Practice Facilitation for Alcohol Use Disorder in HIV Care

Recruiting at 2 trial locations

Overseen By JoAnna Mathena

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Underage, Cognitive impairment, Low AUDIT-C, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to assist people with HIV who struggle with unhealthy alcohol use. It employs a "stepped care" model, offering varying levels of alcohol treatment based on individual needs, such as brief counseling, therapy, or medication. The trial aims to determine if a practice coach at HIV clinics can enhance the adoption and maintenance of these alcohol treatments. Suitable participants have HIV, receive care at one of the three specific clinics, and currently exhibit unhealthy alcohol use according to a common screening test. As an unphased trial, this study provides a unique opportunity to contribute to innovative care strategies for those facing HIV and alcohol use challenges.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on alcohol use and HIV care, so it's best to discuss your current medications with the trial team.

What prior data suggests that practice facilitation is safe for implementing alcohol use disorder interventions in HIV care?

Research has shown that a step-by-step approach to treating alcohol use in people with HIV is both feasible and potentially effective. This method delivers proven alcohol treatments, supporting alcohol cessation and improving liver health.

Studies also suggest that components of this plan, such as short counseling sessions, talk therapy, and alcohol-related medication, are generally well-received. However, these treatments do not always work for everyone, so some individuals might not experience the same benefits, and results can vary.

Overall, research supports that this approach is safe and could help people, especially those with HIV, reduce their alcohol use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Alcohol Stepped Care approach because it customizes treatment based on the severity of alcohol use disorder in individuals with HIV. Unlike standard treatments that often use a one-size-fits-all method, this approach offers a personalized pathway. It includes options like brief interventions, cognitive behavioral therapy, and pharmacotherapy, which can be delivered either in person or via computer, providing flexibility and accessibility. This tailored strategy not only aims to enhance effectiveness but also empowers patients to engage in their treatment actively.

What evidence suggests that practice facilitation is effective for reducing unhealthy alcohol use in HIV care?

Research has shown that a step-by-step approach to reducing alcohol use, known as Alcohol Stepped Care, can be effective for people with HIV. In this trial, participants will receive interventions based on the severity of their alcohol use, including brief alcohol intervention, cognitive behavioral therapy, or pharmacotherapy for alcohol use disorder. Studies have found that combining short counseling sessions, therapy, and medication can help lower unhealthy drinking. This method works well, especially when adjusted to fit individual drinking levels. Although counseling and medication are not often used in HIV treatment settings, they can greatly improve outcomes when applied. This approach not only helps reduce alcohol use but also supports adherence to HIV treatments, leading to better health. ^{6 7 8 9 10}

Who Is on the Research Team?

Geetanjali Chander, MD

Principal Investigator

Johns Hopkins University

Betsy McCaul, PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for clinic staff over 18 years old, who work in certain HIV clinics and speak English. They must be able to complete surveys or interviews. It's not specified who can't join, so it seems open to all clinic staff meeting the inclusion criteria.

Inclusion Criteria

Patients: Confirmed to be a person with HIV (PWH) receiving HIV care and participating in CNICS at one of the three clinic sites

Patients: English speaking

I am over 18 years old.

Exclusion Criteria

I am under 18 years old.

Patients: Scoring AUDIT-C <3 for women or <4 for men or <4 for transgender women or men

I am unable to participate in alcohol use treatment due to cognitive reasons.

Timeline for a Trial Participant

Pre-implementation Planning

Tailor the practice facilitation intervention to each site using mixed methods

Not specified

Implementation with Formative Evaluation

Determine the effect of practice facilitation on reach, adoption, and maintenance of evidence-based alcohol treatment using mixed methods

12 months

Post-implementation Summative Evaluation

Determine the effects of practice facilitation on implementation of stepped care and alcohol use and HIV-related outcomes using interrupted time series analysis with synthetic controls

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Alcohol Stepped Care
• Practice Facilitation

Trial Overview The study tests if 'practice facilitation' helps HIV clinics better adopt alcohol treatment programs. A coach will help with tools and guidance to implement a stepped care model for treating unhealthy alcohol use, which includes brief interventions, therapy, and medication.

How Is the Trial Designed?

Group I: Alcohol Stepped Care Experimental Treatment 2 Interventions

Based on severity of alcohol use, individuals receive brief alcohol intervention delivered in person or by computer, cognitive behavioral therapy by person or computer, or pharmacotherapy for alcohol use disorder

Alcohol Stepped Care is already approved in United States, European Union for the following indications:

Approved in United States as Alcohol Stepped Care for:

• Unhealthy Alcohol Use
• Alcohol Use Disorder

Approved in European Union as Alcohol Stepped Care for:

• Alcohol Dependence
• Harmful Drinking

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+

University of North Carolina

Collaborator

Trials

174

Recruited

1,457,000+

Fenway Community Health

Collaborator

Trials

36

Recruited

5,833,000+

Published Research Related to This Trial

The integrated stepped alcohol treatment (ISAT) was tested in a randomized trial with 93 participants, but it only recruited 37% of the target population, indicating challenges in engaging patients with HIV and at-risk alcohol use.

Despite the multi-step approach of ISAT, there was no significant difference in alcohol consumption between participants receiving ISAT and those receiving standard care after 24 weeks, suggesting that more effective strategies are needed to motivate and retain patients in alcohol treatment programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated stepped alcohol treatment for patients with HIV and at-risk alcohol use: a randomized trial. Edelman, EJ., Maisto, SA., Hansen, NB., et al.[2021]

Providers in HIV clinics recognize the importance of motivational tools to engage patients in addressing unhealthy alcohol use, but they desire more flexibility in the treatment approach.

