Scaling up the brief alcohol intervention to prevent HIV infection in Vietnam: a cluster randomized, implementation trial

在越南扩大短期酒精干预措施以预防艾滋病毒感染：一项整群随机实施试验

• 批准号: 10542098
• 负责人: VIVIAN F. GO
• 金额: $ 63.86万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-15 至 2027-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10542098
• 关键词: Active Learning; Address; Alcohol consumption; Alcohols; Attitude; Behavior; Characteristics; Clinic; Clinical; Cognitive Therapy; Consent; Counseling; Effectiveness; Ensure; General Population; HIV; HIV Infections; Happiness; Health; Health Personnel; High Prevalence; Hybrids; Impairment; Incidence; Injections; Intervention; Measures; Mediating; Methods; Nurses; Outcome; Pathway interactions; Penetration; Persons; Physicians; Positioning Attribute; Professional counselor; Randomized; Randomized Controlled Trials; Readiness; Reporting; Resources; Risk; Staff Attitudes; Training; Translating; Uncertainty; Vietnam; Viral; Virus; Work; alcohol abuse therapy; alcohol intervention; alcohol measurement; alcohol misuse; alcohol use disorder; antiretroviral therapy; arm; base; brief alcohol intervention; cohort; cost; drinking; effective intervention; effectiveness outcome; expectation; experience; flexibility; hazardous drinking; implementation barriers; implementation intervention; implementation outcomes; implementation strategy; implementation trial; improved; intervention delivery; motivational enhancement therapy; novel; organizational climate; prevent; recruit; reduced alcohol use; scale up; secondary outcome; skills; social; social expectations; standard of care; therapy adherence; tool; transmission process; treatment as prevention; trial comparing; uptake

PROJECT SUMMARY More than 25% of people with HIV (PWH) globally report unhealthy alcohol use, defined as a spectrum of use from risky/hazardous (drinking more than the recommended daily, weekly or per-occasion amounts resulting in increased risk for health consequences) to alcohol use disorder. PWH with unhealthy alcohol use may not adhere to their antiretroviral therapy (ART), leading to unsuppressed virus and increasing the potential for HIV transmission to sexual and injection partners. Interventions that address alcohol use among PWH are needed to prevent HIV transmission. We previously showed that the brief alcohol intervention (BAI) is effective at reducing alcohol use and increasing viral suppression in Vietnam. The BAI is ready for scale-up but one barrier to scale-up is attitudes towards alcohol interventions among clinical staff, especially in regions with normative unhealthy alcohol use. Addressing clinical staff attitudes may be essential for scale-up. We propose a hybrid type 3, cluster randomized implementation trial to examine effective strategies to scale up the BAI in ART clinics in Vietnam. One arm will receive only facilitation for BAI implementation. Facilitation is a flexible strategy that helps clinics to address common barriers, such as counselor skills, competing priorities, and resource deficits. In the other arm, in addition to facilitation, clinic staff, irrespective of their own alcohol use, will be offered the BAI themselves as experiential learning to address their own alcohol-related attitudes and behaviors. We hypothesize that EBAI, added to facilitation, will increase BAI fidelity, acceptability, and penetration at the clinic level, and improve viral suppression among PWH with unhealthy alcohol use. Our specific aims are to: 1) Compare BAI implementation using facilitation (FAC) only to experiential BAI plus facilitation (EBAI+FAC) in ART clinics in Vietnam; 2) Explore the mechanisms of successful BAI scale up in both the FAC and EBAI+FAC arms; and 3) Measure the impact of EBAI on clinic staff. ART clinics (n=30) across Vietnam will be randomized to receive FAC or EBAI+FAC. PWH in the clinics will be screened for unhealthy alcohol use with the AUDIT-C; if positive, they will be offered the BAI. The primary implementation outcomes are clinic-level BAI fidelity (primary), with secondary outcomes of acceptability, penetration, and cost. The effectiveness outcomes are viral suppression (primary) and alcohol use (secondary), measured among a cohort of PWH recruited in each clinic. Outcomes will be measured at 3 months (implementation outcomes only) and 12 months (all outcomes). In parallel with the trial, we will use mixed methods to examine the organizational and clinic staff characteristics that underly successful BAI scale-up. Given the importance of the clinic staff in the BAI implementation, we will also explore the impact of the BAI on their own alcohol-related attitudes and use and considering whether they received the BAI themselves or not. This trial will present critical information for worldwide HIV treatment as prevention efforts, providing strategies for effective scale-up of the BAI among PWH with unhealthy alcohol use.

项目总结 全球超过25%的艾滋病毒携带者(PWH)报告称使用了不健康的酒精，这被定义为一种使用范围 远离危险/危险(饮酒量超过建议的每日、每周或每次饮酒量，导致 增加健康后果的风险)酒精使用障碍。使用不健康酒精的威尔斯亲王医院可能不会 坚持他们的抗逆转录病毒疗法(ART)，导致病毒未被抑制，并增加艾滋病毒的可能性 传播给性伴侣和注射伴侣。有必要对威斯康星医院的饮酒问题进行干预 以防止艾滋病毒的传播。我们之前已经证明，短暂的酒精干预(BAI)对 在越南减少酒精使用和加强病毒抑制。BAI已经做好了扩大规模的准备，但有一个障碍 扩大是临床工作人员对酒精干预的态度，特别是在规范的地区 不健康的饮酒行为。解决临床工作人员的态度可能是扩大规模的关键。我们提出了一种混合动力 类型3，分组随机实施试验，以检查扩大ART中BAI的有效策略 越南的诊所。其中一个ARM将只为BAI的实施提供便利。便利化是一种灵活的战略 这有助于诊所解决常见的障碍，如咨询人员技能、相互竞争的优先事项和资源 赤字。在另一个部门，除了促进，诊所工作人员，无论他们自己饮酒，将被 为白族人提供了经验学习，以解决他们自己与酒精相关的态度和 行为。我们假设，在促进的基础上，eBAI将提高BAI的保真度、可接受性和 在临床层面上渗透，并改善不健康饮酒的PWH患者的病毒抑制。我们的 具体目标是：1)仅将使用促进的BAI实施(FAC)与体验式BAI Plus进行比较 促进(EBAI+FAC)在越南ART临床中的应用；2)探索BAI在越南成功推广的机制 FAC和EBAI+FAC两个分支；以及3)衡量EBAI对诊所工作人员的影响。ART诊所(n=30) 越南各地将随机接受FAC或EBAI+FAC。将对诊所的威尔斯亲王医院进行筛查 不健康的酒精使用与审计-C；如果是积极的，他们将提供BAI。主要实施 结果是临床水平的BAI保真度(主要)，次要结果是可接受性、渗透率和 成本。有效性结果是衡量的病毒抑制(主要)和饮酒(次要) 在每个诊所招募的PWH队列中。将在3个月内衡量结果(执行 仅限结果)和12个月(所有结果)。在审判的同时，我们将使用混合方法来检查 组织和诊所员工的特点，认为BAI扩容不成功。鉴于……的重要性 该诊所的工作人员在白酒的实施中，我们还将探讨白酒对自身酒精的影响 态度和用途，并考虑到他们自己是否收到了白皮书。这场审判将呈现 作为预防工作的全球艾滋病毒治疗的关键信息，为有效扩大规模提供战略 在不健康饮酒的威尔斯亲王中，白种人的比例较高。