Text Messaging Intervention to Improve ART Adherence among HIV-positive Youth

描述（由申请人提供）：正如PAS-10-098所强调的，青年艾滋病病毒感染者（YLH）是一个易感人群。大多数艾滋病毒感染者是少数族裔，可能会使用非法药物，并且经常难以坚持服用艾滋病毒药物。本研究的目的是测试SMS短信技术对提高YLH药物依从性的作用。拟议的研究是一项随机对照试验，旨在研究16-29岁未坚持抗逆转录病毒治疗的YLH中短信提醒对坚持抗逆转录病毒治疗的影响。每天发送短信提醒，根据患者的用药计划随机分配到干预组，持续6个月。一项小型可行性研究（N=25），包括需要酒精和/或药物治疗的青年比例很高（即60%），提供了这一方法潜在有效性的初步证据。我们将招募152名年龄16-29岁的非依从性YLH。一半的样本（N=76）随机分配到干预组，每天收到短信提醒用药，另一半随机分配到对照组（N=76），只接受标准护理（SOC）。在对照试验中，依从性水平和病毒载量将在基线、3个月和6个月随访时收集。此外，在最初6个月的登记期结束时，对照组的参与者将过渡到短信干预，干预条件的参与者将停止接受短信干预。依从性和病毒载量数据将在9个月和12个月的随访点从每组收集。这些附加特征的优点是，它们使我们能够向所有参与者提供干预，评估对照组的干预效果（确认干预效果），评估干预组的持续干预效果（干预后）。我们假设，在干预条件下的年轻人在基线后3个月和6个月的依从性将显示出具有临床意义的增加，从大约70%到90%的ART依从性。我们的具体目标是：1)确定短信干预对我们的主要结果的有效性：在6个月的干预期内，16-29岁（一个显示出药物使用高风险的群体）依从性差的YLH坚持抗逆转录病毒治疗；2)在6个月的干预期内，探讨短信干预对次要的探索性结果的疗效：病毒载量和CD4计数；3)从客观和主观两方面评价该干预和临床试验方法的可行性、可接受性和满意度。我们的主要假设是：1)与仅接受SOC的青少年相比，随机分配到SMS短信干预组的青少年在基线后3个月和6个月的干预期间对ART的依从性和次要结果的改善程度更大。我们假设3个月和6个月时两组依从性水平有10个点的差异，干预才具有临床意义；2)在9个月和12个月的随访中，随机分配到短信干预组的青少年将保持改善（即，bb0 - 90%的依从性）。

DESCRIPTION (provided by applicant): As emphasized in PAS-10-098, youth living with HIV (YLH) are a vulnerable subpopulation. The majority of YLH are of minority status, are likely to use illicit substances, and often struggle with adherence to HIV medications. The purpose of the proposed study is to test SMS text messaging technology to improve medication adherence among YLH. The proposed study is a randomized controlled trial of the effect of text message reminders on ART adherence among non-adherent YLH, ages 16-29. Daily text message reminders will be sent to patients randomized to the intervention group according to their medication schedule, for 6 months. A small feasibility study (N=25), including a high percentage of youth in need of alcohol and/or drug treatment (i.e., 60%), provided preliminary evidence of the potential effectiveness of this approach. We will enroll 152 non-adherent YLH, ages 16-29. Half of the sample (N=76), randomized to the intervention, will receive daily SMS text message medication reminders and half will be randomized to the control condition (N=76) and receive standard of care (SOC) only. For the controlled trial, adherence levels and viral load will be collected at baseline, 3-month and 6-month follow-up. In addition, at the end of the initial 6-month enrollment period, participants in the control condition will cross-over to the SMS intervention and participants in the intervention condition will cease to receive the SMS intervention. Adherence and viral load data will be collected from each group at 9- and 12-month follow-up points. The advantages of these additional features are that they allow us to offer the intervention to all participants, to evaluate the intervention effect in the control group (to confirm the intervention effect) and to assess sustained intervention effects in the intervention group (post-intervention). We hypothesize that youth in the intervention condition will demonstrate a clinically meaningful increase in adherence at 3 and 6 months post-baseline, from approximately 70% to 90% adherence to ART. Our specific aims are: 1) to determine the efficacy of an SMS text messaging intervention on our primary outcome: adherence to ART among poorly adherent YLH, ages 16-29 (a group shown to be at high risk for substance use) over a 6-month intervention period; 2) to explore the efficacy of an SMS text messaging intervention on a secondary, exploratory outcome: viral load and CD4 counts, over a 6-month intervention period; 3) to assess the feasibility, acceptability, and satisfaction of this intervention and clinical trial approach by both objective and subjective measures. Our primary hypotheses are: 1) youth randomized to the SMS text messaging intervention will show greater improvements in levels of adherence to ART and secondary outcomes during the intervention period at 3 and 6 months post-baseline, in comparison to those receiving SOC only. We hypothesize a 10-point difference in adherence level between groups at 3 and 6 months for the intervention to be clinically meaningful; 2) youth randomized to SMS text messaging intervention will maintain improvements (i.e., > 90% adherence) at 9-month and 12-month follow-ups. PUBLIC HEALTH RELEVANCE: As emphasized in PAS-10-098, youth living with HIV (YLH) are a vulnerable subpopulation. The majority of YLH are of minority status, are likely to use illicit substances, and often struggle with adherence to HIV medications. The purpose of the proposed study is to test SMS text messaging technology to improve medication adherence among YLH. Effective interventions to improve adherence may decrease the population burden of disease.