Applying user-centered design strategies to develop a tablet-optimized intervention to help high-risk men starting PrEP reduce their heavy drinking and adhere to their medication

应用以用户为中心的设计策略来开发平板电脑优化的干预措施，帮助开始 PrEP 的高危男性减少酗酒并坚持用药

• 批准号: 10002156
• 负责人: Philip Andrew Chan
• 金额: $ 22.6万
• 依托单位: BROWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-01 至 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10002156
• 关键词: AIDS prevention; Address; Adherence; Affect; Alcohol consumption; Alcohols; Antiviral Agents; Area; Attention; Biological Markers; Caring; Clinic; Clinical; Computers; Consumption; Data; Development; Diagnosis; Diphosphates; Dose; Drug Prescriptions; Effectiveness; Ensure; Exercise; Feedback; Fumarates; Future; Goals; HIV; HIV Infections; HIV Seronegativity; Health; Heavy Drinking; High Prevalence; Human immunodeficiency virus test; Incidence; Individual; Infection; Internet; Intervention; Length; Literature; Longitudinal Studies; Maintenance; Meta-Analysis; Methods; Motivation; Online Systems; Outcome; Pathway interactions; Patient Self-Report; Pattern; Pharmaceutical Preparations; Phase; Pilot Projects; Process; Professional counselor; Provider; Publishing; Qualitative Research; Randomized; Randomized Controlled Trials; Recording of previous events; Reporting; Research; Research Design; Research Methodology; Resources; Risk; Tablets; Tenofovir; Testing; Theoretical model; Time; Training; Treatment Efficacy; United States; Update; Viral Load result; Work; adherence rate; alcohol effect; alcohol intervention; base; binge drinking; brief alcohol intervention; brief intervention; brief motivational intervention; clinical trial analysis; control trial; cost; design; drinking; emtricitabine; follow-up; game development; high risk men; implementation strategy; improved; intervention effect; medication compliance; men who have sex with men; motivational enhancement therapy; phosphatidylethanol; post intervention; pre-exposure prophylaxis; prevent; sexual risk behavior; therapy design; tool; transmission process; trend; usability; user centered design; web app

Project Summary/Abstract Although overall annual HIV incidence in the United States (US) has declined in recent years, the rate of new infections remains stable specifically among men who have sex with men (MSM). A once-daily antiviral drug (emtricitabine/tenofovir) has recently been approved in the US for use as HIV pre-exposure prophylaxis (PrEP), and could offer an important pathway for achieving a sustained decline in new HIV infections among MSM. However, its effectiveness depends on sufficient adherence and persistence to the drug. A robust literature shows that heavy drinking disrupts adherence to similar medications when used for HIV treatment, resulting in onward transmissions and poorer health outcomes among those living with HIV. Our ongoing work shows that heavy drinking days occur more frequently during lapses in PrEP adherence that are sufficient to reduce its effectiveness (4+ days of missed doses) than periods with more consistent adherence, suggesting that heavy drinking may similarly affect adherence to PrEP. Meta-analyses show that brief interventions can help many at-risk individuals reduce their alcohol use and adhere to antiviral drugs prescribed for HIV treatment, even when these interventions are delivered via computer. Moreover, some of the more robust effects on these outcomes have been demonstrated for interventions based on the Trans-Theoretical Model of Change (TTM) or that were inspired by Motivational Interviewing (i.e., brief motivational interventions [BMIs]). Brief, computer-delivered interventions like these also have a number of advantages in terms of scalability, cost, and feasibility of implementation into resource-constrained clinical settings. We recently developed a tablet-optimized, internet-facilitated BMI called Game Plan that was designed to help high-risk MSM in HIV testing clinics reduce their alcohol use and sexual risk (R347AA023478). Preliminary data shows that this intervention encourages non-treatment-seeking MSM to set drinking-related change goals and ultimately reduce their drinking in the months following intervention. The proposed research will support the development of a similar intervention, called Game Plan for PrEP, that is intended to help heavy drinking MSM on PrEP reduce heavy episodic drinking and adhere to/persist with PrEP. Specifically, we will (1) employ user-centered design methods to help design and develop a tablet-optimized, internet-facilitated intervention that addresses these goals by drawing on the perspectives of intended users, as well as existing alcohol BMIs and medication adherence interventions. We will also (2) conduct a small randomized-controlled pilot study exploring the intervention’s effects on biomarkers of alcohol use and PrEP adherence over a 6-month period. If results are supportive, this research will produce one of the first scalable brief interventions addressing alcohol use in the context of PrEP care. Future research can explore the intervention’s effects in a full-scale randomized control trial, as well as its mechanisms and approaches for boosting its effects on key outcomes.

项目总结/摘要 尽管近年来美国的艾滋病毒年度总发病率有所下降，但新感染率仍在上升。 感染率保持稳定，特别是在男男性行为者（MSM）中。每日一次的抗病毒药物 （恩曲他滨/替诺福韦）最近在美国被批准用于HIV暴露前预防 （PrEP），并可为实现艾滋病毒新发感染持续下降提供重要途径， 男男性接触者然而，其有效性取决于对药物的足够依从性和持久性。一个强大 文献表明，大量饮酒会破坏对用于艾滋病毒治疗的类似药物的依从性， 导致艾滋病毒感染者的进一步传播和更差的健康结果。我们正在进行的工作 显示，大量饮酒日更频繁地发生在PrEP依从性的失误期间，这足以 减少其有效性（漏服4天以上），而不是更一致的坚持，这表明 大量饮酒可能同样影响PrEP的依从性。荟萃分析显示， 帮助许多高危人群减少饮酒，坚持服用抗艾滋病毒药物 即使这些干预措施是通过计算机提供的。此外，一些更强大的 对这些结果的影响已被证明是基于跨理论模型的干预措施， 改变（TTM）或动机面试的启发（即，简短的动机干预（BMI）。 像这样的简短的、计算机提供的干预措施在可扩展性方面也有许多优势， 成本和在资源受限的临床环境中实施的可行性。我们最近开发了一个 平板电脑优化，互联网促进BMI称为游戏计划，旨在帮助艾滋病毒中的高风险MSM 检测诊所减少他们的酒精使用和性风险（R347 AA 023478）。初步数据显示， 干预鼓励非寻求治疗的MSM设定与饮酒相关的改变目标， 在干预后的几个月内减少饮酒。拟议的研究将支持开发 类似的干预措施，称为PrEP游戏计划，旨在帮助大量饮酒的MSM接受PrEP治疗。 减少重度间歇性饮酒，坚持/坚持PrEP。具体而言，我们将（1）采用以用户为中心的 设计方法，以帮助设计和开发平板电脑优化，互联网促进干预，解决 这些目标是通过借鉴预期用户的观点，以及现有的酒精BMI和药物 坚持干预。我们还将（2）进行一项小型随机对照试点研究，探索 干预对酒精使用和PrEP依从性的生物标志物的影响超过6个月。如果结果 支持，这项研究将产生第一个可扩展的简短干预措施之一，解决酒精使用的 PrEP护理的背景。未来的研究可以在全面的随机对照中探索干预的效果 试验，以及其机制和方法，以提高其对关键成果的影响。