SBIRT for Alcoholism in PrEP Users

(SEAL Trial)

Overseen By Vania Remenik, MD

Age: 18+

Sex: Any

Trial Phase: Academic

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 All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 months

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a specific approach, called SBIRT (Screening, Brief Intervention, and Referral to Treatment), can reduce alcohol use in people taking PrEP (a medication to prevent HIV). Researchers aim to determine if this approach helps individuals adhere to their PrEP medication plan and how it affects alcohol's impact on gut and liver health. The trial includes different groups based on alcohol use levels to test SBIRT's effectiveness in various scenarios. Ideal participants are PrEP users who may be drinking more than is healthy and are interested in seeing if early intervention can help. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve health outcomes for many.

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 prior data suggests that the SBIRT protocol is safe for PrEP users?

Research has shown that the SBIRT method (Screening, Brief Intervention, and Referral to Treatment) is generally safe for addressing alcohol problems. Studies have found that this approach effectively reduces alcohol and drug use. For example, one study reported a 128.8% increase in the number of people who stopped using alcohol or illegal drugs after participating in SBIRT, indicating that participants generally handle SBIRT well.

In another study, researchers used SBIRT with over 490 young people, most of whom received a brief intervention, a key part of SBIRT. This supports the idea that SBIRT is a safe way to address alcohol use.

These findings suggest that SBIRT is a safe and effective method to help people reduce harmful alcohol use. There are no significant reports of negative effects, showing it is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SBIRT protocol for alcoholism in PrEP users because it offers a holistic approach to managing alcohol use. Unlike traditional treatments that often focus solely on reducing alcohol consumption, SBIRT (Screening, Brief Intervention, and Referral to Treatment) integrates screening and tailored interventions to also enhance the effectiveness of PrEP (pre-exposure prophylaxis) for HIV prevention. This dual focus not only addresses hazardous drinking but also aims to improve overall health outcomes by keeping individuals engaged in their PrEP regimen. By potentially reducing alcohol-related harm and improving medication adherence, SBIRT could represent a significant advancement in both substance use and HIV prevention strategies.

What evidence suggests that SBIRT is effective for reducing alcohol use in PrEP users?

Research has shown that SBIRT, which stands for Screening, Brief Intervention, and Referral to Treatment, effectively reduces alcohol use. In this trial, participants with an AUDIT score greater than 8 will join an experimental arm to receive SBIRT. One study found a significant drop in alcohol and drug use within 30 days of using this method. Another study demonstrated that SBIRT reduced alcohol use in at-risk individuals when implemented in settings like emergency rooms. This approach identifies and addresses alcohol issues early, providing support and resources to reduce harmful drinking. By acting early, SBIRT aims to improve participants' overall health. ^{1 2 4 5 6}

Who Is on the Research Team?

Shirish Barve, PhD

Principal Investigator

University of Louisville

Are You a Good Fit for This Trial?

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 mentally capable of understanding and giving consent.

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

PrEP users

Exclusion Criteria

Existing diagnosis of major psychiatric illness

Autoimmune disease

I have a severe stomach or liver condition.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• SBIRT

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

1. samhsa.gov samhsa.gov/substance-use/treatment/sbirt

Screening, Brief Intervention, and Referral to Treatment ... The percentage of clients who reported they had not used alcohol or illegal drugs within the past 30 days increased by 128.8% between initial ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5312829/

A Randomized Study of the Use of Screening, Brief ... Screening, brief intervention, and referral to treatment (SBIRT) is an evidence-based practice that has been shown to reduce alcohol and drug use.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5654886/

Effectiveness of SBIRT for Alcohol Use Disorders in the ... We undertook a systematic review of the effectiveness of ED brief interventions for patients identified through screening who are at risk for AUD.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1054139X22003482

Substance Use Screening, Brief Intervention, and Referral ... Of the 141,230 youth screened, over 12,000 received a brief intervention, and over 2,000 received a referral to treatment.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0740547216303750

A randomized study of the use of screening, brief ... This study tests the effectiveness of SBIRT with jail inmates in a randomized control trial design.

6. jahonline.org jahonline.org/article/S1054-139X(22)00348-2/fulltext

Substance Use Screening, Brief Intervention, and Referral ... More than 490 youth were screened in these sites; 92% received a BI, and 47% were referred to more formal treatment. SBIRT was also successfully implemented in ...