Trial Summary
What is the purpose of this trial?This randomized control trial study among Pre-exposure prophylactic users (PrEP) aims to learn and determine the efficacy of Screening, brief intervention, and referral to treatment (SBRIT) in reducing the risk of alcohol use. The main questions it aims to answer are:
1. How alcohol use impacts the PrEP continuum and to understand how early intervention and treatment approach affects alcohol use and PrEP adherence.
2. Investigate the effectiveness of the SBIRT intervention in preventing hazardous alcohol use and its impact on gut dysbiosis in PrEP users.
3. To determine alterations in the gut microbiome (dysbiosis), intestinal homeostasis, systemic inflammation, and markers of liver disease associated with hazardous alcohol use among PrEP users.
Is SBIRT a promising treatment for alcoholism in PrEP users?Yes, SBIRT is a promising treatment because it helps identify and reduce risky alcohol use. It can be used in many healthcare settings to provide early intervention and connect people to further treatment if needed.23579
What safety data exists for SBIRT in treating alcoholism?The SBIRT model, which includes screening, brief intervention, and referral to treatment, has been evaluated in various settings and populations. It is endorsed by governmental agencies and professional societies for reducing alcohol consumption and consequences in unhealthy drinkers. While most trials support its efficacy, results are heterogeneous, and some negative studies exist. The safety of SBIRT is generally supported by its widespread recommendation and use in primary care and emergency department settings, as well as its application in specific populations like active-duty military personnel and women in reproductive health clinics.46789
Do I have to stop taking my current medications for this trial?The trial protocol does not specify if you need to stop taking your current medications. However, if you are taking immunosuppressants, chemotherapy, daily antibiotics, or probiotics, you cannot participate in the trial.
What data supports the idea that SBIRT for Alcoholism in PrEP Users is an effective treatment?The available research shows that SBIRT is effective in reducing alcohol consumption and its negative effects in people who drink too much. It has been successful in both primary care and emergency department settings. For example, a study on active-duty military personnel found that SBIRT helped reduce risky alcohol use. Although some studies show mixed results, many trials support its effectiveness, leading to endorsements by government agencies and professional societies in several countries.14678
Eligibility Criteria
This trial is for adults aged 18-85 who use PrEP to prevent HIV, can speak English or Spanish, and are able to give consent. They must be free of severe illnesses like cancer, major psychiatric conditions, autoimmune diseases, and not on immunosuppressants or daily antibiotics/probiotics.Treatment Details
The study tests the SBIRT approach (Screening, Brief Intervention, Referral to Treatment) in reducing alcohol misuse among PrEP users. It examines how early intervention affects alcohol consumption patterns and adherence to PrEP medication.
3Treatment groups
Experimental Treatment
Active Control
Group I: AUDIT >8 + SBIRTExperimental Treatment1 Intervention
This is an experimental arm, and AUDIT \>8 is hazardous. The goal is to make connections on the impact of the SBIRT intervention on PrEP engagement and alcohol use among the participants to create a full picture of the impact of the intervention on groups exhibiting different types of alcohol use.
Group II: AUDIT <8Active Control1 Intervention
Participants whose audit score is less than eight are assigned to this arm. AUDIT is a 10-item screening tool developed by the World Health Organization (WHO) to assess alcohol consumption, dependence, and experience of alcohol-related harm. AUDIT \<8 is non-hazardous.
Group III: AUDIT > 8 NO SBIRTActive Control1 Intervention
This is NOT an experimental arm, despite an AUDIT score \> 8.
Find a clinic near you
Research locations nearbySelect from list below to view details:
University of LouisvilleLouisville, KY
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Who is running the clinical trial?
Shirish S BarveLead Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Collaborator
References
Ethnic differences in the effect of drug use and drug dependence on brief motivational interventions targeting alcohol use. [2022]We examined the effects of baseline drug use and dependence on alcohol use outcomes following brief motivational intervention for at-risk drinking (BMI-ETOH).
Integrating screening, brief intervention, and referral to treatment (SBIRT) into clinical practice settings: a brief review. [2022]Screening, brief intervention, and referral to treatment (SBIRT) is a public health approach to the delivery of early intervention and treatment services for individuals at risk of developing substance use disorders (SUDs) and those who have already developed these disorders. SBIRT can be flexibly applied; therefore, it can be delivered in many clinical care settings. SBIRT has been adapted for use in hospital emergency settings, primary care centers, office- and clinic-based practices, and other community settings, providing opportunities for early intervention with at-risk substance users before more severe consequences occur. In addition, SBIRT interventions can include the provision of brief treatment for those with less severe SUDs and referrals to specialized substance abuse treatment programs for those with more severe SUDs. Screening large numbers of individuals presents an opportunity to engage those who are in need of treatment. However, additional research is needed to determine how best to implement SBIRT.