The implementation of a stepped care model for unhealthy alcohol use is supported by its alignment with VA priorities and the providers' confidence in their ability to deliver the intervention, highlighting the need for ongoing skill development and alternative delivery models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of integrated stepped care for unhealthy alcohol use in HIV clinics. Edelman, EJ., Hansen, NB., Cutter, CJ., et al.[2018]

Integrated Stepped Alcohol Treatment (ISAT) significantly increased the likelihood of participants receiving alcohol treatment medications compared to standard treatment, with 51% of ISAT participants receiving at least one medication versus 26% in the treatment as usual group.

Despite the increased access to treatment in the ISAT group, there was no significant difference in alcohol consumption between the ISAT and treatment as usual groups at week 24, indicating a need for improved strategies to enhance patient engagement and retention in alcohol-related care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated stepped alcohol treatment for patients with HIV and alcohol use disorder: a randomised controlled trial. Edelman, EJ., Maisto, SA., Hansen, NB., et al.[2022]

Oral naltrexone (NTX) and injectable extended-release naltrexone (XR-NTX) have been shown to effectively reduce alcohol use and improve viral suppression in individuals living with HIV/AIDS, based on a systematic review of 7 studies.

Both NTX and XR-NTX were found to be safe, with no significant adverse events reported, and did not negatively impact adherence to antiretroviral therapy (ART).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of naltrexone treatment for alcohol use disorders in HIV: a systematic review. Farhadian, N., Moradi, S., Zamanian, MH., et al.[2023]

HIV care providers are in a key position to help HIV-infected patients reduce alcohol use through screening and brief interventions, but they face several barriers such as limited time and patients' reluctance to disclose alcohol use.

Facilitators for successfully implementing alcohol reduction strategies include having enough time for screenings, access to helpful resources, and using concise screening tools to engage patients effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers and facilitators in implementing "prevention for positives" alcohol-reduction support: the perspectives of directors and providers in hospital-based HIV care centers. Strauss, SM., Munoz-Plaza, CE., Tiburcio, NJ., et al.[2021]

The STEP Trials are designed to evaluate the effectiveness of an integrated stepped care approach for treating unhealthy alcohol use among HIV-positive patients, involving 3 parallel randomized controlled trials across five Infectious Disease Clinics.

Participants with varying levels of alcohol use will receive tailored interventions, starting with brief interventions and potentially escalating to more intensive therapies, with the primary outcome being assessed at 24 weeks to measure changes in alcohol consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Starting Treatment for Ethanol in Primary care Trials (STEP Trials): Protocol for Three Parallel Multi-Site Stepped Care Effectiveness Studies for Unhealthy Alcohol Use in HIV-Positive Patients. Edelman, EJ., Maisto, SA., Hansen, NB., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7161741/

Integrated stepped alcohol treatment for patients with HIV ... Methods. In this multi-site randomized trial conducted in five Veterans Affairs-based HIV clinics , we enrolled PLWH and AUD who were not ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4711105/

Implementation of integrated stepped care for unhealthy ... Effective counseling and pharmacotherapy for unhealthy alcohol use are rarely provided in HIV treatment settings to patients.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05241990

Practice Facilitation as a Strategy to Improve Alcohol ... Using mixed methods, The investigators specifically propose to meet the following specific aims: (Aim 1) Tailor the practice facilitation intervention to each ...

4. ascpjournal.biomedcentral.com ascpjournal.biomedcentral.com/articles/10.1186/s13722-020-00200-y

Integrated stepped alcohol treatment for patients with HIV and ... At-risk levels of alcohol use threaten the health of patients with HIV (PWH), yet evidence-based strategies to decrease alcohol use and ...

5. digitalcommons.library.tmc.edu digitalcommons.library.tmc.edu/cgi/viewcontent.cgi?article=2631&context=baylor_docs

Contingency Management With Stepped Care for Unhealthy ... Methods: PWH in care recruited from clinics across the United States who reported unhealthy alcohol use, had a phosphatidylethanol (PEth) >20ng/ ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10460633/

Contingency management with stepped care for unhealthy ... Although unhealthy alcohol use is associated with increased morbidity and mortality among people with HIV (PWH), many are ambivalent about engaging in ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0740547219301941

Integrated stepped alcohol treatment for patients with HIV ... ISAT is feasible and potentially effective at enhancing delivery of evidence-based alcohol treatment to promote alcohol abstinence and improve liver biomarkers.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12276704/

Alcohol reduction strategies among persons with hiv Alcohol consumption is associated with poor health outcomes in people with HIV (PWH). Although various alcohol reduction strategies exist, ...

9. thelancet.com thelancet.com/journals/lanhiv/article/PIIS2352-3018(19)30076-1/abstract

Integrated stepped alcohol treatment for patients with HIV ... In this multisite, randomised controlled trial, conducted in five Veterans Affairs-based HIV clinics in the USA (Atlanta, GA; Brooklyn-Manhattan ...

10. ysph.yale.edu ysph.yale.edu/ysph/ycas/dcc/projects/stepped-care/

Integrated Stepped Care for Unhealthy Alcohol Use in HIV In addition, counseling and medication interventions do not uniformly decrease alcohol consumption or related harms in all patients – intervention effects tend ...