Comparative Effectiveness Trial for Retention-Adherence-Health

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形式-基于诊所与手机 提供-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坚持率。参与，保留和坚持护理是必要的，以实现艾滋病毒抑制和艾滋病毒感染的长期临床管理。不幸的是，药物使用、贫困和其他障碍阻碍了临床护理，损害了许多艾滋病毒感染者的健康。在美国，只有大约一半的已知艾滋病毒感染者得到护理，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。我们将对两种临床干预提供模式进行比较有效性研究（CER），使用（a）诊所办公室访问咨询或（B）手机提供咨询。行为自我调节咨询是一种以证据为基础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，以改善药物依从性和护理保留。这种积极主动的干预措施旨在增加护理参与，促进保留，最大限度地坚持和改善健康结果。行为自我调节咨询已被证明是有效的，无论是基于诊所和电话交付的格式。然而，在临床护理中提供行为干预的这些替代形式的比较成本和有效性尚未得到测试。我们的目标是对行为自我调节咨询进行比较有效性研究，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率偏远社区的200名男子和200名妇女，他们经常使用酒精或其他药物，并正在接受艾滋病毒治疗。在筛选、知情同意和基线评估后，参与者将被分配接受（a）整合到其基于办公室的护理中的行为自我调节咨询或（B）在家中通过手机提供的行为自我调节咨询。参与者将在实施后接受12个月的随访。主要终点被映射到HIV治疗级联，包括酒精使用的生物标志物，临床确认的保留护理，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，将确定促进者和障碍，诊所和手机实施和成本核算的资源，以实现最佳结果。一个由国际公认的专家组成的小组将组成一个工作组，以最低的额外费用指导业务评价。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坚持干预措施。

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.