Nurse Delivered Cell-Phone HIV Adherence Intervention

护士提供手机艾滋病毒依从干预

基本信息

批准号：
8416256
负责人：
SETH C KALICHMAN
金额：
$ 51.25万
依托单位：
UNIVERSITY OF CONNECTICUT STORRS
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-03-17 至 2016-01-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8416256
关键词：
18 year old AIDS/HIV problem Acquired Immunodeficiency Syndrome Adherence Adverse effects Alcohol or Other Drugs use Anti-Retroviral Agents Behavior Behavior Control Behavior Therapy Behavioral Cellular Phone Clinic Visits Clinical Cognitive Communication Communities Counseling Data Development Dose Experimental Designs Feedback Genotype HIV HIV Infections Head Health Health Care Costs Health behavior change Human Informal Social Control Informed Consent Interruption Intervention Intervention Trial Lead Life Maintenance Mediating Mental Depression Modeling Monitor Motivation Nurses Outcome Participant Patient Noncompliance Patients Pharmaceutical Preparations Pharmacy facility Problem Solving Procedures Productivity Provider RNA Randomized Randomized Clinical Trials Recruitment Activity Regimen Reminder Systems Request for Applications Research Resistance Resources Rural Rural Population Technology Testing Text Time Training Urban Population Viral Viral Load result Visit Woman antiretroviral therapy base design drug resistant virus effective intervention experience follow-up genetic variant health disparity improved medication compliance meetings men pill post intervention prevent public health relevance randomized trial response routine care rural area screening skills stress management theories treatment adherence urban area viral resistance

项目摘要

DESCRIPTION (provided by applicant): This application tests a theory-based HIV treatment adherence intervention delivered by cell phone to patients in urban and rural areas. Adherence to antiretroviral (ART) medications is necessary to achieve HIV suppression and non-adherence can lead to treatment resistant genetic variants of HIV. People living with HIV/AIDS often experience difficulty sustaining high-levels of treatment adherence. Most factors that interfere with adherence are unanticipated and occur between clinical visits, including depression, side effects, substance use, and lapses in pharmacy refill. We will conduct a randomized clinical trial to test a cell phone-delivered theory-based medication adherence counseling intervention. The intervention is grounded in Self-Regulation Model and utilizes unannounced pill counts to monitor adherence and guide corrective feedback within the counseling context. Using pill count adherence information for counseling allows providers to detect and correct patient non-adherence within a time frame that can head off viral resistance. An experimental factorial design will test the effects of counseling and a text message reminder system as well the interaction of counseling and text message components with 600 men and women receiving HIV treatment. Following screening, informed consent and baseline assessments participants will be randomized to one of four intervention conditions:(a) self-regulation counseling + regimen tailored text message reminders; (b) self-regulation counseling + control messages; (c) control counseling + regimen tailored text reminders; or (d) control counseling + control messages. The study will therefore use a 2 (self-regulation counseling) x 2 (text message reminders) full factorial deign with participants followed for 12 months post-intervention. The primary endpoints are medication adherence assessed by unannounced pill counts and HIV RNA (viral load). This newly developed intervention strategy is grounded in Self-Regulation Theory and is designed for use in clinical settings with limited resources.

描述（由申请人提供）：此申请测试由手机提供给城市和农村地区患者的基于理论的HIV治疗依从性干预措施。对抗逆转录病毒（ART）药物的遵守对于实现HIV抑制是必要的，并且不遵守可以导致HIV的抗治疗遗传变异。患有艾滋病毒/艾滋病的人通常会遇到难以维持高级治疗依从性的困难。干扰依从性的大多数因素都是意外的，并且在临床就诊之间发生，包括抑郁，副作用，药物使用和药房补充的失误。我们将进行一项随机临床试验，以测试基于手机的基于理论的药物依从性咨询干预措施。该干预措施基于自我调节模型，并利用未经宣布的药丸计数来监测依从性的依从性，并在咨询环境中指导纠正反馈。使用药丸计数依从性信息进行咨询，使提供者可以在可以脱离病毒性的时间范围内检测并纠正患者的不遵守。实验阶乘设计将测试咨询和短信提醒系统的效果，以及咨询和短信组件与600名男女接受HIV治疗的相互作用。筛选后，知情同意和基线评估参与者将被随机分为四个干预条件之一：（a）自我调节咨询 +方案量身定制的文本消息提醒；（b）自我调节咨询 +控制消息；（c）控制咨询 +方案量身定制的文本提醒；或（d）控制咨询 +控制消息。因此，该研究将使用2（自我调节咨询）x 2（短信提醒）与参与者进行完整的析因，然后进行干预后12个月。主要终点是通过未宣布的药丸计数和HIV RNA（病毒载量）评估的药物依从性。这种新开发的干预策略基于自我调节理论，旨在在资源有限的临床环境中使用。