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}

Research Team

Shirish Barve, PhD

Principal Investigator

University of Louisville

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.

Who Is Running the Clinical Trial?

Shirish S Barve

Lead Sponsor

Trials

1

Recruited

120+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Dr. George F. Koob

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Chief Executive Officer since 2014

PhD in Neurobiology from the Scripps Research Institute

Dr. Patricia Powell

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Chief Medical Officer since 2015

MD from an accredited institution

Findings from Research

In a study of 1,871 adolescents, the SBIRT (Screening, Brief Intervention, and Referral to Treatment) approach led to fewer psychiatry visits and lower rates of mental health and chronic conditions after one year compared to usual care.

After three years, adolescents receiving SBIRT had fewer total outpatient visits and were less likely to have substance use diagnoses, while also showing an increase in substance use treatment visits, indicating improved health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health Care Use Over 3 Years After Adolescent SBIRT. Sterling, S., Kline-Simon, AH., Jones, A., et al.[2020]

The SBIRT intervention showed some effectiveness in reducing risky alcohol use among higher-risk military personnel, as indicated by significant reductions in AUDIT-C scores and increased self-efficacy for controlled drinking in a complete case analysis.

However, the intent-to-treat analyses did not support the effectiveness of the SBIRT intervention overall, suggesting that while some individuals may benefit, the intervention may not be universally effective across all participants.

NCBI (Pubmed)

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. Reed, MB., Woodruff, SI., DeMers, G., et al.[2022]

In a study involving 1493 patients from a Level-1 trauma center, baseline drug dependence positively influenced alcohol use outcomes for Hispanic individuals after receiving a brief motivational intervention (BMI-ETOH), showing increased abstinence and reduced drinking volume at 6 and 12 months.

The findings suggest that drug dependence does not hinder alcohol treatment outcomes and may even enhance them for certain ethnic groups, particularly Hispanics, indicating the need for tailored interventions based on individual backgrounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ethnic differences in the effect of drug use and drug dependence on brief motivational interventions targeting alcohol use. Field, CA., Cochran, G., Caetano, R.[2022]

In a study of 439 women from reproductive health clinics, clinician-delivered SBIRT significantly reduced cigarette use compared to enhanced usual care, especially in the first three months, although the effect diminished over time.

Electronic SBIRT was effective in reducing illicit drug use compared to enhanced usual care, but neither intervention showed a significant impact on alcohol use, indicating that further research is needed, particularly due to the small sample size for alcohol (n=51).

NCBI (Pubmed)

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. Forray, A., Martino, S., Gilstad-Hayden, K., et al.[2020]

The SBIRT model has been effective in reducing alcohol consumption and its negative consequences in both primary care and emergency department settings, supported by multiple studies and endorsements from health organizations.

A new approach called STIR, which includes the initiation of medication management during the first visit, has shown promising results in two trials: one for nicotine pharmacotherapy leading to sustained abstinence in smokers, and another for buprenorphine that improved treatment engagement and self-reported abstinence in opioid-dependent individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening, treatment initiation, and referral for substance use disorders. Bernstein, SL., D'Onofrio, G.[2018]

In a study of 120,804 respondents, women were more likely to be screened for unhealthy alcohol use but less likely to receive brief interventions or referrals to treatment compared to men, although they were more likely to receive treatment once referred.

Demographic factors significantly influenced SBIRT implementation, with older adults (≥50 years) being less likely to be screened, racial and ethnic minorities facing lower screening rates, and uninsured individuals having reduced access to screening, highlighting the need to address these disparities to improve care outcomes.

NCBI (Pubmed)

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. Mintz, CM., Knox, J., Hartz, SM., et al.[2023]

The SBIRT program, which helps identify and reduce substance abuse, has been effectively integrated into 21 different medical settings, showing consistent workflow processes despite some adaptations to fit local practices.

Successful integration strategies include placing SBIRT providers directly in medical settings and incorporating SBIRT data into electronic health records, enhancing the collaboration between behavioral health and medical care.

NCBI (Pubmed)

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. Kaiser, DJ., Karuntzos, G.[2015]

SBIRT (Screening, Brief Intervention, and Referral to Treatment) is an effective public health strategy for early intervention in individuals at risk of substance use disorders (SUDs), adaptable to various clinical settings such as hospitals and primary care.

While SBIRT can provide immediate support and referrals for those with SUDs, further research is necessary to optimize its implementation and effectiveness in different environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating screening, brief intervention, and referral to treatment (SBIRT) into clinical practice settings: a brief review. Agerwala, SM., McCance-Katz, EF.[2022]

This study will test a nurse-led toolkit designed to enhance the implementation of Screening, Brief Intervention, and Referral to Treatment (SBIRT) in 14 acute care hospitals, aiming to improve the recognition and treatment of risky substance use among patients.

The effectiveness of the SBIRT toolkit will be evaluated by analyzing documentation of its delivery in electronic medical records over 12 months, with the goal of improving clinician engagement in addressing substance use issues and ultimately reducing substance use disorders.

NCBI (Pubmed)

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. Newhouse, R., Janney, M., Gilbert, A., et al.[2020]

References

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

Health Care Use Over 3 Years After Adolescent SBIRT. [2020]

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]

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]

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]

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

Screening, treatment initiation, and referral for substance use disorders. [2018]

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]

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]

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]

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]