Drinkers' Intervention to Prevent Tuberculosis (DIPT Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 680
- 试验地点
- 2
- 主要终点
- Number of Participants With and Without Non-hazardous Drinking, as Determined by Self-report and the Biomarker Phosphatidylethanol, at 3- and 6-months.
研究概览
简要总结
There is an urgent global need to decrease the high mortality of tuberculosis (TB) in persons with HIV as TB is the leading cause of death among persons with HIV worldwide. The DIPT (Drinkers' Intervention to Prevent TB) study is a randomized, 2x2 factorial trial among HIV/TB co-infected adults in Uganda with heavy alcohol use (n=680 persons, 340 each U01). The goal of the study is to determine whether economic incentive interventions can promote both reduced alcohol use and isoniazid (INH) pill taking among HIV/TB co-infected adult heavy drinkers, during isoniazid preventive therapy (IPT: a six-month course of INH) at HIV clinics in southwestern Uganda. Participants will be randomized to one of four arms: Arm 1: no incentives (control); Arm 2: economic incentives for decreasing alcohol use only; Arm 3: economic incentives for IPT adherence only; Arm 4: economic incentives for decreasing alcohol use and for IPT adherence (rewarded independently).
详细描述
TB is the leading cause of death among persons with HIV worldwide, and HIV-infected drinkers are at very high risk for TB disease and mortality. Globally, an estimated 25% of persons with HIV are heavy drinkers, and the risk of TB disease is 3-fold higher among heavy drinkers compared to non-drinkers. Six months of isoniazid (INH) preventive therapy (IPT) reduces TB morbidity and mortality by 30-50% above the benefit of antiretroviral therapy (ART). However, INH can be toxic to the liver, and as a result in many high TB/HIV prevalence settings, such as east Africa, heavy drinkers are not offered IPT. Thus interventions to reduce alcohol use are needed to decrease INH toxicity during IPT among HIV/TB infected drinkers. It is also well established that heavy drinkers have poorer ART adherence, and there is growing evidence of reduced IPT adherence in drinkers. However, interventions to reduce drinking have had limited impact on ART adherence, and further interventions to increase IPT adherence among HIV/TB infected drinkers are likely needed.
The use of incentives to promote healthy behavior is a highly effective approach for reducing substance use and for improving adherence to HIV and TB regimens in resource-rich settings. Economic incentives to reduce alcohol use may create a window for safe and effective IPT use over six months by decreasing hepatotoxicity. Decreases in alcohol use may also improve IPT adherence, or additional incentives for IPT adherence may be needed. Such strategies to reduce alcohol use have not been studied in low-income countries and the effectiveness of incentives to optimize IPT in HIV/TB co-infected drinkers is unknown.
OBJECTIVES
Aim 1: Alcohol Reduction Intervention: Determine the effectiveness of economic incentives contingent on point-of-care (POC) urine ethyl glucuronide (EtG) <300 ng/mL (Arms 2 & 4) versus no alcohol incentives (Arms 1 & 3) to reduce heavy drinking over 6 months, among HIV/TB co-infected adult drinkers receiving IPT. The investigators will randomize participants to low-cost escalating prize incentives for EtG negative urine tests at IPT refill visits (Arms 2+4), versus no incentives (Arms 1+3).
Aim 2: INH Adherence Intervention: Determine the effectiveness of economic incentives contingent on POC (IsoScreen) INH urine positive tests (Arms 3 & 4) versus no INH incentives (Arms 1 & 2) on INH adherence among HIV/TB co-infected adult drinkers. The investigators will randomize participants to low-cost escalating prize incentives for INH positive urine tests at IPT refill visits (Arms 3+4), versus no incentives (Arms 1+2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-infected adult (≥18 years) prescribed antiretroviral therapy (ART) for at least 6 months;
- •Current heavy alcohol use (AUDIT-C positive for prior 3 month drinking and positive EtG urine test);
- •Positive tuberculin skin test (TST) (≥5 mm induration);
- •AST and ALT <2x the upper limit of normal (ULN);
- •Fluent in Runyankole or English;
- •No history of active TB, TB treatment, or TB preventive therapy;
- •Lives within 2-hour travel time or 60 km of the study site.
排除标准
- •Prescribed nevirapine (NVP, an ART drug that is declining in usage due to high risk for hepatotoxicity);
- •Plans to move out of the catchment area within 6 months;
- •Prescribed anti-convulsion medications or history of recurring seizures;
- •ALT or AST elevations (>2X ULN);
- •Suspected or confirmed active TB as determined by symptom screening and followed by chest X-ray and sputum testing;
- •History of prior active TB treatment or prior IPT.
- •Pregnant at time of screening
结局指标
主要结局
Number of Participants With and Without Non-hazardous Drinking, as Determined by Self-report and the Biomarker Phosphatidylethanol, at 3- and 6-months.
时间窗: Both 3 months and 6 months (composite measure)
Non-hazardous drinking is a composite outcome, measured at both 3 and 6 months. An individual must meet criteria for non-hazardous drinking (Alcohol Use Disorders Identification Test - Consumption \[AUDIT-C\], prior 3 months, negative) and phosphatidylethanol (PEth) \<35 ng/mL) at both time-points (3- and 6-months) in order to achieve the outcome.
Number of Participants With >90% Isoniazid (INH) Adherence During Prescribed Course of INH
时间窗: 6 months
Isoniazid (INH) adherence percentage is defined as the number of days with \>0 pill bottle openings divided by the number of prescribed doses, times 100. Pill bottle openings are captured by the Medication Event Monitoring System (MEMS) pill cap, with no more than 1 opening per day counted. The INH adherence outcome is INH adherence percentage, dichotomized as \>90% versus \<= 90%.
次要结局
- Number of Participants With and Without HIV Viral Suppression at 12 Months(12 months)
- Number of Participants With Hepatotoxicity Resulting in Isoniazid (INH) Discontinuation.(up to 9 months)
- INH Concentration in Hair(3 and 6 months)
- Number of Participants With Active Tuberculosis (TB).(12 months)