Comparative Effectiveness Trial for Retention-Adherence-Health

保留-依从-健康的比较有效性试验

基本信息

批准号：
8925755
负责人：
SETH C KALICHMAN
金额：
$ 66.83万
依托单位：
UNIVERSITY OF CONNECTICUT STORRS
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-09-10 至 2019-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8925755
关键词：
18 year old Accounting Adherence Alcohol consumption Alcohol or Other Drugs use Alcohols Behavior Therapy Behavioral Biological Markers Caring Cellular Phone Cities Clinic Clinical Clinical Management Clinical Trials Communities Consent Continuity of Patient Care Cost Analysis Costs and Benefits Counseling Decision Making Drops Effectiveness Evaluation Face Feedback HIV HIV Infections HIV Seropositivity Health Health Policy Health Services Healthcare Home environment Informal Social Control Informed Consent Intervention Knowledge Life Maps Mediating Modeling Monitor Office Visits Outcome Participant Patient Care Patients Pattern Poverty Prevalence Primary Health Care Procedures RNA Recruitment Activity Relative (related person)Research Research Design Resources Services Telephone Testing Treatment outcome United States Viral Viral Load result Woman advanced disease alcohol and other drug antiretroviral therapy base clinical care clinical practice comparative comparative effectiveness compare effectiveness cost cost effectiveness design effective intervention effectiveness research effectiveness trial evidence base head-to-head comparison implementation research improved mHealth medication compliance meetings men novel operation pill prevent primary care setting response routine care rural area screening seropositive skills treatment adherence working group

项目摘要

DESCRIPTION (provided by applicant): This research will compare two delivery formats for effective individually-tailored behavioral self-regulation counseling - clinic-based vs. cell phone delivered - to improve treatment retention and adherence in people living with HIV in resource limited small cities and rural areas. Engagement, retention, and adherence to care are necessary to achieve HIV suppression and the long-term clinical management of HIV infection. Unfortunately, substance use, poverty, and other barriers impede the clinical care and compromise the health of many people living with HIV infection. Only about half of people with known HIV infection in the United States are retained in care and only one in five achieve successful viral control, a pattern that is known as the HIV treatment cascade. We will conduct comparative effectiveness research (CER) on two models of clinical intervention delivery using either (a) clinic office visit counseling or (b) cell phone-delivered counseling. Behavioral self-regulation counseling is an evidence-based individualized patient care approach to monitoring adherence, providing support, and offering guided corrective feedback to improve medication adherence and retention in care. This proactive intervention is designed to increase engagement in care, facilitate retention, maximize adherence and improve health outcomes. Behavioral self-regulation counseling has been demonstrated effective in both clinic-based and phone-delivered formats. However, the comparative costs and effectiveness of these alternative formats for delivering behavioral interventions in clinical care have not been tested. Our aim is to conduct comparative effectiveness research on behavioral self-regulation counseling to guide health policy and clinical resource decision-making. Participants are 200 men and 200 women living in high-HIV prevalence remote communities who actively use alcohol or other drugs and are receiving HIV treatment. Following screening, informed consent, and baseline assessments, participants will be allocated to receive either (a) behavioral self-regulation counseling integrated into their office-based care or (b) behavioral self-regulation counseling delivered at home by cell phone. Participants will be followed for 12-months following implementation. The primary endpoints are mapped onto the HIV treatment cascade and include a biomarker for alcohol use, clinic-confirmed retention to care, medication adherence assessed by unannounced pill counts, and HIV RNA (viral load). The study includes implementation research that will determine facilitators and barriers to clinic and cell phone implementation and cost accounting of resources expended to achieve optimal outcomes. A team of internationally recognized experts will form a working group to guide the operational evaluation at minimal added cost. This study will inform evidence- based care retention and adherence interventions for people living with HIV who are using alcohol or other drugs in resource limited settings.

描述（由申请人提供）：本研究将比较两种有效的个性化行为自我调节咨询的交付方式——基于诊所与手机交付 - 提高资源有限的小城市和农村地区艾滋病毒感染者的治疗保留率和依从性。参与、保留和坚持护理对于实现 HIV 抑制和 HIV 感染的长期临床管理是必要的。不幸的是，药物滥用、贫困和其他障碍阻碍了临床护理并损害了许多艾滋病毒感染者的健康。在美国，只有大约一半已知感染艾滋病毒的人得到护理，只有五分之一的人成功控制了病毒，这种模式被称为艾滋病毒治疗级联。我们将使用（a）诊所访问咨询或（b）手机提供的咨询，对两种临床干预提供模式进行比较有效性研究（CER）。行为自我调节咨询是一种基于证据的个性化患者护理方法，用于监测依从性、提供支持并提供指导性纠正反馈，以提高药物依从性和护理保留率。这种主动干预旨在增加护理参与度、促进保留、最大限度地提高依从性并改善健康结果。行为自我调节咨询已被证明在诊所和电话提供的形式中都是有效的。然而，这些在临床护理中提供行为干预的替代形式的相对成本和有效性尚未经过测试。我们的目标是进行行为自我调节咨询的比较有效性研究，以指导卫生政策和临床资源决策。参与者是生活在艾滋病毒高流行偏远社区的 200 名男性和 200 名女性，他们经常使用酒精或其他药物并正在接受艾滋病毒治疗。经过筛选、知情同意和基线评估后，参与者将被分配接受 (a) 纳入其办公室护理的行为自我调节咨询或 (b) 通过手机在家中提供的行为自我调节咨询。实施后参与者将被跟踪 12 个月。主要终点被映射到 HIV 治疗级联上，包括酒精使用的生物标志物、临床确认的护理保留、通过未公布的药丸计数评估的药物依从性和 HIV RNA（病毒载量）。该研究包括实施研究，将确定诊所和手机实施的促进因素和障碍，以及为实现最佳结果而消耗的资源的成本核算。由国际公认的专家组成的团队将组成一个工作组，以最小的额外成本指导运营评估。这项研究将为在资源有限的环境中使用酒精或其他药物的艾滋病毒感染者提供基于证据的护理保留和依从性干预措施。