HCV RISK REDUCTION INTERVENTION AS SECONDARY CO-MORBIDITY PREVNT
HCV RISK REDUCTION INTERVENTION AS SECONDARY CO-MORBIDITY PREVNT
批准号:
7961265
负责人:
ANGEL M MAYOR
金额:
$14.44万
依托单位国家:
美国
项目类别:
财政年份:
2009
资助国家:
美国
项目状态:
已结题
起止时间:
2009-09-24 至 2010-08-31
关键词:
AIDS/HIV problemAchievementAcquired Immunodeficiency SyndromeAdverse reactionsAttentionBloodBlood specimenComputer Retrieval of Information on Scientific Projects DatabaseComputersConfidentialityConsent FormsControl GroupsCounselingDataDiseaseDrug InteractionsEducationEducational InterventionElementsEvaluationEventFundingGenotypeGrantHIVHepatitis CHepatitis C PrevalenceHepatitis C virusHigh PrevalenceHighly Active Antiretroviral TherapyHygieneImmuneIndividualInfectionInjecting drug userInstitutionInterventionIslandKnowledgeLeadLifeMeasuresMedicalMedical IndigencyModelingMorbidity - disease rateMultimediaNatural HistoryParticipantPerceptionPharmaceutical PreparationsPhasePopulationPredispositionPrevalencePrevention strategyPreventive InterventionProbabilityProcessPublic HealthPuerto RicanPuerto RicoReactionRecruitment ActivityReportingResearchResearch PersonnelResourcesRiskRisk BehaviorsRisk ReductionRoleScreening procedureSecondary PreventionSelf EfficacySeveritiesSeverity of illnessSourceTestingToxic effectTravelUnited StatesUnited States National Institutes of HealthViral Load resultVirus DiseasesWaterbasecohortcostfollow-upgroup interventionhealth beliefinclusion criteriamembermortalityoutcome forecastsocial cognitive theory
中文摘要
这个子项目是许多研究子项目中的一个
由NIH/NCRR资助的中心赠款提供的资源。子项目和
研究者(PI)可能从另一个NIH来源获得了主要资金,
因此可以在其他CRISP条目中表示。所列机构为
中心,不一定是研究者的机构。
介绍
在采用高效抗逆转录病毒疗法后,人类免疫缺陷病毒(艾滋病毒)感染情况发生了巨大变化。与艾滋病相关的机会性条件减少,而丙型肝炎病毒(HCV)感染成为疾病预后的主要因素。波多黎各是美国HIV/AIDS流行率最高的地区之一,HCV合并感染已成为该岛的主要公共卫生问题,特别是在注射毒品使用者(IDUs)中,估计合并感染率超过50%。HCV合并感染对HIV/AIDS疾病的自然史有越来越大的影响,这强调了创建和评估可以针对减少这种合并感染的教育和干预策略的重要性。以健康信念模型和社会认知理论为基础,开发并实施了一种多媒体教育干预,以减少注射毒品使用者(IDUs)中HCV相关的危险行为。我们的研究是一种教育和咨询干预,旨在增加HCV相关知识和对感染严重程度和(个人)易感性的感知。教育和预防干预模块包括四个基于计算机的课程,旨在增加:1)HCV知识,2)对HCV易感性和疾病严重程度的感知,3)对HCV保护措施有效性的感知,以及4)降低风险的自我效能感。在第二个研究阶段,在艾滋病毒/艾滋病感染者(PLWHA)人群中实施并评估了干预措施。以下是过去六年来研究的进展和成就。
研究目的:
第一个总目标。选择一组波多黎各人PLWHA,其成员报告使用注射毒品,并根据他们的HCV知识和危险行为进行表征。
研究参与者招募。共有281名参与者被招募参加这项研究。在参与者进入研究时和一年后再次对他们进行HCV流行率筛查和HCV定性检测。此外,在所有血清学阳性血液样本中进行HCV病毒载量和HCV基因型检测。
截至2009年6月,133例病例和92例对照接受了一次或多次干预。干预组在入组8周后接受教育和咨询干预;对照组在入组6个月后接受教育和咨询干预。干预组在第0、2、4、8周进行干预。共有255名参与者接受了第一次干预,218名第二次,210名第三次,198名第四次。所有研究参与者都获得了津贴,以支付旅行和饮食费用。在干预过程中,向每位参与者提供HCV教育信息、个人卫生用品包、瓶装水和零食。招募、干预或随访期间未报告不良反应,采血期间也无此类反应的证据。3名受试者因不符合入选标准而被研究者退出研究; 2名受试者在签署知情同意书后拒绝参加研究。没有发生违反保密规定的事件。
研究意义
艾滋病毒/艾滋病是波多黎各最相关的公共卫生问题之一。艾滋病流行率在美国及其领土上是最高的。波多黎各超过50%的艾滋病毒感染者是注射吸毒者,其危险行为显著增加了HCV合并感染的可能性。此外,高成本、免疫抑制、潜在的药物相互作用和毒性使PLWHA中HCV的医疗管理变得复杂。越来越多的证据强调艾滋病毒-丙型肝炎病毒合并感染的发病率和死亡率的协同作用,使我们的注意力集中在评估艾滋病毒二级预防策略,以减少丙型肝炎病毒合并感染及其伴随的并发症。因此,本研究评估了在大多数医疗贫困的波多黎各PLWHA队列中可能增加HCV合并和双重感染的危险行为的患病率。该研究还实施和评估了教育和咨询干预措施,旨在降低注射吸毒者中HCV合并和双重感染的风险。这项研究增加了重要的数据,将导致成功管理一个困难的医疗情况下,被组织为一个要素的背景下,艾滋病毒二级预防战略。
英文摘要
This subproject is one of many research subprojects utilizing the
resources provided by a Center grant funded by NIH/NCRR. The subproject and
investigator (PI) may have received primary funding from another NIH source,
and thus could be represented in other CRISP entries. The institution listed is
for the Center, which is not necessarily the institution for the investigator.
