Nurse Delivered Cell-Phone HIV Adherence Intervention

描述（由申请人提供）：该应用程序测试了通过手机向城市和农村地区的患者提供的基于理论的艾滋病毒治疗依从性干预。坚持抗逆转录病毒（ART）药物治疗是实现艾滋病毒抑制的必要条件，不坚持可能导致艾滋病毒的耐药遗传变异。艾滋病毒/艾滋病感染者往往很难坚持高水平的治疗。大多数干扰依从性的因素是不可预见的，发生在临床访视之间，包括抑郁症，副作用，物质使用和药房补货失误。我们将进行一项随机临床试验，以测试手机传递的理论为基础的药物依从性咨询干预。干预是基于自我调节模型，并利用未经宣布的药丸计数，以监测遵守和指导纠正反馈的咨询环境。使用药丸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范围内检测和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，以及咨询和短信组件与600名接受艾滋病毒治疗的男性和女性的相互作用。在筛选、知情同意和基线评估后，参与者将被随机分配至四种干预条件之一：（a）自我调节咨询+方案定制的短信提醒;（B）自我调节咨询+对照消息;（c）对照咨询+方案定制的短信提醒;或（d）对照咨询+对照消息。因此，该研究将使用2（自我调节咨询）× 2（短信提醒）全析因设计，对参与者进行干预后12个月的随访。主要终点是通过未公布的药丸计数和HIV RNA（病毒载量）评估的药物依从性。这种新开发的干预策略以自我调节理论为基础，旨在用于资源有限的临床环境。

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.