Interventions to reduce alcohol use and increase adherence to TB preventive therapy among HIV/TB co-infected drinkers (DIPT 2/2)

减少艾滋病毒/结核病合并感染饮酒者饮酒并提高结核病预防治疗依从性的干预措施（DIPT 2/2）

• 批准号: 10242036
• 负责人: Gabriel Chamie
• 金额: $ 54.61万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-15 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10242036
• 关键词: Address; Adherence; Adult; Africa; Africa South of the Sahara; Alcohol consumption; Alcoholic beverage heavy drinker; Alcohols; Antibiotics; Antitubercular Agents; Behavior; Cause of Death; Cessation of life; Clinic; Clinical; Consumption; Control Groups; Counseling; Country; Data; Disease; Effectiveness; Event; Glucuronides; HIV; HIV/TB; Hair; Heavy Drinking; Hepatotoxicity; Heterogeneity; Hour; Incentives; Incidence; Income; Ingestion; Intervention; Life; Liver; Low income; Measurement; Measures; Mediator of activation protein; Monitor; Morbidity - disease rate; Participant; Patient Self-Report; Pattern; Persons; Pharmaceutical Preparations; Prevalence; Preventive therapy; Prize; Randomized; Regimen; Resources; Rewards; Risk; Safety; Sample Size; Sampling; Savings; System; Testing; Toxic effect; Tuberculosis; Uganda; Urine; Viral; Viral Load result; Visit; alcohol measurement; alcohol use disorder; antiretroviral therapy; arm; base; behavior test; cohort; cost; drinking; economic impact; economic incentive; effectiveness evaluation; high risk; high risk population; improved; incentive strategies; incentive-based intervention; isoniazid; low income country; medication safety; mortality; novel; phosphatidylethanol; pill; point of care; point of care testing; prevent; primary outcome; rapid test; reduced alcohol use; reduced substance use; therapy adherence; treatment arm; virology

ABSTRACT TB is the leading cause of death among persons with HIV worldwide. Globally, approximately 25% of persons with HIV are heavy drinkers, and heavy alcohol use is associated with a 3-fold higher risk of TB disease compared to no alcohol use, thus HIV-infected persons who drink alcohol are at high risk for TB. Six months of isoniazid (INH) preventive therapy (IPT) reduces TB incidence and mortality by 30-50% above the positive impact of antiretroviral therapy (ART). However, INH can be toxic to the liver, and thus many heavy alcohol users in resource-limited settings such as east Africa are not offered IPT. In addition, heavy alcohol users have poorer ART adherence and data suggest decreased IPT adherence as well. Thus interventions are needed to both decrease alcohol use and increase IPT adherence, and thereby reduce INH toxicity, TB morbidity and mortality in this high-risk population. The use of incentives to promote healthy behavior has been shown to be a highly effective approach for reducing substance use and for improving adherence to HIV and TB regimens in high-income countries. Reducing alcohol use may create a window for safe and effective IPT use by decreasing hepatotoxicity and increasing IPT adherence; however, additional interventions for IPT adherence may be needed. The use of incentives conditional on reduced alcohol use or increased INH adherence in resource-limited settings has been previously limited by the lack of reliable, rapid tests for these behaviors. Recent technological advances allow for point of care (POC) urine testing for recent alcohol use with an ethyl glucuronide (EtG) dipstick that is positive for 3 days after heavy drinking, and INH pill-taking using the IsoScreen urine test to test for 24-hour INH ingestion, thereby creating an opportunity to test incentive-based interventions during IPT among heavy drinkers. We propose leveraging two established cohorts of persons with HIV in Uganda for a randomized 2x2 factorial trial among HIV/TB co-infected adults with heavy alcohol use (n=800 persons. 400 each U01 cohort). Aim 1 is to determine whether economic incentives contingent on reduced alcohol use assessed by POC EtG tests conducted at INH refill visits reduces heavy alcohol use over six months of IPT compared to the control. Aim 2 is to determine whether economic incentives contingent on INH positive POC urine tests at these visits compared to the control increases IPT adherence over six months. Aim 3 is to examine the longer-term impact of the intervention on HIV virologic suppression, and examine mediators of an effect. Primary outcomes will be self-reported heavy alcohol use augmented by phosphatidylethanol (PEth) concentrations, and INH adherence, measured using medication event monitoring system (MEMS), with additional measurements of pill ingestion by INH levels in hair samples. Using incentive- based interventions to reduce alcohol use and increase medication safety in low-income settings is novel. This study to optimize IPT in HIV/TB co-infected drinkers will provide new information on low-cost strategies to reduce alcohol use and increase IPT adherence in low-income countries.

