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:10448268
- 负责人:
- 金额:$ 68.92万
- 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 2024-06-30
- 项目状态:已结题
- 来源:
- 关键词:AdherenceBiological AssayCaringChronicClinicClinicalClinical TrialsCollaborationsComplementComplicationDataDevelopmentDiagnosticEnsureEvaluationFocus GroupsGoalsHIVHIV diagnosisHIV therapyHealthHealth PersonnelInterventionLaboratoriesLifeMethodsModelingMonitorNetwork-basedOutcomeParticipantPatient Self-ReportPatient-Focused OutcomesPatientsPersonsPilot ProjectsPoliciesPrincipal InvestigatorProviderQuestionnairesRandomizedRegimenResearchServicesSocial BehaviorSouth AfricaSouth AfricanStructureTenofovirTestingTimeTrainingTreatment outcomeUrineValidationViralViral Load resultViremiaantiretroviral therapyarmbaseclinical efficacyclinical research sitecostcost effectivecost effectivenesscost estimateeconomic 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
项目成果
期刊论文数量(0)
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科研奖励数量(0)
会议论文数量(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:
$ 68.92万 - 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:
$ 68.92万 - 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:
$ 68.92万 - 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:
$ 68.92万 - 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:
$ 68.92万 - 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:
$ 68.92万 - 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:
$ 68.92万 - 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:
$ 68.92万 - 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:
10665728 - 财政年份:2019
- 资助金额:
$ 68.92万 - 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:
$ 68.92万 - 项目类别:
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