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临床试验/NCT05241990
NCT05241990招募中不适用

A Hybrid Type III Implementation Trial Testing Practice Facilitation as a Strategy to Improve Alcohol Treatment Adoption and Implementation in HIV Care

Johns Hopkins University6 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2023年2月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
6
主要终点
Implementation as assessed by the percent of patients receiving an alcohol intervention

研究概览

简要总结

Despite availability of evidence-based alcohol reduction interventions (EBI), unhealthy alcohol use remains a barrier to HIV medication adherence, viral suppression and retention in HIV care and consequently HIV treatment as prevention (TASP). Guided by complementary implementation and evaluation frameworks-the Consolidated Framework for Implementation Research (CFIR) and RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance), The investigators will conduct a Hybrid Type 3 effectiveness-implementation evaluating implementation trial testing whether practice facilitation, an evidence-based multifaceted implementation strategy increases reach, adoption, implementation, and maintenance of stepped care for unhealthy alcohol use in three Center for AIDS Research (CFAR) Network of Integrated Clinical Systems (CNICS) HIV clinics located in Boston, San Diego, and Chapel Hill. The investigators will secondarily test whether practice facilitation is associated with decreased unhealthy alcohol use, and improved Antiretroviral Therapy (ART) adherence and viral suppression at the patient level. In practice facilitation, a practice coach will offer tools, resources, hands-on guidance, and content expertise to assist sites in offering a stepped care model of alcohol treatment to patients with unhealthy alcohol use. Stepped care will include brief intervention, cognitive behavioral therapy, and alcohol pharmacotherapy. The practice facilitation intervention will be rolled out sequentially across sites. There will be three phases at each site: pre-implementation planning, implementation with formative evaluation, and post-implementation summative evaluation. Using mixed methods, The investigators specifically propose to meet the following specific aims: (Aim 1) Tailor the practice facilitation intervention to each site using mixed methods (pre-implementation); (Aim 2a) Determine the effects of practice facilitation on implementation of stepped care (primary) and alcohol use and HIV-related outcomes (secondary) using interrupted time series analysis with synthetic controls (summative evaluation); (Aim 2b) Determine the effect of practice facilitation on reach, adoption, and maintenance of evidence-based alcohol treatment using mixed methods (formative evaluation); and (Aim 3) Describe barriers and facilitators to implementation of alcohol-related interventions at each site to describe maintenance and inform widespread sustainable implementation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

入选标准

  • Clinic Staff
  • Age > 18 years old
  • Confirmed to be clinic staff (clinical or administrative roles).
  • English speaking
  • Cognitively able to complete required survey or interview activities.

排除标准

  • Clinic Staff
  • Unable to speak English
  • Inclusion Criteria, Patients
  • Confirmed to be a person with HIV (PWH) receiving HIV care and participating in CNICS at one of the three clinic sites
  • Scoring AUDIT-C ≥3 for women or ≥4 for men, transgender women or men indicating unhealthy alcohol use.
  • Age ≥ 18 years old.
  • English speaking.
  • Cognitively able to participate in stepped care for unhealthy alcohol use.
  • Exclusion Criteria, Patients
  • Scoring AUDIT-C <3 for women or <4 for men or <4 for transgender women or men
  • Age < 18 years old
  • Participants cognitively unable to participate in the stepped care for unhealthy alcohol use.

研究组 & 干预措施

Alcohol Stepped Care

Experimental

Based on severity of alcohol use, individuals receive brief alcohol intervention delivered in person or by computer, cognitive behavioral therapy by person or computer, or pharmacotherapy for alcohol use disorder

干预措施: Practice Facilitation (Behavioral)

Alcohol Stepped Care

Experimental

Based on severity of alcohol use, individuals receive brief alcohol intervention delivered in person or by computer, cognitive behavioral therapy by person or computer, or pharmacotherapy for alcohol use disorder

干预措施: Alcohol Stepped Care (Behavioral)

结局指标

主要结局

Implementation as assessed by the percent of patients receiving an alcohol intervention

时间窗: 12 months

Percent of patients receiving an alcohol intervention since their last visit among all eligible individuals.

次要结局

  • Antiretroviral therapy adherence as assessed by a self report on a visual analog scale(12 months)
  • Change in unhealthy alcohol use as assessed by the Alcohol Use Disorder Identification test-Consumption (AUDIT-C)(Baseline and 12 months)
  • Viral Suppression as assessed by HIV-RNA copies(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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