PRIME: PrEP Intervention for people who Inject MEthamphetamine
PRIME:针对注射甲基苯丙胺患者的 PrEP 干预
基本信息
- 批准号:10054139
- 负责人:
- 金额:$ 78.68万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2020
- 资助国家:美国
- 起止时间:2020-08-01 至 2025-06-30
- 项目状态:未结题
- 来源:
- 关键词:AIDS preventionAddressAdherenceAdultAffectAttentionBloodBupropionCar PhoneCenters for Disease Control and Prevention (U.S.)Client satisfactionClinical TrialsContractsCounselingDataDiseaseDisease OutbreaksDoseEffectivenessEnrollmentEnsureEpidemicFinancial compensationFutureHIVHIV InfectionsHIV SeronegativityHIV riskHabitsHealthIncentivesInfectionInjecting drug userInjectionsInterventionInterviewLife StyleLocationMeasuresMethamphetamineModelingOralOutcome MeasureParticipantPatternPersonsPharmacologyPopulationQuestionnairesRandomizedRandomized Controlled TrialsRecordsReportingRiskRisk BehaviorsSan FranciscoSexual TransmissionSpottingsStandardizationSurveysSyringesSystemTelephoneTenofovirTestingTimeUnited StatesViralVisitadherence rateaggressive therapyarmbehavior changecondomscontingency managementemtricitabinefollow-uphigh riskhigh risk populationimprovedinjection drug useinterestmedication compliancemethamphetamine usemobile applicationopioid epidemicpre-exposure prophylaxispreventprimary outcomeprogramsrecruitsexual HIV transmissionsexual risk behaviortime usetooltransmission processtrial comparingtwo-arm trialusabilitywillingness
项目摘要
Project Summary/Abstract
Notwithstanding a substantial effort of “getting to zero”, new HIV infections among people who inject drugs are
increasing. Methamphetamine is a primary driver of that increase, as methamphetamine use has been
extensively demonstrated to increase both sexual and injection-related HIV transmission. Methamphetamine
use is also associated with poor medication adherence, such that people with HIV who use methamphetamine
are less likely to be virally suppressed. The most powerful tool for prevention of HIV available today, in addition
to aggressive treatment of people living with HIV to ensure viral suppression, is pre-exposure prophylaxis
(PrEP) with emtricitabine plus a tenofovir product (e.g. FTC/TAF). PrEP has been extensively demonstrated to
reduce HIV infection when taken in sufficient amounts, generally defined as ≥4 doses per week. The Centers
for Disease Control and other health agencies recommend PrEP for people who inject drugs, yet there has
been precious little attention to this population in PrEP clinical trials, implementation studies, and
demonstration projects. Two major reasons for this lack of attention are (1) that syringe access programs,
where available, are powerful tools to lower HIV transmission by injection, and (2) that people who inject drugs
– and in particular people who use methamphetamine – are likely to struggle with medication adherence. In the
context of expanding methamphetamine use – as the next wave of the opioid crisis – and a national effort to
eliminate HIV transmission, syringe access programs are unlikely to be sufficient to prevent the remaining
infections that occur. In this study, “PrEP Intervention for people who Inject Methamphetamine” (PRIME), we
propose to address the second concern by testing a combined adherence intervention. PRIME is a two-arm
trial comparing standardized counseling to video directly-observed treatment with real-time contingency
management (VDOT-CM) for adherence to once-daily emtricitabine/tenofovir alafenamide (FTC/TAF) PrEP
among people who inject methamphetamine. We will randomize 140 adults who inject methamphetamine, are
HIV-negative, and have recently engaged in HIV risk behaviors to VDOT-CM or counseling alone for 24 weeks.
Both groups will receive PrEP and counseling to support PrEP adherence; the intervention condition will also
receive a mobile phone app that video records daily PrEP use and a nominal contingency management
incentive to complete the observed PrEP dosing. We will compare adherence to PrEP in both arms by testing
dried blood spots for tenofovir disphosphate (TFV-DP) levels of ≥ 950 fmol/punch, corresponding to ≥4 doses
per week. We will assess acceptability of PrEP in this population through qualitative interviews and survey
items. Finally, we will compare injection and sexual risk behaviors prior to PrEP to those while on PrEP, to
evaluate for risk compensation. Study results will provide critical data for intensive adherence support for PrEP
among people who inject methamphetamine, a very high risk population for HIV transmission.
项目总结/文摘
项目成果
期刊论文数量(0)
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会议论文数量(0)
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PHILLIP O COFFIN其他文献
PHILLIP O COFFIN的其他文献
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{{ truncateString('PHILLIP O COFFIN', 18)}}的其他基金
Midcareer K24 Award for Mentoring and Patient-Oriented Research
职业生涯中期 K24 指导和以患者为导向的研究奖
- 批准号:
10618740 - 财政年份:2023
- 资助金额:
$ 78.68万 - 项目类别:
Leveraging Psychological Autopsies to Accelerate Research into Stimulant Overdose Mortality
利用心理尸检加速兴奋剂过量死亡率的研究
- 批准号:
10387934 - 财政年份:2021
- 资助金额:
$ 78.68万 - 项目类别:
Leveraging Psychological Autopsies to Accelerate Research into Stimulant Overdose Mortality
利用心理尸检加速兴奋剂过量死亡率的研究
- 批准号:
10664991 - 财政年份:2021
- 资助金额:
$ 78.68万 - 项目类别:
PRIME: PrEP Intervention for people who Inject MEthamphetamine
PRIME:针对注射甲基苯丙胺患者的 PrEP 干预
- 批准号:
10655538 - 财政年份:2020
- 资助金额:
$ 78.68万 - 项目类别:
PRIME: PrEP Intervention for people who Inject MEthamphetamine
PRIME:针对注射甲基苯丙胺患者的 PrEP 干预
- 批准号:
10223260 - 财政年份:2020
- 资助金额:
$ 78.68万 - 项目类别:
PRIME: PrEP Intervention for people who Inject MEthamphetamine
PRIME:针对注射甲基苯丙胺患者的 PrEP 干预
- 批准号:
10424546 - 财政年份:2020
- 资助金额:
$ 78.68万 - 项目类别:
Mirtazapine for methamphetamine use disorder: drug-drug interaction study
米氮平治疗甲基苯丙胺使用障碍:药物相互作用研究
- 批准号:
9983371 - 财政年份:2020
- 资助金额:
$ 78.68万 - 项目类别:
Repeated-dose behavioral intervention to reduce opioid overdose: a two-site randomized-controlled efficacy trial
重复剂量行为干预减少阿片类药物过量:一项两中心随机对照疗效试验
- 批准号:
9896799 - 财政年份:2018
- 资助金额:
$ 78.68万 - 项目类别:
Repeated-dose behavioral intervention to reduce opioid overdose: a two-site randomized-controlled efficacy trial
重复剂量行为干预减少阿片类药物过量:一项两中心随机对照疗效试验
- 批准号:
10374101 - 财政年份:2018
- 资助金额:
$ 78.68万 - 项目类别:
Mid-Career Award in Patient-Oriented Substance Use Research Addressing Opioids, Chronic Pain, and HIV
针对阿片类药物、慢性疼痛和艾滋病毒的以患者为导向的药物使用研究中的职业生涯中期奖
- 批准号:
9981708 - 财政年份:2016
- 资助金额:
$ 78.68万 - 项目类别:
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