SBIRT for Alcoholism in PrEP Users

(SEAL Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Shirish Barve, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Shirish S Barve

Must be taking: PrEP

Must not be taking: Immunosuppressants, Chemotherapy, Antibiotics, Probiotics

Disqualifiers: Major psychiatric illness, Unstable conditions, others

No Placebo Group

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.

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking immunosuppressants, chemotherapy, daily antibiotics, or probiotics.

What data supports the effectiveness of the treatment SBIRT for alcoholism in PrEP users?

Research shows that SBIRT, which includes screening, brief intervention, and referral to treatment, is effective in reducing alcohol consumption in unhealthy drinkers in both primary care and emergency settings. It has been endorsed by various governmental agencies and professional societies for its effectiveness in managing alcohol use. ^{1 2 3 4 5}

Is SBIRT safe for humans?

SBIRT (Screening, Brief Intervention, and Referral to Treatment) has been used safely in various settings, including military personnel and reproductive health clinics, to address alcohol and substance use. It is a widely endorsed approach by governmental agencies and professional societies for reducing unhealthy alcohol use. ^{1 2 4 5 6}

How is the SBIRT treatment for alcoholism in PrEP users different from other treatments?

SBIRT is unique because it combines screening, brief intervention, and referral to treatment in a flexible approach that can be applied in various healthcare settings to identify and address risky alcohol use early, unlike traditional treatments that may focus solely on rehabilitation or medication. ^{4 6 7 8 9}

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.

Inclusion Criteria

I am between 18 and 85 years old.

Confirmation of seronegative HIV, Hep B, and Hep C status

PrEP users

Exclusion Criteria

Existing diagnosis of major psychiatric illness

Autoimmune disease

My medical condition, including cancer, is currently stable.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the SBIRT intervention to reduce alcohol use and its impact on the gut microbiome

12 months

Visits at 3, 6, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• SBIRT (Behavioral Intervention)

Trial Overview 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.

Participant Groups

Group I: AUDIT >8 + SBIRT Experimental Treatment 1 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 <8 Active Control 1 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 SBIRT Active Control 1 Intervention

This is NOT an experimental arm, despite an AUDIT score \> 8.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Louisville Louisville, KY

Who Is Running the Clinical Trial?

Shirish S Barve Lead Sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA) Collaborator

References

1. United States pubmed.ncbi.nlm.nih.gov

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.

2. United States pubmed.ncbi.nlm.nih.gov

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.

3. Ireland pubmed.ncbi.nlm.nih.gov

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).

4. England pubmed.ncbi.nlm.nih.gov

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.

5. England pubmed.ncbi.nlm.nih.gov

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.

6. United States pubmed.ncbi.nlm.nih.gov

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.

7. United States pubmed.ncbi.nlm.nih.gov

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.

8. United States pubmed.ncbi.nlm.nih.gov

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.

9. England pubmed.ncbi.nlm.nih.gov

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.