Nurse Delivered Cell-Phone HIV Adherence Intervention

描述(申请人提供)：这项申请测试了一种通过手机向城乡患者提供的基于理论的艾滋病毒治疗依从性干预。坚持服用抗逆转录病毒药物(ART)对于实现艾滋病毒抑制是必要的，而不坚持则可能导致艾滋病毒耐药基因变种。艾滋病毒/艾滋病患者往往难以维持高水平的坚持治疗。大多数干扰依从性的因素都是意想不到的，发生在临床就诊之间，包括抑郁、副作用、物质使用和药房续药失误。我们将进行一项随机临床试验，以测试基于手机递送理论的服药依从性咨询干预。该干预以自我调节模式为基础，并利用未公布的药片计数来监控依从性并在咨询环境中指导纠正反馈。使用药片计数依从性信息进行咨询，允许提供者在可以阻止病毒耐药性的时间框架内检测并纠正患者的不依从性。一项实验析因设计将测试咨询和短信提醒系统的效果，以及咨询和短信成分与600名接受艾滋病毒治疗的男性和女性的互动。在筛查、知情同意和基线评估之后，参与者将被随机分为四种干预条件之一：(A)自我调节咨询+方案定制短信提醒；(B)自我调节咨询+控制信息；(C)控制咨询+方案定制短信提醒；或(D)控制咨询+控制信息。因此，这项研究将使用2(自我调节咨询)×2(短信提醒)完全析因设计，参与者在干预后跟踪12个月。主要终点是通过未宣布的药片计数和HIV RNA(病毒载量)评估药物依从性。这一新开发的干预策略以自我调节理论为基础，专为资源有限的临床环境而设计。

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.