An Examination of the Workflow Processes of the Screening, Brief Intervention, and Referral to Treatment (SBIRT) Program in Health Care Settings. [2015]Screening, Brief Intervention, and Referral to Treatment (SBIRT) is a public health program used to identify, reduce, and prevent problematic use, abuse, and dependence on alcohol and illicit drugs that has been adapted for implementation in emergency departments and ambulatory clinics nationwide.
Screening, treatment initiation, and referral for substance use disorders. [2018]Substance use remains a leading cause of preventable death globally. A model of intervention known as screening, brief intervention, and referral to treatment (SBIRT) was developed decades ago to facilitate time- and resource-sensitive interventions in acute care and outpatient settings. SBIRT, which includes a psychosocial intervention incorporating the principles of motivational interviewing, has been shown to be effective in reducing alcohol consumption and consequences in unhealthy drinkers both in primary care and emergency department settings. Subsequently, SBIRT for unhealthy alcohol use has been endorsed by governmental agencies and professional societies in multiple countries. Although most trials support the efficacy of SBIRT for unhealthy alcohol use (McQueen et al. in Cochrane Database Syst Rev 8, 2011; Kaner et al. in Cochrane Database Syst Rev 2, 2007; O'Donnell et al. in Alcohol Alcohol 49(1):66-78, 2014), results are heterogenous; negative studies exist. A newer approach to screening and intervention for substance use can incorporate initiation of medication management at the index visit, for individuals willing to do so, and for providers and healthcare systems that are appropriately trained and resourced. Our group has conducted two successful trials of an approach we call screening, treatment initiation, and referral (STIR). In one trial, initiation of nicotine pharmacotherapy coupled with screening and brief counseling in adult smokers resulted in sustained biochemically confirmed abstinence. In a second trial, initiation of buprenorphine for opioid dependent individuals resulted in greater engagement in treatment at 30 days and greater self-reported abstinence. STIR may offer a new, clinically effective approach to the treatment of substance use in clinical care settings.
Study protocol testing toolkit versus usual care for implementation of screening, brief intervention, referral to treatment in hospitals: a phased cluster randomized approach. [2020]Alarming rates of unhealthy alcohol, non-prescription drug, and tobacco use highlight the preventable health risks of substance abuse and the urgent need to activate clinicians to recognize and treat risky use. Screening, brief intervention, and referral to treatment (SBIRT) is an efficacious and effective processes to identify, reduce and prevent risky use of substances. This paper describes a study protocol testing implementation of a toolkit to enhance use of SBIRT in acute care settings to recognize and address patient risky alcohol, drug, and tobacco use.
Health Care Use Over 3 Years After Adolescent SBIRT. [2020]Most studies on adolescent screening, brief intervention, and referral to treatment (SBIRT) have examined substance use outcomes. However, it may also impact service use and comorbidity-an understudied topic. We address this gap by examining effects of SBIRT on health care use and comorbidities.
Assessment of an electronic and clinician-delivered brief intervention on cigarette, alcohol and illicit drug use among women in a reproductive healthcare clinic. [2020]Women are at highest risk for development of a substance use disorder during their reproductive years. We recently evaluated the efficacy of an electronic screening, brief intervention and referral to treatment (e-SBIRT) and a clinician-delivered SBIRT (SBIRT) compared with enhanced usual care (EUC) for reducing overall substance use among women recruited from reproductive health clinics. The present study assessed the impact of the SBIRT interventions within three primary substance subgroups: cigarettes, illicit drugs, and alcohol.
Results of a Randomized Trial of Screening, Brief Intervention, and Referral to Treatment (SBIRT) to Reduce Alcohol Misuse Among Active-Duty Military Personnel. [2022]Rates of heavy alcohol use among active-duty military personnel in the United States are high and negatively affect individuals within the service branches. This study tested the effectiveness of a military-focused screening, brief intervention, and referral to treatment (SBIRT) intervention for reducing risky alcohol use among active-duty patients.
Demographic differences in the cascade of care for unhealthy alcohol use: A cross-sectional analysis of data from the 2015-2019 National Survey on Drug Use and Health. [2023]The screening, brief intervention, and referral to treatment (SBIRT) model is recommended by the U.S. Preventive Services Task Force to improve recognition of and intervention for unhealthy alcohol use. How SBIRT implementation differs by demographic characteristics is poorly understood.