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)的艾滋病毒携带者(PLWH)来说，降低发病率和额外死亡率，以及降低向性伴侣转发传播的可能性都有很大好处。尽管努力在治疗过程中保持PLWH的参与，但据估计，美国只有19%-25%的PLWH和27%的MSM保持抑制的病毒载量(VL)。几个基于技术的ART依从性干预措施已经证明了有效性，然而所有这些干预措施都是单独提供的，都未能利用Web 2.0功能。虽然对等社会支持是一种推荐的提高抗逆转录病毒治疗依从性的策略，并作为一种可推广的干预方法具有巨大的直接吸引力，但尚未有任何对等社会支持抗逆转录病毒药物依从性干预措施在全面的疗效试验中进行测试。“与我一起茁壮成长”(TWM)干预是一种技术提供的点对点社会支持干预，基于针对HIV阳性MSM的信息、动机和行为技能(IMB)模型。除了异步点对点支持能力外，TWM干预还为参与者提供ART依从性自我监测工具、药物剂量提醒和艾滋病毒相关信息内容。TWM干预的一项初步研究证明了这种方法的可行性和可接受性；结果显示，TWM干预组在随访时自我报告的依从性与常规护理对照组相比有所改善，其中最明显的是最近吸毒者。基于TWM研究的令人鼓舞的发现，以及对新的、基于证据的有效ART依从性干预的需要，我们提出了以下研究目标。主要目标(目标1和目标2)是在一项全面的随机对照试验中检查在线和移动启用的TWM干预的有效性。居住在纽约市的HIV阳性MSM可检测到VL，将随机接受TWM干预或仅提供信息的HIV/ART干预，为期5个月。招聘将根据最近的毒品使用情况进行分层，这样一半的人将报告最近使用非法药物。将在基线、干预后以及5个月和10个月的跟踪中收集VL、经过验证的自我报告AR遵从性和干预利用衡量标准。我们假设，与对照组参与者相比，TWM干预组的参与者在每个随访时间点的自我报告的ART依从性和VL方面都会有显著的改善，其中最近吸毒者的改善最大。目标3(次要目标)是检查干预对基于理论的变化过程(即，IMB因素和社会支持)的影响，以改善VL、ART依从性和物质使用结果。该提案具有创新性，因为它使用移动和在线技术作为ART坚持干预的交付工具，并成为首个由技术提供的点对点支持ART坚持干预。这项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规模。

 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.