与我共成长：一项随机对照试验方案，旨在测试一种同伴支持干预措施，以提高男男性行为者的抗逆转录病毒治疗依从性。

Thrive With Me: Protocol for a Randomized Controlled Trial to Test a Peer Support Intervention to Improve Antiretroviral Therapy Adherence Among Men Who Have Sex With Men.

作者信息

Horvath Keith J, Amico K Rivet, Erickson Darin, Ecklund Alexandra M, Martinka Aldona, DeWitt James, McLaughlin Jeffery, Parsons Jeffrey T

机构信息

Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis, MN, United States.

Department of Health Behavior and Health Education, School of Public Health, University of Michigan, Ann Arbor, MI, United States.

出版信息

JMIR Res Protoc. 2018 May 31;7(5):e10182. doi: 10.2196/10182.

BACKGROUND

The suboptimal rate of viral suppression among persons aged 13 years and older and residing in 37 states and the District of Columbia leaves considerable opportunities for onward transmission and contributes to poor health outcomes. Men who have sex with men (MSM) represent one of the most at-risk groups in the United States. There is a clear and continued need for innovative adherence support programs to optimize viral suppression. To address this gap, we designed and are implementing a randomized controlled trial (RCT) to test the efficacy of the Thrive with Me intervention for MSM living with HIV. Critical components of the protocol are presented.

OBJECTIVE

The aim of this study is to describe the protocol for rigorously testing the efficacy of Thrive with Me to improve antiretroviral therapy (ART) adherence among HIV-positive MSM residing in New York City.

METHODS

A community advisory board and beta testing were used to obtain feedback from HIV-positive MSM on the overall look and feel of Thrive with Me and problems with navigation to finalize intervention components and content. We will enroll 400 HIV-positive MSM residing in the New York City area into a two-arm prospective RCT and follow them for 17 months. Men in the Thrive with Me experimental intervention arm will have access to Thrive with Me for 5 months. Thrive with Me has three primary components: (1) a private social networking feature; (2) tailored HIV and ART adherence information; and (3) medication reminders, self-monitoring, and reflection. Gamification components include badges and leveling up to increase intrinsic motivation to engage with the intervention. Men randomized to the control condition will view a weekly newsletter for 5 months. The newsletter will be delivered via email and contains information on topics related to HIV with the exception of ART adherence. Study assessments will occur at enrollment and 5, 11, and 17 months post enrollment. The primary study outcome is HIV viral load, which is considered an objective indicator of ART adherence.

RESULTS

Participant recruitment for the RCT began in October 2016, and the data collection period is anticipated to end in the Fall of 2019.

CONCLUSIONS

The efficacy trial of Thrive with Me will help to fill gaps in understanding about the utility of multicomponent, technology-based interventions to improve ART adherence among HIV-positive MSM. Of importance is the ability for the results of the Thrive with Me trial to inform best practices for conducting technology-based interventions that incorporate social media features.

TRIAL REGISTRATION

ClinicalTrials.gov NCT02704208; https://clinicaltrials.gov/ct2/show/NCT02704208 (Archived by WebCite at http://www.webcitation.org/6zQ8WPra6).

REGISTERED REPORT IDENTIFIER

RR1-10.2196/10182.

背景

在13岁及以上且居住在37个州和哥伦比亚特区的人群中，病毒抑制率未达最佳水平，这为病毒进一步传播留下了相当大的机会，并导致健康状况不佳。男男性行为者（MSM）是美国风险最高的群体之一。显然，持续需要创新的依从性支持项目来优化病毒抑制。为了填补这一空白，我们设计并正在实施一项随机对照试验（RCT），以测试“与我共成长”干预措施对感染HIV的男男性行为者的疗效。本文介绍了该方案的关键组成部分。

目的

本研究的目的是描述严格测试“与我共成长”改善纽约市HIV阳性男男性行为者抗逆转录病毒疗法（ART）依从性疗效的方案。

方法

利用社区咨询委员会和测试版来获取HIV阳性男男性行为者对“与我共成长”的整体外观和感觉以及导航问题的反馈，以最终确定干预措施的组成部分和内容。我们将招募400名居住在纽约市地区的HIV阳性男男性行为者参加一项双臂前瞻性随机对照试验，并对他们进行17个月的跟踪。“与我共成长”实验干预组的男性将有5个月的时间使用“与我共成长”。“与我共成长”有三个主要组成部分：（1）一个私密的社交网络功能；（2）量身定制的HIV和ART依从性信息；（3）药物提醒、自我监测和反思。游戏化组件包括徽章和升级，以增加参与干预的内在动力。随机分配到对照组的男性将在5个月内每周查看一份时事通讯。该时事通讯将通过电子邮件发送，内容包括与HIV相关的主题，但不包括ART依从性。研究评估将在入组时以及入组后5、11和17个月进行。主要研究结果是HIV病毒载量，它被认为是ART依从性的客观指标。