve HIV Outcomes in South Africa
简化艾滋病毒治疗和监测 (STREAM2):护理点尿液替诺福韦依从性和病毒载量检测,以改善南非的艾滋病毒治疗结果
- 批准号:
10448268 - 财政年份:2019
- 资助金额:
$ 34.8万 - 项目类别:
Drug Resistance Genotypic and Phenotypic Correlates of Efavirenz and Dolutegravir based Treatment Outcomes across Non-B HIV-1 subtypes
非 B HIV-1 亚型依非韦伦和多替拉韦治疗结果的耐药性基因型和表型相关性
- 批准号:
10443774 - 财政年份:2019
- 资助金额:
$ 34.8万 - 项目类别:
Simplifying HIV Treatment and Monitoring (STREAM2): Point-of-Care Urine Tenofovir Adherence and Viral Load Testing to Improve HIV Outcomes in South Africa
简化艾滋病毒治疗和监测 (STREAM2):护理点尿液替诺福韦依从性和病毒载量检测,以改善南非的艾滋病毒治疗结果
- 批准号:
9982217 - 财政年份:2019
- 资助金额:
$ 34.8万 - 项目类别:
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