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.

项目概要/摘要 尽管近年来美国的艾滋病毒年发病率总体有所下降，但新发艾滋病毒感染率 感染保持稳定，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艾滋病毒暴露前预防 （PrEP），并且可以为实现新发艾滋病毒感染持续下降提供重要途径 然而，其有效性取决于药物的充分依从性和持久性。 文献表明，在用于艾滋病毒治疗时，大量饮酒会破坏对类似药物的依从性， 导致艾滋病毒感染者的进一步传播和健康状况恶化。 研究表明，在 PrEP 依从性下降期间，酗酒日的发生频率更高，足以导致 与坚持更一致的时期相比，其有效性降低（漏服 4 天以上），表明 大量饮酒可能同样会影响 PrEP 的依从性。荟萃分析表明，简短的干预措施可以。 帮助许多高危人群减少饮酒并坚持服用治疗艾滋病毒的抗病毒药物 治疗，即使这些干预措施是通过计算机进行的。 基于跨理论模型的干预措施对这些结果的影响已得到证实 变革 (TTM) 或受到动机访谈（即简短的动机干预 [BMI]）的启发。 像这样的简短的、由计算机提供的干预措施在可扩展性方面也具有许多优势， 我们最近开发了一种在资源有限的临床环境中实施的成本和可行性。 平板电脑优化、互联网辅助的 BMI 称为“游戏计划”，旨在帮助感染艾滋病毒的高危男男性行为者 测试诊所减少了他们的饮酒和性风险（R347AA023478）。 干预鼓励非寻求治疗的男男性行为者设定与饮酒相关的改变目标，并最终 在干预后的几个月内减少饮酒。拟议的研究将支持这一发展。 类似的干预措施，称为 PrEP 游戏计划，旨在帮助酗酒的 MSM 进行 PrEP 减少间歇性大量饮酒并坚持/坚持 PrEP 具体而言，我们将 (1) 采用以用户为中心的做法。 设计方法，帮助设计和开发针对平板电脑优化的、互联网辅助的干预措施，以解决 这些目标通过借鉴目标用户的观点以及现有的酒精 BMI 和药物来实现 我们还将 (2) 进行一项小型随机对照试点研究，探索 如果结果是，干预措施对 6 个月内饮酒和 PrEP 依从性的生物标志物的影响。 这项研究将产生第一个可扩展的简短干预措施，解决酒精使用问题 未来的研究可以在全面随机对照中探索干预措施的效果。 试验及其增强其对关键结果影响的机制和方法。