Computer-based Alcohol Reduction Intervention for Alcohol-using HIV/HCV+ Russian Women in Clinical Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Percentage of Women Who Test Ethyl Glucuronide (EtG) Negative
研究概览
简要总结
The study harnessed the multidisciplinary expertise of our research team to develop a brief, computer-based, alcohol reduction intervention tailored for HIV/HCV co-infected women and evaluate its efficacy. The intervention, if effective, may be an efficient and cost-effective alcohol reduction strategy, that is scalable and can be readily disseminated and integrated in clinical care at other AIDS Centres in Russia to enhance women's health and reduce HIV/HCV transmission risk.
详细描述
Women co-infected with human immunodeficiency viruses (HIV) and Hepatitis C (HCV) are at elevated risk for adverse health outcomes associated with alcohol use. Evidence-based alcohol reduction interventions for this vulnerable population are limited. To address this gap, the study harnessed the multidisciplinary expertise and experience of collaborative Russian-U.S. research team to develop a brief, computer-based, alcohol reduction intervention tailored for HIV/HCV co-infected women and evaluate its efficacy. The study was conducted in three sequential stages: (1) Adaptation, (2) Implementation, and (3) Evaluation. Participants will be randomized to one of two conditions: (1) adapted computer-based alcohol reduction intervention PLUS PLUS provider-delivered brief motivational counseling, or (2) provider-delivered brief motivational counseling. The trial design and analysis provide an appropriate conceptual and methodological framework to assess the efficacy of the computer-based intervention. The intervention, if effective, may be an efficient and cost-effective alcohol reduction strategy that is scalable and can be readily disseminated and integrated in clinical care at other AIDS Centres in Russia to enhance women's health and reduce HIV/HCV transmission risk.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •receiving HIV medical care at the AIDS Center;
- •chart-documented HIV and chronic HCV infection;
- •currently prescribed an antiretroviral (ARV) regimen;
- •medically, cognitively, and psychologically capable of study participation;
- •laboratory-confirmed recent alcohol use as detected by a Ethylglucuronide (EtG) analysis or self-reported alcohol use
排除标准
- •not identifying as biological female
- •not HIV and HCV positive
- •no laboratory-confirmed or self-reported
- •not willing to participate in the trial
- •not able to participate in the trial due to medical, cognitive, or psychological issues
研究组 & 干预措施
Computer-based alcohol reduction intervention + Clinician-delivered brief MET counseling
Brief, computer-based, alcohol reduction intervention based on motivational enhancement therapy (MET) tailored for HIV/HCV co-infected women who used alcohol.
Clinician-based MET counseling plus standard-of-care (SOC) for current substance users.
干预措施: Computer-based alcohol reduction intervention (Behavioral)
Clinician-delivered brief MET counseling
Clinician-based brief MET counseling plus standard-of-care (SOC) for current substance users. only
干预措施: Brief clinician-delivered MET (Behavioral)
Computer-based alcohol reduction intervention + Clinician-delivered brief MET counseling
Brief, computer-based, alcohol reduction intervention based on motivational enhancement therapy (MET) tailored for HIV/HCV co-infected women who used alcohol.
Clinician-based MET counseling plus standard-of-care (SOC) for current substance users.
干预措施: Brief clinician-delivered MET (Behavioral)
Computer-based alcohol reduction intervention + Clinician-delivered brief MET counseling
Brief, computer-based, alcohol reduction intervention based on motivational enhancement therapy (MET) tailored for HIV/HCV co-infected women who used alcohol.
Clinician-based MET counseling plus standard-of-care (SOC) for current substance users.
干预措施: Standard of care (Behavioral)
Clinician-delivered brief MET counseling
Clinician-based brief MET counseling plus standard-of-care (SOC) for current substance users. only
干预措施: Standard of care (Behavioral)
结局指标
主要结局
Percentage of Women Who Test Ethyl Glucuronide (EtG) Negative
时间窗: 3-, 6-, and 9-month post-baseline
Percentage of women who test ethyl glucuronide (EtG) negative will be estimated to evaluate the efficacy of the adapted computer-based alcohol reduction intervention condition, relative to standard of care condition. Ethyl glucuronide will be measured in urine, with a sample taken at point-of-care at baseline and follow-ups. The definition of EtG negative is \<500ng/mL. A dichotomous score will be created for times 3, 6, and 9-months post baseline, with participants testing EtG negative over the three time points assigned a 0 and participants testing EtG positive at any of the three follow-up points assigned a 1.
次要结局
- CD4 Cell Count(9-month post-baseline)
- Percentage of Women Who Test Phosphatidylethanol (PEth) Negative (<= 8 ng/mL)(9-month post-baseline)
- Percentage of Participants in the Intervention Group With an Undetectable HIV Viral Load Compared to the Percentage of Women in the Control Group With an Undetectable Viral Load(9-month post-baseline)
- Count of Women With a Severe FibroTest Score (3-4) at 9-month Post Baseline(9-month post-baseline)
- Liver Stiffness(9-month post-baseline)