Comparative Effectiveness Trial for Retention-Adherence-Health

保留-依从-健康的比较有效性试验

• 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
• 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

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）：本研究将比较有效的单独行为自我调节咨询的两种送货格式 - 基于诊所的手机与手机 交付 - 以改善在有限的小城市和农村地区的艾滋病毒携带者中的治疗保留和依从性。对于实现HIV抑制和对HIV感染的长期临床管理是必要的。不幸的是，药物使用，贫困和其他障碍阻碍了许多艾滋病毒感染患者的健康状况。在美国，只有大约一半的患有艾滋病毒感染的人被保留在护理中，只有五分之一获得了成功的病毒控制，这种模式被称为艾滋病毒治疗级联。我们将使用（a）诊所办公室咨询或（b）手机交付的咨询对两种临床干预措施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的纠正反馈，以改善药物依从性和保留率。这种主动的干预旨在增加参与护理，促进保留，最大化依从性并改善健康结果。行为自我调节咨询已在基于诊所和电话传递格式中有效。但是，尚未测试这些替代格式用于提供临床护理行为干预措施的比较成本和有效性。我们的目的是对行为自我调节咨询进行比较有效性研究，以指导健康政策和临床资源决策。参与者是200名男性和200名居住在高HIV患病率偏远社区中的女性，她们积极使用酒精或其他药物并接受HIV治疗。在筛选，知情同意和基线评估后，将分配参与者以（a）纳入基于办公室的护理中的行为自我调节咨询，或者（b）通过手机在家中提供的行为自我调节咨询。实施后，将遵循参与者的12个月。将主要终点映射到HIV治疗级联反应上，并包括用于饮酒的生物标志物，临床确认的保留率以护理，通过未经宣布的药丸计数评估的药物依从性和HIV RNA（病毒负荷）。该研究包括实施研究，这些研究将确定临床和手机实施的促进者以及障碍以及用于实现最佳结果的资源的成本核算。一个国际认可的专家团队将组成一个工作组，以最少的增加成本指导运营评估。这项研究将为在有限的环境中使用酒精或其他药物的艾滋病毒患者提供基于证据的护理保留和依从性干预措施。