Alcohol Misuse, Gut Microbial Dysbiosis and PrEP Care Continuum: Application and Efficacy of SBIRT Intervention

酒精滥用、肠道微生物失调和 PrEP 护理连续体：SBIRT 干预的应用和功效

• 批准号: 10542284
• 负责人: SHIRISH S BARVE
• 金额: $ 70.28万
• 依托单位: UNIVERSITY OF LOUISVILLE
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-10 至 2027-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10542284
• 关键词: AIDS prevention; Address; Adherence; Adverse event; Affect; Alcohol abuse; Alcohol consumption; Alcohols; Ambulatory Care Facilities; Behavioral; Biological; Caring; Clinic; Clinical; Clinical Research; Continuity of Patient Care; Data; Data Collection; Decision Making; Early Intervention; Early treatment; Effectiveness; Event; Exhibits; Feedback; Goals; HIV; HIV Seronegativity; Health; Healthcare; Individual; Injury to Kidney; Internal Medicine; Intervention; Interview; Intestinal permeability; Kidney Diseases; Liver diseases; Longitudinal Studies; Longitudinal cohort study; Maintenance; Movement; Nausea and Vomiting; Outcome; Participant; Pathogenicity; Pattern; Persons; Pharmaceutical Preparations; Population; Process; Public Health; Qualitative Methods; Randomized; Randomized Controlled Trials; Reaction; Regimen; Research; Research Personnel; Risk; Structure; Subgroup; Time; Treatment Effectiveness; Triage; Universities; alcohol measurement; alcohol misuse; alcohol risk; appetite loss; attenuation; dysbiosis; effectiveness testing; enteric dysbiosis; experience; gastrointestinal; gut dysbiosis; gut microbiome; gut-liver axis; inflammatory marker; intestinal homeostasis; liver function; liver injury; microbial; microbial community; pre-exposure prophylaxis; prevent; recruit; reduced alcohol use; research study; screening; screening, brief intervention, referral, and treatment; side effect; systemic inflammatory response; transmission process; treatment as usual; treatment program; uptake

Pre-exposure prophylaxis (PrEP), a medication regimen to reduce HIV transmission risk among HIV negative individuals, has utility in helping to reach national HIV prevention goals. However, clinical side effects, particularly those impacting gastrointestinal (GI) (nausea, vomiting, loss of appetite), hepatic and renal injury outcomes may inhibit PrEP persistence. Importantly, alcohol use which is frequent in PrEP users may interact with PrEP and exacerbate PrEP-associated adverse GI effects and consequently affect PrEP persistence. Recent data implicates that these side effects are likely associated with changes in the gut microbiome (dysbiosis). Despite the important ramifications that PrEP, alcohol, and their combined use may have on the gut dysbiosis and subsequent PrEP continuance, there is little research to elucidate this interaction and few attempts to address it. Moreover, there is little research exploring decision-making processes regarding alcohol and PrEP utilization and adherence among PrEP users. To address these gaps in research, this study will employ the following aims. Aim 1: Qualitatively explore mechanisms by which alcohol use impacts movement through the PrEP continuum and understand how an early intervention and treatment approach impacts alcohol use and PrEP adherence. Aim 2: Investigate the effectiveness of the SBIRT intervention in preventing hazardous alcohol use and its impact on gut dysbiosis in PrEP users. Within this longitudinal cohort study, we will identify alcohol impacted participants, with patterns of use ranging from episodic to long-term (engaging in risky or hazardous use). Aim 3: To determine alterations in the gut microbiome (dysbiosis), intestinal homeostasis, systemic inflammation, and markers of liver disease associated with hazardous alcohol use among PrEP users. Recruiting from local PrEP clinics, we will determine alterations in the gut microbiome, intestinal homeostasis, systemic inflammation and markers of liver disease associated with alcohol and PrEP use. We will also execute a randomized control trial among PrEP users demonstrating heightened alcohol use to test the effectiveness of the Screening, Brief Intervention, & Referral to Treatment (SBIRT) intervention to reduce alcohol use and examine subsequent impact on the gut microbiome compared to individuals receiving treatment as usual and PrEP users not demonstrating elevated alcohol use. Finally, we will employ qualitative methods (in-depth interviews) and analysis to understand decision-making factors influencing PrEP adherence and alcohol use over time. Priority populations, including those engaging in alcohol use, need to increase engagement in the PrEP Care Continuum to optimize HIV prevention. Clinical research has yet to focus on interactions between PrEP, alcohol use and GI adverse events. This study may have important implications for mitigating a salient challenge to PrEP adherence and persistence (side-effects) and elucidating, from clinical and public health standpoints, factors promoting maintenance in the PrEP care continuum.

暴露前预防（PREP），一种药物治疗方案，可降低HIV阴性的HIV传播风险 个人有帮助实现国家艾滋病毒预防目标的实用性。但是，临床副作用， 特别是那些影响胃肠道（GI）（恶心，呕吐，食欲不振），肝和肾脏损伤的人 结果可能会抑制准备持久性。重要的是，准备用户经常使用的饮酒可能会互动 随着预备和加剧预科相关的不良GI效应，因此会影响持久性。 最近的数据暗示这些副作用可能与肠道微生物组的变化有关 （营养不良）。尽管有重要的后果，但可以做好准备，酒精及其联合用途可能会在 肠道营养不良和随后的准备连续性，几乎没有研究来阐明这种相互作用，很少 试图解决它。而且，很少有研究探讨有关酒精的决策过程 以及准备用户的准备利用率和依从性。为了解决研究中的这些差距，这项研究将 采用以下目标。目标1：定性探索酒精使用影响的机制 通过准备连续体运动，了解早期干预和治疗方式 方法会影响酒精使用和准备依从性。目标2：调查SBIRT的有效性 干预预防危险饮酒及其对准备使用者对肠道营养不良的影响。之内 这项纵向队列研究，我们将通过使用模式来确定受酒精影响的参与者 从情节到长期（从事风险或危险使用）。目标3：确定 肠道微生物组（营养不良），肠内稳态，全身炎症和 肝病的标志物与预备使用者之间的危险性饮酒有关。从当地人招募 预科诊所，我们将确定肠道微生物组，肠内稳态，全身炎症的改变 和与酒精和预先使用有关的肝病标记。我们还将执行一个随机控件 预备用户的试验证明酒精使用量增加以测试筛查的有效性，简短 干预措施，并转介治疗（SBIRT）干预措施以减少饮酒并检查随后 与像往常一样接受治疗的人相比，对肠道微生物组的影响和准备用户不 证明饮酒升高。最后，我们将采用定性方法（深入访谈）和 分析以了解影响准备依从性和随着时间的饮酒的决策因素。优先事项 人口，包括从事酒精使用的人群，需要增加参与预备护理的参与度 连续性以优化预防HIV。临床研究尚未关注PREP之间的相互作用， 酒精使用和胃肠道不良事件。这项研究可能对缓解显着性具有重要意义 挑战临床和公众的准备依从性和持久性（副作用）和阐明 健康的角度，促进预科护理连续体维护的因素。