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: 10701829
• 负责人: SHIRISH S BARVE
• 金额: $ 69.01万
• 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/10701829
• 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; 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; Testing; Time; Treatment Effectiveness; Triage; Universities; Vomiting; alcohol measurement; alcohol misuse; alcohol risk reduction; appetite loss; attenuation; dysbiosis; effectiveness testing; efficacy evaluation; enteric dysbiosis; experience; gastrointestinal; gut dysbiosis; gut microbiome; gut-liver axis; improved; intestinal homeostasis; liver function; liver injury; microbial; microbial community; pre-exposure prophylaxis; prevent; recruit; reduced alcohol use; 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)，一种降低艾滋病毒阴性者艾滋病毒传播风险的药物方案 在帮助实现国家艾滋病毒预防目标方面有用处。然而，临床副作用， 尤其是影响胃肠道(GI)(恶心、呕吐、食欲不振)、肝和肾损伤 结果可能会抑制PrEP的持久性。重要的是，PrEP使用者中经常使用的酒精可能会相互作用 并加重PrEP相关的不良胃肠道反应，从而影响PrEP的持久性。 最近的数据表明，这些副作用很可能与肠道微生物群的变化有关 (生态失调)。尽管PrEP、酒精及其联合使用可能会对 肠道生物失调和随后的PrEP持续，几乎没有研究来阐明这种相互作用 试图解决这个问题。此外，很少有研究探讨与酒精有关的决策过程 以及PrEP用户对PrEP的利用率和依从性。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：定性地探索酒精使用影响的机制 通过PrEP连续体的运动并了解早期干预和治疗 方法影响酒精使用和PrEP的遵守。目的2：调查SBIRT的有效性 预防危险酒精使用的干预措施及其对PrEP使用者肠道生物失调的影响。在 在这项纵向队列研究中，我们将确定受酒精影响的参与者，以及使用模式 从间歇性到长期(从事危险或危险使用)不等。目标3：确定 肠道微生物群的改变(生物失调)，肠道内环境平衡，全身炎症，以及 PrEP使用者中与危险酒精使用相关的肝病标记物。从当地人那里招聘 预科诊所，我们将确定肠道微生物群的变化，肠道内环境平衡，全身炎症 以及与酒精和PrEP使用相关的肝病标志物。我们还将进行随机对照 在PrEP使用者中进行的试验表明酒精使用量增加以测试筛查的有效性，Brief 减少酒精使用的干预和转诊治疗(SBIRT)干预并检查随后的 与正常接受治疗和PrEP使用者不接受治疗相比，对肠道微生物群的影响 显示酒精使用量升高。最后，我们将采用定性的方法(深度访谈)和 分析以了解影响PrEP依从性和随时间饮酒的决策因素。优先性 包括饮酒者在内的人群需要更多地参与PrEP护理 优化艾滋病毒预防的连续体。临床研究尚未将重点放在PrEP和PEP之间的相互作用上。 酒精使用和胃肠道不良事件。这项研究可能对缓解显著的 临床和公众对PrEP坚持和坚持(副作用)和阐明的挑战 健康观点，促进PrEP护理连续体中维持的因素。

项目成果

A conceptual analysis of SBIRT implementation alongside the continuum of PrEP awareness: domains of fit and feasibility.

• DOI: 10.3389/fpubh.2023.1310388
• 发表时间: 2023
• 期刊: FRONTIERS IN PUBLIC HEALTH
• 影响因子: 5.2
• 作者: Harris, Lesley M.;Kerr, Jelani C.;Skidmore, Blake D.;Ghare, Smita;Reyes-Vega, Andrea;Remenik-Zarauz, Vania;Samanapally, Harideep;Anwar, Rana Usman;Rijal, Rishikesh;Bryant, Kendall;Hall, Martin T.;Barve, Shirish
• 通讯作者: Barve, Shirish