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: 10705221
• 负责人: VIVIAN F. GO
• 金额: $ 59.05万
• 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/10705221
• 关键词: Active Learning; Address; Alcohol consumption; Alcohols; Attitude; Behavior; Characteristics; Classification; 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; Recommendation; Reporting; Resources; Risk; Staff Attitudes; Training; Translating; Uncertainty; Vietnam; Vietnamese; Viral; Virus; Work; alcohol abuse therapy; alcohol intervention; alcohol measurement; alcohol misuse; alcohol use disorder; antiretroviral therapy; arm; brief alcohol intervention; cohort; cost; drinking; effective intervention; effectiveness outcome; expectation; experience; flexibility; implementation barriers; implementation intervention; implementation outcomes; implementation strategy; implementation trial; improved; intervention delivery; motivational enhancement therapy; novel; optimism; 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; viral transmission

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.

项目摘要 全球超过25%的艾滋病毒感染者（PWH）报告不健康的酒精使用，定义为使用范围 风险/危险（每天、每周或每次饮酒超过推荐量，导致 增加健康后果的风险）到酒精使用障碍。不健康饮酒的PWH可能不会 坚持抗逆转录病毒治疗（ART），导致病毒未受抑制，增加了感染艾滋病毒的可能性 传播给性伴侣和注射伴侣。需要采取干预措施，解决PWH中的酒精使用问题 防止艾滋病传播。我们以前曾表明，短暂的酒精干预（BAI）是有效的， 在越南减少酒精使用和增加病毒抑制。BAI已经准备好扩大规模，但有一个障碍 扩大规模是临床工作人员对酒精干预的态度，特别是在规范的地区， 不健康的饮酒解决临床工作人员的态度可能是必不可少的规模扩大。我们提出了一种混合 3型，整群随机实施试验，以检查在ART中扩大BAI的有效策略 越南的诊所其中一个部门将只得到实施BAI的便利。便利化是一种灵活的策略 帮助诊所解决常见的障碍，如咨询师技能、竞争优先事项和资源 赤字在另一个手臂，除了促进，诊所工作人员，无论他们自己的酒精使用，将 提供BAI本身作为经验学习，以解决他们自己与酒精有关的态度， 行为。我们假设，EBAI，加上促进，将增加BAI的保真度，可接受性， 在诊所层面的渗透，并改善病毒抑制与不健康的酒精使用的威尔斯亲王医院。我们 具体的目标是：1）比较BAI实施使用促进（FAC），只有经验BAI加 促进（EBAI+FAC）在越南的ART诊所; 2）探索成功的BAI规模扩大的机制， FAC和EBAI+FAC组;以及3）测量EBAI对诊所工作人员的影响。ART诊所（n=30） 将在越南各地随机接受FAC或EBAI+FAC。诊所内的威尔斯亲王医院会接受检查， 不健康的酒精使用与AUDIT-C;如果积极的，他们将提供BAI。主要实现 结果是临床水平的BAI保真度（主要），次要结果是可接受性、渗透性和 成本有效性结果是病毒抑制（主要）和酒精使用（次要）， 在每间诊所招募的威尔斯亲王医院的一个队列中。将在3个月时衡量成果（实施 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 成功扩大BAI规模的组织和诊所工作人员特征。鉴于必须 在BAI实施的诊所工作人员中，我们也将探讨BAI对自身酒精相关的影响 态度和使用，并考虑他们是否收到BAI本身或没有。这次审判将呈现 作为预防工作的全球艾滋病毒治疗的重要信息，为有效扩大规模提供战略 在有不健康饮酒行为的威尔斯亲王医院中，