Reduction of Medical Complications Associated With Injection Drug Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 2
- 主要终点
- Reduction in self-reported high-risk injection practices for bacterial infections (as measured through the Bacterial Infections Risk Scale for Injectors)
研究概览
简要总结
The purpose of this study is to develop and test an intervention to reduce bacterial and viral infections among injection drug users.
详细描述
Injection drug use (IDU) is a major public health problem that is associated with a host of medical complications, including blood-borne viral disease (e.g., HIV, Hepatitis C) and bacterial infections (e.g., skin abscesses, endocarditis), that often result from high-risk drug injection practices. There are no current interventions designed to reduce bacterial infections among IDUs, despite high rates of infection.
The objective of this study is to develop and test the efficacy of a skin and needle hygiene intervention for IDUs to reduce practices associated with bacterial and viral infections. In the first phase of the study, focus group interviews were conducted to determine key areas of emphasis for an intervention with this population. An initial intervention was developed, pilot tested, and refined. The final 2-session intervention combines psychoeducation, skill-building, and motivational interviewing.
Following refinement of the intervention, a small randomized controlled trial (n = 60; 30 in each group) to examine the efficacy of the intervention compared to an assessment-only condition will be conducted. The goals of this two-year study are to: 1) reduce high-risk injection practices among active IDUs that lead to bacterial and viral infections, 2) improve skin and needle cleaning behavioral skills, and 3) increase skin cleaning prior to injection and reduce subcutaneous/intramuscular injection.
In addition to examining these goals over a six-month period, the acceptability and feasibility of the intervention will be examined.
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
- •18 years of age or older
- •injection of heroin on at least three different days in the last week
- •injection of heroin for at least three months
- •visible track marks/puncture wounds from needles
- •positive urine screen for heroin
排除标准
- •currently exhibiting active psychotic symptoms
- •cannot complete study assessments or the intervention
- •cannot provide informed consent
- •unable to provide names and contact information for at least two verifiable locator persons who will know where to find client
- •plans to relocate from area or be jail over next six months
- •have been in a Project Safe study in the last year
- •report being pregnant or attempting to become pregnant
结局指标
主要结局
Reduction in self-reported high-risk injection practices for bacterial infections (as measured through the Bacterial Infections Risk Scale for Injectors)
时间窗: 6 months
Reduction in self-reported high-risk injection practices for HIV/HCV viral infections (as measured through the Risk Assessment Battery)
时间窗: 6 months
次要结局
- Improvement in skin and needle cleaning behavioral skills (as measured through Behavioral Skill Demonstration of Hand/Skin and Needle Cleaning)(6 months)
- Increase in skin cleaning prior to injection and decrease in subcutaneous/intramuscular injection, as measured through Timeline Followback (TLFB) recall.(6 months)
研究者
Kristina Phillips
Associate Professor
University of Northern Colorado