Nurse Delivered Cell-Phone HIV Adherence Intervention

描述（由申请人提供）：本申请测试一种基于理论的艾滋病毒治疗依从性干预，通过手机向城市和农村地区的患者提供。坚持抗逆转录病毒药物治疗是抑制艾滋病毒的必要条件，不坚持治疗可导致艾滋病毒的耐药遗传变异。艾滋病毒/艾滋病感染者往往难以维持高水平的治疗依从性。大多数干扰依从性的因素是意料之外的，发生在临床就诊之间，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，以测试基于理论的手机传递药物依从性咨询干预。干预以自我调节模型为基础，利用未公布的药丸数量来监测依从性，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，使提供者能够在可以阻止病毒耐药性的时间框架内发现和纠正患者的不依从性。实验因子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的相互作用，600名接受艾滋病毒治疗的男性和女性。在筛选、知情同意和基线评估之后，参与者将被随机分配到四种干预条件中的一种：(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+方案定制文本提醒；(d)控制咨询+控制信息。因此，该研究将采用2（自我调节咨询）x 2（短信提醒）全因子设计，参与者在干预后随访12个月。主要终点是通过未公布的药丸数量和HIV RNA（病毒载量）来评估药物依从性。这种新开发的干预策略以自我调节理论为基础，设计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. PUBLIC HEALTH RELEVANCE: Persistent adherence to antiretroviral therapy is necessary for the successful treatment of HIV infection. The proposed research will test a theory-based behavioral intervention that includes objectively monitoring HIV treatment adherence with corrective feedback delivered by cell phone. The study will also test the independent effects of an automated text message reminder system for sustaining adherence improvements. The intervention under study has utility for people living with HIV/AIDS In resource limited rural and urban settings.