抽象的 结核病是全世界艾滋病毒患者中死亡的主要原因。全球，大约25％的人 艾滋病毒是大量饮酒者，大量饮酒与结核病疾病的风险更高3倍 与不使用酒精相比，饮酒的艾滋病毒感染者对结核病的风险很高。六个月 异念珠菌（INH）预防疗法（IPT）将结核病的发病率和死亡率降低了30-50％ 抗逆转录病毒疗法（ART）的影响。但是，INH可能对肝脏有毒，因此许多浓的酒精 没有提供在资源有限的设置（例如东非）的用户。此外，大量酒精使用者有 较差的艺术依从性和数据也表明IPT依从性也降低。因此需要干预措施 既降低酒精使用又会增加IPT依从性，从而降低INH毒性，结核病发病率和 这个高风险人口的死亡率。使用激励措施促进健康行为已被证明是 一种高效的方法，用于减少物质使用和改善对艾滋病毒和结核病方案的依从性 在高收入国家。减少饮酒可能会创建一个窗口，以安全有效地使用 降低肝毒性并增加IPT依从性；但是，IPT依从性的其他干预措施 可能需要。通过减少酒精使用或增加依从性的激励措施的使用 以前，由于缺乏对这些行为的可靠，快速测试，资源有限的设置已受到限制。 最近的技术进步允许进行护理点（POC）尿液测试，以供乙基用乙基饮酒 大量饮用后3天阳性的葡萄糖醛酸（ETG）量油含量 等尿液测试以测试24小时INH摄入，从而创造了一个基于激励的机会 在体重饮酒者中，IPT中的干预措施。我们建议利用两个成熟的人 在乌干达与HIV/TB共同感染的大量酒精的艾滋病毒进行随机2x2阶乘试验 使用（n = 800人。每个U01队列400人）。目的1是确定是否取决于 通过INH补充访问进行的POC ETG测试评估的饮酒减少可减少大量的酒精使用 与对照相比，IPT六个月。目标2是确定是否取决于 与对照相比，INH阳性POC尿液测试在六个月内增加了IPT的依从性。 目标3是检查干预对HIV病毒学抑制的长期影响，并检查 效果的介体。主要结果将是自我报告的大量饮酒增加 使用药物事件监测测量的磷脂酰乙醇（Peth）浓度和INH依从性 系统（MEMS），通过头发样品中INH水平摄入药丸的其他测量。使用激励 - 在低收入环境中，基于减少酒精使用并提高药物安全性的干预措施是新颖的。这 研究以优化艾滋病毒/结核病联合感染者IPT的研究将提供有关低成本策略的新信息 在低收入国家中减少酒精使用并增加IPT依从性。

项目成果

Concordance Between Point-of-Care Urine Ethyl Glucuronide Alcohol Tests and Self-Reported Alcohol Use in Persons with HIV in Uganda.

• DOI: 10.1007/s10461-022-03597-6
• 发表时间: 2022-08
• 期刊: AIDS AND BEHAVIOR
• 影响因子: 4.4
• 作者: Alcover, Karl C.;Emenyonu, Nneka, I;Fatch, Robin;Kekibiina, Allen;Marson, Kara;Chamie, Gabriel;Muyindike, Winnie R.;Beesiga, Brian;Kamya, Moses R.;Lodi, Sara;Kane, Jeremy C.;Hahn, Judith A.;McDonell, Michael G.
• 通讯作者: McDonell, Michael G.