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

描述（由申请人提供）：正如PAS-10-098中所强调的，感染艾滋病毒的青年（YLH）是一个脆弱的亚群。大多数YLH是少数民族，可能使用非法药物，并经常坚持使用艾滋病毒药物。这项研究的目的是测试短信技术，以提高YLH的药物依从性。该研究是一项随机对照试验，旨在研究短信提醒对年龄在16-29岁的非依从性YLH患者的ART依从性的影响。将根据患者的用药时间表向随机分配至干预组的患者发送每日短信提醒，持续6个月。一项小型可行性研究（N=25），包括需要酒精和/或药物治疗的高比例青年（即，60%），提供了这种方法的潜在有效性的初步证据。我们将招募152名年龄在16-29岁的非依从性YLH。随机分配至干预组的一半样本（N=76）将接受每日SMS短信药物提醒，另一半样本将随机分配至对照组（N=76），仅接受标准治疗（SOC）。对于对照试验，将在基线、3个月和6个月随访时收集依从性水平和病毒载量。此外，在最初的6个月入组期结束时，对照条件下的受试者将交叉至SMS干预，干预条件下的受试者将停止接受SMS干预。将在9个月和12个月随访时收集每组的依从性和病毒载量数据。这些附加功能的优点是，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（以确认干预效果），并评估干预组的持续干预效果（干预后）。我们假设，处于干预条件下的青少年在基线后3个月和6个月时将表现出具有临床意义的依从性增加，从大约70%增加到90%。我们的具体目标是：1）确定短信干预对我们主要结局的疗效：在16-29岁的YLH依从性差的患者中，（一组被证明是在高风险的物质使用）在6个月的干预期; 2）探讨短信短信干预对次要的，探索性的结果的疗效：病毒载量和CD 4计数，在6个月的干预期; 3）评估的可行性，可接受性，并通过客观和主观的措施，这种干预和临床试验方法的满意度。我们的主要假设是：1）与仅接受SOC的青少年相比，随机接受SMS短信干预的青少年在基线后3个月和6个月的干预期间将显示出对ART的依从性水平和次要结局的更大改善。我们假设3个月和6个月时两组之间的依从性水平存在10分差异，干预具有临床意义; 2）随机接受短信干预的青少年将保持改善（即，在9个月和12个月随访时，依从性> 90%。 公共卫生相关性：正如PAS-10-098所强调的，感染艾滋病毒的青年（YLH）是一个脆弱的亚群。大多数YLH是少数民族，可能使用非法药物，并经常坚持使用艾滋病毒药物。这项研究的目的是测试短信技术，以提高YLH的药物依从性。提高依从性的有效干预措施可能会降低疾病的人口负担。

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.