Brief Intervention for Alcohol Use in HIV Prevention

No longer recruiting at 2 trial locations

Overseen By Narges Joharchi, MSc

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Centre for Addiction and Mental Health

Must be taking: PrEP

Disqualifiers: Not TGH/MLMC patient, others

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

Compensation: Varies

Number of Visits: 7

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a brief intervention aimed at reducing alcohol use in men taking PrEP, a medication that helps prevent HIV. The trial compares the effectiveness of this new alcohol-focused intervention against the usual treatment, which lacks the alcohol-focused program. Participants receive personalized feedback on their drinking habits and tips for safe alcohol consumption. Men who have been on PrEP for at least three months and drink heavily may be suitable candidates for this trial. As an unphased trial, this study provides an opportunity to contribute to research that could improve health outcomes for men on PrEP.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on alcohol use and PrEP treatment, so it's best to ask the trial coordinators for more details.

What prior data suggests that this alcohol-focused brief intervention is safe?

Research has shown that brief interventions focused on alcohol are generally safe and well-tolerated. These interventions often help reduce risky behaviors, such as heavy drinking, without causing serious side effects. For instance, studies have found that brief interventions can help people drink less and improve health outcomes related to HIV.

Importantly, these interventions are non-invasive. They typically involve providing personalized feedback and advice, without the use of medications or physical treatments. This makes them a low-risk option for participants.

Overall, brief alcohol interventions have been used in many settings and have demonstrated positive results without major negative effects. This suggests they are a safe choice for those wanting to reduce alcohol use, especially when combined with HIV prevention strategies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for alcohol use, which often involve in-person counseling or medication, the alcohol-focused brief intervention in this trial provides a personalized drinking feedback report delivered electronically. This unique approach allows individuals to see how their drinking habits compare to peers, which can be a powerful motivator for change. Additionally, the intervention includes specific recommendations for safe alcohol consumption, making it a practical and accessible tool for reducing alcohol use. Researchers are excited about this method because it leverages digital technology to offer immediate and tailored feedback, potentially increasing engagement and effectiveness compared to conventional methods.

What evidence suggests that this alcohol-focused brief intervention could be effective for reducing alcohol use in the context of HIV prevention?

Research shows that short programs to help people drink less can be effective. In this trial, participants in the alcohol-focused brief intervention arm will receive an electronically-delivered, personalized drinking feedback report. These programs are especially useful for people with HIV because they can help them adhere to their treatment plans. Some studies have found that these programs not only reduce drinking but also improve HIV treatment outcomes. However, not all studies agree, as some found no change in risky sexual behaviors. Overall, evidence suggests that these short programs can help people drink less, which is important for those using HIV prevention treatments like PrEP. ^{6 7 8 9 10}

Who Is on the Research Team?

Paul A. Shuper, PhD

Principal Investigator

Senior Scientist and Section Head

Are You a Good Fit for This Trial?

This trial is for men aged 18 or older who identify as gay, bisexual, or have sex with other men and are patients at TGH or MLMC. They must be on PrEP for HIV prevention for at least 3 months and drink alcohol at levels considered hazardous.

Inclusion Criteria

Participants must be a patient of Toronto General Hospital (TGH) or Maple Leaf Medical Clinic (MLMC)

I am a man who identifies as gay, bisexual, or has sex with other men.

Participants must meet the criteria for hazardous drinking (i.e., based on a score of ≥4 on the Alcohol Use Disorders Identification Test-Consumption measures (AUDIT-C))

Exclusion Criteria

Participants will be excluded if they do not meet all of the above-mentioned inclusion criteria.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessment including biomarker testing and self-report electronic surveys

1 week

1 visit (in-person)

Treatment

Participants receive either a tablet-based, alcohol-reduction brief intervention or treatment-as-usual

6 months

3 visits (in-person) at baseline, 3-months, and 6-months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of PrEP adherence and alcohol consumption

6 months

3 visits (in-person) at baseline, 3-months, and 6-months

What Are the Treatments Tested in This Trial?

Interventions

• Alcohol-focused brief intervention

Trial Overview The study tests if a brief intervention focused on reducing alcohol use can be practical, well-received, and effective among individuals using HIV pre-exposure prophylaxis (PrEP) treatment.

How Is the Trial Designed?

Group I: Alcohol-focused brief intervention Experimental Treatment 1 Intervention

Intervention arm participants will be provided with an electronically-delivered, personalized drinking feedback report that compares their drinking with other Canadian males of the same age. This report also includes other relevant feedback, including an assessment of severity of alcohol use, and it provides recommendations for safe levels of alcohol consumption.

Group II: Treatment as usual Active Control 1 Intervention

Treatment as usual (TAU) participants will not receive the intervention.

Who Is Running the Clinical Trial?

Centre for Addiction and Mental Health

Lead Sponsor

Trials

388

Recruited

84,200+

University Health Network, Toronto

Collaborator

Trials

1,555

Recruited

526,000+

Maple Leaf Research

Collaborator

Trials

5

Recruited

280+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8190977/

Current Interventions for People Living with HIV Who Use ... Alcohol is the most misused substance in the world. For people living with HIV (PLWH), alcohol misuse may impact ART adherence and viral suppression.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11170841/

Scaling up a brief alcohol intervention to prevent HIV ... Brief alcohol interventions (BAIs) are proven effective for addressing unhealthy alcohol use among PWH [12, 13]; however, in settings where ...

3. mental.jmir.org mental.jmir.org/2023/1/e43653

Findings From the Step Up, Test Up Study of an Electronic ... We found no effect of electronic brief intervention to reduce alcohol use and some effect on sexual risk among youth aged 16 years to 25 years who present for ...

4. buffalo.edu buffalo.edu/cria/research/prev_proj.host.html/content/shared/www/cria/research/researc_projects/previous_research/AA11714.detail.html

Enhancing HIV Prevention Through Drinking Reduction Analyses of one-year post-intervention follow-up data indicated that the alcohol-focused brief interventions reduced alcohol use but had no impact on sexual ...

5. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-08382-5

A Brief Alcohol Intervention (BAI) to reduce alcohol use and ... Studies in the USA [31] and Vietnam [28,29,30] have found that the BAI is an effective intervention for reducing alcohol use and improving HIV- ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4919277/

Brief Motivational Intervention to Reduce Alcohol and HIV ... The results showed reductions in both risky behaviors, leading the authors to call for a future randomized controlled trial to assess efficacy.

7. implementationscience.biomedcentral.com implementationscience.biomedcentral.com/articles/10.1186/s13012-024-01368-6

Scaling up a brief alcohol intervention to prevent HIV infection ... We present an implementation trial using an experiential implementation strategy to address clinicians' knowledge, attitudes, and behaviors.

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37921633/

Brief interventions for alcohol misuse among people living ... The meta-analysis sought to evaluate the effectiveness of brief interventions (BI) on alcohol and HIV outcomes in PLHIV with alcohol misuse.

9. sciencedirect.com sciencedirect.com/science/article/pii/S2589537024006242

Alcohol use and HIV suppression after completion of ... Six months of alcohol reduction incentives were effective at promoting no/low alcohol use at 12 months, demonstrating persistent effects post-intervention.

10. link.springer.com link.springer.com/article/10.1007/s11904-021-00558-x

Current Interventions for People Living with HIV Who Use ... Estimates suggest that 35 to 40% of PLWH may misuse alcohol [10]. Furthermore, myriad challenges often intersect with alcohol misuse that ...