Introduction
The Human Immunodeficiency Virus (HIV)-infection profile changed dramatically after the introduction of highly active antiretroviral therapy. AIDS-related opportunistic conditions decreased, while Hepatitis C Virus (HCV)-infection became a primary factor for disease prognosis. Puerto Rico has one of the highest prevalence of HIV/AIDS in the US, and HCV co-infection has emerged as a major public health problem on the island, particularly among injecting drug users (IDUs), who have an estimated co-infection rate greater than 50%. HCV co-infection has an increasing effect on the natural history of HIV/AIDS disease, which underlines the importance of creating and evaluating educational and interventional strategies that can be directed at reducing this co-infection. A multimedia educational intervention, based on the Health Beliefs Model and Social Cognitive Theory was developed and implemented to reduce HCV-associated risk behaviors among injecting drug users (IDUs). Our study is an educational and counseling intervention directed at increasing both HCV-related knowledge and the perception of the severity of and (an individual's) susceptibility to the infection. The education and prevention intervention modules consist of four computer-based sessions that are intended to increase: 1) HCV knowledge, 2) the perception of HCV susceptibility and disease severity, 3) the perception of the efficacy of HCV protective measures, and 4) risk reduction self-efficacy perception. In this second study phase, the intervention was implemented and evaluated in a population of people living with HIV/AIDS (PLWHA). The following relates the study's progress and achievements over the last six years.
Study Aims:
First General Aim. The selection of a cohort of Puerto Rican PLWHA whose members reported using injecting drugs, and who were characterized according to their HCV knowledge and risk behaviors.
Study participant recruitment. A total of 281 participants were recruited for the study. HCV prevalence screening with an HCV qualitative test was done on the participants at their entry into the study and again one year later. In addition, HCV viral load and HCV genotype testing were done in all serologically positive blood samples.
By June 2009, 133 cases and 92 controls received one or more intervention session. The intervention group received the education and counseling interventions 8 weeks after having entered the study; the control group received the education and counseling interventions 6 months following their entry into the study. The sessions were held at weeks zero, two, four, and eight in the intervention group. A total of 255 participants received the first intervention, 218 the second, 210 the third, and 198 the fourth. A stipend was given to all study participants to cover travel and dietary expenses. HCV educational information, personal hygiene kits, bottled water, and snacks were given to each participant during the interventional process. No adverse reactions were reported during the recruitment, intervention, or follow-up, nor was there evidence of such reactions during the blood draws. Three participants were withdrawn from the study by the investigator, because they did not fulfill the inclusion criteria; two refused to participate after signing the consent form. There were no events in which breach of confidentiality occurred.
Significance of the study
HIV/AIDS is one of the most relevant public health problems in Puerto Rico. AIDS prevalence is among the highest in the United Stated and its territories. Over fifty percent of the PLWHA in Puerto Rico are IDUs, with risk behaviors that significantly increase the probability of HCV co-infection. Additionally, the medical management of HCV in PLWHA is complicated by the high costs, immune suppression, and the potential drug interactions and toxicities. The increasing evidence that emphasizes the synergistic role of HIV-HCV co-infection in the morbidity and mortality of PLWHA has focused our attention on the evaluation of HIV secondary prevention strategies targeted at reducing HCV co-infection and its attendant complications. Thus, this study evaluated the prevalence of risk behaviors that could increase HCV co- and super-infection in a cohort of mostly medically indigent Puerto Rican PLWHA. The study also implemented and evaluated an educational and counseling intervention, directed at decreasing risks of HCV co- and super-infection in IDU PLWHAs. This study adds important data that will lead to the successful management of a difficult medical scenario directed to be organized as one element within the context of HIV secondary prevention strategies.
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HCV RISK REDUCTION INTERVENTION AS SECONDARY CO-MORBIDITY PREVNT
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批准号:7724745
-
项目类别:
-
资助金额:$21.04万
-
财政年份:2008
-
负责人:ANGEL M MAYOR
-
依托单位:
PROJ 2:UCC:HCV RISK REDUCTION INTERVENTION AS SECONDARY CO-MORBIDITY PREVNT
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批准号:7622826
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项目类别:
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资助金额:$13.3万
-
财政年份:2007
-
负责人:ANGEL M MAYOR
-
依托单位:
PROJ 2:UCC:HCV RISK REDUCTION INTERVENTION AS SECONDARY CO-MORBIDITY PREVNT
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批准号:7380872
-
项目类别:
-
资助金额:$25.19万
-
财政年份:2006
-
负责人:ANGEL M MAYOR
-
依托单位:
PROJ 2:UCC:HCV RISK REDUCTION INTERVENTION AS SECONDARY CO-MORBIDITY PREVNT
-
批准号:7167060
-
项目类别:
-
资助金额:$41.87万
-
财政年份:2005
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负责人:ANGEL M MAYOR
-
依托单位:
PROJ 2:UCC:HCV RISK REDUCTION INTERVENTION AS SECONDARY CO-MORBIDITY PREVNT
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批准号:6983002
-
项目类别:
-
资助金额:$6.41万
-
财政年份:2004
-
负责人:ANGEL M MAYOR
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依托单位:
海外基金