A Technology-Delivered Peer-to-Peer Support ART Adherence Intervention for HIV+ Adults

 描述（由申请人提供）：研究表明，对于坚持抗逆转录病毒治疗（ART）的艾滋病毒感染者（PLWH），降低发病率和过度死亡率以及降低向性伴侣传播的可能性具有实质性益处。尽管努力维持PLWH沿着治疗级联的参与，但据估计，在美国只有19- 25%的PLWH和27%的MSM维持抑制的病毒载量（VL）。几种基于技术的ART依从性干预措施已证明有效，但所有这些干预措施都是单独提供的，未能利用Web 2.0功能。虽然点对点的社会支持是一种推荐的策略，以提高抗逆转录病毒治疗的依从性，并有巨大的直接吸引力，作为一种可推广的干预方法，没有点对点的社会支持抗逆转录病毒治疗依从性干预措施已被测试在一个全面的疗效试验。“与我一起茁壮成长”（TWM）干预是一种基于信息、动机和行为技能（IMB）模型的技术提供的同伴社会支持干预。除了异步点对点支持功能，TWM干预为参与者提供ART依从性自我监测工具，药物剂量提醒和HIV相关信息内容。TWM干预的试点研究证明了这种方法的可行性和可接受性;结果表明，TWM干预组自我报告的改善，在后续的遵守相比，通常的护理控制组，与最近的吸毒者中明显的最大收益。基于TWM研究的令人鼓舞的发现和对新的、基于证据的有效ART依从性干预的需求，我们提出了以下研究目标。主要目的（目的1和2）是在一项全面随机对照试验中检查在线和移动的TWM干预的有效性。居住在纽约市的可检测到VL的HIV阳性MSM将随机接受为期5个月的TWM干预或仅提供信息的HIV/ART干预。招募将按最近的药物使用情况分层，这样一半的人将报告最近的非法药物使用情况。将在基线、干预后以及5个月和10个月随访时收集VL、经验证的自我报告的AR依从性和干预利用指标。我们假设，与对照组参与者相比，TWM干预组参与者在每个随访时间点的自我报告ART依从性和VL方面将表现出显着改善，近期吸毒者的改善最大。目标3（次要目标）是检查干预措施对基于理论的变革过程的影响（即，IMB因素和社会支持），以改善VL，ART依从性和物质使用结果。该提案是创新的，因为它使用移动的和在线技术作为ART依从性干预递送工具，并且是第一个技术递送的点对点支持ART依从性干预。拟议研究的公共卫生意义在于，它为最需要干预的人推进了ART依从性干预，如果有效，可能会迅速扩大传播。

 DESCRIPTION (provided by applicant): Studies show substantial benefit to reduce morbidity and excess mortality for people living with HIV (PLWH) who adhere to antiretroviral therapy (ART), and to lower the probability of forward transmission to sexual partners. Despite efforts to maintain engagement of PLWH along the treatment cascade, it is estimated that only 19-25%% of PLWH and 27% of MSM in the US maintain suppressed viral load (VL). Several technology- based ART adherence interventions have demonstrated efficacy, however all have been individually delivered and have failed to leverage Web 2.0 features. While peer-to-peer social support is a recommended strategy to improve ART adherence and has enormous immediate appeal as a generalizable intervention approach, no peer-to-peer social support ART adherence interventions have been tested in a full-scale efficacy trial. The "Thrive with Me" (TWM) intervention is a technology-delivered peer-to-peer social support intervention grounded in the Information, Motivation, and Behavioral Skills (IMB) model for HIV-positive MSM. In addition to asynchronous peer-to-peer support capabilities, the TWM intervention provides participants with ART adherence self-monitoring tools, medication dose reminders, and HIV-related informational content. A pilot study of the TWM intervention demonstrated feasibility and acceptability of this approach; results showed that the TWM intervention group self-reported improvement in adherence at follow-up compared to the usual care control group, with greatest gains evident among recent drug users. Based on the encouraging findings of TWM study and the need for novel, evidence-based effective ART adherence interventions, we propose the following study aims. Primary aims (Aims 1 and 2) are to examine the efficacy of the online and mobile- enabled TWM intervention in a full-scale randomized controlled trial. HIV-positive MSM with detectable VL residing in New York City will be randomized to receive the TWM intervention or an information-only HIV/ART intervention for a 5-month period. Recruitment will be stratified by recent drug use, such that half will report recent illicit drug use. VL, validated self-reported AR adherence, and intervention utilization measures will be collected at baseline, post-intervention, and 5-, and 10-month follow up. We hypothesize that participants in the TWM intervention will demonstrate significant improvements in self-reported ART adherence and VL at each follow-up time point compared to control participants, with greatest improvements among recent drug users. Aim 3 (a secondary aim) is to examine the effects of the intervention on theory-based change processes (i.e., IMB factors and social support) for improving VL, ART adherence, and substance use outcomes. The proposal is innovative for its use of mobile and online technology as an ART adherence intervention delivery tool, and for being the first technology-delivered peer-to-peer support ART adherence intervention. The public health significance of the proposed study is that it advances ART adherence intervention for persons in greatest need of intervention and, if effective, may be quickly scaled up for dissemination.