Study Protocol for a Non-inferiority Trial of Electronic Versus Face-to-face Brief Intervention Following Alcohol Screening in Zacatecas, Mexico and Alexandra Township, South Africa
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- HBSA
- 入组人数
- 1,200
- 试验地点
- 4
- 主要终点
- Average daily quantity X frequency within last 30 days
研究概览
简要总结
The goal of this clinical trial is to compare two different strategies to deliver brief interventions to people whose scores on the Alcohol Use Disorders Identification Test (AUDIT) suggest that their level of alcohol use may be unhealthy. Brief interventions typically seek to increase the awareness of people whose alcohol use may be unhealthy of the extent and potential adverse consequences of their substance use, and then to provide guidance and motivate them to reduce their consumption. Due to limitations in the use of traditional brief interventions delivered face-to-face by health care providers, applications have been developed to support the electronic delivery of brief interventions. The main question posed in this study is: Is an electronic brief intervention (eBI) delivered via an app on a handheld device at least as effective in reducing alcohol consumption as a traditional in-person brief intervention delivered by a facilitator, who is a trained health educator? We expect that eBI will not be significantly less effective than face-to-face brief intervention.
To test the efficacy of eBI compared to traditional in-person brief intervention, researchers will compare changes in average 30-day quantity and frequency of drinking alcohol, AUDIT scores, and in several additional measures of outcomes related to risky or hazardous alcohol use between participants who received an eBI and those who received a face-to-face brief intervention. In this non-inferiority trial, the intervention (i.e., electronic brief intervention via an app) will be considered effective if it yields reductions in participants' risky or hazardous alcohol use that are no less than those produced by the comparison condition (i.e., a traditional brief intervention through an in-person interaction).
Participants will:
- be invited to complete an alcohol screening using the AUDIT
- be invited to be in a study of alcohol use patterns over time if they have an AUDIT score of 8 or higher
- take a brief survey with demographic and additional recent alcohol use questions
- receive either an eBI or an in-person brief intervention
- complete two additional surveys at 3- and 6-month intervals after the first survey to collect information on alcohol use over time
详细描述
Background and Study Purpose
As is well-documented by the World Health Organization (WHO), alcohol abuse remains a major health hazard worldwide, responsible for 5.3 percent of all deaths annually. It also contributes to over 200 conditions related to disease and injury, which include an array of behavioral and mental health disorders. There is now a substantial body of literature suggesting the effectiveness of Screening and Brief Intervention (SBI) as a strategy to identify people at high risk for alcohol use disorder, and to invite them, within the context of a short motivational interview, to reflect on their drinking patterns and develop a realistic and achievable plan to reduce their consumption. The screening component of SBI typically relies on the Alcohol Use Disorders Identification Test (AUDIT), which comprises two parts. The first is a 3-item assessment (the AUDIT-C); individuals who score 8 or higher are then invited to: (1) respond to 7 additional questions about their alcohol consumption (the AUDIT-7) and (2) participate in a brief intervention that is typically conducted by their primary health care provider or a staff member.
There are a variety of reasons, however, why brief interventions may fail to fulfill expectations of their positive effects. Eligible participants may be reluctant to engage fully in brief interventions because of the stigma attached to doing so; and primary health care providers may lack the time, attention, and confidence in their ability to conduct the brief intervention, or delegate responsibility for its administration to staff members who are insufficiently trained to deliver the intervention as intended, which includes establishing a sufficient rapport with the participant.
Consideration has thus been given to strategies to automate the delivery of brief interventions so that they can be self-administered electronically. Prototypes of this delivery mechanism are under development, and are sufficiently far advanced that they warrant investigations of their effectiveness. The key research question to be addressed by this study is:
• Are brief interventions, as electronically self-administered via an app on handheld devices, at least as effective in reducing the 30-day quantity and frequency of alcohol consumption as brief interventions administered in person by health care providers?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 and above
- •AUDIT screening score of 8 or more
排除标准
- •Having been screened for alcohol use within the past 6 months
结局指标
主要结局
Average daily quantity X frequency within last 30 days
时间窗: 3 months and 6 months
In the past 30 days, on how many days did you have a whole drink, more than a sip or taste, of any alcoholic beverage? In the past 30 days, on the days when you drank alcohol, about how many whole drinks did you typically have?
Average daily quantity X frequency within last 30 days
时间窗: 3 months and 6 months
In the past 30 days, on how many days did you have a whole drink, more than a sip or taste, of any alcoholic beverage? In the past 30 days, on the days when you drank alcohol, about how many whole drinks did you typically have?
次要结局
- Maximum quantity x frequency within last 30 days(3 months and 6 months)
- 30-day frequency of 6+ drinks(3 months and 6 months)
- Past 3 months total 10-item AUDIT score(3 months and 6 months)
- Maximum quantity x frequency within last 30 days(3 months and 6 months)
- 30-day frequency of 6+ drinks(3 months and 6 months)
- Past 3 months total 10-item AUDIT score(3 months and 6 months)