Alcohol Research Consortium in HIV: Relapse Prevention Arm
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in time to relapse
研究概览
简要总结
3-arm type 1 pilot implementation-efficacy trial for people with alcohol use disorders to examine the preliminary effectiveness and feasibility of an adapted 2-session, computerized and person delivered relapse prevention intervention.
详细描述
This study will develop a brief counseling intervention for people with HIV who have resumed alcohol use or resumed hazardous alcohol use after a minimum of 3 years of alcohol abstinence or 'lower risk' alcohol use. The investigators will develop a 2session person delivered and a 2-session computer delivered intervention which the investigators will then compare with the usual treatment for alcohol counseling offered at the HIV clinic. The investigators will also study the acceptability and feasibility of implementing both types of counseling in the clinic.
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
- •Confirmed diagnosis of HIV
- •Aged 18 years or older
- •Must be enrolled in clinical care at Johns Hopkins HIV Clinic.
- •In addition, meet the following alcohol use criteria:
- •lifetime alcohol use disorder
- •patient reported outcomes (PRO) assessment collected by the Center for AIDS Research (CFAR) Network of Clinical Systems as part of usual clinical care that show in the last 3 years: periods of no or lower risk drinking (e.g. women/men who are drinking <11/22 drinks per week) and periods of lapse to higher levels of drinking (=>11/22 drinks per week for women/men)
- •current PRO showing alcohol abstinence or alcohol use at <11/22 drinks per week for women/men.
排除标准
- •Acutely suicidal, homicidal, psychotic or otherwise unable to provide informed consent
- •Non-English speaking because interventions are currently available in English only
研究组 & 干预措施
Computer delivered RPI
2 session computer delivered counseling to prevent relapse to hazardous drinking
干预措施: Relapse Prevention Intervention (Behavioral)
Person delivered RPI
2 session counselor delivered counseling to prevent relapse to hazardous drinking
干预措施: Relapse Prevention Intervention (Behavioral)
Treatment as Usual
Counseling for alcohol use available in clinic as treatment as usual
结局指标
主要结局
Change in time to relapse
时间窗: 6 and 12 months
Time to return to any alcohol use or any at risk alcohol use after intervention.
次要结局
- Alcohol use pattern as assessed by change in number of drinking days(Baseline, 6 and 12 months)
- Alcohol use pattern as assessed by change in number of drinks per drinking day(Baseline, 6 and 12 months)
- Alcohol use pattern as assessed by change in number of days abstinent(Baseline, 6 and 12 months)
- Alcohol use pattern as assessed by change in number of heavy drinking days(Baseline, 6 and 12 months)