The Computer-based Drug and Alcohol Training Assessment in Kenya
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,212
- 试验地点
- 10
- 主要终点
- Mean Difference in alcohol consumption
研究概览
简要总结
The purpose of the two RCT registered here is to determine whether clinicians trained on the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)-linked brief intervention (BI) through the NextGenU.org model of training are able to deliver effective brief intervention for risky level of alcohol use. It is one study part of a larger program of research.
The investigators hypothesize that the NextGenU.org model of online training with mentor and peer activities is an effective way to train clinicians to deliver the ASSIST-linked brief intervention. The investigators hypothesize that eligible participants receiving the brief intervention will decrease their alcohol consumption and experienced improved health and social outcomes more than those receiving only screening results and written information (p<0.05). The investigators hypothesize the level of decrease in alcohol consumption will be similar to that of trials conducted in high-income countries (HIC).
详细描述
The purpose of this project is to answer the challenge of integration of screening and core packages of Mental Health (MH) and Substance Use Disorder (SUD) services into routine primary health care (PHC) through innovative e-learning technologies. The training of health professionals in Kenya (and other LMIC) has very limited content on addressing alcohol, tobacco and other substance use disorder in PHC. The investigators aim to help address this problems by adapting NextGenU training model for capacity-building of health care providers in LMIC to provide SUD screening and core services in PHC. NextGenU.org draws on already-existing, free, expert-created competencies and computer-based learning resources from accredited sources to assemble courses certified by its network of partners. The computer-based didactic learning experience is complemented with 1) peer-to-peer interactions in a local and global community of learners simultaneously studying this topic, and 2) the use of local qualified mentors, which can supplement the training taking into account local variations in organizational structures, culture, tradition and beliefs.
The intervention evaluated through this program of research includes training lay health worker or facility support staff to screen patients presenting to the facility. Those support staff then refer those who are at moderate or high risk from tobacco, alcohol or other substance use to trained PHC clinician for brief intervention (BI) related to any of the substances they use at risky level. The training intervention includes teaching the clinicians to deliver BI, and identify and manage co-morbidities or complications. The program of research around that intervention includes (1) a developmental evaluation of the on-line training through a pilot with students and clinical faculties in educational institutions, followed by the assessment of the training of already practicing health care providers in the field; (2) pre and post training assessment of clinicians and non-clinicians knowledge, attitudes and skills (including assessing their level of stigma toward those who use psychoactive substances); (3) RCTs to assess the impact of the BI on alcohol consumption and other health and social variables of interest in public and private facilities; and (4) the assessment of the impact of quality improvement training on sustainability of the screening and BI. This trial registration is only for the RCTs.
Two independently powered RCTs, one in private facilities and one in public facilities, will be run. The rational to run two independently powered RCT is that other studies of PHC workers training for depression in LMIC have shown that the intervention implemented in public facilities was successful at improving patients' outcomes, while it was not in private facilities. However, since a large proportion of the population uses private facilities, the investigators did not want to exclude private facilities from participating.
The RCT with public institutions takes place in two rural counties, Machakos and Makueni, chosen as they are very similar in terms of geography and socio-demographic characteristics, and are pretty typical of rural counties in Kenya and other LMIC. They both have a population of over 700,000, with a moderate burden of substance abuse for Kenya.
The RCT with private health care institutions (CliniX and Shalom) will takes place in the Nairobi metropolitan area. The Shalom facility is technically in the County of Machakos, very close to Nairobi city limit and serving a very similar population to that of the CliniX facilities (urban middle class Kenyans who can afford private health care consultations out of pocket or who have insurance through their workplace). The RCTs will be complemented with qualitative methodologies to monitor other aspects besides the clinical effectiveness of the intervention. On-going results will be shared with stakeholders, and may result in adapted implementation of the training as the study progresses, as per the developmental evaluation methodology. The context and rationale of any changes will be documented as part of the research process, and are expected to inform the development of the innovation, including scalability.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •18 years or older
- •Have an Assist alcohol score of 11 to 26
排除标准
- •Being pregnant
- •Reaching a score of 27 or higher in one or more substances (other than tobacco or cannabis)
- •Having attended an alcohol treatment program in the last year
- •Reporting symptoms of suicide
- •Having severe neurological or psychiatric impairment (such as overt psychosis)
结局指标
主要结局
Mean Difference in alcohol consumption
时间窗: one, three and six month post BI
Difference in alcohol consumption between intervention and control (average grams/week in previous 7 and 14 day use collected through a timeline follow-back assessment.)
次要结局
- Change from baseline in frequency of drinking(baseline, one, three, and six months)
- Change from baseline in alcohol consumption(baseline, one, three, and six months)
- Change from baseline in frequency of binge drinking(baseline, and at one, three, and six months)
- Change from baseline in stigma related to alcohol use(baseline, and at one, three, and six months)
- difference between group in stigma related to alcohol use,(baseline, and at one, three, and six months)
- depression and suicidality(baseline, and at one, three, and six months)
- Perceived Quality of Life WHO Quality of Life-BREF (WHOQOL-BREF)(baseline, and at one, three, and six months)
- risky sexual behaviors(baseline, and at one, three, and six months)
